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Sample records for ethics review committees

  1. Measuring inconsistency in research ethics committee review.

    Science.gov (United States)

    Trace, Samantha; Kolstoe, Simon Erik

    2017-11-28

    The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.

  2. Measuring inconsistency in research ethics committee review

    OpenAIRE

    Trace, Samantha; Kolstoe, Simon Erik

    2017-01-01

    Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Sha...

  3. Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

    NARCIS (Netherlands)

    de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.

    2012-01-01

    Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We

  4. The Evolution of American Hospital Ethics Committees: A Systematic Review.

    Science.gov (United States)

    Courtwright, Andrew; Jurchak, Martha

    2016-01-01

    During the 1970s and 1980s, legal precedent, governmental recommendations, and professional society guidelines drove the formation of hospital ethics committees (HECs). The Joint Commission on Accreditation of Health Care Organization's requirements in the early 1990s solidified the role of HECs as the primary mechanism to address ethical issues in patient care. Because external factors drove the rapid growth of HECs on an institution-by-institution basis, however, no initial consensus formed around the structure and function of these committees. There are now almost 40 years of empirical studies on the composition, administration, and activities of HECs in the United States. We conducted a systematic review of the available empirical literature on HECs to describe their evolution. As HECs changed over time, they increased their total number of members and percentage of members from nursing and the community. Although physicians increasingly chaired these committees, their presence as a percentage of overall members declined. The percentage of administrative members remained steady, although committees became increasingly likely to have at least one administrative member. HECs were also increasingly likely to report to an administrative body or to the board of trustees or directors rather than to the medical staff. Finally, consultation volume increased steadily over time. There has not, however, been a national survey of the composition of ethics committees, their administration, or volume of consultation in more than 10 years, despite increasing calls for professional standards and quality improvement assessments among HECs. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  5. [Responsibilities of ethics committees].

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    von Bergmann, K

    2000-05-01

    Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

  6. Business ethics in ethics committees?

    Science.gov (United States)

    Boyle, P

    1990-01-01

    The "Ethics committees" column in this issue of the Hastings Center Report features an introduction by Cynthia B. Cohen and four brief commentaries on the roles hospital ethics committees may play in the making of institutional and public health care policy in the 1990s. The pros and cons of a broader, more public role for ethics committees in reconciling the business and patient care aspects of health care delivery are debated by Cohen in "Ethics committees as corporate and public policy advocates," and by Philip Boyle in this article. Boyle is an associate for ethical studies at The Hastings Center.

  7. Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

    Science.gov (United States)

    Langat, Simon K

    2005-10-01

    There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

  8. PROFESSIONAL CODES OF CONDUCT IN PSYCHOLOGY: DESCRIPTIVE STUDY OF COMPLAINTS REVIEWED BY THE COPC ETHICS COMMITTEE

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    Mila Arch

    2013-09-01

    Full Text Available In recent decades a significant increase has been observed in the number of complaints filed with ethical committees. The possibility of being the subject of a complaint is therefore a growing concern for professionals. However, research on ethics and codes of conduct in psychology is still very limited and real data on the complaints filed with Ethics Committees against psychologists are practically nonexistent. This article describes the results of a descriptive analysis of the complaints reviewed by the COPC Ethics Committee from 1998 to 2011. A total of 324 complaints were filed, but only 20% led to opening disciplinary proceedings, the judicial context being the professional area in which the highest percentage of complaints were filed (85%. Among the most prevalent reasons for complaints were making assessments without prior examination and partiality.

  9. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

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    Bouësseau Marie-Charlotte

    2008-03-01

    Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of

  10. Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.

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    Adams, Pornpimon; Prakobtham, Sukanya; Limphattharacharoen, Chanthima; Vutikes, Pitchapa; Khusmith, Srisin; Pengsaa, Krisana; Wilairatana, Polrat; Kaewkungwal, Jaranit

    2015-09-14

    Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand. Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members' reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk-benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population. All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not

  11. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

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    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  12. The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

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    Matthew Hunt

    Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be

  13. The job of 'ethics committees'.

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    Moore, Andrew; Donnelly, Andrew

    2015-11-13

    What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  14. [Accreditation of Independent Ethics Committees].

    Science.gov (United States)

    Ramiro Avilés, Miguel A

    According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

    OpenAIRE

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-01

    Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

  16. Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

    Science.gov (United States)

    Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F

    2017-06-26

    Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to

  17. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

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    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  18. A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

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    Klaus Rose

    2015-05-01

    Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

  19. Human research ethics committees in technical universities.

    Science.gov (United States)

    Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

    2014-07-01

    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.

  20. Rebuilding a Research Ethics Committee

    Science.gov (United States)

    Biggs, John S. G.; Marchesi, August

    2013-01-01

    The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

  1. Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

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    Russ, Hagen

    2009-07-01

    Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  2. Human research ethics committees: examining their roles and practices.

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    Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie

    2012-07-01

    Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

  3. Knowledge about the research and ethics committee at Makerere ...

    African Journals Online (AJOL)

    Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect ...

  4. Institutional Ethics Committee Regulations and Current Updates in India.

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    Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa

    2017-08-01

    The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

  5. Ethics committees in India: Facing the challenges!

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    Kadam, Rashmi; Karandikar, Shashikant

    2012-04-01

    The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

  6. Ethics committees in India: Facing the challenges!

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    Rashmi Kadam

    2012-01-01

    Full Text Available The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC. The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

  7. Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

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    Ignacio Segarra

    2017-07-01

    Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

  8. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

    Science.gov (United States)

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-11

    Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

  9. Report of the Ethics Committee, 2008

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    American Psychologist, 2009

    2009-01-01

    In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. In 2008, ethics adjudication, ethics education and consultation, convention programs, ethics publications,…

  10. A 'good' ethical review: audit and professionalism in research ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2015-01-01

    How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....

  11. Factors influencing the effectiveness of research ethics committees.

    Science.gov (United States)

    Schuppli, C A; Fraser, D

    2007-05-01

    Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.

  12. Report of the Ethics Committee, 2010

    Science.gov (United States)

    American Psychologist, 2011

    2011-01-01

    In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics matters investigated and the major programs undertaken. In 2010, ethics adjudication, ethics education and consultation, and special projects were activities of the Ethics…

  13. Report of the Ethics Committee, 2009

    Science.gov (United States)

    American Psychologist, 2010

    2010-01-01

    In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. This article is a summary of the talks and workshops of 2009, ethics adjudication, ethics education and…

  14. Hospital ethics committees in Israel: structure, function and heterogeneity in the setting of statutory ethics committees

    OpenAIRE

    Wenger, N; Golan, O; Shalev, C; Glick, S

    2002-01-01

    Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment.

  15. Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

    Science.gov (United States)

    2013-01-01

    Background Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively. Methods The study data were extracted from proposals and amendments submitted to the FTM-EC during the period October 2009 – September 2012, and then analyzed qualitatively and quantitatively. The main issues for clarification/revision were analyzed by thematic content analysis. Results 373 proposals were submitted; 44 studies involved minority groups with 21 extra-vulnerable minorities. All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review. For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles. The main issues needing clarification/revision differed between all studies and those involving minorities: participant information sheet (62.2% vs. 86.4%), informed consent/assent form (51.2% vs. 86.4%), and research methodology (80.7% vs. 84.1%), respectively. The main ethical issues arising during the meetings, regarding studies involving minorities, included ensuring no exploitation, coercion, or pressure on the minority to participate; methodology not affecting their legal status; considering ethnicity and cultural structure; and providing appropriate compensation. Conclusion Delays in the approval or non

  16. Informed consent in Sri Lanka: A survey among ethics committee members

    OpenAIRE

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical ap...

  17. Building Capacity in Ethical Review

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    review to ensure the protection of human subjects participating in research. Drawing on fieldwork with the Forum for Ethical Review Committees in the Asian and Western Pacific Region, I explore two distinct forms taken by capacity building within that organization to support and train members of ethics...... review committees. The first, with an emphasis on standards and measurability, takes as its priority international accountability for clinical trial research. e second explores how the organization goes about persuading trainees to see and do ‘ethics’ differently. is distinction between forms of capacity...

  18. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    Science.gov (United States)

    Bain, Luchuo Engelbert

    2017-01-01

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

  19. Ethics Committee or Community? Examining the identity of Czech Ethics Committees in the period of transition.

    Science.gov (United States)

    Simek, Jiri; Zamykalova, Lenka; Mesanyova, Marie

    2010-09-01

    Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic.

  20. Ethics, Ethical Human Research and Human Research Ethics Committees

    Science.gov (United States)

    Lindorff, Margaret

    2010-01-01

    Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…

  1. Research governance: new hope for ethics committees?

    Science.gov (United States)

    Frew, Deborah; Martlew, Ainsley

    2007-01-01

    For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.

  2. Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.

    Science.gov (United States)

    Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

    2015-01-01

    The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.

  3. Human Research Ethics Committees in Technical Universities

    NARCIS (Netherlands)

    Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.

    2014-01-01

    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although

  4. Do ethics committees need a legal framework?

    Science.gov (United States)

    Byk, Christian

    2007-01-01

    The question "do ethics committees need a legal framework" may then raise fundamental discussion in the case of developing countries: will an ethical framework bring them a better capacity to assume their task? And what should this task be if we consider the particularities of clinical research conducted in developing countries?

  5. Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.

    Science.gov (United States)

    Kubar, Olga

    2005-01-01

    The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.

  6. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Ethics review in compassionate use.

    Science.gov (United States)

    Borysowski, Jan; Ehni, Hans-Jörg; Górski, Andrzej

    2017-07-24

    Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.

  8. Ethical assessment of research protocols: the experience of the Research Ethics Committee of the Hospital Israelita Albert Einstein (HIAE

    Directory of Open Access Journals (Sweden)

    Sonia Maria Oliveira de Barros

    2005-03-01

    Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.

  9. Education of ethics committee members: experiences from Croatia.

    NARCIS (Netherlands)

    Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

    2006-01-01

    OBJECTIVES: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. DESIGN: Before/after cross-sectional study using a self administered questionnaire. SETTING: Educational workshop for members of hospital ethics committees,

  10. Ethical Competence Training for Members on Clinical Ethics Committees (CEC)

    DEFF Research Database (Denmark)

    Knox, Jeanette Bresson Ladegaard

    2017-01-01

    To address the moral questions in patient care and medical practice, Danish hospitals are starting to solicit clinical ethics committees (CEC). As in other places around the world, CECs in Denmark is an interdisciplinary group that includes physicians, nurses, social workers, psychologists, lawyers...... lingering moral quandaries. Thus, the creation of CECs in Denmark has raised the question of qualifications for those who serve on a committee. When the Danish Society of Clinical Ethics was formed in 2012, it was therefore at the forefront of its agenda to establish a training program that would offer...... valuable contributions to the ethical aspect of medical decision making and to serve as an important resource for health care providers, patients and their families. This article describes the history, development and preliminary results of the current training program as well as reflects on future ideas...

  11. Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

    Science.gov (United States)

    2012-01-01

    Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

  12. Why to audit to research ethics committees?

    OpenAIRE

    Quiroz, Estela; Médica oftalmóloga, docente de ética y metodología de la investigación, Coordinadora de la Red Peruana de Comités de Ética de la Investigación. Hospital Nacional Hipólito Unanue. Lima, Perú.

    2010-01-01

    Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created. Los comités de ét...

  13. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    Science.gov (United States)

    Smith, T; Moore, E J; Tunstall-Pedoe, H

    1997-05-31

    To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

  14. Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

    Science.gov (United States)

    Gorman, Susanna M

    2011-09-01

    Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

  15. Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

    Science.gov (United States)

    Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

    2018-05-23

    Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training

  16. Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

    Science.gov (United States)

    Pedersen, Reidar; Akre, Victoria; Førde, Reidun

    2009-10-01

    Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

  17. [Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics].

    Science.gov (United States)

    Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel

    2008-08-01

    To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

  18. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  19. Ethical challenges within Veterans Administration healthcare facilities: perspectives of managers, clinicians, patients, and ethics committee chairpersons.

    Science.gov (United States)

    Foglia, Mary Beth; Pearlman, Robert A; Bottrell, Melissa; Altemose, Jane K; Fox, Ellen

    2009-04-01

    To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions.

  20. What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

    Science.gov (United States)

    Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

    2017-06-01

    Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

  1. Is mandatory research ethics reviewing ethical?

    Science.gov (United States)

    Dyck, Murray; Allen, Gary

    2013-08-01

    Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.

  2. Education of ethics committee members: experiences from Croatia.

    Science.gov (United States)

    Borovecki, A; ten Have, H; Oresković, S

    2006-03-01

    To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. Before/after cross-sectional study using a self administered questionnaire. Educational workshop for members of hospital ethics committees, Zagreb, 2003. Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.

  3. The Virtues of National Ethics Committees.

    Science.gov (United States)

    Montgomery, Jonathan

    2017-05-01

    The United Kingdom has many bodies that play their part in carrying out the work of national ethics committees, but its nearest equivalent of a U.S. presidential bioethics commission is the Nuffield Council on Bioethics, established in 1991. The Council is charged with examining ethical questions raised by developments in biological and medical research, publishing reports, and making representations to appropriate bodies in order to respond to or anticipate public concern. It is a nongovernment organization with no defined or guaranteed channels of influence. It has no authority merely by virtue of the position it holds. Rather, it has established relational authority based on its reputation. Unlike the U.S. bioethics commission, it is not part of executive government, nor is it constituted to contribute to the legislative branch, as does the French Comité Consultatif National d'Ethique. Its nongovernmental status notwithstanding, the Nuffield Council's work affects the U.K. government and the British public, and the Council has achieved international recognition for its reports. I was the chairperson from 2012 to 2017 and draw on my experience in this piece to consider three key audiences: governments, publics, and the international community. © 2017 The Hastings Center.

  4. HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

    Science.gov (United States)

    Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

    2011-09-01

    We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

  5. \\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

    Science.gov (United States)

    Sabin, James E

    2016-01-01

    Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  6. Taking on organizational ethics. To do so, ethics committees must first prepare themselves.

    Science.gov (United States)

    Weber, L J

    1997-01-01

    Healthcare ethics committees which have focused almost entirely on clinical ethics, now need to prepare to deal with organizational ethics, a field that is attracting increasing attention. As they did with clinical ethics, ethics committees members must educate themselves in the demands of the newer field. As before, they must respect the perspectives of the actual decision makers while maintaining an independent framework for analyzing the issues at stake. They must ensure that management is properly represented on the committee if they need guidance from a professional ethicist they should seek one with a strong background in business ethics and social justice. Healthcare organizations are likely to need help with a wide range of ethical issues involving patient services (rationing of resources, for example), business and service plans (mergers and joint ventures, for example), business and professional integrity (conflicts of interest, for example), employee rights and responsibilities (downsizing, for example), and the organization's role in in the community (advocacy and lobbying, for example). To be helpful to the organization, the ethics committee must be prepared to say when cost factors trump other considerations and when they do not. An ethics committee will often be asked to give advice on specific occasions-a proposed new policy, for instance. The most important part of its response is its analysis of the issue. Finally, an ethics committee should view its organization as part of the larger social context.

  7. Communicating Qualitative Research Study Designs to Research Ethics Review Boards

    Science.gov (United States)

    Ells, Carolyn

    2011-01-01

    Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…

  8. Different views on ethics: how animal ethics is situated in a committee culture.

    Science.gov (United States)

    Ideland, M

    2009-04-01

    Research that includes non-human animal experimentation is fundamentally a dilemmatic enterprise. Humans use other animals in research to improve life for their own species. Ethical principles are established to deal with this dilemma. But despite this ethical apparatus, people who in one way or another work with animal experimentation have to interpret and understand the principles from their individual points of view. In interviews with members of Swedish animal ethics committees, different views on what the term ethics really means were articulated. For one member, the difficult ethical dilemma of animal experimentation is the lack of enriched cages for mice. For another, the ethical problem lies in regulations restraining research. A third member talks about animals' right not to be used for human interests. These different views on "ethics" intersect once a month in the animal ethics committee meetings. There is no consensus on what constitutes the ethical problem that the members should be discussing. Therefore, personal views on what ethics means, and hierarchies among committee members, characterise the meetings. But committee traditions and priorities of interpretation as well are important to the decisions. The author discusses how "ethics" becomes situated and what implications this may have for committees' decisions.

  9. Research Award: Advisory Committee on Research Ethics Deadline ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Jean-Claude Dumais

    2012-09-12

    Sep 12, 2012 ... Research Award: Advisory Committee on Research Ethics. Deadline: ... The Research Awardee will spend one year at IDRC and work approximately 50% of the time on her/his own research and 50% on ACRE-related tasks.

  10. Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

    Science.gov (United States)

    Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto

    2017-07-01

    The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

  11. Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

    Science.gov (United States)

    Hoecht, Andreas

    2011-01-01

    Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…

  12. Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

    Science.gov (United States)

    Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

    2015-08-01

    For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2

  13. ETHICAL AND LEGAL ASPECTS OF FUNCTIONING OF ETHIC COMMITTEES IN BULGARIA

    Directory of Open Access Journals (Sweden)

    Mariela Deliverska

    2017-06-01

    Full Text Available Scientific research has to be based on ethical standards that promote the protection of human rights. On a national level, the domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials in order to introduce a substantial change in a clinical trial and non-interventional study. The procedure aims to evaluate the compliance of the planned clinical trial with the norms of good clinical practice, the requirements of the Medicinal Products in Human Medicine Act. On European Union level, standards have been set down in Regulation (EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. The licensing regime that has been introduced on a national level requires the performance of documentation evaluation that addresses a major change in a clinical trial and non-interventional research. Legal definitions of the terms "principal investigator" and "coordinating investigator" have been introduced. The "principal investigator" is the medical doctor or the dentist, designated by the sponsor, who leads the overall execution of the clinical trial in accordance with the approved protocol and good clinical practice guidelines and is responsible for the researchers. The "coordinating researcher" is a researcher appointed to coordinate researchers from different centres participating in a multicentre trial. Ethic committees performing review have to provide independent advice on the extent to which a biomedical research proposal complies with recognized ethical standards. Scientific research must necessarily conform to commonly accepted scientific principles and be based on thorough knowledge of scientific literature and other relevant sources of information.

  14. Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary.

    Science.gov (United States)

    Petrini, Carlo; Ricciardi, Walter

    2017-01-01

    The issue addressed in the paper published by the Italian National Bioethics Committee (NBC) entitled "Clinical ethics committees", is highly significant for many reasons. One of these is the fact that the ethics committees charged with assessing clinical trials have so much responsibility and such a heavy work-load that they have little time available for other tasks such as engaging directly with patients "at the bedside", as a result of which the role of committees responsible for assessing clinical cases is especially important. According to the NBC, the opinions of clinical ethics committees should be formulated jointly and are non-binding. The NBC offers practical proposals not only for the Italian context. While the Italian National Institute of Health (Istituto Superiore di Sanità - ISS) is not involved directly in treating patients, its role in providing guidance is crucial to the national health service and it has always paid special attention to these issues.

  15. Bridging problems and models in medical ethics: four images of local ethics committees.

    Science.gov (United States)

    Incorvati, G

    In the context of the continuing debate about how ethics committees in Italy should be structured (see Bulletin 160) Professor Incorvati, from the Comitato Nazionale per la Bioetica in Rome, considers four theoretical models of how such committees may be arranged, and why one in particular looks better placed to face the growing ethical problems that are emerging as a result of current developments in medicine.

  16. Can non-regulators audit Independent Ethic Committees (IEC), and if so, how?

    Science.gov (United States)

    Dent, N J; Sweatman, W J

    A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical Practice (EFGCP). Auditing requirements in these recent guidelines and the EU Clinical Trial Directive are discussed as well as the methodology and type of documentation and SOPs that should be present at an audit. It is argued that both inspectorates and independent auditors need to conduct such audits to improve the overall global standard.

  17. Confessions of an Ethics Committee Chair

    Science.gov (United States)

    Halse, Christine

    2011-01-01

    This essay examines the possibilities of being/becoming an ethical researcher in the academy. It tackles this task through the lens of an ethics application by Mary [pseudonym], a PhD student in sociology whose research thesis was investigating the reasons why married men with children use prostitutes. Two analyses are offered of Mary's story. The…

  18. Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

    Science.gov (United States)

    Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

    2017-12-01

    This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

  19. Committees for Ethics in Research involving human subjects.

    Science.gov (United States)

    Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

    2008-01-01

    In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

  20. Ethics committees in Italy--a time for change?

    Science.gov (United States)

    Wray, E

    2000-01-01

    The Comitato Nazionale per la Bioetica (CNB) in Italy has recently produced an unprecedented discussion document on the state of ethics committees in Italy, with an invitation to interested parties to comment on proposed changes to their fundamental structure. After this consultation, and taking note of relevant official publications and the most recent national and international literature on the subject, the CNB proposes to produce a final, definitive document that will consider options for the future development of such committees.

  1. IDRC's Advisory Committee on Research Ethics | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    ACRE observes IDRC's Corporate Principles on Research Ethics. ... various published statements on the management of environmental research. ... equity while remaining sensitive to the cultural norms and practices of the localities where the ...

  2. Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

    Science.gov (United States)

    Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew

    2017-06-28

    The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster

  3. Early Childhood Special Educators and the Hospital Ethics Committee.

    Science.gov (United States)

    Lowenthal, Barbara

    1989-01-01

    The paper discusses issues of concern to early childhood special educators serving on hospital ethics committees to assist families with seriously ill and handicapped infants in neonatal intensive care units. Issues include infant euthanasia and the right to life, child abuse legislation, and possible effects on families. (Author/JDD)

  4. Payment of research participants: current practice and policies of Irish research ethics committees.

    LENUS (Irish Health Repository)

    Roche, Eric

    2013-09-01

    Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.

  5. Research Award: Advisory Committee on Research Ethics

    International Development Research Centre (IDRC) Digital Library (Canada)

    IDRC CRDI

    ACRE seeks a Research Awardee to study research ethics in an ... The following topics are examples of issues that could be ... advance their career goals, and recognize the dual nature of the position—applied research activity and general ...

  6. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

    Science.gov (United States)

    De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

    2016-01-01

    Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

  7. Informed consent in Sri Lanka: a survey among ethics committee members.

    Science.gov (United States)

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-05-20

    Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

  8. Informed consent in Sri Lanka: A survey among ethics committee members

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-05-01

    Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

  9. Nuclear Safety Research Review Committee

    International Nuclear Information System (INIS)

    Todreas, N.E.

    1990-01-01

    The Nuclear Safety Research Review Committee has had a fundamental difficulty because of the atmosphere that has existed since it was created. It came into existence at a time of decreasing budgets. For any Committee the easiest thing is to tell the Director what additional to do. That does not really help him a lot in this atmosphere of reduced budgets which he reviewed for you on Monday. Concurrently the research arm of Nuclear Regulatory Commission has recognized that the scope of its activity needed to be increased rather than decreased. In the last two-and-a-half-year period, human factors work was reinstated, radiation and health effects investigations were reinvigorated, research in the waste area was given significant acceleration. Further, accident management came into being, and the NRC finally got back into the TMI-2 area. So with all of those activities being added to the program at the same time that the research budget was going down, the situation has become very strained. What that leads to regarding Committee membership is a need for technically competent generalists who will be able to sit as the Division Directors come in, as the contractors come in, and sort the wheat from the chaff. The Committee needs people who are interested in and have a broad perspective on what regulatory needs are and specifically how safety research activities can contribute to them. The author summarizes the history of the Committee, the current status, and plans for the future

  10. [Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].

    Science.gov (United States)

    Jeong, Ihn Sook

    2015-06-01

    This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

  11. Publication Ethics: A Case Series with Recommendations According to Committee on Publication Ethics (COPE).

    Science.gov (United States)

    Fazly Bazzaz, Bibi Seddigheh; Sadeghi, Ramin

    2012-09-01

    Ethical misconduct is not a new issue in the history of science and literature. However, ethical misconducts in science have grown considerably in the modern era which is due to emphasis on the scientific proliferation in research institutes and gauging scientists according to their publications. In the current case series, several misconducts occurring over the previous years in Mashhad University of Medical Sciences (Mashhad, Iran) either for Journals or Faculty members were gathered and specific recommendations were provided to avoid similar events in the future. All recommendations are according to Committee on Publication Ethics (COPE).

  12. Public titles of clinical trials should have ethics review.

    Science.gov (United States)

    Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

    2015-09-01

    A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

  13. Novel Paths to Relevance: How Clinical Ethics Committees Promote Ethical Reflection.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2016-09-01

    How may clinical ethics committees (CECs) inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics.

  14. 78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-08

    ...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...

  15. Doing the right thing! A model for building a successful hospital-based ethics committee in Nunavut

    Directory of Open Access Journals (Sweden)

    Madeleine Cole

    2013-08-01

    Iqaluit in September 2011, we are working to develop a model for the QGH ethics committee that incorporates multi-level perspectives, from that of community to that of front-line worker. Conclusion . Ideally, the scope of the QGH Ethics Committee will grow over time to include ethics education, facilitation of clinical ethical consults, ethical review of policy, advice on governance issues and involvement and support of an external northern Health REB.

  16. A Swedish perspective on research ethics review

    Directory of Open Access Journals (Sweden)

    Hans Thulesius, M.D., G.P., Ph.D.

    2010-12-01

    Full Text Available I have participated in writing ethical approval applications for research projects in Sweden a dozen times. I am also since some years a member of the local ethics advisory board in a mostly rural area serving 180.000 people. From that position I advise on what types of local project applications will have to be sent further to the regional ethics committee, REPN in Sweden. With that background I will try to give a brief Swedish perspective on research ethics reviews in general and regarding CGT (classic grounded theory studies using qualitative data in particular.The most famous Swedish example of unethical research is the 1947-1951 Vipeholm sugar trial (Krasse, 2001. Several hundred intellectually and mentally challenged persons at the Vipeholm institution were for years given an excess amount of sugar, mostly in the shape of candy. This resulted in caries that totally ruined the teeth of 50 persons. Of course participants did not give informed consent. Yet, at the time the research was not considered unethical. At least there was no debate about it.

  17. Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

    Science.gov (United States)

    Carr, Caleb T.

    2015-01-01

    Bullying, often considered an interpersonal or intergroup behaviour, has not been explored as an unintended artefact of organisational structure. Institutional review boards (IRBs), the 'human research ethics committees' at US universities, help oversee the protection of human research subjects, particularly in the social sciences within…

  18. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-01-01

    Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

  19. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Directory of Open Access Journals (Sweden)

    Tahmineh Farajkhoda

    2017-08-01

    Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening

  20. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-02-01

    Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

  1. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    OpenAIRE

    Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.

    1997-01-01

    OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...

  2. Mock Hospital Ethics Committee: An Innovative Simulation to Teach Prelicensure Nursing Students the Complexities of Ethics in Practice.

    Science.gov (United States)

    Hagedorn Wonder, Amy

    Limited opportunities exist for prelicensure nursing students to observe the interprofessional process required to resolve complex ethical cases in practice. Therefore, a mock hospital ethics committee (MHEC) was assembled to teach the application of ethics in practice through simulation. The MHEC meeting is an example of how nursing education and practice can partner to create meaningful learning experiences.

  3. Ethical review in Pakistan: the credibility gap.

    Science.gov (United States)

    Jafarey, Aamir Mustafa; Iqbal, Saima Pervaiz; Hassan, Mariam

    2012-12-01

    The concept of mandatory ethical review of research involving human participants is gradually taking root in Pakistani institutions. Based on the opinions of Institutional Review Board (IRB) members from institutions across the country, the process faces several challenges which threaten its integrity. The lack of registration or accreditation for IRBs has resulted in a wide variation in the calibre and working of such Boards. Despite the recent growth in numbers of people with formal bioethics degrees in the country, a majority of membership remains without any formal training for the work expected from them in ethical review. External pressures to influence deliberations, conflict of interest issues within board leadership and inconsistent application of review requirements all contribute in undermining the reliability of the process. Some of the most significant threats to independent and uninfluenced functioning of such boards arise from institutional leadership itself. In the opinions of IRB members, the review process has to be uniform, consistent and trustworthy if it is to gain the respect of researchers, and IRB need to be given the autonomous space to make independent decisions. Otherwise there is a real danger of IRBs being relegated to being no more than rubber stamping committees.

  4. An ethics for the living world: operation methods of Animal Ethics Committees in Italy

    Directory of Open Access Journals (Sweden)

    Mariano Martini

    2015-09-01

    Full Text Available INTRODUCTION AND OBJECTIVES. Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific purposes", the Authors would like to analyse the topic of the introduction of ethical committees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU. RESULTS AND DISCUSSION. The implementation of the recent Italian law (Decreto Legislativo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protection of animals used for scientific purposes leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Italian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects. CONCLUSIONS. What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26. This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.

  5. Ethics review of health research on human participants in South Africa.

    Science.gov (United States)

    van Wyk, Christa

    2010-06-01

    In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

  6. The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

    Science.gov (United States)

    Strech, Daniel; Hurst, Samia; Danis, Marion

    2013-01-01

    Background Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Results Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. Conclusion This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindvidual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures. PMID:20706163

  7. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

    Directory of Open Access Journals (Sweden)

    Elisabeth De Smit

    2016-02-01

    Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently

  8. Organizational ethics: a literature review.

    Science.gov (United States)

    Suhonen, Riitta; Stolt, Minna; Virtanen, Heli; Leino-Kilpi, Helena

    2011-05-01

    The aim of the study was to report the results of a systematically conducted literature review of empirical studies about healthcare organizations' ethics and management or leadership issues. Electronic databases MEDLINE and CINAHL yielded 909 citations. After a two stage application of the inclusion and exclusion criteria 56 full-text articles were included in the review. No large research programs were identified. Most of the studies were in acute hospital settings from the 1990s onwards. The studies focused on ethical challenges, dilemmas in practice, employee moral distress and ethical climates or environments. Study samples typically consisted of healthcare practitioners, operational, executive and strategic managers. Data collection was mainly by questionnaires or interviews and most of the studies were descriptive, correlational and cross-sectional. There is need to develop conceptual clarity and a theoretical framework around the subject of organizational ethics and the breadth of the contexts and scope of the research needs to be increased. © The Author(s) 2011

  9. Ethics committees and the changed clinical research environment in India in 2016: A perspective!

    Science.gov (United States)

    Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

    2017-01-01

    Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

  10. Ethics of reviewing scientific publications.

    Science.gov (United States)

    Napolitani, Federica; Petrini, Carlo; Garattini, Silvio

    2017-05-01

    The approval or rejection of scientific publications can have important consequences for scientific knowledge, so considerable responsibility lies on those who have to assess or review them. Today it seems that the peer review process, far from being considered an outdated system to be abandoned, is experiencing a new upturn. This article proposes criteria for the conduct of reviewers and of those who select them. While commenting on new emerging models, it provides practical recommendations for improving the peer-review system, like strengthening the role of guidelines and training and supporting reviewers. The process of peer review is changing, it is getting more open and collaborative, but those same ethical principles which guided it from its very origin should remain untouched and be firmly consolidated. The paper highlights how the ethics of reviewing scientific publications is needed now more than ever, in particular with regard to competence, conflict of interest, willingness to discuss decisions, complete transparency and integrity. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  11. Council Adopts New AERA Code of Ethics: Ethics Committee to Emphasize Ethics Education

    Science.gov (United States)

    Herrington, Carolyn D.

    2011-01-01

    At its February 2011 meeting, the AERA Council adopted unanimously a new Code of Ethics. The Code articulates a set of standards for education researchers in education and provides principles and guidance by which they can build ethical practices in professional, scholarly, and scientific activities. The Code reflects the Association's strong…

  12. [Ethic review on clinical experiments of medical devices in medical institutions].

    Science.gov (United States)

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  13. Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

    Science.gov (United States)

    Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R

    2014-12-01

    The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.

  14. Stating the Case for Nursing Research Ethics Committees: A Discussion Paper.

    Science.gov (United States)

    Mitchell, Theresa; Fletcher, Ian

    1998-01-01

    Nurse-led research ethics committees are generally more tolerant of diversity in research proposals than are medical committees steeped in empirical traditions. However, national trends in nursing in Britain may influence a preference for multidisciplinary over nurse-led committees. (SK)

  15. A Study to Determine if Ethics Committees Should be a Decision-Making and Review Mechanism for Matters Relating to No-Code Orders in the Continental United States Army Medical Department Hospitals with over One Hundred Total Operating Beds

    Science.gov (United States)

    1984-08-01

    their role in the hospital. The book Megatrends points out that there are six States which set the pace for national trends. One of these is California...care hospitals but two. Again, one must recall what the book Megatrends says about California and national trends. Another key according to this study...Catholic Hospitals," Ethics Committees Newsletter, Vol 1, No. 2, November 1983, p. 2. 7. R. Veatch, Death, PyiLn and the Biological Revolution, New Haven

  16. Perspectives of Egyptian research ethics committees regarding their effective functioning.

    Science.gov (United States)

    Matar, Amal; Silverman, Henry

    2013-02-01

    The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

  17. [Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

    Science.gov (United States)

    Gonorazky, Sergio E

    2008-01-01

    The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

  18. Qualitative analysis of healthcare professionals' viewpoints on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas.

    Science.gov (United States)

    Marcus, Brian S; Shank, Gary; Carlson, Jestin N; Venkat, Arvind

    2015-03-01

    Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict.

  19. Institutional ethical review and ethnographic research involving injection drug users: a case study.

    Science.gov (United States)

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. A "next generation" ethics committee. St. Joseph Health system has integrated performance-improvement features into its ethics work.

    Science.gov (United States)

    Murphy, Kevin

    2006-01-01

    Understanding the limitations that accompany the traditional model of ethics committees, St. Joseph Health System (SJHS), Orange, CA, has been working to integrate ethics expertise and quality-improvement methodology into its "Next Generation Model" (NG Model) for such committees. However, moving from a traditional structure to the NG Model (introduced to SJHS facilities in 1999) brought some challenges, not the least of which was a deep-rooted culture of resistance to change. Following a 2004 audit of how the NG model was working, some common challenges were identified. To deal with those challenges, SJHS developed some tools and techniques that have helped ease the ongoing transition. These tools have helped the system's ethics committees address such issues as collaboration for the sake of organizational integration, setting goals, and measuring performance of various ethics roles.

  1. A cross-sectional survey to investigate community understanding of medical research ethics committees.

    Science.gov (United States)

    Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C

    2015-07-01

    Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. How not to argue against mandatory ethics review.

    Science.gov (United States)

    Hunter, David

    2013-08-01

    There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion.

  3. Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

    Science.gov (United States)

    Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena

    2015-10-01

    Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was 89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.

  4. Professional ethics in nursing: an integrative review.

    Science.gov (United States)

    Kangasniemi, Mari; Pakkanen, Piiku; Korhonen, Anne

    2015-08-01

    To conduct an integrative review and synthesize current primary studies of professional ethics in nursing. Professional ethics is a familiar concept in nursing and provides an ethical code for nursing practice. However, little is known about how professional ethics has been defined and studied in nursing science. Systematic literature searches from 1948-February 2013, using the CINAHL, PubMed and Scopus electronic databases to look at previously published peer-reviewed studies. A modified version of Cooper's five-stage integrative review was used to review and synthesize current knowledge. Fourteen papers were included in this research. According to our synthesis, professional ethics is described as an intra-professional approach to care ethics and professionals commit to it voluntarily. Professional ethics consist of values, duties, rights and responsibilities, regulated by national legislation and international agreements and detailed in professional codes. Professional ethics is well established in nursing, but is constantly changing due to internal and external factors affecting the profession. Despite the obvious importance of professional ethics, it has not been studied much in nursing science. Greater knowledge of professional ethics is needed to understand and support nurses' moral decision-making and to respond to the challenges of current changes in health care and society. © 2015 John Wiley & Sons Ltd.

  5. [Disability, inability and vulnerability: on ableism or the pre-eminence of ableist and biomedical approaches of the Human Subjects Ethics Committee of UFSC].

    Science.gov (United States)

    Mello, Anahi Guedes de

    2016-10-01

    Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis. In this ethnographic experience, in the light of Crip theory, I observed how the "disability," "vulnerability" and "inability" categories are articulated to reveal the ableism and the primacy of the biomedical model in the case of an ethics review at UFSC regarding the participation and legal capacity of persons with disabilities as subjects of research.

  6. An evaluation of a data linkage training workshop for research ethics committees.

    Science.gov (United States)

    Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A

    2015-03-04

    In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

  7. Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

    Science.gov (United States)

    Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

    2011-09-01

    History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

  8. Participatory action research: considerations for ethical review.

    Science.gov (United States)

    Khanlou, N; Peter, E

    2005-05-01

    This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

  9. Members of research ethics committees accepted a modification of the randomized consent design

    NARCIS (Netherlands)

    Schellings, Ron; Kessels, Alfons G.; ter Riet, Gerben; Kleijnen, Jos; Leffers, Pieter; Knottnerus, J. André; Sturmans, Ferd

    2005-01-01

    Background and Objective: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what

  10. Evaluation in health promotion: thoughts from inside a human research ethics committee.

    Science.gov (United States)

    Allen, Judy; Flack, Felicity

    2015-12-01

    Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

  11. The ethics of peer review in bioethics

    Science.gov (United States)

    Wendler, David; Miller, Franklin

    2014-01-01

    A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. PMID:24131903

  12. A review of ethical issues in dementia.

    Science.gov (United States)

    Johnson, Rebecca A; Karlawish, Jason

    2015-10-01

    Dementia raises many ethical issues. The present review, taking note of the fact that the stages of dementia raise distinct ethical issues, focuses on three issues associated with stages of dementia's progression: (1) how the emergence of preclinical and asymptomatic but at-risk categories for dementia creates complex questions about preventive measures, risk disclosure, and protection from stigma and discrimination; (2) how despite efforts at dementia prevention, important research continues to investigate ways to alleviate clinical dementia's symptoms, and requires additional human subjects protections to ethically enroll persons with dementia; and (3) how in spite of research and prevention efforts, persons continue to need to live with dementia. This review highlights two major themes. First is how expanding the boundaries of dementias such as Alzheimer's to include asymptomatic but at-risk persons generate new ethical questions. One promising way to address these questions is to take an integrated approach to dementia ethics, which can include incorporating ethics-related data collection into the design of a dementia research study itself. Second is the interdisciplinary nature of ethical questions related to dementia, from health policy questions about insurance coverage for long-term care to political questions about voting, driving, and other civic rights and privileges to economic questions about balancing an employer's right to a safe and productive workforce with an employee's rights to avoid discrimination on the basis of their dementia risk. The review highlights these themes and emerging ethical issues in dementia.

  13. Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

    Science.gov (United States)

    Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

    2014-12-01

    Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

  14. Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

    Science.gov (United States)

    Begum, Rasheda; Kolstoe, Simon

    2015-07-25

    Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

  15. Health Research Ethics Committees in South Africa 12 years into democracy

    Directory of Open Access Journals (Sweden)

    Myer Landon

    2007-01-01

    Full Text Available Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56% are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

  16. Enhancing capacity of research ethics review committees

    African Journals Online (AJOL)

    In particular, pharmaceutical companies have been shifting trials from ... cited by participants during the needs assessments were excess workload, and a lack of coordination .... universities and from public and private hospitals, potential.

  17. 77 FR 34046 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2012-06-08

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs... ethics standards to the accreditation process for public health departments; ethical considerations...

  18. International variation in ethics committee requirements: comparisons across five Westernised nations

    Directory of Open Access Journals (Sweden)

    Nachson Israel

    2002-04-01

    Full Text Available Abstract Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm; to society (to ensure good quality research is conducted; and to researchers (to treat their proposals with just consideration and respect. To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.

  19. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

    While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

  20. Ethics support in institutional elderly care: a review of the literature.

    Science.gov (United States)

    van der Dam, Sandra; Molewijk, Bert; Widdershoven, Guy A M; Abma, Tineke A

    2014-09-01

    Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases (Pubmed, CINAHL/PsycINFO, Ethxweb). Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: 'institutional bodies' (ethics committee and consultation team); 'frameworks' (analytical tools to assist care professionals); 'educational programmes and moral case deliberation'; and 'written documents and policies'. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  1. Balanced Ethics Review: A Guide for Institutional Review Board Members

    Directory of Open Access Journals (Sweden)

    Ames Dhai

    2016-12-01

    Full Text Available The aim of this pocket-book size manual is to assist Institutional Review Board (IRB members and chairs conduct ethics review by balancing the two major morally relevant considerations in health research

  2. Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

    Science.gov (United States)

    Abdulrahman, Mahera; Nair, Satish Chandrasekhar

    2017-04-01

    Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

  3. A Study on the Directed Living Non-Related Donor Kidney Transplantation Submitted to the Hospital Transplant Ethics Committee at the National Kidney and Transplant Institute.

    Science.gov (United States)

    Suguitan, G; Arakama, M-H I; Danguilan, R

    2017-03-01

    In the latter part of 2009, the Department of Health of the Philippines prohibited kidney transplantation with non-related kidney donors. Hence, the National Kidney and Transplant Institute created a Hospital Transplant Ethics Committee. This study describes directed non-related kidney donation at the National Kidney and Transplant Institute. This retrospective study reviewed the profiles of recipients and directed living non-related kidney transplant donors submitted to the Hospital Transplant Ethics Committee. A total 74 recipients and donors were reviewed by the Hospital Transplant Ethics Committee in 2014. Donors initiated the talks about being a donor (75%) to repay the good deeds that were done by the recipient for them or their families; examples of which are: sometime in their lives they needed financial assistance for hospitalization for their relatives and it was the patient who paid the hospital bill; or because they pitied the recipient, whom they found to be a good person, thus they would want to give one of their kidneys. Seventy-four (100%) said that they were not expecting anything in return for this act but wanted to be of help to the recipient. Of these 74 cases, 70 cases (95%) were approved and the others were disapproved. With a Hospital Transplant Ethics Committee in place, directed kidney donation is a valuable tool as an additional source of kidney donor without violating any ethical issues. Copyright © 2016. Published by Elsevier Inc.

  4. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    2014-01-01

    Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

  5. Pulsed Power Peer Review Committee Report

    International Nuclear Information System (INIS)

    BLOOMQUIST, DOUGLAS D.

    2002-01-01

    In 1993, the Government Performance and Results Act (GPRA, PL 103-62) was enacted. GPRA, which applies to all federal programs, has three components: strategic plans, annual performance plans, and metrics to show how well annual plans are being followed. As part of meeting the GRPA requirement in FY2002, a 15-member external review committee chaired by Dr. Alvin Trivelpiece (the Trivelpiece Committee) was convened by Sandia National Laboratories (SNL) on May 7-9, 2002 to review Sandia National Laboratories' Pulsed Power Programs as a component of the Performance Appraisal Process negotiated with the National Nuclear Security Administration of the Department of Energy (NNSA/DOE). The scope of the review included activities in high energy density physics (HEDP), inertial confinement fusion (ICF), radiation/weapon physics, the petawatt laser initiative (PW) and fast ignition, equation-of-state studies, radiation effects science and lethality, x-ray radiography, ZR development, basic research and pulsed power technology research and development, as well as electromagnetics and work for others. In his charge to the Committee, Dr. Jeffrey P. Quintenz, Director of Pulsed Power Sciences (Org. 1600) asked that the evaluation and feedback be based on three criteria: (1) quality of technical activities in science, technology, and engineering, (2) programmatic performance, management, and planning, and (3) relevance to national needs and agency missions. In addition, the director posed specific programmatic questions. The accompanying report, produced as a SAND document, is the report of the Committee's finding

  6. 49 CFR 8.9 - Information Security Review Committee.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Information Security Review Committee. 8.9 Section.../DECLASSIFICATION/ACCESS Classification/Declassification of Information § 8.9 Information Security Review Committee. (a) There is hereby established a Department of Transportation Information Security Review Committee...

  7. Controversies in nursing ethics: a historical review.

    Science.gov (United States)

    Olsen, D P

    1992-09-01

    The author critiques the dialectic between justice-based ethics and an ethic of caring from a historical perspective (by analogy with the dialectic between agape and friendship). Justice-based ethics have been problematic for nursing because of the decontextualized approach. The ethic of caring is problematic because caring, being contextual, is particularistic and therefore can be based on morally irrelevant factors, such as liking. There is a tradition of writing which seeks to reconcile the particularistic obligations of friendship with the moral duty to all others equally. Ideas from the following authors are reviewed for relevance to nursing: Aristotle, Aelred of Rievaulx, Augustine, John Cassian, Cicero, George Berkeley, Immanuel Kant, Michel de Montaigne, Jeremy Taylor and Max Weber. The authors concludes by noting that both sides of the dialectic are synthesized in the lived experience of individuals. A synthesis in thought is called for on this basis.

  8. Pulsed Power Peer Review Committee Report

    International Nuclear Information System (INIS)

    Bloomquist, Douglas D.

    2000-01-01

    In 1993, the Government Performance and Results Act (GPRA, PL 103-62) was enacted. GPRA, which applies to all federal programs, has three components: strategic plans, annual performance plans, and metrics to show how well annual plans are being followed. As part of meeting the GRPA requirement in FY2000, a 14-member external peer review panel (the Garwin Committee) was convened on May 17-19, 2000 to review Sandia National Laboratories' Pulsed Power Programs as a component of the Performance Appraisal Process negotiated with the Department of Energy (DOE). The scope of the review included activities in inertial confinement fission (ICF), weapon physics, development of radiation sources for weapons effects simulation, x-ray radiography, basic research in high energy density physics (HEDP), and pulsed power technology research and development. In his charge to the committee, Jeffrey Quintenz, Director of Pulsed Power Sciences (1600) asked that the review be based on four criteria (1) quality of science, technology, and engineering, (2) programmatic performance, management, and planning, (3) relevance to national needs and agency missions, and (4) performance in the operation and construction of major research facilities. In addition, specific programmatic questions were posed by the director and by the DOE-Defense Programs (DP). The accompanying report, produced as a SAND document, is the report of the committee's findings

  9. The ethics of peer review in bioethics.

    Science.gov (United States)

    Wendler, David; Miller, Franklin

    2014-10-01

    A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. 77 FR 2549 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2012-01-18

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and... territorial health departments in their efforts to address public health ethics challenges, approaches for...

  11. 75 FR 57044 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2010-09-17

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and...; efforts to support state, tribal, local and territorial health departments address ethical issues in the...

  12. 76 FR 29755 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-05-23

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... of public health ethics questions and issues arising from programs, scientists and practitioners... April 28, 2011, ACD, CDC meeting; discussion of next steps on addressing potential public health ethical...

  13. 76 FR 55678 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-09-08

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues... in their efforts to address public health ethics challenges. The agenda is subject to change as...

  14. 75 FR 30409 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

    Science.gov (United States)

    2010-06-01

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In... to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... address public health ethics issues and coordination of these efforts with the CDC Office of State, Tribal...

  15. 76 FR 3909 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-01-21

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and... submitted on the ethical considerations document for the allocation of ventilators during a severe pandemic...

  16. 75 FR 72831 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2010-11-26

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... strategy for addressing its charge to provide a preliminary overview to the ACD on ethical issues related...

  17. 77 FR 58397 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

    Science.gov (United States)

    2012-09-20

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. Matters To Be Discussed: Agenda items will include the following topics: Ethical considerations...

  18. Nurses serving on clinical ethics committees: A qualitative exploration of a competency profile

    NARCIS (Netherlands)

    dr. Bart Cusveller

    2014-01-01

    The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two

  19. Evaluation of the work of hospital districts' research ethics committees in Finland.

    Science.gov (United States)

    Halila, Ritva

    2014-12-01

    The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  20. Contesting the science/ethics distinction in the review of clinical research

    Science.gov (United States)

    Dawson, Angus J; Yentis, Steve M

    2007-01-01

    Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389

  1. Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

    Science.gov (United States)

    Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri

    2015-12-02

    The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals

  2. Ethics policy review: a case study in quality improvement.

    Science.gov (United States)

    Frolic, Andrea Nadine; Drolet, Katherine

    2013-02-01

    Policy work is often cited as one of the primary functions of Hospital Ethics Committees (HECs), along with consultation and education. Hospital policies can have far reaching effects on a wide array of stakeholders including, care providers, patients, families, the culture of the organisation and the community at large. In comparison with the wealth of information available about the emerging practice of ethics consultation, relatively little attention has been paid to the policy work of HECs. In this paper, we hope to advance the development of best practices in HEC policy work by describing the quality improvement process that we undertook at Hamilton Health Sciences, Hamilton, Ontario, Canada. In the first section of the paper we describe the context of our HEC policy work, and the shortcomings of our historical review process. In subsequent sections, we detail the quality improvement project we undertook in 2010, the results of the project and the specific tools we developed to enhance the quality of HEC policy work. Our goal in sharing this organisational case study is to prompt other HECs to publish qualitative descriptions of their policy work, in order to generate a body of knowledge that can inform the development of best practices for ethics policy review.

  3. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

    Science.gov (United States)

    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  4. The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

    Directory of Open Access Journals (Sweden)

    Caroline A. Smith

    2011-01-01

    Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.

  5. Ethical Business Cultures: A Literature Review and Implications for HRD

    Science.gov (United States)

    Ardichvili, Alexandre; Jondle, Douglas

    2009-01-01

    This literature review identifies characteristics of ethical business cultures, describes factors, considered to be important in developing such cultures, describes current practices of developing ethical culture programs, and discusses the role of HRD in developing ethical business cultures. We argue that ethical thinking and behavior can be…

  6. Payment of research participants: current practice and policies of Irish research ethics committees.

    Science.gov (United States)

    Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

    2013-09-01

    Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

  7. The "Ethics Committee": A Practical Approach to Introducing Bioethics and Ethical Thinking

    Science.gov (United States)

    Goodwin, Mark; Kramer, Cas; Cashmore, Annette

    2012-01-01

    Bioethics is an increasingly important part of the biosciences curriculum at school and in higher education, but few science teachers have much experience of teaching the subject in an engaging or interactive manner. This article sets out a session that allows students to practise the skills of ethical thinking and ethical debate in a relevant…

  8. Co-design and implementation research: challenges and solutions for ethics committees.

    Science.gov (United States)

    Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

    2015-11-16

    Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with

  9. Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion.

    Science.gov (United States)

    2016-10-01

    Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6). Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  10. Human somatic cell nuclear transfer and reproductive cloning: an Ethics Committee opinion.

    Science.gov (United States)

    2016-04-01

    This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804-7. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  11. A role for research ethics committees in exchanges of human biospecimens through material transfer agreements.

    Science.gov (United States)

    Chalmers, Donald; Nicol, Dianne; Nicolás, Pilar; Zeps, Nikolajs

    2014-09-01

    International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.

  12. 7 CFR 929.125 - Committee review procedures.

    Science.gov (United States)

    2010-01-01

    ... MASSACHUSETTS, RHODE ISLAND, CONNECTICUT, NEW JERSEY, WISCONSIN, MICHIGAN, MINNESOTA, OREGON, WASHINGTON, AND LONG ISLAND IN THE STATE OF NEW YORK Rules and Regulations § 929.125 Committee review procedures... Committee within 30 days after receipt of the Committee's determination of sales history, a request for a...

  13. Impact of the economic crisis on the activity of a clinical research ethics committee

    Directory of Open Access Journals (Sweden)

    Paula Arcenillas

    2014-11-01

    Full Text Available Purpose: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT and observational studies (ES from the activity of an Research Ethics Committee (REC. Method: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1 promoted by pharmaceutical industry, 2 by scientific societies with industry support, 3 by scientific societies with government support and 4 unfunding.Two periods were compared: pre-crisis (2003-2007 and crisis (2008-2012. Results: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Conclusions: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

  14. [Impact of the economic crisis on the activity of a clinical research ethics committee].

    Science.gov (United States)

    Redondo Capafons, S; Arcenillas, Paula; Giménez, Nuria; March López, Pablo; Soriano, Laura; Pla, Ramon; Quintana, Salvador

    2014-11-03

    Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  15. Ethics and Transgenic Crops: a Review

    OpenAIRE

    Robinson, Jonathan

    1999-01-01

    This article represents a review of some of the ethical dilemmas that have arisen as a result of the development and deployment of transgenic crop plants. The potential for transgenic crops to alleviate human hunger and the possible effects on human health are discussed. Risks and benefits to the environment resulting from genetic engineering of crops for resistance to biotic and abiotic stresses are considered, in addition to effects on biodiversity. The socio-economic impacts and distributi...

  16. Surgical innovation: the ethical agenda: A systematic review.

    Science.gov (United States)

    Broekman, Marike L; Carrière, Michelle E; Bredenoord, Annelien L

    2016-06-01

    The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might

  17. Italian ethical committee intervention in a case of embryo-fetal medicine.

    Science.gov (United States)

    Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane

    2011-06-01

    Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.

  18. Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment.

    Science.gov (United States)

    Marcus, Brian S; Carlson, Jestin N; Hegde, Gajanan G; Shang, Jennifer; Venkat, Arvind

    2016-03-01

    We sought to evaluate whether health care professionals' viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108-tertiary care center, 92-large community hospitals, 40-small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.

  19. Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

    Science.gov (United States)

    Yanar, Zeynep M; Fazli, Mehria; Rahman, Jahanara; Farthing, Rys

    2016-04-01

    Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines. © The Author(s) 2016.

  20. AWARENESS OF MEDICAL SPECIALISTS AND PATIENTS IN BULGARIA OF ETHICS COMMITTEES AND THE BENEFITS OF THEIR WORK

    Directory of Open Access Journals (Sweden)

    Neli Gradinarova

    2018-02-01

    Full Text Available In today’s healthcare, the role of morality emerges to the forefront as a result of the high degree of uncertainty in our modern environment. Ethically responsible behaviour is therefore perceived as a prerequisite for preventing and counteracting a number of moral risks in society. With regard to moral hazard and responsibility, ethical codes represent a rational control mechanism, lowering the extent of the probability of moral peril. Ethics committees are also founded based on such ethical codes, the purpose of such committees being the proclamation and observation of the principles and norms set forth. At the healthcare institutions of the Republic of Bulgaria, ethics committees are established that are based on the principles of medical ethics and medical law. The significance with which ethics committees are charged regarding the sustainable development of the healthcare system consists of protecting the patients, the medical professionals and the institution itself. Awareness of the significance, functions and benefits of ethics committees and their impact on the medical practice and patients in Bulgaria is, however, insufficiently low. In a questionnaire survey conducted among 149 medical specialists employed at three medical establishments for hospital care in the country, and 269 patients under treatment at them, at being asked “Do you think that ethics committees contribute to protecting and respecting patients’ rights?”, 26.2% of the respondents among the medical professionals replied that they are not sure, while 25.7% of did not provide an answer to the question thus asked due to being unfamiliar with ethics committees as an institutionalized body and their functions. The analysis of the results of the abovementioned survey among medical professionals and patients evidences a low level of awareness of the ethics committees and their work on the territory of the Republic of Bulgaria. It is essential for healthcare

  1. 75 FR 4830 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

    Science.gov (United States)

    2010-01-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES..., CDC, regarding a broad range of public health ethics questions and issues arising from programs...

  2. "The Project Cannot Be Approved in Its Current Form": Feminist Visual Research Meets the Human Research Ethics Committee

    Science.gov (United States)

    Pitt, Penelope

    2014-01-01

    This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…

  3. Ethical Guideline to Authors,Editors,and Reviewers

    Institute of Scientific and Technical Information of China (English)

    Editorial office of CHM

    2016-01-01

    Drug products are specific goods with safety and effectiveness in medical health case.All of researchers(authors),reviewers,and editors must abide by medical ethical obligation,and also must deter to the ethical obligation for publication.These guidelines are offered as ethical

  4. From "a Fair Game" to "a Form of Covert Research": Research Ethics Committee Members' Differing Notions of Consent and Potential Risk to Participants Within Social Media Research.

    Science.gov (United States)

    Hibbin, R A; Samuel, G; Derrick, G E

    2018-04-01

    Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.

  5. Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.

    Science.gov (United States)

    Simpson, Bob; Khatri, Rekha; Ravindran, Deapica; Udalagama, Tharindi

    2015-04-01

    Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  6. What scientists want from their research ethics committee.

    Science.gov (United States)

    Keith-Spiegel, Patricia; Tabachnick, Barbara

    2006-03-01

    Whereas investigators have directed considerable criticism against Institutional Review Boards (IRBs), the desirable characteristics of IRBs have not previously been empirically determined. A sample of 886 experienced biomedical and social and behavioral scientists rated 45 descriptors of IRB actions and functions as to their importance. Predictions derived from organizational justice research findings in other work settings were generally borne out. Investigators place high value on the fairness and respectful consideration of their IRBs. Expected differences between biomedical and social behavioral researchers and other variables were unfounded. Recommendations are offered for educating IRBs to accord researchers greater respect and fair treatment.

  7. A Hospital-Based Committee of Moral Philosophy to Revive Ethics.

    Science.gov (United States)

    Illy, Margaux; Le Coz, Pierre; Mege, Jean-Louis

    2017-08-15

    The Méditerranée Infection Foundation's primary goal is supporting a research hospital for the treatment of infectious diseases in Marseille. The main objective of this innovative center is to understand the mechanisms of contagion and face them. The Foundation will include a committee on moral philosophy that will accompany and supervise biomedical research. This is not a conventional ethics committee, frequently giving rise to a board's bureaucratic excesses, which might slow down creative biomedical clinical research without necessarily restricting abuses. Moral philosophy, however, can handle contemporary biomedical issues. In all its diversity, this discipline is able to enrich the debate on medical issues, thanks to many philosophical currents such as deontological ethics and consequentialism. The purpose of this committee is therefore to advance reflection on the bioethical issues encountered in biomedical research in infectious diseases, while respecting the precepts of moral philosophy. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  8. Joint Integration Office Independent Review Committee annual report, 1985

    International Nuclear Information System (INIS)

    1986-08-01

    Comprised of seven persons with extensive experience in the issues of nuclear waste, the Independent Review Committee (IRC) provides independent and objective review of Defense Transuranic Waste Program (DTWP) activities managed by the Joint Integration Office (JIO), formerly the Defense Transuranic Waste Lead Organization (TLO). The Committee is ensured a broad, interdisciplinary perspective since its membership includes representatives from the fields of nuclear engineering, nuclear waste transportation, industrial quality control, systems and environmental engineering and state and local government. The scope of IRC activities includes overall review of specific TLO plans, projects and activities, and technical review of particular research and development projects. The Committee makes specific suggestions and recommendations based upon expertise in the field of TRU Waste Management. The IRC operates as a consulting group, under an independent charter providing objective review of program activities. This report summarizes the 12 major topics reviewed by the committee during 1985

  9. Getting the justification for research ethics review right.

    Science.gov (United States)

    Dunn, Michael

    2013-08-01

    Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the 'governance problem' in research ethics that they allude to ought to be explained differently.

  10. Nurses' knowledge, attitudes and willingness to participate officially in workplace Healthcare Ethics Committees (HEC).

    Science.gov (United States)

    Rubinstein, Dorit; Tabak, Nili

    2012-03-01

    This research was designed to assess nurses' perceptions, knowledge, attitudes and intentions in relation to nurse participation in Healthcare Ethics Committees (HECs). A convenience sample of 87 nurses from five Israeli hospitals completed a self-administered questionnaire, whose data were then analyzed by quantitative statistics. The main findings were that large percentages of nurses were totally ignorant of the existence and functioning of the HEC in their workplaces. Nurses in managerial roles were (a) much more knowledgeable on these matters than staff nurses and (b) regarded more positively the idea that nurses had an obligation to sit on such committees. Workplace role and rank in the organizational hierarchy had a stronger impact on nurse attitudes to HEC work than level of education. Overall, nurse willingness to sit on an HEC and to take special training in preparation for such a role were high.

  11. The role of religious beliefs in ethics committee consultations for conflict over life-sustaining treatment.

    Science.gov (United States)

    Bandini, Julia I; Courtwright, Andrew; Zollfrank, Angelika A; Robinson, Ellen M; Cadge, Wendy

    2017-06-01

    Previous research has suggested that individuals who identify as being more religious request more aggressive medical treatment at end of life. These requests may generate disagreement over life-sustaining treatment (LST). Outside of anecdotal observation, however, the actual role of religion in conflict over LST has been underexplored. Because ethics committees are often consulted to help mediate these conflicts, the ethics consultation experience provides a unique context in which to investigate this question. The purpose of this paper was to examine the ways religion was present in cases involving conflict around LST. Using medical records from ethics consultation cases for conflict over LST in one large academic medical centre, we found that religion can be central to conflict over LST but was also present in two additional ways through (1) religious coping, including a belief in miracles and support from a higher power, and (2) chaplaincy visits. In-hospital mortality was not different between patients with religiously versus non-religiously centred conflict. In our retrospective cohort study, religion played a variety of roles and did not lead to increased treatment intensity or prolong time to death. Ethics consultants and healthcare professionals involved in these cases should be cognisant of the complex ways that religion can manifest in conflict over LST. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. Impact of three years training on operations capacities of research ethics committees in Nigeria.

    Science.gov (United States)

    Folayan, Morenike Oluwatoyin; Adaranijo, Aisha; Durueke, Florita; Ajuwon, Ademola; Adejumo, Adebayo; Ezechi, Oliver; Oyedeji, Kola; Akanni, Olayide

    2014-04-01

    This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants' knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. © 2012 John Wiley & Sons Ltd.

  13. Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?

    Science.gov (United States)

    Gefenas, E; Dranseika, V; Cekanauskaite, A; Hug, K; Mezinska, S; Peicius, E; Silis, V; Soosaar, A; Strosberg, M

    2011-01-01

    We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. PMID:20606000

  14. Research Ethics: Institutional Review Board Oversight of Art Therapy Research

    Science.gov (United States)

    Deaver, Sarah P.

    2011-01-01

    By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

  15. Electronic monitoring of offenders: an ethical review.

    Science.gov (United States)

    Bülow, William

    2014-06-01

    This paper considers electronic monitoring (EM) a promising alternative to imprisonment as a criminal sanction for a series of criminal offenses. However, little has been said about EM from an ethical perspective. To evaluate EM from an ethical perspective, six initial ethical challenges are addressed and discussed. It is argued that since EM is developing as a technology and a punitive means, it is urgent to discuss its ethical implications and incorporate moral values into its design and development.

  16. Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

    Science.gov (United States)

    Glass, Kathleen Cranley; Kaufert, Joseph

    2007-06-01

    CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.

  17. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

    Science.gov (United States)

    Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

    2018-02-27

    Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question

  18. Methods of legitimation: how ethics committees decide which reasons count in public policy decision-making.

    Science.gov (United States)

    Edwards, Kyle T

    2014-07-01

    In recent years, liberal democratic societies have struggled with the question of how best to balance expertise and democratic participation in the regulation of emerging technologies. This study aims to explain how national deliberative ethics committees handle the practical tension between scientific expertise, ethical expertise, expert patient input, and lay public input by explaining two institutions' processes for determining the legitimacy or illegitimacy of reasons in public policy decision-making: that of the United Kingdom's Human Fertilisation and Embryology Authority (HFEA) and the United States' American Society for Reproductive Medicine (ASRM). The articulation of these 'methods of legitimation' draws on 13 in-depth interviews with HFEA and ASRM members and staff conducted in January and February 2012 in London and over Skype, as well as observation of an HFEA deliberation. This study finds that these two institutions employ different methods in rendering certain arguments legitimate and others illegitimate: while the HFEA attempts to 'balance' competing reasons but ultimately legitimizes arguments based on health and welfare concerns, the ASRM seeks to 'filter' out arguments that challenge reproductive autonomy. The notably different structures and missions of each institution may explain these divergent approaches, as may what Sheila Jasanoff (2005) terms the distinctive 'civic epistemologies' of the US and the UK. Significantly for policy makers designing such deliberative committees, each method differs substantially from that explicitly or implicitly endorsed by the institution. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Ethical Issues Surrounding Personalized Medicine: A Literature Review

    Directory of Open Access Journals (Sweden)

    Pooneh Salari

    2017-03-01

    Full Text Available More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

  20. Ethical Issues Surrounding Personalized Medicine: A Literature Review.

    Science.gov (United States)

    Salari, Pooneh; Larijani, Bagher

    2017-03-01

    More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

  1. Ethics interventions for healthcare professionals and students: A systematic review.

    Science.gov (United States)

    Stolt, Minna; Leino-Kilpi, Helena; Ruokonen, Minka; Repo, Hanna; Suhonen, Riitta

    2018-03-01

    The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients' rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions. To examine ethics interventions conducted on healthcare professionals and healthcare students to achieve ethics-related outcomes. A systematic review. Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher's Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis. Ethical consideration: This systematic review was conducted following good scientific practice in every phase. It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics. Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals.

  2. Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

    NARCIS (Netherlands)

    Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

    2006-01-01

    OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the

  3. Public health ethics theory: review and path to convergence.

    Science.gov (United States)

    Lee, Lisa M

    2012-01-01

    Public health ethics is a nascent field, emerging over the past decade as an applied field merging concepts of clinical and research ethics. Because the "patient" in public health is the population rather than the individual, existing principles might be weighted differently, or there might be different ethical principles to consider. This paper reviewed the evolution of public health ethics, the use of bioethics as its model, and the proposed frameworks for public health ethics through 2010. Review of 13 major public health ethics frameworks published over the past 15 years yields a wide variety of theoretical approaches, some similar foundational values, and a few similar operating principles. Coming to a consensus on the reach, purpose, and ends of public health is necessary if we are to agree on what ethical underpinnings drive us, what foundational values bring us to these underpinnings, and what operating principles practitioners must implement to make ethical decisions. If public health is distinct enough from clinical medicine to warrant its own set of ethical and philosophical underpinnings, then a decision must be made as to whether a single approach is warranted or we can tolerate a variety of equal but different perspectives. © 2012 American Society of Law, Medicine & Ethics, Inc.

  4. Ethical issues in public health surveillance: a systematic qualitative review.

    Science.gov (United States)

    Klingler, Corinna; Silva, Diego Steven; Schuermann, Christopher; Reis, Andreas Alois; Saxena, Abha; Strech, Daniel

    2017-04-04

    Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

  5. Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

    Science.gov (United States)

    Newcombe, J P; Kerridge, I H

    2007-01-01

    Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

  6. [Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

    Science.gov (United States)

    Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

    2013-01-01

    To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

  7. Nursing ethical values and definitions: A literature review.

    Science.gov (United States)

    Shahriari, Mohsen; Mohammadi, Eesa; Abbaszadeh, Abbas; Bahrami, Masoud

    2013-01-01

    Ethical values offer a framework for behavior assessment, and nursing values influence nurses' goals, strategies, and actions. A literature review was adopted in order to determine and define ethical values for nurses. This literature review was conducted based on the Centre for Reviews and Dissemination guidelines. The key words used to search relevant sources were nursing, ethics, ethical values, and nursing values. The search of articles in English was carried out in Medline, CINAHL, PubMed, Scopus, Ovid, and Proquest databases. The search of articles in Persian was conducted in databases of Magiran, SID, and Irandoc publications. After assessing and analyzing the obtained data, 17 articles which had a distinct definition of ethical values were chosen and subjected to a thorough study. The search yielded 10 nursing ethical values: Human dignity, privacy, justice, autonomy in decision making, precision and accuracy in caring, commitment, human relationship, sympathy, honesty, and individual and professional competency. This study showed that common ethical values are generally shared within the global community. However, in several areas, influences of social, cultural, and economical status and religious beliefs on values result in a different definition of these values. This study revealed that based on humanistic nature of nursing, common values in nursing protect human dignity and respect to the patients. Recognizing and definition of ethical values can help to improve nursing practice and develop codes of ethics.

  8. The ethical desirability of moral bioenhancement: A review of reasons

    NARCIS (Netherlands)

    J. Specker (Jona); F. Focquaert (Farah); K. Raus (Kasper); S. Sterckx (Sigrid); M.H.N. Schermer (Maartje)

    2014-01-01

    textabstractBackground: The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and

  9. Ethical Risk Management Education in Engineering: A Systematic Review.

    Science.gov (United States)

    Guntzburger, Yoann; Pauchant, Thierry C; Tanguy, Philippe A

    2017-04-01

    Risk management is certainly one of the most important professional responsibilities of an engineer. As such, this activity needs to be combined with complex ethical reflections, and this requirement should therefore be explicitly integrated in engineering education. In this article, we analyse how this nexus between ethics and risk management is expressed in the engineering education research literature. It was done by reviewing 135 articles published between 1980 and March 1, 2016. These articles have been selected from 21 major journals that specialize in engineering education, engineering ethics and ethics education. Our review suggests that risk management is mostly used as an anecdote or an example when addressing ethics issues in engineering education. Further, it is perceived as an ethical duty or requirement, achieved through rational and technical methods. However, a small number of publications do offer some critical analyses of ethics education in engineering and their implications for ethical risk and safety management. Therefore, we argue in this article that the link between risk management and ethics should be further developed in engineering education in order to promote the progressive change toward more socially and environmentally responsible engineering practices. Several research trends and issues are also identified and discussed in order to support the engineering education community in this project.

  10. Locating Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2013-01-01

    Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...

  11. Ethical tensions: A qualitative systematic review of new graduate perceptions.

    Science.gov (United States)

    Hazelwood, Tori; Murray, Carolyn M; Baker, Amy; Stanley, Mandy

    2017-01-01

    New graduate transition into the workforce is challenging and can involve managing ethical tensions. Ethical tensions cause new graduates to doubt their capabilities due to their lack of experience. To support new graduates, we need to know what these ethical tensions are. To explore the ethical tensions perceived to occur in practice for new graduate health professionals. This qualitative systematic review involved a search of five databases (Medline, EMBASE, AMED, CINAHL and Scopus) which resulted in the retrieval of 3554 papers. After the two-phased screening process, eight studies were identified that met the inclusion criteria and had rich data on the review question. Articles were read several times, critically appraised and analysed through thematic analysis. Ethical considerations: No ethical approval was required for the systematic review. The review was conducted following well-established reporting guidelines enabling transparency and rigour. Studies originated from Australia, United States, Iran and China. One study included speech pathologists and seven were with nurses. Four themes included the following: (1) enduring an unknown workplace culture that generates uncertainty without support for new graduates; (2) being vulnerable because of distress from bullying, exclusion and being a scapegoat; (3) constraining systems and institutional restrictions that cause dilemmas; and (4) experiencing disillusionment from lost ideals about ethical practice. This review has brought to light the vulnerability of new graduates to negative workplace culture and collegial incivility. In addition, new graduates are subjected to ethical tensions created by institutional constraints which can create dilemmas and uncertainties through practice that does not align with what they anticipated. Understanding ethical tensions experienced by new graduates enables provision of informed support. There needs to be considerable cultural change for orientation and socialisation of

  12. Agriculture’s Ethical Horizon, book review

    Science.gov (United States)

    Roughly 6.5 billion people inhabit the earth, but over 1 billion people regularly go hungry. This food shortfall poses an ethical dilemma for agriculture, and Agriculture's Ethical Horizon grapples with this dilemma. It argues that agricultural productivity has been the quintessential value of agr...

  13. Moral and Ethical Decision Making: Literature Review

    Science.gov (United States)

    2005-08-08

    exploration and elaboration of both rational and intuitive decision making processes. In addition, emotions may also play an important role in...More specifically, it suggests that both rational and intuitive decision making processes are likely to play an important role in ethical decision ...and military literature related to ethical decision making more generally. Specifically, it suggests that both rational and intuitive decision making

  14. 76 FR 57744 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES) Correction: This notice was published in the Federal Register on September 8, 2011, Volume 76, Number 174...

  15. 75 FR 7483 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

    Science.gov (United States)

    2010-02-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES); Correction AGENCY: Centers for Disease Control and Prevention (CDC), HHS. ACTION: Notice of meeting; meeting...

  16. Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

    Czech Academy of Sciences Publication Activity Database

    Altavilla, A.; Giaquinto, C.; Giocanti, D.; Manfredi, C.; Aboulker, J.-P.; Bartoloni, F.; Cattani, E.; Giudice, M. L.; Mellado Peňa, M.J.; Nagler, R.; Peterson, C.; Vajnerová, Olga; Bonifazi, F.; Ceci, A.

    2009-01-01

    Roč. 11, 1-2 (2009), s. 79-87 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : ethic committees * clinical trials * pediatrics Subject RIV: FP - Other Medical Disciplines

  17. Ethical issues in trauma-related research: a review.

    Science.gov (United States)

    Newman, Elana; Risch, Elizabeth; Kassam-Adams, Nancy

    2006-09-01

    ETHICAL DECISION-MAKING ABOUT TRAUMA-RELATED STUDIES requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.

  18. Nurses' ethical conflicts in performance of utilization reviews.

    Science.gov (United States)

    Bell, Sue Ellen

    2003-09-01

    This article describes the ethical conflicts that a sample of US nurse utilization reviewers faced in their work, and also each nurse's self-reported ethical orientation that was used to resolve the dilemmas. Data were collected from a sample of 97 registered nurses who were working at least 20 hours per week as utilization reviewers. Respondents were recruited from three managed care organizations that conduct utilization reviews in a large midwestern city. A cross-sectional survey design was used to collect demographic data and to ask closed-response, short-answer and open-ended questions. Ethical conflicts reported by nurses were similar across utilization review settings and many were justice orientated. Self-reported ethical orientations were similar across organizations, with beneficence dominating. Implications of these findings are discussed.

  19. [Presumptive organ donations for transplants agreement of the Ethics Committee of the University of Chile Medical School].

    Science.gov (United States)

    Roa, A; Rosselot, E

    1995-04-01

    The ethics committee of the Faculty of Medicine, University of Chile was consulted about the ethical aspects of presumptive organ donation for transplantation. After analyzing the problem, the committee concluded that every human being has the right to make use of his organs freely, voluntarily and according to his own discernment. The society has no right to make obligatory this donation, even after death. The foundations of this agreement were laid in a series of reasons. In fact, the corpse is not a juridical but a ethical asset and deserves respect for whom it was. It cannot be commercialized and is the only non-religious object susceptible of profanation. It is also object of popular affective and religious manifestations. Beliefs and affects must be respected. Organ donation is an act of charity and cannot be compulsory. The organ donation consent must be explicit, voluntary and solemn.

  20. Making Room for Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    This article examines the work that goes in to ‘making room’ for ethics, literally and figuratively. It follows the activities of a capacity building Asia-Pacific NGO in training and recognising ethics review committees, using multi-sited field materials collected over 12 months between 2009...

  1. Committees review activities at December meetings

    Science.gov (United States)

    The Education and Human Resources Committee reported having approved participation in the Association for Women Geoscientist's (AWG) national survey. During the summer of 1983 the AWG designed a 75-question survey targeted to women but also applicable to men. The survey consisted of five sections (in addition to such demographics as age, salary, education, job area, and society membership): feelings and attitude toward job, career/family balance, sexual harassment and discrimination, opinions on national energy and conservation policy, and attitude toward AWG. The questionnaire was mailed to AWG members (just over 1000) and to AGU female members (about 1300). Survey participants were asked to give copies to their male colleagues to create a comparison group. About 25% of the 800 responses were from men. The responses were split about 50/50 between AWG and AGU members. The Education and Human Resources Committee will have the results from the survey presented at their next meeting in Cincinnati, May 15.

  2. Feasibility of rapid ethical assessment for the Ethiopian health research ethics review system.

    Science.gov (United States)

    Addissie, Adamu; Davey, Gail; Newport, Melanie; Farsides, Bobbie; Feleke, Yeweyenhareg

    2015-01-01

    One of the challenges in the process of ethical medical research in developing countries, including Ethiopia, is translating universal principles of medical ethics into appropriate informed consent documents and their implementation. Rapid Ethical Assessment (REA) has been suggested as a feasible approach to meet this application gap. In the past few years REA has been employed in few research project in Ethiopia and have been found to be a useful and practical approach. Feasibility assessment of REA for the Ethiopian research setting was conducted between 2012-2013 in order to inform the subsequent introduction of REA into research ethics review and governance system in the country. REA was found to be an appropriate, relevant and feasible venture. We argue that REA can be integrated as part of the ethics review and governance system in Ethiopia. REA tools and techniques are considered relevant and acceptable to the Ethiopian research community, with few practical challenges anticipated in their implementation. REA are considered feasible for integration in the Ethiopian ethics review system.

  3. Young people's views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study.

    Science.gov (United States)

    Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

    2016-09-02

    Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance

  4. Review of Instructional Approaches in Ethics Education.

    Science.gov (United States)

    Mulhearn, Tyler J; Steele, Logan M; Watts, Logan L; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

    2017-06-01

    Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training (d = 0.50) and Field-Specific Compliance Training (d = 0.46) appear to be viable approaches to ethics training based on Cohen's d effect size estimates. By contrast, two commonly used approaches, General Discussion Training (d = 0.31) and Norm Adherence Training (d = 0.37), were found to be considerably less effective. The implications for instruction in ethics training are discussed.

  5. LOS COMITÉS DE ÉTICA DE INVESTIGACIÓN BIOMÉDICA Y PSICOSOCIAL EN BOLIVIA OS COMITÊS DE ÉTICA DE PESQUISA BIOMÉDICA E PSICOSSOCIAL NA BOLIVIA BIOMEDICAL AND PSICOSOCIAL SCIENTIFIC ETHICAL REVIEW COMMITTEES IN BOLIVIA

    Directory of Open Access Journals (Sweden)

    Elizabeth C. Zwareva Mashiri

    2010-06-01

    Full Text Available Este artículo reporta un estudio realizado en las ciudades de La Paz, Cochabamba y Santa Cruz en Bolivia. Interesaba saber cuál era la situación de la bioética en Bolivia y cómo se estaba protegiendo a los sujetos de investigación. Luego de revisar algunos conceptos bioéticos, la legislación boliviana y los métodos del estudio se dan a conocer los resultados del mismo, los cuales revelan gran desconocimiento respecto de cómo proteger los derechos de los sujetos, por la casi ausencia o el inadecuado funcionamiento de los comités de ética de la investigación.Este artigo reporta a um estudo realizado nas cidades de La Paz, Cochabamba, e Santa Cruz, na Bolivia. Interessava-se saber qual era a situação da bioética na Bolivia e como se estava protegendo os sujeitos de pesquisa. Ao revisar alguns conceitos bioéticos, a legislação boliviana e os métodos de estudo foi possível identificar os resultados pesquisados; esses revelaram grande desconhecimento a respeito de como garantir os direitos dos sujeitos de pesquisa, por conta da quase ausência e/ou do inadequado funcionamento dos comitês de ética de pesquisa.This article reports a study carried out in the cities of La Paz, Cochabamba and Santa Cruz in Bolivia. The interest was to know the situation of bioethics in Bolivia and how research subjects are being protected. After revising some bioethical concepts, Bolivian legislation and study methods, results revealed great lack of knowledge on how to protect research subjects, due to the almost absence or inadequate functioning of scientific ethical review committees.

  6. Resisting the seduction of "ethics creep": using Foucault to surface complexity and contradiction in research ethics review.

    Science.gov (United States)

    Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G

    2013-12-01

    In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Spent nuclear fuel Canister Storage Building CDR Review Committee report

    International Nuclear Information System (INIS)

    Dana, W.P.

    1995-12-01

    The Canister Storage Building (CSB) is a subproject under the Spent Nuclear Fuels Major System Acquisition. This subproject is necessary to design and construct a facility capable of providing dry storage of repackaged spent fuels received from K Basins. The CSB project completed a Conceptual Design Report (CDR) implementing current project requirements. A Design Review Committee was established to review the CDR. This document is the final report summarizing that review

  8. Regional Infant and Child Mortality Review Committee--2011 final report.

    Science.gov (United States)

    Wilson, Ann L; Sideras, James

    2012-12-01

    The 2011 annual report of the Regional Infant and Child Mortality Review Committee (RICMRC) is presented. Since 1997, the committee has reviewed 224 deaths to achieve its mission to "review infant and child deaths so that information can be transformed into action to protect young lives." In 2011, the committee reviewed 21 deaths (22 met the committee's criteria) of infants and children who were residents of Minnehaha, Turner, Lincoln, Hanson and Brookings counties in South Dakota. The manner of 12 of the reviewed deaths was natural with eight of these the result of progressive neurological diseases or conditions. In 2011 there were no deaths attributed to Sudden Infant Death Syndrome (SIDS), though there were two deaths of infants during sleep. One of these infants was ruled accidental as the baby died of aspiration and the other death occurred in an unsafe environment with its manner determined to be undecided. Six deaths were accidental, one of which occurred as a result of a fire in a home without functional smoke alarms. One motor vehicle death occurred, through no fault of the teen age driver. Another death resulted from tubing over a low head dam on the Big Sioux River. One youth suicide occurred to a resident of the region.

  9. 76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

    Science.gov (United States)

    2011-06-27

    ...; Submission for OMB Review; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... contractor business ethics compliance program and disclosure requirements. Public comments are particularly... Information Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements...

  10. Human rights, politics, and reviews of research ethics.

    Science.gov (United States)

    Beyrer, Chris; Kass, Nancy E

    2002-07-20

    Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.

  11. Centers for manufacturing technology: Industrial Advisory Committee Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-01

    An advisory committee, composed of senior managers form industrial- sector companies and major manufacturing trade associations and representatives from appropriate educational institutions, meets semi-annually to review and advise the Oak Ridge Centers for Manufacturing Technology (ORCMT) on its economic security program. Individual papers have been indexed separately for the database.

  12. 15 CFR 2008.19 - Classification Review Committee.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Classification Review Committee. 2008.19 Section 2008.19 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF THE UNITED...

  13. Report of the marketing science editorial review committee

    NARCIS (Netherlands)

    Fader, Peter S.; Bronnenberg, B.J.J.A.M.; Lyer, Ganesh; Neslin, Scott A.; Netzer, Oded; Srinivasan, Kannan

    2014-01-01

    This is an abridged version of an evaluation report for Marketing Science, which was commissioned by the INFORMS Publications Committee as part of its periodic review of every INFORMS journal. The coauthors listed here comprised the task force that conducted the research project and strategic

  14. Ethical challenges for accountable care organizations: a structured review.

    Science.gov (United States)

    DeCamp, Matthew; Farber, Neil J; Torke, Alexia M; George, Maura; Berger, Zackary; Keirns, Carla C; Kaldjian, Lauris C

    2014-10-01

    Accountable care organizations (ACOs) are proliferating as a solution to the cost crisis in American health care, and already involve as many as 31 million patients. ACOs hold clinicians, group practices, and in many circumstances hospitals financially accountable for reducing expenditures and improving their patients' health outcomes. The structure of health care affects the ethical issues arising in the practice of medicine; therefore, like all health care organizational structures, ACOs will experience ethical challenges. No framework exists to assist key ACO stakeholders in identifying or managing these challenges. We conducted a structured review of the medical ACO literature using qualitative content analysis to inform identification of ethical challenges for ACOs. Our analysis found infrequent discussion of ethics as an explicit concern for ACOs. Nonetheless, we identified nine critical ethical challenges, often described in other terms, for ACO stakeholders. Leaders could face challenges regarding fair resource allocation (e.g., about fairly using ACOs' shared savings), protection of professionals' ethical obligations (especially related to the design of financial incentives), and development of fair decision processes (e.g., ensuring that beneficiary representatives on the ACO board truly represent the ACO's patients). Clinicians could perceive threats to their professional autonomy (e.g., through cost control measures), a sense of dual or conflicted responsibility to their patients and the ACO, or competition with other clinicians. For patients, critical ethical challenges will include protecting their autonomy, ensuring privacy and confidentiality, and effectively engaging them with the ACO. ACOs are not inherently more or less "ethical" than other health care payment models, such as fee-for-service or pure capitation. ACOs' nascent development and flexibility in design, however, present a time-sensitive opportunity to ensure their ethical operation

  15. A Systematic Literature Review of US Engineering Ethics Interventions.

    Science.gov (United States)

    Hess, Justin L; Fore, Grant

    2018-04-01

    Promoting the ethical formation of engineering students through the cultivation of their discipline-specific knowledge, sensitivity, imagination, and reasoning skills has become a goal for many engineering education programs throughout the United States. However, there is neither a consensus throughout the engineering education community regarding which strategies are most effective towards which ends, nor which ends are most important. This study provides an overview of engineering ethics interventions within the U.S. through the systematic analysis of articles that featured ethical interventions in engineering, published in select peer-reviewed journals, and published between 2000 and 2015. As a core criterion, each journal article reviewed must have provided an overview of the course as well as how the authors evaluated course-learning goals. In sum, 26 articles were analyzed with a coding scheme that included 56 binary items. The results indicate that the most common methods for integrating ethics into engineering involved exposing students to codes/standards, utilizing case studies, and discussion activities. Nearly half of the articles had students engage with ethical heuristics or philosophical ethics. Following the presentation of the results, this study describes in detail four articles to highlight less common but intriguing pedagogical methods and evaluation techniques. The findings indicate that there is limited empirical work on ethics education within engineering across the United States. Furthermore, due to the large variation in goals, approaches, and evaluation methods described across interventions, this study does not detail "best" practices for integrating ethics into engineering. The science and engineering education community should continue exploring the relative merits of different approaches to ethics education in engineering.

  16. Unintended consequences of human research ethics committees: au revoir workplace studies?

    Science.gov (United States)

    Bamber, Greg J; Sappey, Jennifer

    2007-07-01

    To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) are in conflict with an important stream of industrial sociological research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a 'good news story' guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences.

  17. A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

    Science.gov (United States)

    Hedgecoe, Adam

    2014-02-01

    Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

  18. A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

    Science.gov (United States)

    Chenneville, Tiffany; Menezes, Lynette; Kosambiya, Jayendrakumar; Baxi, Rajendra

    2016-12-01

    Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

  19. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Directory of Open Access Journals (Sweden)

    Thomas Richardson

    Full Text Available Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis.Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the

  20. Ethics education for pediatric residents: a review of the literature

    Directory of Open Access Journals (Sweden)

    Raywat Deonandan

    2015-04-01

    Full Text Available Background: Ethics education and research on medical residents is needed because, unlike medical students or experienced doctors, medical residents have to perform multiple roles simultaneously – student, teacher and clinician – thus exposing them to unique ethical stressors.  In this paper we reviewed the literature concerning ethics education in postgraduate pediatrics training programs.  Our goal was not to simply describe educational strategies and programs, but also to explore measurements and experiences of current practices to address gaps in ethics education during residency. Method: We conducted a structured literature review to explore the extent of ethics education in pediatric residency programs.  Results:  Twelve relevant studies were found.  The studies suggest that existing training regimens are insufficient to meet the real life ethical challenges experienced in actual practice, particularly with respect to palliative care and the commission of clinical errors.  Conclusions: The increasing diversity of culture and beliefs in the clinical workplace is also serving to complicate educational needs. An interdisciplinary approach, spread over the entirety of a physician’s training, is a proposed solution worthy of more attention.

  1. Ethical aspects of brain computer interfaces: a scoping review.

    Science.gov (United States)

    Burwell, Sasha; Sample, Matthew; Racine, Eric

    2017-11-09

    Brain-Computer Interface (BCI) is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, such as those with amyotrophic lateral sclerosis or spinal cord injury. The technology has also been suggested for enhancement and entertainment uses, and there are companies currently marketing BCI devices for those purposes (e.g., gaming) as well as health-related purposes (e.g., communication). The unprecedented direct connection created by BCI between human brains and computer hardware raises various ethical, social, and legal challenges that merit further examination and discussion. To identify and characterize the key issues associated with BCI use, we performed a scoping review of biomedical ethics literature, analyzing the ethics concerns cited across multiple disciplines, including philosophy and medicine. Based on this investigation, we report that BCI research and its potential translation to therapeutic intervention generate significant ethical, legal, and social concerns, notably with regards to personhood, stigma, autonomy, privacy, research ethics, safety, responsibility, and justice. Our review of the literature determined, furthermore, that while these issues have been enumerated extensively, few concrete recommendations have been expressed. We conclude that future research should focus on remedying a lack of practical solutions to the ethical challenges of BCI, alongside the collection of empirical data on the perspectives of the public, BCI users, and BCI researchers.

  2. Research Ethics II: Mentoring, Collaboration, Peer Review, and Data Management and Ownership

    Science.gov (United States)

    Horner, Jennifer; Minifie, Fred D.

    2011-01-01

    Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics II", the authors review the RCR domains of mentoring,…

  3. Report From the International Linear Collider Technical Review Committee

    International Nuclear Information System (INIS)

    Loew, Gregory A.

    2003-01-01

    The International Linear Collider Technical Review Committee (ILC-TRC), formed in 1994, was reconvened in February 2001 by the International Committee for Future Accelerators (ICFA) to assess the current technical status of all electron-positron linear collider designs at hand in the world: TESLA, JLC-C, JLC-X/NLC and CLIC. The ILC-TRC worked for exactly two years and submitted its report to ICFA in February 2003. This paper presents the motivation behind the study, the charge to the committee and its organization, a table of machine parameters for 500 GeV c.m. energy and later upgrades to higher energies, the methodology used to assess the designs, and a ranked list of R and D tasks still deemed necessary between now and the time any one of the projects is selected by the HEP community and begins construction. Possible future developments are briefly discussed

  4. Social and ethical aspects of forensic genetics: A critical review.

    Science.gov (United States)

    Williams, R; Wienroth, M

    2017-07-01

    This review describes the social and ethical responses to the history of innovations in forensic genetics and their application to criminal investigations. Following an outline of the three recurrent social perspectives that have informed these responses (crime management, due process, and genetic surveillance), it goes on to introduce the repertoire of ethical considerations by describing a series of key reports that have shaped subsequent commentaries on forensic DNA profiling and databasing. Four major ethical concerns form the focus of the remainder of the paper (dignity, privacy, justice, and social solidarity), and key features of forensic genetic practice are examined in the light of these concerns. The paper concludes with a discussion of the concept of "proportionality" as a resource for balancing the social and ethical risks and benefits of the use of forensic genetics in support of criminal justice. Copyright © 2017 Central Police University.

  5. Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

    Science.gov (United States)

    Greeff, Minrie; Rennie, Stuart

    2016-04-01

    Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

  6. Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

    Science.gov (United States)

    Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

    2017-08-01

    For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  7. Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

    Science.gov (United States)

    Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

    2013-05-01

    This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

  8. Ethics.

    Science.gov (United States)

    Pellegrino, Edmund D

    In this brief annual review of ethical issues in medicine, Pellegrino focuses on two issues, AIDS and surrogate mothers. The AIDS epidemic has generated debate over public health needs vs. individual rights, modification of sexual practices, screening programs to detect infected persons, confidentiality of test results, experimental therapies, and the duty of physicians to care for AIDS patients. Surrogate motherhood arrangements have become one of the more controversial of the new reproductive technologies. The publicity that accompanied the custody battle over New Jersey's "Baby M" intensified debate over the commercialization of childbearing and the regulation of reproduction. Pellegrino concludes that physicians, along with ethicists and policymakers, have an obligation to "lead society in careful and judicious deliberation" of the ethical issues raised by AIDS and by reproductive technologies.

  9. Ethical Issues in Radiology Journalism, Peer Review, and Research.

    Science.gov (United States)

    Katz, Douglas S; Gardner, James B; Hoffmann, Jason C; Patlas, Michael N; Bhargava, Puneet; Moshiri, Mariam; Remer, Erick M; Gould, Elaine S; Smith, Stacy

    2016-08-17

    Although some research and publication practices are clearly unethical, including fraud and plagiarism, other areas of research and publication, such as informed consent and conflicts of interest, fall into grayer areas. The purposes of this article are, therefore, to review a variety of relevant ethical issues in radiology-related journalism, peer review, and research; to review the radiology literature to date that has addressed these issues; and to present position statements and potential solutions to these problems.

  10. Report of the Review Committee of the R and D subjects on Computational Science and Engineering

    International Nuclear Information System (INIS)

    1999-08-01

    The Ad Hoc Review Committee composed of seven experts was set up under the Research Evaluation Committee of JAERI in order to review the R and D subjects to be implemented for five years starting in a 2000 fiscal year at the Center for promotion of Computational Science and Engineering. The review meeting took place on April 26, 1999. According to the review methods consisting of review items, points of review and review criteria given by the Research Evaluation Committee, the review was conducted based on the materials submitted in advance and presentations of CCSE. The Research Evaluation Committee received the review report and its explanations from the Review Committee on July 5. The Research Evaluation Committee has acknowledged appropriateness of the review results. This report describes the review results. (author)

  11. Description and Evaluation of the Research Ethics Review Process in Japan: Proposed Measures for Improvement.

    Science.gov (United States)

    Suzuki, Mika; Sato, Keiko

    2016-07-01

    Research Ethics Committees (RECs) are designed to protect human subjects in research. It is essential to recognize whether the RECs are achieving this goal. Several studies have reported on RECs; however, detailed data regarding the quality of research protocols and the review process of RECs have not been reported in Japan. We examine research protocols reviewed by RECs and the review processes at three institutions using a novel checklist we developed. The data show that approximately half of all examined protocols lacked a clearly written "Background" section that defines the study rationale and design. These results reiterate suggestions made in previous research regarding educational programs and support departments that could enhance responsible conduct in clinical research to protect human subjects in Japan. © The Author(s) 2016.

  12. Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review

    Science.gov (United States)

    Pan, Stephen W; Mathews, Allison; Stein, Gabriella; Bayus, Barry; Rennie, Stuart

    2018-01-01

    Background Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, judging contributions, recognizing a subset of contributors, and sharing with the community. Objective This scoping review describes crowdsourcing contests by stage, examines ethical problems at each stage, and proposes potential ways of mitigating risk. Methods Our analysis was anchored in the specific example of a crowdsourcing contest that our team organized to solicit videos promoting condom use in China. The purpose of this contest was to create compelling 1-min videos to promote condom use. We used a scoping review to examine the existing ethical literature on crowdsourcing to help identify and frame ethical concerns at each stage. Results Crowdsourcing has a group of individuals solve a problem and then share the solution with the public. Crowdsourcing contests provide an opportunity for community engagement at each stage: organizing, soliciting, promoting, judging, recognizing, and sharing. Crowdsourcing poses several ethical concerns: organizing—potential for excluding community voices; soliciting—potential for overly narrow participation; promoting—potential for divulging confidential information; judging—potential for biased evaluation; recognizing—potential for insufficient recognition of the finalist; and sharing—potential for the solution to not be implemented or widely disseminated. Conclusions Crowdsourcing contests can be effective and engaging public health tools but also introduce potential ethical problems. We present methods for the responsible conduct of crowdsourcing contests. PMID:29523500

  13. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 5. Summary - Piping Review Committee conclusions and recommendations

    International Nuclear Information System (INIS)

    1985-04-01

    This document summarizes a comprehensive review of NRC requirements for Nuclear Piping by the US NRC Piping Review Committee. Four topical areas, addressed in greater detail in Volumes 1 through 4 of this report, are included: (1) Stress Corrosion Cracking in Piping of Boiling Water Reactor Plants; (2) Evaluation of Seismic Design; (3) Evaluation of Potential for Pipe Breaks; and (4) Evaluation of Other Dynamic Loads and Load Combinations. This volume summarizes the major issues, reviews the interfaces, and presents the Committee's conclusions and recommendations for updating NRC requirements on these issues. This report also suggests research or other work that may be required to respond to issues not amenable to resolution at this time

  14. A Selected Review of the Underpinnings of Ethics for Human Performance Technology Professionals--Part One: Key Ethical Theories and Research.

    Science.gov (United States)

    Dean, Peter J.

    1993-01-01

    Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…

  15. Philosophy of organ donation: Review of ethical facets.

    Science.gov (United States)

    Dalal, Aparna R

    2015-06-24

    Transplantation ethics is a philosophy that incorporates systematizing, defending and advocating concepts of right and wrong conduct related to organ donation. As the demand for organs increases, it is essential to ensure that new and innovative laws, policies and strategies of increasing organ supply are bioethical and are founded on the principles of altruism and utilitarianism. In the field of organ transplantation, role of altruism and medical ethics values are significant to the welfare of the society. This article reviews several fundamental ethical principles, prevailing organ donation consent laws, incentives and policies related to the field of transplantation. The Ethical and Policy Considerations in Organ Donation after Circulatory Determination of Death outline criteria for death and organ retrieval. Presumed consent laws prevalent mostly in European countries maintain that the default choice of an individual would be to donate organs unless opted otherwise. Explicit consent laws require organ donation to be proactively affirmed with state registries. The Declaration of Istanbul outlines principles against organ trafficking and transplant tourism. World Health Organization's Guiding Principles on Human Cell, Tissue and Organ Transplantation aim at ensuring transparency in organ procurement and allocation. The ethics of financial incentives and non-financial incentives such as incorporation of non-medical criteria in organ priority allocation have also been reviewed in detail.

  16. The nature and scope of psychiatric ethics: review article | Radden ...

    African Journals Online (AJOL)

    Both the professional code of conduct required in the practice of psychiatry, and the broader set of moral and ethical problems distinctive to, or at least magnified by, the mental health care setting are reviewed here. Some perennial aspects of mental disorder and its cultural history are introduced, together with problems ...

  17. Ethical concerns of nursing reviewers: an international survey.

    Science.gov (United States)

    Broome, Marion; Dougherty, Molly C; Freda, Margaret C; Kearney, Margaret H; Baggs, Judith G

    2010-11-01

    Editors of scientific literature rely heavily on peer reviewers to evaluate the integrity of research conduct and validity of findings in manuscript submissions. The purpose of this study was to describe the ethical concerns of reviewers of nursing journals. This descriptive cross-sectional study was an anonymous online survey. The findings reported here were part of a larger investigation of experiences of reviewers. Fifty-two editors of nursing journals (six outside the USA) agreed to invite their review panels to participate. A 69-item forced-choice and open-ended survey developed by the authors based on the literature was pilot tested with 18 reviewers before being entered into SurveyMonkey(TM). A total of 1675 reviewers responded with useable surveys. Six questions elicited responses about ethical issues, such as conflict of interest, protection of human research participants, plagiarism, duplicate publication, misrepresentation of data and 'other'. The reviewers indicated whether they had experienced such a concern and notified the editor, and how satisfied they were with the outcome. They provided specific examples. Approximately 20% of the reviewers had experienced various ethical dilemmas. Although the majority reported their concerns to the editor, not all did so, and not all were satisfied with the outcomes. The most commonly reported concern perceived was inadequate protection of human participants. The least common was plagiarism, but this was most often reported to the editor and least often led to a satisfactory outcome. Qualitative responses at the end of the survey indicate this lack of satisfaction was most commonly related to feedback provided on resolution by the editor. The findings from this study suggest several areas that editors should note, including follow up with reviewers when they identify ethical concerns about a manuscript.

  18. Focus on the Activity of a Local Ethics Committee in Italy

    Directory of Open Access Journals (Sweden)

    Pamela Barbadoro

    2008-06-01

    Full Text Available

    Background: The continuing evolution of medical treatments and the loss of neutrality of medicine with respect to morality of human values have represented the major tracking elements towards settings of sharing of choices between society and medicine. Several concerns have been raised upon links between pharmaceutical corporations and researchers. Moreover, being in a learning environment, we must pay even more attention to these items because students appear to be at risk for unrecognized influence by marketing efforts. The aim of this study is to focus on the activities of a local ethics committee (LEC and the characteristics of the protocols discussed in an Italian LEC during a three year period (2001-2003.

    Methods: Three years of activity of a LEC were analysed by a questionnaire registering: main sponsorship, setting, technical characteristics of trials, outcome of the submission to the LEC, state of progress. Approved trials were followed-up until April 30th, 2005.

    Results: A total of 345 protocols were discussed. 67.8% (n = 198 of approved protocols were submitted by a pharmaceutical corporation. 72.6% (n = 212 of studies approved in 2001 were still in progress in 2005. 91.3% (n = 73 of closed trials had a pharmaceutical corporation as their main sponsor. None of the submitted studies focused on prevention strategies.

    Conclusions: These results show how important grants offered by pharmaceutical industries are, the efforts spent on therapy and the lack of investors in prevention.

  19. An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

    Directory of Open Access Journals (Sweden)

    Sharmila V Jalgaonkar

    Full Text Available Protocol deviations (PDs may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47. Maximum study procedure related PDs were due to patient visiting outside window period (126/304. Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447. The most common corrective actions stated by PI were participant counseling (85/323 and caution in future (70/323. The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

  20. Research ethics committee decision-making in relation to an efficient neonatal trial.

    Science.gov (United States)

    Gale, C; Hyde, M J; Modi, N

    2017-07-01

    Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. A Critical Review of Theories and Measures of Ethics-Related Leadership.

    Science.gov (United States)

    Zhu, Weichun; Zheng, Xiaoming; Riggio, Ronald E; Zhang, Xi

    2015-01-01

    This chapter reviews the different theoretical perspectives and measurements of ethics-related leadership models, including ethical leadership, transformational leadership, authentic leadership, servant leadership, spiritual leadership, and a virtues-based approach to leadership ethics. The similarities and differences among these theoretical models and measures to ethics-related leadership are discussed. © 2015 Wiley Periodicals, Inc., A Wiley Company.

  2. Safety Review Committee - Annual Report 1991-1992

    International Nuclear Information System (INIS)

    1993-01-01

    During the year under review. The Safety Review Committee (SRC) assessed the safety of ANSTO's operations. This was done by site visits, examination of documentation and briefing by ANSTO officers responsible for particular operations, and includes HIFAR and Moata reactors, radioisotope production, packing and dispatch, radioactive waste management practices, occupational health and safety activities and ANSTO's arrangements for public health and safety beyond the site. This report describes the activities and findings of the SRC during the year ending 30 June 1992. 8 figs., ills

  3. National scientific literature on nursing ethics: a systematic Review

    Directory of Open Access Journals (Sweden)

    Ilka Nicéia D’Aquino Oliveira Teixeira

    2010-03-01

    Full Text Available Objective: To identify the most prevalent nursing ethical issues published in scientific Brazilian journals. Methods: A systematic literature review with the following inclusion criteria: (1 articles on Nursing Ethics written in Portuguese, English, French, and Spanish; (2 published in Brazilian journals; (3 in the period from January 1997 to February 2009. The search was carried out in four databases BDENF, LILACS, MEDLINE, and SCIELO. The key-words were ethics AND nursing. The selected studies were classified into categories. The content of the articles were analyzed using the Collective Subject Discourse. The categories generated discourses by organizing the main excerpts from the abstracts of the selected studies, which are the “key expressions”. Results: A hundred and thirty three articles that met the inclusion criteria were classified into eight categories: 1. Nursing Care; 2. Dilemmas and Controversies; 3. Education; 4. Legal Aspects; 5. Research; 6. Management; 7. Values and Beliefs; 8. Perspectives and Health Policies. The category “Nursing Care” prevailed in 36% of the selected articles, and it was classified into six subcategories. “Dilemmas and Controversies” was the second most prevalent category (15%. Conclusion: The number of theoretical papers on ethical issues is high, but there is little research on the ethical experiences in nursing practice.

  4. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Ethical considerations for peer review in forensic neuropsychology.

    Science.gov (United States)

    Johnson-Greene, Doug; Bechtold, Kathleen T

    2002-02-01

    The role of an expert is to assist the trier of fact in weighing evidence and reaching conclusions. Critical evaluation of opposing experts is an integral part of this process. In more recent times, cross-examination has given way to critical evaluation of opposing experts outside of the courtroom, a tactic we refer to as peer review in this paper. Though neuropsychologists frequently review the work of their colleagues, we are concerned here primarily with commentary that is at best misleading, and occasionally malicious, unethical, and unprofessional. Despite a growing trend to use experts as peer reviewers in the medicolegal arena, expectations concerning ethical and professional conduct of neuropsychologists have been absent. Enforcement of appropriate conduct is further complicated by the ambiguity of existing ethical standards and state statutes, and their limited applicability to all neuropsychologists who provide forensic services. This article provides an overview of ethical and professional issues pertaining to forensic peer review and concludes with recommendations for appropriate professional conduct.

  6. Revisión de los aspectos éticos en la investigación biomédica: la experiencia del Comité de Ética del Centro de Investigación sobre el Síndrome del Aceite Tóxico y Enfermedades Raras (CISATER Review of ethical aspects in biomedical research: The experience of the Ethics Committee of the Center for Toxic Oil Syndrome and Rare Diseases (CISATER

    Directory of Open Access Journals (Sweden)

    M.C. Martín-Arribas

    2003-12-01

    Full Text Available El objetivo de este artículo es dar a conocer las decisiones tomadas por el Comité de Ética del Instituto de Salud Carlos III para el Síndrome del Aceite Tóxico en relación con el desarrollo de proyectos de investigación en los que se podían utilizar muestras recogidas con anterioridad y para cuyo uso no se disponía del consentimiento de los pacientes, sobre una situación muy común en el ámbito de la investigación biomédica. A partir del proceso de debate acerca de la idoneidad ética de la utilización secundaria de estas muestras, se llegó a la conclusión de que en los estudios prospectivos se debe solicitar expresamente y por escrito el consentimiento del participante en el estudio para conservar las muestras y que éstas puedan ser utilizadas en investigaciones futuras, estableciendo con el donante los límites de su utilización.This Field Note aims to make known the decisions taken by the Ethics Committee of the Instituto de Salud Carlos III for Toxic Oil Syndrome regarding the secondary use of research specimens in biological research when informed consent is lacking. This is a common concern in the field of biomedical research. After debating the ethical suitability of the secondary use of these samples, our main conclusion is that researchers conducting prospective studies should expressly solicit written informed consent from participants in the study about i whether there will or could be any secondary use of the samples and, if so, ii whether such secondary use would be conditional on the type of research.

  7. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Science.gov (United States)

    2010-04-01

    ... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

  8. Lapse in Institutional Animal Care and Use Committee Continuing Reviews.

    Directory of Open Access Journals (Sweden)

    Min-Fu Tsan

    Full Text Available The United States federal animal welfare regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that institutional animal care and use committees (IACUCs conduct continuing reviews of all animal research activities. However, little is known about the lapse rate of IACUC continuing reviews, and how frequently investigators continue research activities during the lapse. It is also not clear what factors may contribute to an institution's lapse in IACUC continuing reviews. As part of the quality assurance program, the Department of Veterans Affairs (VA has collected performance metric data for animal care and use programs since 2011. We analyzed IACUC continuing review performance data at 74-75 VA research facilities from 2011 through 2015. The IACUC continuing review lapse rates improved from 5.6% in 2011 to 2.7% in 2015. The rate of investigators continuing research activities during the lapse also decreased from 47.2% in 2012 to 7.4% in 2015. The type of IACUCs used and the size of animal research programs appeared to have no effect in facility's rates of lapse in IACUC continuing reviews. While approximately 80% of facilities reported no lapse in IACUC continuing reviews, approximately 14% of facilities had lapse rates of >10% each year. Some facilities appeared to be repeat offenders. Four facilities had IACUC lapse rates of >10% in at least 3 out of 5 years, suggesting a system problem in these facilities requiring remedial actions to improve their IACUC continuing review processes.

  9. Forensic psychiatry, one subspecialty with two ethics? A systematic review.

    Science.gov (United States)

    Niveau, Gérard; Welle, Ida

    2018-04-10

    Forensic psychiatry is a particular subspecialty within psychiatry, dedicated in applying psychiatric knowledge and psychiatric training for particular legal purposes. Given that within the scope of forensic psychiatry, a third party usually intervenes in the patient-doctor relationship, an amendment of the traditional ethical principles seems justified. Thus, 47 articles, two book chapters and the guidelines produced by the World Psychiatric Association, the American Association of Psychiatry and the Law, as well as by the Royal Australian and New Zealand College of psychiatrists, were analyzed. The review revealed that the ethics of correctional forensic psychiatry and those of legal forensic psychiatry do not markedly differ from each other, but they are incongruent in terms of implementation. In an effort to better understand which ethical principles apply to forensic psychiatry, a chronological review of the literature published from 1950 to 2015 was carried out. The ethics of correctional forensic psychiatry are primarily deontological. The principle of justice translates into the principle of health care equivalence, the principle of beneficence into providing the best possible care to patients, and the principle of respect of autonomy into ensuring confidentiality and informed consent. The ethics of legal forensic psychiatry are rather consequentialist. In this latter setting, the principle of justice is mainly characterized by professionalism, the principle of beneficence by objectivity and impartiality, and the principle of respect of autonomy by informed consent. However, these two distinct fields of forensic psychiatry share in common the principle of non maleficence, defined as the non collaboration of the psychiatrist in any activity leading to inhuman and degrading treatment or to the death penalty.

  10. Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

    Science.gov (United States)

    Coleman, Carl H; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, Francois; Colonna, Pierre; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, Marie-France; Maoundé, Dionko; Martinent, Eric; Ntsiba, Honoré; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie-Christine; Sarr, Samba Cor; Sepou, Abdoulaye; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Van Nieuwenhove, Simon; Strub-Wourgaft, Nathalie

    2015-12-01

    Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. © 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.

  11. Ethical considerations in sexual health research: A narrative review

    Directory of Open Access Journals (Sweden)

    Maryam Shirmohammadi

    2018-01-01

    Full Text Available Background: There is an assumption that sexual health research has great influence on the quality of human life through elevating sexual health standards, and their results will eliminate the burden of sexual health challenges on family relationships. The aim of this study was to review ethical considerations in sexual health research. Materials and Methods: This narrative review was conducted between January 1990 and December 2017 based on the five-step approach of York University. The keywords used to search for the studies included ethical issues, research, sexual health, reproductive health, and sensitive topics. The language of the literatures was English and the search process was performed on PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, ProQuest, WHO website, Kinsey Confidential, and Worldsexology. Results: After assessing the quality and eligibility of 94 articles, 13 were selected. The results of the present study showed that the most important ethical considerations were protecting the confidentiality and privacy of participants, obtaining informed consent, and paying attention to vulnerable people. Conclusions: The review of literature exhibited several considerations that sexual health researchers are faced with. In order to manage these considerations, the researcher should have sufficient understanding of them. The important matter is that strategies to manage these challenges should be completely rational and practical according to each context. These strategies can also be applied in other societies with great similarities in their context.

  12. Rewind, review, reflect and fast forward: from Ethics to GeoEthics.

    Science.gov (United States)

    Marone, Eduardo

    2017-04-01

    Philosophy has as many definitions as philosophers but, at the end of the day, it is no more and no less than the science of thinking using the reason. It gives us tools for rationalizing, following logical paths and with a critical eye, to understand the material and immaterial substance of the universe. It has many branches, and a couple of them, Ethics and Epistemology, are central for the evolution of the human knowledge, among many others. Today, at the XXI Century, it seems that the lack of formal and adequate education on such important matters is making the act of "thinking" not so important when compared with the accumulation of "information", right or wrong, pasteurized or in disconnected pieces, with no much room/time for critical and logical analysis (Philosophy). If the tools to build the knowledge (Epistemology) are not usually familiar to the scientists and, worst, the need of taking the right actions with the generated new and existing knowledge (Ethics) is not a priority; the outputs cannot be the best ones. There have been several academic works and meetings looking into the causes of the scholarly illiteracy on Ethics and Epistemology in Earth Sciences. Among them, our sessions at EGU have endured showing important aspects that need to be tackled and, particularly, insisting in the fact that it is a continuous effort. However, we still need to go back (Rewind) to the main principles of Philosophy, Epistemology and Ethics, looking at them with care (Review), and think (Reflecting) returning to the present (Fast Forward) to make the world better for future generations. Geoethics consists of research and reflection on the values that underpin appropriate behaviours and practices, wherever human activities interact with the Earth system. Although more general ethical issues, which affect other/all sciences practices and behaviours, are included among the Geoethic concerns (as plagiarism, harassment, gender equity, etc.), the focus remains at the

  13. Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine.

    Science.gov (United States)

    Zhang, Cheng-Bin; Li, En-Chang

    2018-04-01

    Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

  14. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

    Science.gov (United States)

    Nicholls, Stuart G.; Hayes, Tavis P.; Brehaut, Jamie C.; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

    2015-01-01

    Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Results Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Discussion Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review. PMID:26225553

  15. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    Science.gov (United States)

    Nicholls, Stuart G; Hayes, Tavis P; Brehaut, Jamie C; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

    2015-01-01

    To date there is no established consensus of assessment criteria for evaluating research ethics review. We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

  16. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    Directory of Open Access Journals (Sweden)

    Stuart G Nicholls

    Full Text Available To date there is no established consensus of assessment criteria for evaluating research ethics review.We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

  17. 75 FR 17953 - Native American Graves Protection and Repatriation Review Committee Findings Related to the...

    Science.gov (United States)

    2010-04-08

    ... Repatriation Review Committee Findings Related to the Identity of Cultural Items in the Possession of the.... 3006(c)(3)), reviewed the record and made findings of fact related to the identity of 45 cultural items... Review Committee found that each of the 45 cultural items was both a ``sacred object'' (25 U.S.C. 3001(3...

  18. Implications of the ethical-legal framework for adolescent HIV ...

    African Journals Online (AJOL)

    Nicky

    Fourthly, the institutional framework for establishing research priorities and regulation of ethical review is being strengthened with the establishment of new institutions such as the National. Health Research Ethics Committee. The South African ethical-legal framework and its implications for adolescent HIV vaccine trials ...

  19. Supporting ethical competence of nurses during recruitment and performance reviews - the role of the nurse leader.

    Science.gov (United States)

    Poikkeus, Tarja; Leino-Kilpi, Helena; Katajisto, Jouko

    2014-09-01

    The aim of this study was to analyse how nurse leaders support the ethical competence of nurses during recruitment and performance reviews. Ethical competence of nurses refers to ethical behaviour and action requiring ethical knowledge and reflection. Nurse leaders have a key role in supporting the ethical competence of nurses, but little is known about just how this should be done. The data were collected using a structured questionnaire and analysed statistically. The target sample consisted of nurse leaders (n = 198) from two university hospitals in two healthcare districts in Finland. Nurse leaders support the ethical competence of nurses more often during performance reviews than during recruitment. During recruitment, nurse leaders ensure the ethical behaviour and knowledge of nurses to varying degrees. During performance reviews, nurse leaders ensure that nurses meet the requirements for collegiality and comply with ethical guidelines and that they do so according to nursing values and principles. There seems to be a need to examine and improve support for the ethical competence of nurses, both during recruitment and performance reviews. Future priorities should include a focus on supporting the ethical knowledge, reflection and behaviour of nurses. An important aspect in terms of supporting the ethical competence of nurses has to do with the ethical knowledge and education of nurse leaders and organisational policies or recommendations for ethical support. © 2013 John Wiley & Sons Ltd.

  20. [Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

    Science.gov (United States)

    Millán-González, Ricardo

    2012-03-01

    Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  1. Ethics in nursing: A systematic review of the framework of evidence perspective.

    Science.gov (United States)

    Yıldız, Erman

    2017-01-01

    To determine the current state of knowledge on nursing and ethics and to assess the knowledge and experience based on the evidence in this regard. Although ethics is at the center of the nursing profession and the ethical issues affecting nurses are given much importance, few studies have focused on professional ethics in nursing. In this respect, ethics has become a concept that contains controversial and ambiguous situations. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guide, a basic search algorithm, was taken. Cochrane, PubMed, CINAHL Complete, PsycINFO, and ULAKBIM from 2012 to 2016. Following a systematic search strategy, all papers were assessed in relation to inclusion criteria and type of study. When sufficient information was not available in the title and summary of the works, the necessary data were evaluated in full texts. This review was completed with 27 articles meeting the research criteria. The evaluation identified six themes: (1) ethics and nursing, (2) ethical difficulties/ethical dilemmas and nursing, (3) ethical competence and nursing, (4) professional ethics and nursing, (5) ethics, education, and nursing, and (6) ethics in health research. As a result of the review, a synthesis of high evidence-level research relating to nursing ethics was obtained. The emphasis was on the importance of further research and education so that the ethical aspects of nursing can be better understood throughout the studies. Nursing researchers' level of evidence on ethics and their orientation to high research design will shed light on uncertain and controversial aspects of the subject. Ethical consideration: Since this was a systematic review, no ethical approval was required. There is no conflict of interest in this literature review.

  2. [Experience of a research Ethics Committee and the challenges of the new Chilean legislation on research in human beings].

    Science.gov (United States)

    Oyarzún G, Manuel; Pinto C, María Eugenia; Raineri B, Gina G; Amigo, Hugo; Cifuentes O, Lucía; González, María Julieta; Horwitz, Nina; Marshall F, Claudia; Orellana V, Gricel

    2014-07-01

    The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.

  3. Discussing End-of-Life Decisions in a Clinical Ethics Committee: An Interview Study of Norwegian Doctors' Experience.

    Science.gov (United States)

    Bahus, Marianne K; Førde, Reidun

    2016-09-01

    With disagreement, doubts, or ambiguous grounds in end-of-life decisions, doctors are advised to involve a clinical ethics committee (CEC). However, little has been published on doctors' experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors' experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients' relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs' discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs' discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians.

  4. The Ethics of Sharing Plastic Surgery Videos on Social Media: Systematic Literature Review, Ethical Analysis, and Proposed Guidelines.

    Science.gov (United States)

    Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F

    2017-10-01

    Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.

  5. 42 CFR 61.15 - Moral character or loyalty; reference to Special Review Committee; review and recommendation.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Moral character or loyalty; reference to Special... § 61.15 Moral character or loyalty; reference to Special Review Committee; review and recommendation. (a) Moral character or loyalty; reference to Special Review Committee. Whenever the Surgeon General...

  6. International Linear Collider Technical Review Committee: Second Report, 2003

    Energy Technology Data Exchange (ETDEWEB)

    Loew, Gregory

    2003-02-21

    As this report is being published, the international high energy physics (HEP) community finds itself confronting a set of fascinating discoveries and new questions regarding the nature of matter and its fundamental particles and forces. The observation of neutrino oscillations that indicates that neutrinos have mass, measurements of the accelerating expansion of the universe that may be due to dark energy, and evidence for a period of rapid inflation at the beginning of the Big Bang are stimulating the entire field. Looming on the horizon are the potential discoveries of a Higgs particle that may reveal the origin of mass and of a whole family of supersymmetric particles that may be part of the cosmic dark matter. For the HEP community to elucidate these mysteries, new accelerators are indispensable. At this time, after careful deliberations, all three regional organizations of the HEP community (ACFA in Asia, HEPAP in North America, and ECFA in Europe) have reached the common conclusion that the next accelerator should be an electron-positron linear collider with an initial center-of-mass energy of 500 Giga-electronvolts (GeV), later upgradable to higher energies, and that it should be built and operated in parallel with the Large Hadron Collider under construction at CERN. Hence, this second report of the International Linear Collider Technical Review Committee (ILC-TRC) comes at a very timely moment. The report was requested by the International Committee on Future Accelerators (ICFA) in February 2001 to assess the current technical status of electron-positron linear collider designs in the various regions. Note that the ILC-TRC was not asked to concern itself with either cost studies or the ultimate selection process of a machine. This Executive Summary gives a short outline of the genesis of the report, the charge given to the committee, and its organization. It then presents a brief description of four electron-positron linear collider designs at hand. The

  7. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    NARCIS (Netherlands)

    Hem, M.H.; Pedersen, R.; Norvoll, R.; Molewijk, A.C.

    2015-01-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five

  8. Medical Ethics in Plastic Surgery: A Mini Review.

    Science.gov (United States)

    Nejadsarvari, Nasrin; Ebrahimi, Ali; Ebrahimi, Azin; Hashem-Zade, Haleh

    2016-09-01

    Currently, cosmetic surgery is spread around the world. Several factors are involved in this rapidly evolving field such as socio-economic development, changes in cultural norms, globalization and the effects of Western culture, advertising, media, and mental disorders. Nowadays the cosmetic surgery is becoming a profitable business, which deals exclusively with human appearance and less from the perspective of beauty based on physical protests and considering factors such as sex, age, and race. The morality of plastic surgery subspecialty has undergone many moral dilemmas in the past few years. The role of the patient regardless of his unrealistic dreams has questionable ethical dimension. The problem is the loss of human values and replacing them with false values, of pride and glory to a charismatic person of higher status, that may underlie some of the posed ethical dilemmas. Cosmetic surgery has huge difference with the general principle of legal liability in professional orientation, because the objective for cosmetic surgeries is different from common therapeutic purposes. To observe excellence in the medical profession, we should always keep in mind that these service providers, often as a therapist (healer) must maintain a commitment and priority for patient safety and prior to any action, a real apply for this service recipient should be present. Also, patient-physician confidentiality is the cornerstone of medical ethics. In this review, we study the issues addressed and the ways that they can be resolved.

  9. The ethics of complexity. Genetics and autism, a literature review.

    Science.gov (United States)

    Hens, Kristien; Peeters, Hilde; Dierickx, Kris

    2016-04-01

    It is commonly believed that the etiology of autism is at least partly explained through genetics. Given the complexity of autism and the variability of the autistic phenotype, genetic research and counseling in this field are also complex and associated with specific ethical questions. Although the ethics of autism genetics, especially with regard to reproductive choices, has been widely discussed on the public fora, an in depth philosophical or bioethical reflection on all aspects of the theme seems to be missing. With this literature review we wanted to map the basic questions and answers that exist in the bioethical literature on autism genetics, research, counseling and reproduction, and provide suggestions as to how the discussion can proceed. We found 19 papers that fitted the description of "bioethics literature focusing on autism genetics," and analyzed their content to distill arguments and themes. We concluded that because of the complexity of autism, and the uncertainty with regard to its status, more ethical reflection is needed before definite conclusions and recommendations can be drawn. Moreover, there is a dearth of bioethical empirical studies querying the opinions of all parties, including people with autism themselves. Such empirical bioethical studies should be urgently done before bioethical conclusions regarding the aims and desirability of research into autism genes can be done. Also, fundamental philosophical reflection on concepts of disease should accompany research into the etiology of autism. © 2016 Wiley Periodicals, Inc.

  10. 15 CFR 2002.1 - Trade Policy Committee Review Group.

    Science.gov (United States)

    2010-01-01

    ... OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE OPERATION OF COMMITTEES § 2002.1 Trade Policy Committee..., December 11, 1971 (15 CFR 2002.1), is abolished and there is hereby established as a subordinate body of...

  11. When reviews attack: ethics, free speech, and the peer review process.

    Science.gov (United States)

    Hadjistavropoulos, T; Bieling, P J

    2000-08-01

    The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.

  12. [Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

    Science.gov (United States)

    de Lecuona, Itziar

    2018-05-31

    The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. [Ethical issues linked to the professional practice of nurses in a hospital infection control committee].

    Science.gov (United States)

    Alves, Débora Cristina Ignácio; Evora, Yolanda Dora Martinez

    2002-01-01

    This qualitative work was developed according to Bardin's method of content analysis. It aimed at finding out the perceptions of nurses that are members of a Hospital Infection Control Commission about ethical issues that are inherent to their professional practice as well as understanding the clinical nurses opinion regarding the professional practice of the nurses that are members of the Hospital Infection Control Commission, considering the ethical aspects. In order to achieve an ethical, efficient and effective professional practice, there is a need for governmental changes and professional recognition through autonomy, respect and exclusivity in the Service of Hospital Infection Control, as well as improvements regarding information, the care provided to the patient and professional secret. The predominance of bureaucratic activities and team work were mentioned by the clinical nurses as differentiating factors of the activities performed by nurses that are members of the Commission.

  14. Ongoing ethical issues concerning authorship in biomedical journals: an integrative review

    Science.gov (United States)

    Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

    2015-01-01

    Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors’ (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care. PMID:26257520

  15. Ongoing ethical issues concerning authorship in biomedical journals: an integrative review.

    Science.gov (United States)

    Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

    2015-01-01

    Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors' (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care.

  16. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  17. Ethics Education for Professionals in Japan: A Critical Review

    Science.gov (United States)

    Maruyama, Yasushi; Ueno, Tetsu

    2010-01-01

    Ethics education for professionals has become popular in Japan over the last two decades. Many professional schools now require students to take an applied ethics or professional ethics course. In contrast, very few courses of professional ethics for teaching exist or have been taught in Japan. In order to obtain suggestions for teacher education,…

  18. The ethical desirability of moral bioenhancement: a review of reasons

    Science.gov (United States)

    2014-01-01

    Background The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. Discussion A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don’t) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Summary Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing ‘the whole of humanity’, we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise. PMID:25227512

  19. Access to fertility services by transgender persons: an Ethics Committee opinion.

    Science.gov (United States)

    2015-11-01

    This statement explores the ethical considerations surrounding the provision of fertility services to transgender individuals and concludes that denial of access to fertility services is not justified. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  20. The Battlefield Health and Trauma Research Institute Scientific Ethics Committee: An Evolving Model for Fostering a Culture of Integrity

    Science.gov (United States)

    2012-01-01

    grants and contracts.8 The ORI defines research misconduct as ‘‘fabrication, falsification, or plagiarism in proposing, performing, or reviewing research...fabrication, falsification, or plagiarism (FFP) is only 1% to 2%, based on self-reporting.10,11 However, approx- imately 33% of scientists admitted...provide investigators training and guidance? THE ACADEMIC MODEL Just as regulations governing the ethical use of human and animal research subjects grew

  1. Ethical challenges with welfare technology: a review of the literature.

    Science.gov (United States)

    Hofmann, Bjørn

    2013-06-01

    Demographical changes in high income counties will increase the need of health care services but reduce the number of people to provide them. Welfare technology is launched as an important measure to meet this challenge. As with all types of technologies we must explore its ethical challenges. A literature review reveals that welfare technology is a generic term for a heterogeneous group of technologies and there are few studies documenting their efficacy, effectiveness and efficiency. Many kinds of welfare technology break with the traditional organization of health care. It introduces technology in new areas, such as in private homes, and it provides new functions, e.g. offering social stimuli and entertainment. At the same time welfare technology is developed for groups that traditionally have not been extensive technology users. This raises a series of ethical questions with regard to the development and use of welfare technologies, which are presented in this review. The main challenges identified are: (1) Alienation when advanced technology is used at home, (2) conflicting goals, as welfare technologies have many stakeholders with several ends, (3) respecting confidentiality and privacy when third-party actors are involved, (4) guaranteeing equal access and just distribution, and (5) handling conflicts between instrumental rationality and care in terms of respecting dignity and vulnerability. Addressing these issues is important for developing and implementing welfare technologies in a morally acceptable manner.

  2. Evaluating the Intervention of an Ethics' Class in Students' Ethical Decision-Making: A Summative Review

    Science.gov (United States)

    Walker, Marquita

    2013-01-01

    This summative evaluation is the result of two years' of data reflecting the impact of an ethics class in terms of students' ethical decision-making. The research compares aggregate responses from scenario-based pre- and post-survey open-ended survey questions designed to measure changes in ethical decision-making by comparing students' cognitive…

  3. Review: Will van den Hoonaard (Ed. (2002. Walking the Tightrope: Ethical Issues for Qualitative Researchers

    Directory of Open Access Journals (Sweden)

    Rod Gerber

    2004-05-01

    Full Text Available This publication basically represents a collection of former conference papers and some other contributions mainly by North American social scientists on the dilemmas that qualitative researchers encounter when they submit research applications to research ethics committees. Collectively, the contributions demonstrate the tensions that exist in the policy and practice of applied research ethics in qualitative research. Thirteen chapters are included in this volume. They focus on the themes of: differentiating between ethics and morality; dealing with ethics committees and policies; research processes; research ethics trends; and, ethical issues when submitting research applications. The emphasis is on research policy in a North American context (Canada and the United States, but can be relevant for qualitative researchers in other parts of the world. One challenge to this context is that it does not capture the essence of some European perspectives, especially those from Continental Europe. However, it does raise the issue of ethics in qualitative research to a high level. URN: urn:nbn:de:0114-fqs040214

  4. [Ethical problems experienced by nurses in primary health care: integrative literature review].

    Science.gov (United States)

    Nora, Carlise Rigon Dalla; Zoboli, Elma Lourdes Campos Pavone; Vieira, Margarida

    2015-03-01

    The aim of this study is to identify ethical problems experienced by nurses in primary health care and resources for coping based on publications on the subject. An integrative literature review was performed between the months of October and November 2013, using the databases: BDTD, CINAHL, LILACS, MEDLINE, Biblioteca Cochrane, PubMed, RCAAP and SciELO. Articles, dissertations and theses published in Portuguese, English and Spanish were included, totalling 31 studies published from 1992 to 2013. This analysis resulted in four categories: ethical problems in the relationship between team members, ethical problems in the relationship with the user, ethical problems in health services management and resources for coping with ethical problems. Results showed that nurses need to be prepared to face ethical problems, emphasizing the importance of ethics education during the education process before and during professional practice to enhance the development of ethical sensitivity and competence for problem resolution.

  5. Ethical problems experienced by nurses in primary health care: integrative literature review

    Directory of Open Access Journals (Sweden)

    Carlise Rigon Dalla Nora

    Full Text Available The aim of this study is to identify ethical problems experienced by nurses in primary health care and resources for coping based on publications on the subject. An integrative literature review was performed between the months of October and November 2013, using the databases: BDTD, CINAHL, LILACS, MEDLINE, Biblioteca Cochrane, PubMed, RCAAP and SciELO. Articles, dissertations and theses published in Portuguese, English and Spanish were included, totalling 31 studies published from 1992 to 2013. This analysis resulted in four categories: ethical problems in the relationship between team members, ethical problems in the relationship with the user, ethical problems in health services management and resources for coping with ethical problems. Results showed that nurses need to be prepared to face ethical problems, emphasizing the importance of ethics education during the education process before and during professional practice to enhance the development of ethical sensitivity and competence for problem resolution.

  6. The full spectrum of ethical issues in dementia care: systematic qualitative review.

    Science.gov (United States)

    Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

    2013-06-01

    Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

  7. Ethical issues in the use of in-depth interviews: literature review and discussion

    OpenAIRE

    Allmark, Peter; Boote, Jonathan; Chambers, E.; Clarke, Amanda; McDonnell, A.; Thompson, Andrew; Tod, Angela

    2009-01-01

    This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes probe unexpe...

  8. Ethical issues in the use of in-depth interviews: literature review and discussion\\ud

    OpenAIRE

    Allmark, P.; Boote, J.; Chambers, E.; Clarke, A.; McDonnell, A.; Thompson, A.R.; Tod, A.

    2009-01-01

    This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three\\ud types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst\\ud many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular\\ud manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes\\ud ...

  9. Patient decision-making: medical ethics and mediation.

    OpenAIRE

    Craig, Y J

    1996-01-01

    A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part of an eirenic ethic alr...

  10. Report of the Review Committee on valuation of the research subjects in the fields of advanced science research

    International Nuclear Information System (INIS)

    2000-07-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods, etc. the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research theme completed in FY1998 and those planned for five years starting in FY2000 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on September 17, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research results/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on March 14, 2000. As a result, the Research Evaluation Committee acknowledged appropriateness of the review results. This report describes the review results. (author)

  11. Committees

    Science.gov (United States)

    2012-11-01

    Leadership Team of the IAHR Committee for Hydraulic Machinery and Systems Eduard EGUSQUIZA, UPC Barcelona, Spain, Chair François AVELLAN, EPFL-LMH, Switzerland, Past Chair Richard K FISHER, Voith Hydro Inc., USA, Past Chair Fidel ARZOLA, Edelca, Venezuela Michel COUSTON, Alstom Hydro, France Niklas DAHLBÄCKCK, Vatenfall, Sweden Normand DESY, Andritz VA TECH Hydro Ltd., Canada Chisachi KATO, University of Tokyo, Japan Andrei LIPEJ, Turboinstitut, Slovenija Torbjørn NIELSEN, NTNU, Norway Romeo SUSAN-RESIGA, 'Politehnica' University Timisoara, Romania Stefan RIEDELBAUCH, Stuggart University, Germany Albert RUPRECHT, Stuttgart University, Germany Qing-Hua SHI, Dong Fang Electrical Machinery Co., China Geraldo TIAGO, Universidade Federal de Itajubá, Brazil International Advisory Committee Shouqi YUAN (principal) Jiangsu University China QingHua SHI (principal) Dong Fang Electrical Machinery Co. China Fidel ARZOLA EDELCA Venezuela Thomas ASCHENBRENNER Voith Hydro GmbH & Co. KG Germany Anton BERGANT Litostroj Power doo Slovenia B C BHAOYAL Research & Technology Centre India Hermod BREKKE NTNU Norway Stuart COULSON Voith Hydro Inc. USA Paul COOPER Fluid Machinery Research Inc USA V A DEMIANOV Power Machines OJSC Russia Bart van ESCH Technische Universiteit Eindhoven Netherland Arno GEHRER Andritz Hydro Graz Austria Akira GOTO Ebara Corporation Japan Adiel GUINZBURG The Boeing Company USA D-H HELLMANN KSB AG Germany Ashvin HOSANGADI Combustion Research and Flow Technology USA Byung-Sun HWANG Korea Institute of Material Science Korea Toshiaki KANEMOTO Kyushu Institute of Technology Japan Mann-Eung KIM Korean Register of Shipping Korea Jiri KOUTNIK Voith Hydro GmbH & Co. KG Germany Jinkook LEE Eaton Corporation USA Young-Ho LEE Korea Maritime University Korea Woo-Seop LIM Hyosung Goodsprings Inc Korea Jun MATSUI Yokohama National University Japan Kazuyoshi Mitsubishi H I Ltd, Japan MIYAGAWA Christophe NICOLET Power Vision Engineering Srl Switzerland Maryse PAGE Hydro

  12. What Is Everyday Ethics? A Review and a Proposal for an Integrative Concept.

    Science.gov (United States)

    Zizzo, Natalie; Bell, Emily; Racine, Eric

    2016-01-01

    "Everyday ethics" is a term that has been used in the clinical and ethics literature for decades to designate normatively important and pervasive issues in healthcare. In spite of its importance, the term has not been reviewed and analyzed carefully. We undertook a literature review to understand how the term has been employed and defined, finding that it is often contrasted to "dramatic ethics." We identified the core attributes most commonly associated with everyday ethics. We then propose an integrative model of everyday ethics that builds on the contribution of different ethical theories. This model proposes that the function of everyday ethics is to serve as an integrative concept that (1) helps to detect current blind spots in bioethics (that is, shifts the focus from dramatic ethics) and (2) mobilizes moral agents to address these shortcomings of ethical insight. This novel integrative model has theoretical, methodological, practical, and pedagogical implications, which we explore. Because of the pivotal role that moral experience plays in this integrative model, the model could help to bridge empirical ethics research with more conceptual and normative work. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  13. International Linear Collider Technical Review Committee Report, 1995

    International Nuclear Information System (INIS)

    1995-12-01

    This 1995 report of the International Linear Collider Technical Review Committee is the first attempt to gather in one document the current status of all major e + e - linear collider projects in the world. The report is the result of a collaborative effort of scientists from many laboratories working together over a period of about one year. A short description of the organization, origins and history of the report is given below. To get an idea of the organization, the reader should first refer to the Table of Contents. Chapter 1 is an introduction and general overview of the respective 500 GeV c.m. energy machines. In contrast, Chapter 2, cutting across individual machine boundaries, gives a comparative description and discussion of all the major machine sub-systems as well as particle physics experimentation, showing where these subjects stand today and what additional work needs to be done in the next few years to reach the point where complete design reports can be prepared. Chapter 3 describes the various paths to energy upgrades, and other experimental options (γγ, e - e - , etc.). Chapter 4 gives a short status report of the machine experiments and test facilities being built in the world. Chapter 5 outlines current and other possible areas of collaboration and finally., Chapter 6 summarizes our principal conclusions

  14. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

    Directory of Open Access Journals (Sweden)

    Subhrojyoti Bhowmick

    2014-01-01

    Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

  15. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    Science.gov (United States)

    Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

    2015-06-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

  16. Ethical considerations in the study of online illness narratives: a qualitative review.

    Science.gov (United States)

    Heilferty, Catherine McGeehin

    2011-05-01

    This aim of the review was to describe differences in ethical approaches to research on Internet communication during illness and to report conclusions drawn relevant to a proposed narrative analysis of parent blogs of childhood illness. As the study of the online expression of illness experiences becomes more expansive, discussion of related ethical issues is central to promoting research trustworthiness and rigour. Ethical considerations are central to the patient-provider relationship. The EBSCO Host, CINAHL, Medline, Communication & Mass Media Complete, and Google Scholar databases were searched from January 1990 to September 2009 using the terms 'Internet research and ethics', 'Internet research, illness and ethics' and 'blog, Internet research and ethics'. Of the 4114 references found, 21 met the inclusion criteria for the review. The review was designed to be a comprehensive assessment of the concepts analysed and the qualitative research measures taken concerning ethics in Internet research across formats. Three main approaches to ethical conduct in Internet research on illness experiences were found: human subjects, representation and open source approaches. The personal and sensitive nature of online illness narratives demand their consideration in health care as 'human subjects' research. The best hope for ethical treatment of author-participants is the creation of a comprehensive plan for addressing any and all potential ethical conflicts that may arise in the collection, analysis and reporting of data, taking into consideration rapid changes in technology. © 2011 Blackwell Publishing Ltd.

  17. The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2016-01-01

    When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

  18. A Scoping Study on the Ethics of Health Systems Research.

    Science.gov (United States)

    Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A

    2016-12-01

    Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.

  19. The end of the nuclear power generation. On the recommendations of the ethics committee according to the 13th amendment to the Atomic Energy Act

    International Nuclear Information System (INIS)

    Becker, Peter

    2011-01-01

    With the 13th Amendment to the Atomic Energy Act the nuclear consequences of the earthquake disaster in Japan will result in an end to nuclear power generation in Germany. Here, the legislature resorted to unusual methods. For the first time, the legislature received advices from the ''ethics committee reliable energy supply''. This Ethics Commission adopted its recommendations ''on behalf of the Chancellor'' in the period from 4th April to 28th May, 2011. The understanding of this development, its epochal character and speed of decision-making requires an excursion into the economic history and the establishment of nuclear power generation with their legal protection.

  20. DRIVING CORPORATE SOCIAL RESPONSIBILITY (CSR THROUGH THE COMPANIES ACT: AN OVERVIEW OF THE ROLE OF THE SOCIAL AND ETHICS COMMITTEE

    Directory of Open Access Journals (Sweden)

    Henk J Kloppers

    2013-04-01

    policy requiring the implementation of socially responsible practices by the entire private sector is a necessity. Governments in general are increasingly beginning to view CSR as cost-effective means to enhance their sustainable development strategies, and as a part of their national competitiveness strategies to attract foreign direct investment. Given South Africa's history, legislation should be viewed as one of the main instruments enabling the Government to address the private sector's social, environmental and economic outreach activities.Against this background, this contribution identifies the regulations released in terms of the Companies Act 71 of 2008 in which the issue of the social and ethics committee is dealt with, as an important measure taken by Government to create a possible CSR platform. This contribution argues that the requirements regarding the creation of a social and ethics committee have the potential to embed the CSR notion in the corporate conscience. The aim of the contribution is to provide an overview of the role of the social and ethics committee, as envisaged by the Companies Regulations, 2011, as a potential driver of CSR.

  1. Integer Linear Programming for Constrained Multi-Aspect Committee Review Assignment

    Science.gov (United States)

    Karimzadehgan, Maryam; Zhai, ChengXiang

    2011-01-01

    Automatic review assignment can significantly improve the productivity of many people such as conference organizers, journal editors and grant administrators. A general setup of the review assignment problem involves assigning a set of reviewers on a committee to a set of documents to be reviewed under the constraint of review quota so that the reviewers assigned to a document can collectively cover multiple topic aspects of the document. No previous work has addressed such a setup of committee review assignments while also considering matching multiple aspects of topics and expertise. In this paper, we tackle the problem of committee review assignment with multi-aspect expertise matching by casting it as an integer linear programming problem. The proposed algorithm can naturally accommodate any probabilistic or deterministic method for modeling multiple aspects to automate committee review assignments. Evaluation using a multi-aspect review assignment test set constructed using ACM SIGIR publications shows that the proposed algorithm is effective and efficient for committee review assignments based on multi-aspect expertise matching. PMID:22711970

  2. Tiny tweaks, big changes: An alternative strategy to empower ethical culture of human research in anesthesia (A Taiwan Acta Anesthesiologica Taiwanica-Ethics Review Task Force Report).

    Science.gov (United States)

    Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen

    2015-03-01

    For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.

  3. Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States.

    Science.gov (United States)

    Hemminki, Elina

    2016-01-19

    The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries - England, Canada, the United States of America (USA) - in the late 2000s. Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized. In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland. The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.

  4. EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

    Science.gov (United States)

    Oberbichler, S; Hackl, W O; Hörbst, A

    2017-10-18

    Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the

  5. Ethical review of research on human subjects at Unilever: reflections on governance.

    Science.gov (United States)

    Sheehan, Mark; Marti, Vernon; Roberts, Tony

    2014-07-01

    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.

  6. Ethical issues experienced by healthcare workers in nursing homes: Literature review.

    Science.gov (United States)

    Preshaw, Deborah Hl; Brazil, Kevin; McLaughlin, Dorry; Frolic, Andrea

    2016-08-01

    Ethical issues are increasingly being reported by care-providers; however, little is known about the nature of these issues within the nursing home. Ethical issues are unavoidable in healthcare and can result in opportunities for improving work and care conditions; however, they are also associated with detrimental outcomes including staff burnout and moral distress. The purpose of this review was to identify prior research which focuses on ethical issues in the nursing home and to explore staffs' experiences of ethical issues. Using a systematic approach based on Aveyard (2014), a literature review was conducted which focused on ethical and moral issues, nurses and nursing assistants, and the nursing home. The most salient themes identified in the review included clashing ethical principles, issues related to communication, lack of resources and quality of care provision. The review also identified solutions for overcoming the ethical issues that were identified and revealed the definitional challenges that permeate this area of work. The review highlighted a need for improved ethics education for care-providers. © The Author(s) 2015.

  7. E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

    Science.gov (United States)

    Dainesi, Sonia Mansoldo; Goldbaum, Moisés

    2012-12-01

    The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

  8. 76 FR 28237 - Center for Scientific Review; Notice of Closed Meetings

    Science.gov (United States)

    2011-05-16

    ... commercial property such as patentable material, and personal information concerning individuals associated... Committee: Center for Scientific Review Special Emphasis Panel, Societal and Ethical Issues in Research...

  9. An Ethical Review of Euthanasia and Physician-assisted Suicide.

    Science.gov (United States)

    Banović, Božidar; Turanjanin, Veljko; Miloradović, Anđela

    2017-02-01

    In the majority of countries, active direct euthanasia is a forbidden way of the deprivation of the patients' life, while its passive form is commonly accepted. This distinction between active and passive euthanasia has no justification, viewed through the prism of morality and ethics. Therefore, we focused on attention on the moral and ethical implications of the aforementioned medical procedures. Data were obtained from the Clinical Hospital Center in Kragujevac, collected during the first half of the 2015. The research included 88 physicians: 57 male physicians (representing 77% of the sample) and 31 female physicians (23% of the sample). Due to the nature, subject and hypothesis of the research, the authors used descriptive method and the method of the theoretical content analysis. A slight majority of the physicians (56, 8%) believe that active euthanasia is ethically unacceptable, while 43, 2% is for another solution (35, 2% took a viewpoint that it is completely ethically acceptable, while the remaining 8% considered it ethically acceptable in certain cases). From the other side, 56, 8% of respondents answered negatively on the ethical acceptability of the physician-assisted suicide, while 33% of them opted for a completely ethic viewpoint of this procedure. Out of the remaining 10, 2% opted for the ethical acceptability in certain cases. Physicians in Serbia are divided on this issue, but a group that considers active euthanasia and physician-assisted suicide as ethically unacceptable is a bit more numerous.

  10. A Review of Contemporary Ethical Decision-Making Models for Mental Health Professionals

    Science.gov (United States)

    Francis, Perry C.

    2015-01-01

    Mental health professionals are faced with increasingly complex ethical decisions that are impacted by culture, personal and professional values, and the contexts in which they and their clients inhabit. This article presents the reasons for developing and implementing multiple ethical decision making models and reviews four models that address…

  11. Professional Ethics Education for Future Teachers: A Narrative Review of the Scholarly Writings

    Science.gov (United States)

    Maxwell, Bruce; Schwimmer, Marina

    2016-01-01

    This article provides a narrative review of the scholarly writings on professional ethics education for future teachers. Against the background of a widespread belief among scholars working in this area that longstanding and sustained research and reflection on the ethics of teaching have had little impact on the teacher education curriculum, the…

  12. Methods for Practising Ethics in Research and Innovation : A Literature Review, Critical Analysis and Recommendations

    NARCIS (Netherlands)

    Reijers, Wessel; Wright, David; Brey, Philip; Weber, Karsten; Rodrigues, Rowena; O’Sullivan, Declan; Gordijn, Bert

    2017-01-01

    This paper provides a systematic literature review, analysis and discussion of methods that are proposed to practise ethics in research and innovation (R&I). Ethical considerations concerning the impacts of R&I are increasingly important, due to the quickening pace of technological innovation and

  13. Review Article: Ethical Issues in the Study of Second Language Acquisition--Resources for Researchers

    Science.gov (United States)

    Thomas, Margaret

    2009-01-01

    Two recent books provide varied resources for exploring ethical issues in the social sciences. Reflection on ethical issues aims to sensitize scholars to a range of consequences of their research, and to scholars' responsibilities to their discipline, their colleagues, and the public. This review article assesses the utility of these texts (and of…

  14. Genetic screening: programs, principles, and research--thirty years later. Reviewing the recommendations of the Committee for the Study of Inborn Errors of Metabolism (SIEM).

    Science.gov (United States)

    Simopoulos, A P

    2009-01-01

    Screening programs for genetic diseases and characteristics have multiplied in the last 50 years. 'Genetic Screening: Programs, Principles, and Research' is the report of the Committee for the Study of Inborn Errors of Metabolism (SIEM Committee) commissioned by the Division of Medical Sciences of the National Research Council at the National Academy of Sciences in Washington, DC, published in 1975. The report is considered a classic in the field worldwide, therefore it was thought appropriate 30 years later to present the Committee's modus operandi and bring the Committee's recommendations to the attention of those involved in genetics, including organizational, educational, legal, and research aspects of genetic screening. The Committee's report anticipated many of the legal, ethical, economic, social, medical, and policy aspects of genetic screening. The recommendations are current, and future committees should be familiar with them. In 1975 the Committee stated: 'As new screening tests are devised, they should be carefully reviewed. If the experimental rate of discovery of new genetic characteristics means an accelerating rate of appearance of new screening tests, now is the time to develop the medical and social apparatus to accommodate what later on may otherwise turn out to be unmanageable growth.' What a prophetic statement that was. If the Committee's recommendations had been implemented on time, there would be today a federal agency in existence, responsive and responsible to carry out the programs and support research on various aspects of genetic screening, including implementation of a federal law that protects consumers from discrimination by their employers and the insurance industry on the basis of genetic information. Copyright 2008 S. Karger AG, Basel.

  15. Ethical issues in sports medicine: a review and justification for ethical decision making and reasoning.

    Science.gov (United States)

    Greenfield, Bruce H; West, Charles Robert

    2012-11-01

    Ethical issues present a challenge for health care professionals working with athletes of sports teams. Health care professionals-including the team physician, the physical therapist, and the athletic trainer-are faced with the challenge of returning an athlete to competition as quickly as possible but as safely as possible. Conflicts of interest arise due to conflicting obligations of the team physician to the athlete and other members of the sports organization, including coaches and the team owner. The multiple stakeholders involved in sports teams challenge the traditional notion of confidentiality and autonomy. The aims of this article are to explicate the ethics of sports medicine, highlight the ethical issues, and provide some strategies and suggestions for ethical decision making.

  16. Monitoring 'monitoring' and evaluating 'evaluation': an ethical framework for monitoring and evaluation in public health.

    Science.gov (United States)

    Gopichandran, Vijayaprasad; Indira Krishna, Anil Kumar

    2013-01-01

    Monitoring and evaluation (M&E) is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to institutionalise the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees.

  17. Research Ethics Capacity Building in Sub-Saharan Africa: A Review of NIH Fogarty-Funded Programs 2000–2012

    Science.gov (United States)

    Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A.; Meslin, Eric M.

    2014-01-01

    The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program. PMID:24782070

  18. Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012.

    Science.gov (United States)

    Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A; Meslin, Eric M

    2014-04-01

    The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

  19. The Impact of Ethics Review on a Research-Led University Curriculum: Results of a Qualitative Study in Australia.

    Science.gov (United States)

    Wynn, L L

    2016-04-01

    In the human sciences, a student research-centered pedagogy is constrained by institutional ethics review, yet there is little research on the impact of ethics review on research-led teaching. This article documents a range of ways that Australian universities are responding to ethics review of undergraduate human research. Forty teachers and administrators were interviewed at 14 universities using purposive sampling to document the range of ways teachers are avoiding ethics review or incorporating it into their curriculum. Some reported halting undergraduate research or evading ethics review, regarding it as meaningless bureaucracy divorced from actual ethical thinking. Those who incorporated ethics review into student research did so by collaborating with administrators. Institutions can facilitate research-led teaching by designing dedicated forms and decentralized review procedures for student research. © The Author(s) 2016.

  20. Ethics Review of Pediatric Multi-Center Drug Trials

    NARCIS (Netherlands)

    Needham, Allison C.; Kapadia, Mufiza Z.; Offringa, Martin

    2015-01-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider

  1. Ethical issues with colorectal cancer screening-a systematic review.

    Science.gov (United States)

    Hofmann, Bjørn

    2017-06-01

    Colorectal cancer (CRC) screening is widely recommended and implemented. However, sometimes CRC screening is not implemented despite good evidence, and some types of CRC screening are implemented despite lack of evidence. The objective of this article is to expose and elucidate relevant ethical issues in the literature on CRC screening that are important for open and transparent deliberation on CRC screening. An axiological question-based method is used for exposing and elucidating ethical issues relevant in HTA. A literature search in MEDLINE, Embase, PsycINFO, PubMed Bioethics subset, ISI Web of Knowledge, Bioethics Literature Database (BELIT), Ethics in Medicine (ETHMED), SIBIL Base dati di bioetica, LEWI Bibliographic Database on Ethics in the Sciences and Humanities, and EUROETHICS identified 870 references of which 114 were found relevant according to title and abstract. The content of the included papers were subject to ethical analysis to highlight the ethical issues, concerns, and arguments. A wide range of important ethical issues were identified. The main benefits are reduced relative CRC mortality rate, and potentially incidence rate, but there is no evidence of reduced absolute mortality rate. Potential harms are bleeding, perforation, false test results, overdetection, overdiagnosis, overtreatment (including unnecessary removal of polyps), and (rarely) death. Other important issues are related to autonomy and informed choice equity, justice, medicalization, and expanding disease. A series of important ethical issues have been identified and need to be addressed in open and transparent deliberation on CRC screening. © 2016 John Wiley & Sons, Ltd.

  2. ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.

    Science.gov (United States)

    Famenka, Andrei

    2011-04-01

    The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research, observed in a number of countries of Central and Eastern Europe. Different social, economical and political factors of transition have major impact on capacities of the Belarusian RECs to ensure adequate protection of human subjects. Among the main problems identified are non-equivalent stringency of ethical review for different types of biomedical research; lack of independence, multidisciplinarity, pluralism and lay representation experienced by RECs; low level of research ethics education and transparency of RECs activities. Recommendations are made to raise the issue of research ethics on the national agenda in order to develop and maintain the research ethics system capable to effectively protect research participants and promote ethical conduct in research.

  3. Ethical framework of assistive devices: review and reflection.

    Science.gov (United States)

    Mansouri, Nazanin; Goher, Khaled; Hosseini, Seyed Ebrahim

    2017-01-01

    The population of ageing is growing significantly over the world, and there is an emerging demand for better healthcare services and more care centres. Innovations of Information and Communication Technology has resulted in development of various types of assistive robots to fulfil elderly's needs and independency, whilst carrying out daily routine tasks. This makes it vital to have a clear understanding of elderly's needs and expectations from assistive robots. This paper addresses current ethical issues to understand elderly's prime needs. Also, we consider other general ethics with the purpose of applying these theories to form a proper ethics framework. In the ethics framework, the ethical concerns of senior citizens will be prioritized to satisfy elderly's needs and also to diminish related expenses to healthcare services.

  4. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

    Science.gov (United States)

    2012-01-01

    Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

  5. International Perspectives of Ethical Approval: The New Zealand scene

    Directory of Open Access Journals (Sweden)

    Antoinette McCallin Ph.D.

    2010-12-01

    Full Text Available The paper “Navigating the process of ethical approval” (Carey, 2010 raises many issues about the influence Institutional Ethics Committees have on research methodology and what can or cannot take place in research. Carey draws attention to the ethical challenges classic grounded theory researchers face when an ethical proposal that follows the principles of the methodology is presented to an Ethics Committee, whose main responsibility is the protection of participants. Ethics committees not only guide researchers on acceptable ethical practice, but are charged with monitoring ethical standards and ensuring researchers act in accordance with professional expectations for researchers within the jurisdiction. These committees aim to ensure consistency of ethical practice in research. While there is generally some flexibility in the review process researchers often find ethical requirements constraining, as guidelines are primarily prescriptive and are designed to ensure consistency in the application of universal ethical principles in research. In New Zealand, consistency includes paying attention to broader socio-cultural responsibilities to society that includes promoting awareness of the Code of Health and Disability Services Consumer Rights 1996, the Health Information Privacy Code 1994, and promoting ethical practices which involve Maori (the local indigenous people in research proposals as much as possible (Ministry of Health, 2006. So while researchers in training assume that their prime interest concerns the management of a research topic and methodology, they quickly find out that ethical guidelines influence research design. Even though there is an international code of ethics (Universal Declaration of Human Rights, 2005 that defines ethical standards for researchers around the world, each country has its own specific requirements depending on the context. In this paper, ethical drivers in the New Zealand context are outlined and

  6. A new prescription for empirical ethics research in pharmacy: a critical review of the literature

    OpenAIRE

    Cooper, R J; Bissell, P; Wingfield, J

    2007-01-01

    Empirical ethics research is increasingly valued in bioethics and healthcare more generally, but there remain as yet under-researched areas such as pharmacy, despite the increasingly visible attempts by the profession to embrace additional roles beyond the supply of medicines. A descriptive and critical review of the extant empirical pharmacy ethics literature is provided here. A chronological change from quantitative to qualitative approaches is highlighted in this review, as well as differi...

  7. Child-rearing ability and the provision of fertility services: an Ethics Committee opinion.

    Science.gov (United States)

    2017-12-01

    Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53). Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  8. A narrative review of undergraduate peer-based healthcare ethics teaching.

    Science.gov (United States)

    Hindmarch, Thomas; Allikmets, Silvia; Knights, Felicity

    2015-12-12

    This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. A narrative review of the literature concerning peer-based ethics teaching was conducted. MEDLINE, EMBASE, CINAHL, SCOPUS databases, and the Cochrane Library, were systematically searched for studies of peer-based ethics or professionalism teaching. Selected studies related peer-based teaching to ethics education outcomes. Ten publications were identified. Selected studies were varied in their chosen intervention methodology and analysis. Collectively, the identified studies suggest peer-based ethics education is an effective and valued educational methodology in training healthcare professionals. One paper suggests peer-based ethics teaching has advantages over traditional didactic methods. Peer-based ethics teaching also receives positive feedback from student participants. However, the limited literature base demonstrates a clear need for more evaluation of this pedagogy. The current literature base suggests that undergraduate peer based healthcare ethics teaching is valuable in terms of efficacy and student satisfaction. We conclude that the medical community should invest in further study in order to capitalise upon the potential of peer-based ethics teaching in undergraduate healthcare education.

  9. Teaching Medical Ethics in Graduate and Undergraduate Medical Education: A Systematic Review of Effectiveness.

    Science.gov (United States)

    de la Garza, Santiago; Phuoc, Vania; Throneberry, Steven; Blumenthal-Barby, Jennifer; McCullough, Laurence; Coverdale, John

    2017-08-01

    One objective was to identify and review studies on teaching medical ethics to psychiatry residents. In order to gain insights from other disciplines that have published research in this area, a second objective was to identify and review studies on teaching medical ethics to residents across all other specialties of training and on teaching medical students. PubMed, EMBASE, and PsycINFO were searched for controlled trials on teaching medical ethics with quantitative outcomes. Search terms included ethics, bioethics, medical ethics, medical students, residents/registrars, teaching, education, outcomes, and controlled trials. Nine studies were found that met inclusion criteria, including five randomized controlled trails and four controlled non-randomized trials. Subjects included medical students (5 studies), surgical residents (2 studies), internal medicine house officers (1 study), and family medicine preceptors and their medical students (1 study). Teaching methods, course content, and outcome measures varied considerably across studies. Common methodological issues included a lack of concealment of allocation, a lack of blinding, and generally low numbers of subjects as learners. One randomized controlled trial which taught surgical residents using a standardized patient was judged to be especially methodologically rigorous. None of the trials incorporated psychiatry residents. Ethics educators should undertake additional rigorously controlled trials in order to secure a strong evidence base for the design of medical ethics curricula. Psychiatry ethics educators can also benefit from the findings of trials in other disciplines and in undergraduate medical education.

  10. A systematic review of ethical issues in vaccine studies involving pregnant women.

    Science.gov (United States)

    Beeler, Jennifer A; Lambach, Philipp; Fulton, T Roice; Narayanan, Divya; Ortiz, Justin R; Omer, Saad B

    2016-08-02

    Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs

  11. A critical review of health research ethical guidelines regarding ...

    African Journals Online (AJOL)

    Trials, 2006;[22] and Ethics in Health Research Principles, Structures and Procedures, 2015[15]) regarding caregivers' consent in research involving minors as research ..... 11. Jeff H, Ramesh R, Sanjay MB. Pediatric airway management.

  12. Philosophy of organ donation: Review of ethical facets

    OpenAIRE

    Dalal, Aparna R

    2015-01-01

    Transplantation ethics is a philosophy that incorporates systematizing, defending and advocating concepts of right and wrong conduct related to organ donation. As the demand for organs increases, it is essential to ensure that new and innovative laws, policies and strategies of increasing organ supply are bioethical and are founded on the principles of altruism and utilitarianism. In the field of organ transplantation, role of altruism and medical ethics values are significant to the welfare ...

  13. Report of the review committee on evaluation of the R and D subjects in the field of nuclear safety research

    International Nuclear Information System (INIS)

    2000-09-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on Nuclear Safety Research composed of twelve experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY2000 in the Nuclear Safety Research Center (Department of Reactor Safety Research, Department of Fuel Cycle Safety Research and Department of Safety Research Technical Support). The Ad Hoc Review Committee meeting was held on January 20, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

  14. A systematic review of ethics knowledge in audiology (1980-2010).

    Science.gov (United States)

    Naudé, Alida Maryna; Bornman, Juan

    2014-06-01

    The purpose of this research was to apply multiple perspectives as part of a systematic review to analyze literature regarding ethics in audiology. Audiologists are particularly vulnerable to the changing requirements of the discipline that compel them to straddle both professional obligations and business principles, creating a hybrid professional. The authors used a 2-phase mixed-method approach to analyze publications. Publications were sorted into categories, namely, ethics approach, author, decade, role of the audiologist, component of morality, and common themes. The sample consisted of peer-reviewed articles cited in MEDLINE, CINAHL, ERIC, MasterFILE Premier, E-Journals, Africa-Wide Information, and Academic Search Premier electronic databases and non-peer-reviewed articles in Seminars in Hearing. The publications were predominantly philosophical, focused on the rehabilitative role of the audiologist, and addressed the moral judgment component of moral behavior. Despite the fact that knowledge of ethics grew between 1980 and 2010, this retrospective analysis identified gaps in current knowledge. Research is needed to address the unique ethical problems commonly encountered in all 8 roles of the audiologist; patient perspectives on ethics; ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in audiology.

  15. Nudging in screening: Literature review and ethical guidance.

    Science.gov (United States)

    Hofmann, Bjørn; Stanak, Michal

    2018-03-27

    Nudging is the purposeful alteration of choices presented to people that aims to make them choose in predicted ways. While nudging has been used to assure high uptake and good outcome of screening programs, it has been criticized for being paternalistic, undermining free choice, and shared decision making. Accordingly, the objective of this study is to explore a) nudging strategies identified in screening, b) arguments for and against nudging; and on basis of this, to c) suggest a tentative conclusion on how to handle nudging in screening. Literature searches in Ovid MEDLINE and PsycINFO for combinations of screening and nudging. Screening based on content analysis of titles, abstracts, and articles. 239 references were identified and 109 were included. Several forms of nudging were identified: framed information, default bias, or authority bias. Uptake and public health outcome were the most important goals. Arguments for nudging were bounded rationality, unavoidability, and beneficence, while lack of transparency, crowding out of intrinsic values, and paternalism were arguments against it. The analysis indicates that nudging can be acceptable for screenings with (high quality) evidence for high benefit-harm ratio (beneficence), where nudging does not infringe other ethical principles, such as justice and non-maleficence. In particular, nudging should not only focus on attendance rates, but also on making people "better choosers." Four specific recommendations follow from the review and the analysis: 1) Nudging should be addressed in an explicit and transparent manner. 2) The means of nudging have to be in proportion to the benefit-harm ratio. 3) Disagreement on the evidence for either benefits or harms warrants special care. 4) Assessing and assuring the intended outcome of nudging appears to be crucial, as it can be context dependent. Copyright © 2018 Elsevier B.V. All rights reserved.

  16. Why Are There So Few Ethics Consults in Children's Hospitals?

    Science.gov (United States)

    Carter, Brian; Brockman, Manuel; Garrett, Jeremy; Knackstedt, Angie; Lantos, John

    2017-10-03

    In most children's hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children's hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are (1) ethics committee meetings, (2) Nursing Ethics Forum, (3) ethics Brown Bag workshops, (4) PICU ethics rounds, (5) Grand Rounds, (6) NICU Comprehensive Care Rounds, (7) Palliative Care Team (PaCT) case conferences, (8) multidisciplinary consults in Fetal Health Center, and (9) ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of "core competencies" than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple "moral spaces" in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set

  17. Report of the review committee on evaluation of the R and D subjects in the field of nuclear fusion research

    International Nuclear Information System (INIS)

    2000-10-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of 12 experts was set up under the Research Evaluation Committee of the JAERI in order to review the whole R and D subjects in fusion research, including post-review for those completed in FY1998, intermediate-review for those started in FY1999, and pre-review for those to be implemented in FY2001. The Ad Hoc Review Committee meeting was held on March 9, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

  18. Ethics of health policy and systems research: a scoping review of the literature.

    Science.gov (United States)

    Pratt, Bridget; Paul, Amy; Hyder, Adnan A; Ali, Joseph

    2017-07-01

    Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in

  19. Ethical Challenges when Interviewing Close Relatives Together – An Integrative Review

    DEFF Research Database (Denmark)

    Voltelen, Barbara; Konradsen, Hanne; Østergaard, Birte

    and search terms. Results In total 17 articles were located, 9 containing relevant information about dyadic interviewing, only dealing subtly with questions of ethics. Another 8 articles addressed both dyadic interviewing and ethical considerations. Findings were divided into three different themes......Background and purpose Interviewing two interrelated persons (or more) simultaneously might pose different ethical considerations than interviewing just one person. Such ethical considerations, however, remain largely undescribed in literature, challenging the researcher who wishes to conduct them....... The purpose of this study is to describe the special ethical perspectives concerning joint interviews with interrelated persons. Method An integrative review was performed. A search was conducted in Pub Med, Cinahl, Philosophers Index and Academic Search from 1980 -2014. Data corpus from the 17 articles...

  20. Hazy Boundaries: Virtual Communities and Research Ethics

    Directory of Open Access Journals (Sweden)

    Helena Kantanen

    2016-10-01

    Full Text Available This paper examines ethical issues specific to research into virtual communities. Drawing on an empirical case with online forums of education experts, we identify the following key issues: publicity versus privacy of the community; the definition of human subjects research; participant recruitment; informed consent; and ethical questions associated with observing virtual communities, and with reporting and disseminating research results. We maintain that different research cultures in different countries can present challenges when studying global forums. Acknowledging the ephemeral characteristics of Internet contexts, this paper argues that ethical considerations should be more case-based, instead of relying on one model for all solutions. We suggest that local ethics committees or institutional review boards could, with their expert knowledge of ethics, provide valuable support for researchers operating in the complex and dynamic terrain of Internet research, as well as in fields and research settings where an ethical review is not a standard part of the research process.

  1. Report of the Committee to review safeguards requirements at power reactors

    International Nuclear Information System (INIS)

    1983-05-01

    In October 1982, NRC's Executive Director for Operations appointed a five-member Committee to review NRC security requirements at nuclear power plants with a view toward evaluating the impact of these requirements on operational safety. During visits to five power reactor sites and more than a dozen days of meetings over a period of four months, the Committee observed plant operating conditions and obtained views from abut 100 persons representing 16 nuclear utilities and industry organizations. They also interviewed about 40 NRC employees, including Resident Inspectors, and members of the Regional and Headquarters staffs. Overall, the Committee did not identify any clear operational safety problems associated with implementation of the NRC's security requirements. However, they did find that the potential existed, to varying degrees, at licensed facilities. The Committee's report, dated February 28, 1983, contains five basic findings and a number of associated recommendations intended to minimize the potential impact of security on safety

  2. Enabling Ethical Code Embeddedness in Construction Organizations: A Review of Process Assessment Approach.

    Science.gov (United States)

    Oladinrin, Olugbenga Timo; Ho, Christabel Man-Fong

    2016-08-01

    Several researchers have identified codes of ethics (CoEs) as tools that stimulate positive ethical behavior by shaping the organisational decision-making process, but few have considered the information needed for code implementation. Beyond being a legal and moral responsibility, ethical behavior needs to become an organisational priority, which requires an alignment process that integrates employee behavior with the organisation's ethical standards. This paper discusses processes for the responsible implementation of CoEs based on an extensive review of the literature. The internationally recognized European Foundation for Quality Management Excellence Model (EFQM model) is proposed as a suitable framework for assessing an organisation's ethical performance, including CoE embeddedness. The findings presented herein have both practical and research implications. They will encourage construction practitioners to shift their attention from ethical policies to possible enablers of CoE implementation and serve as a foundation for further research on ethical performance evaluation using the EFQM model. This is the first paper to discuss the model's use in the context of ethics in construction practice.

  3. 药物临床试验伦理委员会运作实践%The Operation of Ethics Committees in Drug Clinical Trials

    Institute of Scientific and Technical Information of China (English)

    鲁瑞萍; 单志桂; 申洁

    2013-01-01

    在药物临床试验的过程中,必须对受试者的个人权益给予充分的保障,并确保试验的科学性和可靠性.伦理委员会与知情同意书是保障受试者权益的主要措施.为确保临床试验中受试者的权益,须成立独立的伦理委员会,并向国家食品药品监督管理局备案.介绍了某医院药物临床试验伦理委员会的组成及备案、规范伦理委员会运作、存在的问题以及解决的对策与方法.%In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects'rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.

  4. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods

    Directory of Open Access Journals (Sweden)

    Bernabe Rosemarie D L C

    2012-04-01

    Full Text Available Abstract Background Research ethics committees (RECs are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision. Conclusion As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task.

  5. An author's guide to publication ethics: a review of emerging standards in biomedical journals.

    Science.gov (United States)

    Roberts, Jason

    2009-04-01

    Universal definitions of ethical issues related to medical publishing have remained somewhat elusive. Training in the art of writing for medical journals is inconsistent and most commonly informal, involving collaborative efforts between mentors and students. This approach inadvertently may perpetuate erroneous assumptions as to what constitutes acceptable behavior. In contrast to instruction on composition, ethical considerations related to the publication of a paper are likely to receive little attention. Even so, consequent to the ever-increasing scrutiny from the media and government agencies, journals are recognizing the need for greater transparency in peer review and are thus more inclined to enforce ethical standards. Understanding that some apparent ethical contraventions are the result of confusion or a lack of knowledge, some journals are assuming the responsibility of educating their community about ethical issues in publishing. This paper reviews the key ethical issues (eg, authorship criteria, conflicts of interest, redundant publication, data access and biases in data reporting, image manipulation) that authors should consider before submitting a manuscript. It also surveys some of the policies of the most highly cited clinical medical journals. In the future, authors can anticipate that their submissions will be required to meet an expanding array of ethical standards.

  6. Ethical issues in obesity prevention for school children: a systematic qualitative review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2017-12-01

    Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. Literature was searched in Medline, EBSCO and others. Three different search strategies with varied scopes were applied and their output was compared. Qualitative content analysis was used for extracting and categorizing ethical issues. 109 publications (published from 1995 to 2015) were finally included. The qualitative analysis resulted in 60 potentially relevant ethical issues. The three search strategies showed substantial differences regarding their search results. The presented spectrum provides an initial evidence base for dealing with ethical issues adequately. The findings of the study further suggest that a broader scope is more fruitful for systematic reviews on ethical issues in the field of public health.

  7. Can Neuroscience Contribute to Practical Ethics? A Critical Review and Discussion of the Methodological and Translational Challenges of the Neuroscience of Ethics.

    Science.gov (United States)

    Racine, Eric; Dubljević, Veljko; Jox, Ralf J; Baertschi, Bernard; Christensen, Julia F; Farisco, Michele; Jotterand, Fabrice; Kahane, Guy; Müller, Sabine

    2017-06-01

    Neuroethics is an interdisciplinary field that arose in response to novel ethical challenges posed by advances in neuroscience. Historically, neuroethics has provided an opportunity to synergize different disciplines, notably proposing a two-way dialogue between an 'ethics of neuroscience' and a 'neuroscience of ethics'. However, questions surface as to whether a 'neuroscience of ethics' is a useful and unified branch of research and whether it can actually inform or lead to theoretical insights and transferable practical knowledge to help resolve ethical questions. In this article, we examine why the neuroscience of ethics is a promising area of research and summarize what we have learned so far regarding its most promising goals and contributions. We then review some of the key methodological challenges which may have hindered the use of results generated thus far by the neuroscience of ethics. Strategies are suggested to address these challenges and improve the quality of research and increase neuroscience's usefulness for applied ethics and society at large. Finally, we reflect on potential outcomes of a neuroscience of ethics and discuss the different strategies that could be used to support knowledge transfer to help different stakeholders integrate knowledge from the neuroscience of ethics. © 2017 John Wiley & Sons Ltd.

  8. Understanding bureaucracy in health science ethics: toward a better institutional review board.

    Science.gov (United States)

    Bozeman, Barry; Slade, Catherine; Hirsch, Paul

    2009-09-01

    Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.

  9. Report of the review committee on evaluation of the research subjects in the field of advanced science research (FY2000)

    International Nuclear Information System (INIS)

    2000-10-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research themes completed in FY1999, those to be ended through FY2000, and those planned for five years starting in FY2001 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on July 17, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

  10. Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

    Science.gov (United States)

    Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J

    2016-04-01

    Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.

  11. Minors and euthanasia: a systematic review of argument-based ethics literature.

    Science.gov (United States)

    Cuman, Giulia; Gastmans, Chris

    2017-07-01

    Euthanasia was first legalised in the Netherlands in 2002, followed by similar legislation in Belgium the same year. Since the beginning, however, only the Netherlands included the possibility for minors older than 12 years to request euthanasia. In 2014, the Belgian Act legalising euthanasia was amended to include requests by minors who possess the capacity of discernment. This amendment sparked great debate, and raised difficult ethical questions about when and how a minor can be deemed competent. We conducted a systematic review of argument-based literature on euthanasia in minors. The search process followed PRISMA guidelines. Thirteen publications were included. The four-principle approach of medical ethics was used to organise the ethical arguments underlying this debate. The justification for allowing euthanasia in minors is buttressed mostly by the principles of beneficence and respect for autonomy. Somewhat paradoxically, both principles are also used in the literature to argue against the extension of legislation to minors. Opponents of euthanasia generally rely on the principle of non-maleficence. The present analysis reveals that the debate surrounding euthanasia in minors is at an early stage. In order to allow a more in-depth ethical discussion, we suggest enriching the four-principle approach by including a care-ethics approach. What is Known: • The Netherlands and Belgium are the only two countries in the world with euthanasia legislation making it possible for minors to receive euthanasia. • This legislation provoked great debate globally, with ethical arguments for and against this legislation. What is New: • A systematic description of the ethical concepts and arguments grounding the debate on euthanasia in minors, as reported in the argument-based ethics literature. • A need has been identified to enrich the debate with a care-ethics approach to avoid oversimplifying the ethical decision-making process.

  12. Technology and its ethics in nursing and caring journals: An integrative literature review.

    Science.gov (United States)

    Korhonen, Eila-Sisko; Nordman, Tina; Eriksson, Katie

    2015-08-01

    Over the past 20 years, the impact of technology has increased significantly in health care. The diversity of technology is growing and its knowledge scattered. The concept of technology is ambiguous in caring and nursing sciences and its ethics remains unidentified. To find evidence on how the concept of technology and its ethics are defined in caring and nursing sciences and practice. The purpose of this study is to describe and summarize the concept of technology and its ethics in the past nursing and caring literature. The integrative literature review of the past nursing and caring literature. The data were collected from caring and nursing journal articles from 2000 to 2013 focusing on technology and its ethics.The results were summarized and themed. Technology as a concept has three implications. First, technology is devices and products, including ICT and advanced, simple and assistive technology. Second, technology refers to a process consisting of methods for helping people. Third, technology as a service indicates the production of care by technology. The ethics of technology has not been established as a guiding principle. Some studies excluded ethical reflection completely. Many studies discussed the ethics of technology as benefits such as improved communication and symptoms management, and the simple use of e-health services whilst others remained critical presenting ethical problems such as unwillingness and the inability to use technology, or conflicts with human aspects or questions of inequality. In conclusion, this study indicates that technology as a concept is described diversely. The relation between technology and ethics is not a truism. Despite some evidence, more is needed to promote ethical care when using technology. © The Author(s) 2014.

  13. Report of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. Result evaluation in fiscal year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)

  14. Report of the evaluation by the Ad Hoc Review Committee on Health Physics. Result evaluation in fiscal year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Health Physics in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Health Physics in Tokai Research Establishment and at related departments in other Establishments of JAERI. The Ad Hoc Review Committee consisted of six specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from October 2000 to January 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on October 10, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Health Physics. (author)

  15. Report of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. Result evaluation in fiscal year 2000

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)

  16. In defence of governance: ethics review and social research.

    Science.gov (United States)

    Sheehan, Mark; Dunn, Michael; Sahan, Kate

    2017-10-10

    There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake-protecting researchers' freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy-raise relevant ethical considerations that are reasonably contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Progress in centralised ethics review processes: Implications for multi-site health evaluations.

    Science.gov (United States)

    Prosser, Brenton; Davey, Rachel; Gibson, Diane

    2015-04-01

    Increasingly, public sector programmes respond to complex social problems that intersect specific fields and individual disciplines. Such responses result in multi-site initiatives that can span nations, jurisdictions, sectors and organisations. The rigorous evaluation of public sector programmes is now a baseline expectation. For evaluations of large and complex multi-site programme initiatives, the processes of ethics review can present a significant challenge. However in recent years, there have been new developments in centralised ethics review processes in many nations. This paper provides the case study of an evaluation of a national, inter-jurisdictional, cross-sector, aged care health initiative and its encounters with Australian centralised ethics review processes. Specifically, the paper considers progress against the key themes of a previous five-year, five nation study (Fitzgerald and Phillips, 2006), which found that centralised ethics review processes would save time, money and effort, as well as contribute to more equitable workloads for researchers and evaluators. The paper concludes with insights for those charged with refining centralised ethics review processes, as well as recommendations for future evaluators of complex multi-site programme initiatives. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Specialist committee's review reports for experimental fast reactor JOYO' MK-III performance tests

    International Nuclear Information System (INIS)

    Yamashita, Kiyonobu; Okubo, Toshiyuki; Kamide, Hideki

    2004-02-01

    Performance tests (startup-physics tests and power elevation tests) were planed for experimental fast reactor 'JOYO' MK-III where irradiation performances were upgraded by power increase from 100 to 140 MW. The reactor safety committee of O-arai Engineering Center has established a specialist committee for 'JOYO' MK-III Performance Tests at the first meeting of 2003 on 23th. April 2003, to accomplish the tests successfully. Subjects of the specialist committee were reviews of following items covering a wide range. 1) Contents of modification works. 2) Reflections of functional test results to the plant and facilities. 3) Reflections of safety rule modification to instruction and manual for operation. 4) Quality assurances and pre-calculation for performance test. 5) Inspection plan and its results. 6) Adequacy of performance test plan. 7) Confirmation of performance test results. Before test-starts, the specialist committee has confirmed by reviewing the items from 1) to 6) based on explanations and documents of the Division of Experimental Reactor, that the test plan and pre-inspections are adequate. After the tests, the specialist committee had confirmed by reviewing the item 7) in the same way, that the each test result satisfies the corresponding criterion. The specialist committee has concluded from these review's results before and after the tests that the 'JOYO' MK-III Performance Tests were carried out appropriately. Besides, the first criticality of the JOYO MK-III was achieved on 2nd. July 2003, and the continuous full power operation was carried on 20th. Nov. 2003. Finally, all performance tests were completed by the pass of the last governmental pre-serviced inspection (dose rate measurement during the shut down condition). (author)

  19. Consensus, contracts, and committees.

    Science.gov (United States)

    Moreno, J D

    1991-08-01

    Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this level of analysis than about the ethics committee phenomenon itself.

  20. Preparing students for the ethical challenges on international health electives: A systematic review of the literature on educational interventions.

    Science.gov (United States)

    Rahim, Anika; Knights Née Jones, Felicity; Fyfe, Molly; Alagarajah, Janagan; Baraitser, Paula

    2016-09-01

    International health electives pose specific ethical challenges for students travelling from to low and middle income countries. We undertook a systematic review of the literature on interventions to prepare students to identify ethical issues addressed, educational approaches and to collate evidence on the effectiveness of different strategies. We searched nine electronic databases of peer-reviewed literature and identified grey literature through key word searches; supplemented through citation mapping and expert consultation. Articles that described ethical training conducted by universities or professional bodies were included for review. We reviewed forty-four full text articles. Ten sources of published literature and seven sources of grey literature met our inclusion criteria. We identified thirteen ethical situations that students should be prepared to manage and eight generic skills to support this process. Most interventions were delivered before the elective, used case studies or guidelines. Some suggested ethical principles or a framework for analysis of ethical issues. Only two papers evaluated the intervention described. Our paper collates a small but growing body of work on education to prepare students to manage ethical issues. Ethical training should have elements that are delivered before, during and after the elective. Interventions should include case studies covering thirteen ethical issues identified here, linked to ethical principles and a process for responding to ethical issues. We suggest that evaluations of interventions are an important area for future research.

  1. 77 FR 74875 - Native American Graves Protection and Repatriation Review Committee Findings Related to the...

    Science.gov (United States)

    2012-12-18

    ... to convene the parties to a dispute relating to the identity and return of cultural items, and to... American Graves Protection and Repatriation Review Committee Findings Related to the Identity and Return of Cultural Items in the Possession of the University of Pennsylvania Museum of Archaeology and Anthropology...

  2. 42 CFR 50.405 - What is the structure of review committees?

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false What is the structure of review committees? 50.405 Section 50.405 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Public Health Service Grant Appeals Procedure § 50.405 What is the...

  3. Extra-Judicial Complaints Review: First Experiences of the Dutch Public Procurement Experts Committee

    NARCIS (Netherlands)

    Jansen, C.E.C.; Janssen, J.G.J.; Muntz-Beekhuis, J.S.

    2014-01-01

    Article 4.27 of the Dutch Public Procurement Act 2012 (‘Aanbestedingswet’) provides for a statutory basis for extra-judicial public procurement complaints review by an independent body: The Public Procurement Experts Committee (‘Commissie van Aanbestedingsexperts’), hereinafter referred to as: ‘the

  4. Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices.

    Science.gov (United States)

    Watts, Logan L; Todd, E Michelle; Mulhearn, Tyler J; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

    2017-01-01

    Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.

  5. Ethical Challenges of Medicine and Health on the Internet: A Review

    Science.gov (United States)

    2001-01-01

    Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role

  6. Ethical challenges of medicine and health on the Internet: a review.

    Science.gov (United States)

    Dyer, K A

    2001-01-01

    Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role

  7. Nursing and euthanasia: a review of argument-based ethics literature.

    Science.gov (United States)

    Quaghebeur, Toon; Dierckx de Casterlé, Bernadette; Gastmans, Chris

    2009-07-01

    This article gives an overview of the nursing ethics arguments on euthanasia in general, and on nurses' involvement in euthanasia in particular, through an argument-based literature review. An in-depth study of these arguments in this literature will enable nurses to engage in the euthanasia debate. We critically appraised 41 publications published between January 1987 and June 2007. Nursing ethics arguments on (nurses' involvement in) euthanasia are guided primarily by the principles of respect for autonomy, nonmaleficence, beneficence and justice. Ethical arguments related to the nursing profession are described. From a care perspective, we discuss arguments that evaluate to what degree euthanasia can be considered positively or negatively as a form of good nursing care. Most arguments in the principle-, profession- and care-orientated approaches to nursing ethics are used both pro and contra euthanasia in general, and nurses' involvement in euthanasia in particular.

  8. Ethical Considerations Regarding the Use of Smart Home Technologies for Older Adults: An Integrative Review.

    Science.gov (United States)

    Chung, Jane; Demiris, George; Thompson, Hilaire J

    2016-01-01

    With the wide adoption and use of smart home applications, there is a need for examining ethical issues regarding smart home use at the intersection of aging, technology, and home environment. The purpose of this review is to provide an overview of ethical considerations and the evidence on these ethical issues based on an integrative literature review with regard to the utilization of smart home technologies by older adults and their family members. REVIEW DESIGN AND METHODS: We conducted an integrative literature review of the scientific literature from indexed databases (e. g., MEDLINE, CINAHL, and PsycINFO). The framework guiding this review is derived from previous work on ethical considerations related to telehealth use for older adults and smart homes for palliative care. Key ethical issues of the framework include privacy, informed consent, autonomy, obtrusiveness, equal access, reduction in human touch, and usability. Six hundred and thirty-five candidate articles were identified between the years 1990 and 2014. Sixteen articles were included in the review. Privacy and obtrusiveness issues appear to be the most important factors that can affect smart home technology adoption. In addition, this article recommends that stigmatization and reliability and maintenance of the system are additional factors to consider. When smart home technology is used appropriately, it has the potential to improve quality of life and maintain safety among older adults, ultimately supporting the desire of older adults for aging in place. The ability to respond to potential ethical concerns will be critical to the future development and application of smart home technologies that aim to enhance safety and independence.

  9. Review of the Fusion Theory and Computing Program. Fusion Energy Sciences Advisory Committee (FESAC)

    International Nuclear Information System (INIS)

    Antonsen, Thomas M.; Berry, Lee A.; Brown, Michael R.; Dahlburg, Jill P.; Davidson, Ronald C.; Greenwald, Martin; Hegna, Chris C.; McCurdy, William; Newman, David E.; Pellegrini, Claudio; Phillips, Cynthia K.; Post, Douglass E.; Rosenbluth, Marshall N.; Sheffield, John; Simonen, Thomas C.; Van Dam, James

    2001-01-01

    At the November 14-15, 2000, meeting of the Fusion Energy Sciences Advisory Committee, a Panel was set up to address questions about the Theory and Computing program, posed in a charge from the Office of Fusion Energy Sciences (see Appendix A). This area was of theory and computing/simulations had been considered in the FESAC Knoxville meeting of 1999 and in the deliberations of the Integrated Program Planning Activity (IPPA) in 2000. A National Research Council committee provided a detailed review of the scientific quality of the fusion energy sciences program, including theory and computing, in 2000.

  10. Ethics in Online Publications.

    Science.gov (United States)

    Vervaart, Peter

    2014-10-01

    Journals have been publishing the results of scientific investigations since the founding of Philosophical Transactions in 1665. Since then we have witnessed a massive expansion in the number of journals to the point that there are now approximately 28,000 active, peer reviewed journals collectively publishing more than 1.8 million articles per year. Before the mid-1990s, these journals were only available on paper but by the end of the 20th century, most journals had moved to online platforms. Online publication has also served as the impetus for the move to 'open-access' to the information contained in journals. The fact that a publication is 'on-line' and 'open-access' does not negate the responsibility of the author and the publisher to publish in an ethical way. [1] The document produced by the IFCC Ethics Task Force (TF-E) on publication ethics states that 'Ethics in Science at its broadest level encompasses research ethics, medical ethics, publication ethics, conflicts of interest, ethical responsibilities as educator, plus many other areas.' Thus publication ethics is a continuum from the first step of research design through to the information being read by the reader. In general terms 'publication ethics' includes the ethical behaviour of the authors in writing and submitting a scientific manuscript to a publisher for the purpose of publication, thus any discussion of publication ethics must include the role of the authors, referees, publisher and reader and the issues of authorship (and the use of 'ghosts'), plagiarism, duplicate publication (including in different languages), image manipulation (particularly in the era of digitisation), and conflict of interest [2]. To aid the authors, and others involved in the process of publication, a number of resources are now available particularly those from the Committee on Publication Ethics (COPE) [3] and the World Association of Medical Editors (WAME) [4]. More recently the issue of 'publisher ethics' has

  11. Guidelines for the Ethical Publication of Facial Photographs and Review of the Literature.

    Science.gov (United States)

    Bennett, Katelyn G; Bonawitz, Steven C; Vercler, Christian J

    2018-01-01

    Facial photography presents a unique ethical dilemma, as faces are difficult to deidentify for publication. We performed a review of the literature to examine current guidelines for the publication of facial photographs. We also reviewed societies' websites, journal requirements, and ethical and legal aspects of confidentiality. Most articles emphasized the importance of consent for photography and publication. Masking is not appropriate, but some journals continue to allow masking. Most legislation allows patients to restrict the uses of photographs. In the end, it is imperative to protect patient privacy by obtaining consent for photograph publication after full disclosure of risks, and specific recommendations are provided regarding a comprehensive consent process.

  12. Boards of directors, audit committees and financial reporting quality. A systematic review

    Directory of Open Access Journals (Sweden)

    Karolina Skorulska

    2016-12-01

    Full Text Available Measurement of financial reporting quality is a problematic task because financial reporting is difficult to observe and measure. The aim of the article is to present the methods of financial reporting quality meas-urement and a systematic review of literature on the effects of corporate governance reforms on the qualityof financial reporting. The main research questions are: (1 what are the possibilities of measuring financial reporting for research purposes, (2 which of the methods of measuring the quality of financial reporting are used in research on corporate governance, and (3 which variables used in measuring corporate gov-ernance factors affect financial reporting quality? To answer these questions, a critical analysis of literature and a systematic review of research results using meta-analysis was made. For selecting the best articles a three-step collection strategy was used, which resulted in a database of 38 publications. The review has shown that for measuring the quality of financial reporting researchers most frequently use models based on measurement of risk management, and the most common independent variables describing corporate governance are: the size of the audit committee, presence of independent directors on the supervisory board, dual role of CEO, proportion of independent directors in the audit committee, size of the supervisory board, proportion of accounting experts in the audit committee, and frequency of audit committee meetings

  13. Applying for ethical approval for research: the main issues.

    Science.gov (United States)

    Gelling, Leslie

    2016-01-13

    The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

  14. The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

    Science.gov (United States)

    McLennan, Stuart; Kahrass, Hannes; Wieschowski, Susanne; Strech, Daniel; Langhof, Holger

    2018-04-01

    To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict. A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective. A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care. The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.

  15. Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

    Science.gov (United States)

    Salman Popattia, Amber; Winch, Sarah; La Caze, Adam

    2018-04-01

    The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines. © 2018 Royal Pharmaceutical Society.

  16. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

    Science.gov (United States)

    Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

    2007-07-01

    National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more

  17. Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

    Science.gov (United States)

    Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

    2007-01-01

    National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework

  18. Strategic appraisal of environmental risks: a contrast between the United Kingdom's Stern Review on the Economics of Climate Change and its Committee on Radioactive Waste Management.

    Science.gov (United States)

    Dietz, Simon; Morton, Alec

    2011-01-01

    In this article, we compare two high-profile strategic policy reviews undertaken for the U.K. government on environmental risks: radioactive waste management and climate change. These reviews took very different forms, both in terms of analytic approach and deliberation strategy. The Stern Review on the Economics of Climate Change was largely an exercise in expert modeling, building, within a cost-benefit framework, an argument for immediate reductions in carbon emissions. The Committee on Radioactive Waste Management, on the other hand, followed a much more explicitly deliberative and participative process, using multicriteria decision analysis to bring together scientific evidence and stakeholder and public values. In this article, we ask why the two reviews were different, and whether the differences are justified. We conclude that the differences were mainly due to political context, rather than the underpinning science, and as a consequence that, while in our view "fit for purpose," they would both have been stronger had they been less different. Stern's grappling with ethical issues could have been strengthened by a greater degree of public and stakeholder engagement, and the Committee on Radioactive Waste Management's handling of issues of uncertainty could have been strengthened by the explicitly probabilistic framework of Stern. © 2010 Society for Risk Analysis.

  19. Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

    Science.gov (United States)

    Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

    2015-12-01

    Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed 'too great an emphasis on guidelines and research ethics review', which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. © 2014 John Wiley & Sons Ltd.

  20. Review of existing issues, ethics and practices in general medical research and in radiation protection research

    International Nuclear Information System (INIS)

    Schreiner-Karoussou, A.

    2008-01-01

    A literature review was carried out in relation to general medical research and radiation protection research. A large number of documents were found concerning the subject of ethics in general medical research. For radiation protection research, the number of documents and the information available is very limited. A review of practices in 13 European countries concerning general medical research and radiation protection research was carried out by sending a questionnaire to each country. It was found that all countries reviewed were well regulated for general medical research. For research that involves ionising radiation, the UK and Ireland are by far the most regulated countries. For other countries, there does not seem to be much information available. From the literature review and the review of practices, a number of existing ethical issues were identified and exposed, and a number of conclusions were drawn. (authors)

  1. Sexuality in institutionalized elderly persons: a systematic review of argument-based ethics literature.

    Science.gov (United States)

    Mahieu, Lieslot; Gastmans, Chris

    2012-03-01

    Admission to a nursing home might challenge the way in which individuals experience their own sexuality, but it does not automatically diminish their need and desire for sexual fulfillment. Despite the fact that sexuality proves to be an intrinsic part of human existence, the sexual expression of geriatric residents remains a sensitive subject for many caregivers and family members. It evokes a variety of ethical issues and concerns, especially when dementia patients are involved. The overall objective of this review was to examine the ethical arguments and concepts about the debate on sexuality within a nursing home environment. We conducted a systematic search for argument-based ethics literature focusing on sexuality in institutionalized elderly people. Twenty-five appropriate studies were identified. A thematic analysis of the included literature led us to distinguish two major groups of ethical arguments: (i) principles and (ii) care. Ethics arguments on sexuality in institutionalized elderly are particularly guided by the principle of respect for autonomy and the concomitant notion of informed consent. Arguments related to care were also apparent within the research literature although they received considerably less attention than the arguments related to the principles of respect for autonomy, beneficence, nonmaleficence and justice. The lack of clarity in the conceptualization of the arguments referred to in the research literature indicates that there is a pressing need for a better defined, more fundamental philosophical-ethical analysis of the values at stake.

  2. Ethical leadership

    NARCIS (Netherlands)

    den Hartog, D.N.

    2015-01-01

    High-profile cases of leaders’ ethical failure in different settings and sectors have led to increased attention to ethical leadership in organizations. In this review, I discuss the rapidly developing field of ethical leadership from an organizational behavior/psychology perspective, taking a

  3. Report of the Review Committee on evaluation of the R and D subjects in the fields of Environmental Science and Health Physics

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-07-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods, etc., the Ad Hoc Review Committee composed of nine experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY2000 in the Department of Environmental Science and Department of Health Physics. The Ad Hoc Review Committee meeting was held on August 30, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on March 14, 2000. As a result, the Research Evaluation Committee acknowledged appropriateness of the review results. This report describes the review results. (author)

  4. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Hyuk; Min, Byung Joo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2007-10-15

    After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET.

  5. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    International Nuclear Information System (INIS)

    Kwon, Hyuk; Min, Byung Joo

    2007-01-01

    After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET

  6. Ethical Decision Making in Academic Dishonesty with Application of Modified Theory of Planned Behavior: A Review

    Science.gov (United States)

    Meng, Chan Ling; Othman, Jamilah; D'Silva, Jeffrey Lawrence; Omar, Zoharah

    2014-01-01

    This conceptual paper studies the application of the Theory of Planned Behavior (TBP) in academic dishonesty with the mediating variable of ethical ideologies. The study reviews literature on the Theory of Planned Behavior and past studies pertaining to academic dishonesty. The paper analyses the relationship of the variables of TPB on academic…

  7. Action Researchers Encountering Ethical Review: A Literature Synthesis on Challenges and Strategies

    Science.gov (United States)

    Fouché, Christa B.; Chubb, Laura A.

    2017-01-01

    Action research (AR) comprises a diverse family of methodologies. Common amongst most types of AR are both an emergent design--leading to action or change--and participation or community involvement. While this type of research has expanded considerably since the early 2000s, the criteria used for ethical review have apparently been slow to adapt…

  8. Workplace Incivility in Nursing: A Literature Review Through the Lens of Ethics and Spirituality.

    Science.gov (United States)

    Phillips, Gwenda Smith; MacKusick, Carol Isaac; Whichello, Ramona

    A literature review was conducted to evaluate existing knowledge of incivility in the nursing workplace through the lens of nursing ethics and spirituality. Study articles presented a consistent theme of improved organizational commitment and job satisfaction when spirituality was injected into the workplace. It seems plausible to suggest a positive correlation between spirituality and more civil environments in nursing workplaces.

  9. Palliative Sedation for Existential Suffering: A Systematic Review of Argument-Based Ethics Literature.

    Science.gov (United States)

    Rodrigues, Paulo; Crokaert, Jasper; Gastmans, Chris

    2018-06-01

    Although unanimity exists on using palliative sedation (PS) for controlling refractory physical suffering in end-of-life situations, using it for controlling refractory existential suffering (PS-ES) is controversial. Complicating the debate is that definitions and terminology for existential suffering are unclear, ambiguous, and imprecise, leading to a lack of consensus for clinical practice. To systematically identify, describe, analyze, and discuss ethical arguments and concepts underpinning the argument-based bioethics literature on PS-ES. We conducted a systematic search of the argument-based bioethics literature in PubMed, CINAHL, Embase ® , The Philosopher's Index, PsycINFO ® , PsycARTICLES ® , Scopus, ScienceDirect, Web of Science, Pascal-Francis, and Cairn. We included articles published in peer-reviewed journals till December 31, 2016, written in English or French, which focused on ethical arguments related to PS-ES. We used Peer Review of Electronic Search Strategies protocol, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and The Qualitative Analysis Guide of Leuven for data extraction and synthesis of themes. We identified 18 articles that met the inclusion criteria. Our analysis revealed mind-body dualism, existential suffering, refractoriness, terminal condition, and imminent death as relevant concepts in the ethical debate on PS-ES. The ethical principles of double effect, proportionality, and the four principles of biomedical ethics were used in argumentations in the PS-ES debate. There is a clear need to better define the terminology used in discussions of PS-ES and to ground ethical arguments in a more effective way. Anthropological presuppositions such as mind-body dualism underpin the debate and need to be more clearly elucidated using an interdisciplinary approach. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  10. A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making

    Directory of Open Access Journals (Sweden)

    Steven P. McCulloch

    2018-06-01

    Full Text Available Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE,~foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Committee and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an “Ethics Council for Animal Policy” to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs and examine some widely used ethical frameworks (e.g., Banner’s principles and the ethical matrix. The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i Problematisation of the policy issue, (ii utilitarian analysis, (iii animal rights analysis, (iv virtue-based analysis, (v animal welfare ethic analysis, and (vi integrated ethical analysis. The~paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

  11. A Review of Future and Ethical Perspectives of Robotics and AI

    Directory of Open Access Journals (Sweden)

    Jim Torresen

    2018-01-01

    Full Text Available In recent years, there has been increased attention on the possible impact of future robotics and AI systems. Prominent thinkers have publicly warned about the risk of a dystopian future when the complexity of these systems progresses further. These warnings stand in contrast to the current state-of-the-art of the robotics and AI technology. This article reviews work considering both the future potential of robotics and AI systems, and ethical considerations that need to be taken in order to avoid a dystopian future. References to recent initiatives to outline ethical guidelines for both the design of systems and how they should operate are included.

  12. Whether Audit Committee Financial Expertise Is the Only Relevant Expertise: A Review of Audit Committee Expertise and Timeliness of Financial Reporting

    Directory of Open Access Journals (Sweden)

    Saeed Rabea Baatwah

    2013-06-01

    Full Text Available This study reviews the literature on audit committee expertise and financial reporting timeliness. Financial reporting timeliness and audit committee expertise are two areas of research gaining the attention of a large number of stakeholders because they contribute to the reliability and the  relevancy of financial reporting. Indeed, the focus of this review is primarily on the recent developments in the pertinent literature in order to show the limitations of such research and encourage future research to overcome these limitations. By also looking at the development of the audit committee expertise literature, this study concludes that (1 like most audit committee literature, financial reporting timeliness literature continues to assume the absence of the contribution of expertise other than financial expertise, and ignore the role of audit committee chair; (2 most of this literature fails to find a significant effect because it ignores the interaction among corporate governance mechanisms. Accordingly, this study posits that ignoring the issues raised in such research by future research would lead to major mistakes in reforms relating to how the quality of financial reporting can be enhanced.

  13. e-Government Ethics : a Synergy of Computer Ethics, Information Ethics, and Cyber Ethics

    OpenAIRE

    Arief Ramadhan; Dana Indra Sensuse; Aniati Murni Arymurthy

    2011-01-01

    Ethics has become an important part in the interaction among humans being. This paper specifically discusses applied ethics as one type of ethics. There are three applied ethics that will be reviewed in this paper, i.e. computer ethics, information ethics, and cyber ethics. There are two aspects of the three applied ethics that were reviewed, i.e. their definition and the issues associated with them. The reviewing results of the three applied ethics are then used for defining e-Government eth...

  14. The use of care robots in aged care: A systematic review of argument-based ethics literature.

    Science.gov (United States)

    Vandemeulebroucke, Tijs; Dierckx de Casterlé, Bernadette; Gastmans, Chris

    2018-01-01

    As care robots become more commonplace in aged-care settings, the ethical debate on their use becomes increasingly important. Our objective was to examine the ethical arguments and underlying concepts used in the ethical debate on care robot use in aged care. We conducted a systematic literature search for argument-based ethics publications focusing on care robot use in aged-care practices. We used an innovative methodology that consisted of three steps: (a) identifying conceptual-ethical questions, (b) conducting a literature search, and (c) identifying, describing and analyzing the ethical arguments in connection with the conceptual-ethical questions. Twenty-eight appropriate publications were identified. All were published between 2002 and 2016. Four primary ethical approaches were distinguished: (a) a deontological, (b) a principlist, (c) an objective-list, and (d) a care-ethical. All approaches were equally represented across the articles, and all used similar concepts that grounded their diverse ethical arguments. A small group of publications could not be linked to an ethical approach. All included publications presented a strong ethical rationale based on fully elaborated normative arguments. Although the reviewed studies used similar grounding concepts, the studies' arguments were very diverse and sometimes diametrically opposed. Our analysis shows how one envisions care robot use in aged-care settings is influenced by how one views the traditional boundaries of the ethical landscape in aged care. We suggest that an ethical analysis of care robot use employs "democratic spaces," in which all stakeholders in aged care, especially care recipients, have a voice in the ethical debate. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  16. Proceedings of RIKEN BNL Research Center Workshop, Volume 91, RBRC Scientific Review Committee Meeting

    Energy Technology Data Exchange (ETDEWEB)

    Samios,N.P.

    2008-11-17

    The ninth evaluation of the RIKEN BNL Research Center (RBRC) took place on Nov. 17-18, 2008, at Brookhaven National Laboratory. The members of the Scientific Review Committee (SRC) were Dr. Dr. Wit Busza (Chair), Dr. Miklos Gyulassy, Dr. Akira Masaike, Dr. Richard Milner, Dr. Alfred Mueller, and Dr. Akira Ukawa. We are pleased that Dr. Yasushige Yano, the Director of the Nishina Institute of RIKEN, Japan participated in this meeting both in informing the committee of the activities of the Nishina Institute and the role of RBRC and as an observer of this review. In order to illustrate the breadth and scope of the RBRC program, each member of the Center made a presentation on his/her research efforts. This encompassed three major areas of investigation, theoretical, experimental and computational physics. In addition the committee met privately with the fellows and postdocs to ascertain their opinions and concerns. Although the main purpose of this review is a report to RIKEN Management (Dr. Ryoji Noyori, RIKEN President) on the health, scientific value, management and future prospects of the Center, the RBRC management felt that a compendium of the scientific presentations are of sufficient quality and interest that they warrant a wider distribution. Therefore we have made this compilation and present it to the community for its information and enlightenment.

  17. The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

    Science.gov (United States)

    Seitzer, F; Kahrass, H; Neitzke, G; Strech, D

    2016-02-01

    Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.

  18. Ethics challenges and guidance related to research involving adolescent post-abortion care: a scoping review.

    Science.gov (United States)

    Zulu, Joseph M; Ali, Joseph; Hallez, Kristina; Kass, Nancy; Michelo, Charles; Hyder, Adnan A

    2018-05-02

    An increase in post abortion care (PAC) research with adolescents, particularly in low- and middle-income countries, has brought to attention several associated research ethics challenges. In order to better understand the ethics context of PAC research with adolescents, we conducted a scoping review of published literature. Following a systematic search of PubMed, HINARI, and Google Scholar, we analysed articles meeting inclusion criteria to determine common themes across both the ethical challenges related to PAC research with adolescents and any available guidance on the identified challenges. The literature search identified an initial 3321 records of which 14 were included in analysis following screening. Several ethical challenges stem from abortion being a controversial, sensitive, and stigmatized topic in many settings. Ethical dilemmas experienced by researchers conducting adolescent PAC research included: difficulties in convincing local health providers to permit PAC research; challenges in recruiting and seeking consent due to sensitivity of the subject; effectively protecting confidentiality; managing negative effects of interventions; creating a non-prejudicial atmosphere for research; managing emotional issues among adolescents; and dealing with uncertainty regarding the role of researchers when observing unethical health care practices. Suggested strategies for addressing some of these challenges include: using several sources to recruit study participants, using research to facilitate dialogue on abortion, briefing health workers on any observed unethical practices after data collection, fostering a comprehensive understanding of contextual norms and values, selecting staff with experience working with study populations, and avoiding collection of personal identifiers. Addressing ethical challenges that researchers face when conducting PAC research with adolescents requires guidance at the individual, institutional, community, and international

  19. Provision of fertility services for women at increased risk of complications during fertility treatment or pregnancy: an Ethics Committee opinion.

    Science.gov (United States)

    2016-11-01

    This opinion addresses the ethics of providing fertility treatment to women at elevated risk from fertility treatment or pregnancy. Providers ethically may treat women at elevated risk provided that they are carefully assessed; that specialists in their medical condition are consulted as appropriate; and that patients are fully informed about risks, benefits, and alternatives, including oocyte and embryo donation, use of a gestational surrogate, not undergoing fertility care, and adoption. Providers also may conclude that the risks are too high for them to treat particular patients ethically; such determinations must be made in a medically objective and unbiased manner and patients must be fully informed of the decision. Counseling of women who wish to initiate fertility treatment with underlying medical conditions that confer increased risk during treatment or pregnancy should incorporate the most current knowledge available, being cognizant of the woman's personal determinants in relation to her reproductive desires. In such a way, both physician and patient will optimize decision making in an ethically sound, patient-supportive context. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  20. A missing ethical competency? A review of critical reflection in health promotion.

    Science.gov (United States)

    Tretheway, Rebecca; Taylor, Jane; O'Hara, Lily; Percival, Nikki

    2015-12-01

    There is increasing emphasis in the health promotion literature on the ethical imperative for the profession to move towards critical practice. A key challenge for health promotion is that critical practice appears both under-developed and under-practiced. This is evident in the omission of critical reflection from Australian and international competencies for health promotion practitioners. A narrative literature review was undertaken to explore the current use of critical reflection in health promotion. Critical reflection models relevant to health promotion were identified and critiqued. There was a dearth of literature on critical reflection within health promotion, despite recognition of its potential to support critical practice. The discipline of critical social work provided literature on the use, effect and outcome of critical reflection in practice. The interdisciplinary critical reflection model was identified as the model most applicable to health promotion. Underpinned by critical theory, this model emphasises both critical and ethical practice. Critical reflection is a core competency for health promotion practitioners to address the ethical imperative to move towards critical practice. There is a need to explore the application of a critical reflection model in health promotion to determine how it may support critical and ethical practice. So what? If health promotion is to meet its ethical responsibilities, then critical reflection needs to be articulated as a core health promotion competency and a model for its application in health promotion developed.

  1. Ethical Design of Intelligent Assistive Technologies for Dementia: A Descriptive Review.

    Science.gov (United States)

    Ienca, Marcello; Wangmo, Tenzin; Jotterand, Fabrice; Kressig, Reto W; Elger, Bernice

    2017-09-22

    The use of Intelligent Assistive Technology (IAT) in dementia care opens the prospects of reducing the global burden of dementia and enabling novel opportunities to improve the lives of dementia patients. However, with current adoption rates being reportedly low, the potential of IATs might remain under-expressed as long as the reasons for suboptimal adoption remain unaddressed. Among these, ethical and social considerations are critical. This article reviews the spectrum of IATs for dementia and investigates the prevalence of ethical considerations in the design of current IATs. Our screening shows that a significant portion of current IATs is designed in the absence of explicit ethical considerations. These results suggest that the lack of ethical consideration might be a codeterminant of current structural limitations in the translation of IATs from designing labs to bedside. Based on these data, we call for a coordinated effort to proactively incorporate ethical considerations early in the design and development of new products.

  2. Ethical Delphi Manual

    NARCIS (Netherlands)

    Millar, K.; Tomkins, S.; Thorstensen, E.; Mepham, B.; Kaiser, M.

    2006-01-01

    An ethical Delphi is an iterative participatory process between experts for exchanging views and arguments on ethical issues. The method is structured around the notion of a virtual committee where the exchange of ideas is conducted remotely through a series of opinion exchanges. The ethical Delphi

  3. [ETHICAL CONDUCT FOR RESEARCH INVOLVING INDIGENOUS PEOPLE IN FRANCE: A COMMENT OF THE CNRS ETHICS COMMITTEE OPINION ON THE IMPERATIVE OF FAIRNESS IN THE RELATIONSHIP BETWEEN RESEARCHERS AND INDIGENOUS PEOPLES].

    Science.gov (United States)

    Burelli, Thomas; Bambridge, Tamatoa

    2015-12-01

    Historically, scientific research and colonization process have maintained very close ties. In order to frame research involving indigenous peoples and to avoid situations of abuse, some States have developed very detailed ethicalframeworks. In France, there are no ethicalframework comparable to those observed in particular in Anglo-Saxon countries like Canada. Extensive discussions were conducted by the Ethics Committee of the CNRS leading to the adoption of an opinion of a high quality but which appears largely unknown and under-exploited. This opinion deals with "the delicate question of the rights of local and indigenous populations during the research projected conducted with their support in developed and developing countries (DCs)". In this paper, we propose to analyze how this opinion can be considered remarkable because it recognizes the current challenges of research projects involving indigenous people, but also because of his recommendations. We still see that the scope of its recommendations is however limited so far although some encouraging experiences like the recent adoption of the CRIOBE centre code of ethics in French Polynesia can be observed.

  4. DOE Advanced Scientific Computing Advisory Committee (ASCAC) Report: Exascale Computing Initiative Review

    Energy Technology Data Exchange (ETDEWEB)

    Reed, Daniel [University of Iowa; Berzins, Martin [University of Utah; Pennington, Robert; Sarkar, Vivek [Rice University; Taylor, Valerie [Texas A& M University

    2015-08-01

    On November 19, 2014, the Advanced Scientific Computing Advisory Committee (ASCAC) was charged with reviewing the Department of Energy’s conceptual design for the Exascale Computing Initiative (ECI). In particular, this included assessing whether there are significant gaps in the ECI plan or areas that need to be given priority or extra management attention. Given the breadth and depth of previous reviews of the technical challenges inherent in exascale system design and deployment, the subcommittee focused its assessment on organizational and management issues, considering technical issues only as they informed organizational or management priorities and structures. This report presents the observations and recommendations of the subcommittee.

  5. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  6. ETHICS OF SMART HOUSE WELFARE TECHNOLOGY FOR OLDER ADULTS: A SYSTEMATIC LITERATURE REVIEW.

    Science.gov (United States)

    Sánchez, Veralia Gabriela; Taylor, Ingrid; Bing-Jonsson, Pia Cecilie

    2017-01-01

    The University College of Southeast Norway has an on-going project to develop a smart house welfare system to allow older adults and people with disabilities to remain in their homes for as long as they wish in safe, dignified, living conditions. This article reviews reported ethical challenges to implementing smart houses for older adults. A systematic literature review identified twenty-four articles in English, French, Spanish, and Norwegian, which were analyzed and synthesized using Hofmann's question list to investigate the reported ethical challenges. Smart houses offer a promising way to improve access to home care for older adults and people with disabilities. However, important ethical challenges arise when implementing smart houses, including cost-effectiveness, privacy, autonomy, informed consent, dignity, safety, and trust. The identified ethical challenges are important to consider when developing smart house systems. Due to the limitations of smart house technology, designers and users should be mindful that smart houses can achieve a safer and more dignified life-style but cannot solve all the challenges related to ageing, disabilities, and disease. At some point, smart houses can no longer help persons as they develop needs that smart houses cannot meet.

  7. The 2008 annual report of the Regional Infant and Child Mortality Review Committee.

    Science.gov (United States)

    Randall, Brad; Wilson, Ann

    2009-12-01

    The 2008 annual report of the Regional Infant and Child Mortality Review Committee (RICMRC) is presented. This committee has as its mission the review of infant and child deaths so that information can be transformed into action to protect young lives. The 2008 review area includes South Dakota's Minnehaha, Turner, Lincoln, Moody, Lake, McCook, Union, Hansen, Miner and Brookings counties. Within our region in 2008, there were six infant deaths labeled as Sudden Unexpected Infant Deaths (SUID), of which two met the criteria for the Sudden Infant Death Syndrome (SIDS). The four non-SIDS SUID deaths all represented deaths where asphyxia from unsafe sleeping environments could not be excluded. In addition, there were two accidental deaths from asphyxia in unsafe sleeping enviroments. We need to continue to promote the "Back to Sleep" campaign message of not only placing infants to sleep on their backs, but also making sure infants are put down to sleep on safe, firm, sleeping surfaces and are appropriately dressed for the ambient temperature. Parents need to be aware of the potential hazards of bed-sharing with their infants. In both 2007 and 2008, four children died in motor vehicle crashes, none of which were alcohol-related. Three fire-related childhood deaths were associated with one house fire involving a nonfunctional smoke alarm and a sleeping arrangement without an easy egress from a fire. Since 1997, the RICMRC has sought to achieve its mission to "review infant and child deaths so that information can be transformed into action to protect young lives". For 2008, the committee reviewed 21 deaths from Minnehaha, Turner, Lincoln, Moody, Lake, McCook, Union, Hansen, Miner and Brookings counties that met the following criteria: Children under the age of 18 dying subsequent to hospital discharge following delivery. Children who either died in these counties from causes sustained in them, or residents who died elsewhere from causes sustained in the ten-county region.

  8. Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review

    Science.gov (United States)

    Ahmed, Shahd; Norman, Gill; Booth, Andrew

    2017-01-01

    Background Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. Objective The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. Methods A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. Results In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. Conclusions Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an

  9. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

  10. The Service Review Committee: Royal College of Radiologists. Philosophy, role, and lessons to be learned

    International Nuclear Information System (INIS)

    Thind, R.; Barter, S.

    2008-01-01

    The Service Review Committee (SRC) was established by the Board of the Faculty of Clinical Radiology in 2000. At the time, the RCR identified a clear need to respond appropriately and swiftly to requests for review of service provision in clinical radiology departments where trusts were concerned about standards or performance issues. It was recognized by the College that the poorly performing radiologist is often part of a department that is itself dysfunctional, and that sub-optimal performance may often reflect inadequate management, lack of support, overwhelming workload, or inadequate facilities. Following the completion of a range of service reviews during its first 6 years, the SRC recognized that among the reviews there were recurring themes and causes for poorly functioning departments. The committee felt it appropriate to share these with the wider radiological community. In doing so, it is hoped that other departments may recognize their own problems at an early stage and take appropriate steps to prevent any escalation of difficulties

  11. [International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

    Science.gov (United States)

    de Lecuona, Itziar

    2013-01-01

    The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in

  12. Ethics, big data and computing in epidemiology and public health.

    Science.gov (United States)

    Salerno, Jennifer; Knoppers, Bartha M; Lee, Lisa M; Hlaing, WayWay M; Goodman, Kenneth W

    2017-05-01

    This article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to "big data." This article presents a summary and further discussion of that symposium session. Three topic areas were presented: the policy implications of big data and computing, the fallacy of "secondary" data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy. To address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. A Review of Future and Ethical Perspectives of Robotics and AI

    OpenAIRE

    Jim Torresen

    2018-01-01

    In recent years, there has been increased attention on the possible impact of future robotics and AI systems. Prominent thinkers have publicly warned about the risk of a dystopian future when the complexity of these systems progresses further. These warnings stand in contrast to the current state-of-the-art of the robotics and AI technology. This article reviews work considering both the future potential of robotics and AI systems, and ethical considerations that need to be taken in order to ...

  14. [Continuing education in ethics: from clinical ethics to institutional ethics].

    Science.gov (United States)

    Brazeau-Lamontagne, Lucie

    2012-01-01

    The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

  15. Ethical considerations for field research on fishes

    Directory of Open Access Journals (Sweden)

    Rhett H. Bennett

    2016-12-01

    field research to minimise impacts on fish populations. It is envisaged that this review will be a useful resource for journal editorial committees intending to introduce ethical requirements for publication and for researchers, managers, conservation practitioners and research organisations when designing field studies on fishes, applying for ethical clearance and developing institutional ethical guidelines.

  16. Ethics Standards Impacting Test Development and Use: A Review of 31 Ethics Codes Impacting Practices in 35 Countries

    Science.gov (United States)

    Leach, Mark M.; Oakland, Thomas

    2007-01-01

    Ethics codes are designed to protect the public by prescribing behaviors professionals are expected to exhibit. Although test use is universal, albeit reflecting strong Western influences, previous studies that examine the degree issues pertaining to test development and use and that are addressed in ethics codes of national psychological…

  17. Report of the review committee on the Fermilab HGQ R and D program

    International Nuclear Information System (INIS)

    Devred, A.; Anerella, M.; Leroy, D.; Ostojic, R.; Schermer, R.; Vedrine, P.

    1999-04-01

    This document is the report of the committee which met at Fermi National Accelerator Laboratory on 18 and 19 March 1999 to review the Fermilab R and D program on High Gradient Quadrupole magnets for the Large Hadron Collider Insertion Regions. The promising results of model magnet HGQ05 constitute a significant step forward and provide a solid basis upon which to base the magnet program. Although, the quench performance of magnet HGQ05 shows good progress, it is not yet fully satisfactory and can still be improved. The committee recommends that particular attention be paid to the first training quenches at 1.9 K and that more analyses be carried out to find possible correlations between quench start localization and specific mechanical features. In particular, the committee recommends analyzing in detail collar deflection data that seem to indicate that the first training quenches at 1.9 K may have originated in a region of low azimuthal coil pre-compression. The relative success of magnet HGQ05 and a detailed understanding of the reason behind it should help focus the magnet program on a limited number of clearly identified issues. The magnet program should be revised immediately to incorporate the lessons learned from magnet HGQ05 and to address the most outstanding issues. (authors)

  18. Ethical issues in using data from quality management programs.

    Science.gov (United States)

    Nerenz, David R

    2009-08-01

    Since the advent of formal, data-driven quality improvement programs in health care in the late 1980s and early 1990s, there are have been questions raised about requirements for ethical committee review of quality improvement activities. A form of consensus emerged through a series of articles published between 1996 and 2007, but there is still significant variation among ethics review committees and individual project leaders in applying broad policies on requirements for committee review and/or written informed consent by participants. Recent developments in quality management, particularly the creation and use of multi-site disease registries, have raised new questions about requirements for review and consent, since the activities often have simultaneous research and quality improvement goals. This article discusses ways in which policies designed for local quality improvement projects and data bases may be adapted to apply to multi-site registries and research projects related to them.

  19. 影响医务人员医学伦理审查认知的因素分析%Analysis of the Influential Factors of Medical Staff's Cognition on Medical Ethics Review

    Institute of Scientific and Technical Information of China (English)

    黄娟; 孙昌林; 张静; 程雨蒙; 左玉玲

    2017-01-01

    Objective:To analyze the influential factors of medical staff's cognition on medical ethics review in Wuhan municipal medical institutions,and thus to provide suggestions for strengthening the ethical construction.Methods:Aquestionnaire survey was conducted among medical staff.Chi-square test and Logistic regression method were performed to analyze the influential factors of medical staff's cognition on medical ethics review.Results:The results showed that medical staff's cognition on medical ethics review was affected by the technical tide,education background,whether had received ethical education,the cognition on ethics committees and whether the medical institution had established ethics committee.With higher technical titles,they thought more necessity to establish ethics committees and conduct ethical review of the clinical applications of new technology and new business.Those with higher technical titles and had read the ethical propaganda materials thought it more necessary to conduct ethical review of the clinical application of new technology and new business and the ethical review of biomedical research involved human beings.Conclusions:The medical institution should embody the establishment and standardization of ethical committees into the hospital assessment management system,as a necessary condition for the application of research projects and achievement awards.Also,it should conduct medical ethics training for all medical staff.Only those passed the examination can enter into the research and clinical operation with certificates,which can protect the medical ethics education into practice.It should strengthen the medical staff's cognition on ethical review,constantly innovate the operation rules and management system based on following the basic ethical review principles,and constantly improve the medical ethical review mechanism.%目的 分析影响武汉市级医疗机构医务人员医学伦理审查认知的因素,为加强

  20. What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews.

    Science.gov (United States)

    Mertz, Marcel; Strech, Daniel; Kahrass, Hannes

    2017-12-19

    (Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological

  1. The ethics of HIV research with people who inject drugs in Africa: a desk review.

    Science.gov (United States)

    Mamotte, Nicole

    2012-03-01

    Injecting drug use is a growing problem in Africa and a growing risk factor for contracting HIV in the region. It is imperative that HIV research includes injecting drug users so that they too are able to benefit from safe and effective behavioural interventions and biomedical HIV prevention and treatment products. This article relates a critical review of the findings of a desk review of previously published literature. The article examines injecting drug use in relation to HIV-related risk and research in Kenya, Mauritius, Nigeria, South Africa and Tanzania. The ethical challenges of including people who inject drugs in HIV research in Africa are also presented. The review found injecting drug use to be on the increase in all the countries reviewed. HIV-risk behaviour among people who inject drugs, such as needle-sharing and higher-risk sexual behaviour, was also found to be widespread. Furthermore, criminalisation of drug use and strict anti-drug laws are common in the countries reviewed, while harm-reduction programmes for people who inject drugs were found to be limited. The review identified a number of ethical challenges to the involvement of people who inject drugs in HIV research in Africa. This includes the illegal status and stigma surrounding injecting drug use, which may complicate participant recruitment, enrolment and retention. In addition, a lack of funding for supportive programmes to help injecting drug users may hinder the provision of appropriate standards of prevention and care and treatment for those who seroconvert.

  2. Ethical issues in autologous stem cell transplantation (ASCT in advanced breast cancer: A systematic literature review

    Directory of Open Access Journals (Sweden)

    Scheibler Fueloep

    2011-04-01

    Full Text Available Abstract Background An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. Methods We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Results Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud, which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. Conclusions The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

  3. Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.

    Science.gov (United States)

    Droste, Sigrid; Herrmann-Frank, Annegret; Scheibler, Fueloep; Krones, Tanja

    2011-04-15

    An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

  4. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  5. The 2007 annual report of the Regional Infant and Child Mortality Review Committee.

    Science.gov (United States)

    Randall, Brad; Wilson, Ann L

    2008-08-01

    The mission of the Regional Infant and Child Mortality Review Committee (RICMRC) is to review infant and child deaths so that information can be transformed into action to protect young lives. The 2007 review area includes South Dakota's Minnehaha, Turner, Lincoln, Moody, Lake, McCook, Union, Hansen, Miner and Brookings counties. Although there were no deaths in 2007 that met the criteria of the Sudden Infant Death Syndrome (SIDS) in our region, there were three infant deaths associated with unsafe sleeping environments (including adult co-sleeping) that either caused or potentially may have caused these infants' deaths. We need to continue to promote the "Back to Sleep" campaign message of not only placing infants to sleep on their backs, but also making sure infants are put down to sleep on safe, firm sleeping surfaces and that they are appropriately dressed for the ambient temperature. Parents need to be aware of the potential hazards of co-sleeping with their infants. Compared to nine such deaths in 2006, only four deaths in 2007 involved motor-vehicle crashes, none of which were alcohol related. Two drowning deaths illustrated the rapidity in which even momentary caregiver distractions can lead to deaths in children in and around water. Since 1997 the Regional Infant and Child Mortality Review Committee (RICMRC) has sought to achieve its mission to "review infant and child deaths so that information can be transformed into action to protect young lives." For 2007, the committee reviewed 25 deaths from Minnehaha, Turner, Lincoln, Moody, Lake, McCook, Union, Hansen, Miner and Brookings counties that met the following criteria: Children under the age of 18 dying subsequent to hospital discharge following delivery. Children who either died in these counties from causes sustained in them, or residents who died elsewhere from causes sustained in the 10-county region. The report that follows reviews the committee's activities for 2007. No deaths meeting the criteria

  6. (No) Limits to Anglo-American Accounting? Reconstructing the History of the International Accounting Standards Committee ; A Review Article

    OpenAIRE

    Botzem, S.; Quack, S.

    2009-01-01

    The development of the current International Accounting Standards Board (IASB) from the earlier International Accounting Standards Committee (IASC) provides insight into many issues of international financial reporting, among them the characteristics of international accounting standards themselves. This article reviews Camfferman and Zeff’s [Camfferman, K., & Zeff, S. A. (2007). Financial reporting and global capital markets. A history of the international accounting standards committee 1973...

  7. Report of the International Review Committee of the joint proposal of the Japan Hadron Facility (KEK) and the Neutron Science Project (JAERI)

    International Nuclear Information System (INIS)

    1999-08-01

    The International Review Committee composed of twelve Japanese and foreign experts was set up under the Research Evaluation Committee of JAERI, and has reviewed the proposed joint project combining JAERI's Neutron Science Project and KEK's Japan Hadron Facility into one major facility. The review meeting took place on April 26-27, 1999, at JAERI Head quarters, Tokyo. According to the points of review given in advance, the review was implemented based on the joint project report submitted and presentations of both institutions. The Research Evaluation Committee received the review report and its explanations from the Review Committee on July 5. The Research Evaluation Committee has acknowledged appropriateness of the review results. This report describes the review results. (author)

  8. Under the shelter of ethics.

    Science.gov (United States)

    Lichterman, Boleslav L

    2005-01-01

    Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

  9. Ethical experiential learning in medical, nursing and allied health education: A narrative review.

    Science.gov (United States)

    Grace, Sandra; Innes, Ev; Patton, Narelle; Stockhausen, Lynette

    2017-04-01

    Students enrolled in medical, nursing and health science programs often participate in experiential learning in their practical classes. Experiential learning includes peer physical examination and peer-assisted learning where students practise clinical skills on each other. To identify effective strategies that enable ethical experiential learning for health students during practical classes. A narrative review of the literature. Pubmed, Cinahl and Scopus databases were searched because they include most of the health education journals where relevant articles would be published. A data extraction framework was developed to extract information from the included papers. Data were entered into a fillable form in Google Docs. Findings from identified studies were extracted to a series of tables (e.g. strategies for fostering ethical conduct; facilitators and barriers to peer-assisted learning). Themes were identified from these findings through a process of line by line coding and organisation of codes into descriptive themes using a constant comparative method. Finally understandings and hypotheses of relevance to our research question were generated from the descriptive themes. A total of 35 articles were retrieved that met the inclusion criteria. A total of 13 strategies for ethical experiential learning were identified and one evaluation was reported. The most frequently reported strategies were gaining written informed consent from students, providing information about the benefits of experiential learning and what to expect in practical classes, and facilitating discussions in class about potential issues. Contexts that facilitated participation in experiential learning included allowing students to choose their own groups, making participation voluntary, and providing adequate supervision, feedback and encouragement. A total of 13 strategies for ethical experiential learning were identified in the literature. A formal process for written consent was evaluated

  10. Equality as a central concept of nursing ethics: a systematic literature review.

    Science.gov (United States)

    Kangasniemi, Mari

    2010-12-01

    Equality is a central concept in the Western way of thinking and in health care. In ethics research within nursing science, equality is a key concept but the meaning of its contents is more or less presumptive. The purpose of this study was to define the concept of equality as a value of nursing ethics research. Data were collected through systematic literature review and analysed using deductive and inductive content analysis. Equality has been studied as a concept and in relation to ethical theories. In nursing ethics, research on equality on theoretical and functional level is presented. These levels consist of dimensions, i.e. themes, that equality is related to. The dimensions of the theoretical level are the equality of being, i.e. universal human value, and distributive equality, i.e. equal opportunities, circumstances and results. The dimensions of functional equality included themes such as critique of distributive equality, context, difference, power and care. Critique is aimed at incompatibility of theoretical level with practice. Context raises questions of each nursing situation in relation to equality. Variation within context is closely related to differences involving parties to nursing, and it is a starting point to questions of equality. Power is understood as comprising knowledge, skills and authority that create differences and questions of equality between nurses and patients and nurses and other professionals or students. Nursing as care always includes relationship between two or more persons and needs to be inspected from the point of view of equality. The concept of equality has been complex to achieve in practice. The dimensions of the levels of equality defined in this study provide an opportunity to reach a better understanding of equality in nursing ethics. There is still a great demand for more research on the concept of equality. © 2010 The Author. Scandinavian Journal of Caring Sciences © 2010 Nordic College of Caring Science.

  11. Opening the black box of ethics policy work: evaluating a covert practice.

    Science.gov (United States)

    Frolic, Andrea; Drolet, Katherine; Bryanton, Kim; Caron, Carole; Cupido, Cynthia; Flaherty, Barb; Fung, Sylvia; McCall, Lori

    2012-01-01

    Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the "black box" of this health care ethics practice by providing two detailed case examples of ethics policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews.

  12. Research ethics consultation: ethical and professional practice challenges and recommendations.

    Science.gov (United States)

    Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-05-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

  13. Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

    Science.gov (United States)

    Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-01-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

  14. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

    Directory of Open Access Journals (Sweden)

    von Dadelszen Peter

    2010-07-01

    Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

  15. Global Ethics Applied: Global Ethics, Economic Ethics

    OpenAIRE

    Stückelberger, Christoph

    2016-01-01

    Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...

  16. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues.

    Science.gov (United States)

    Gekas, Jean; Langlois, Sylvie; Ravitsky, Vardit; Audibert, François; van den Berg, David Gradus; Haidar, Hazar; Rousseau, François

    2016-01-01

    Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening) was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women.

  17. The Environmental and ethical basis of the geological disposal of long-lived radioactive waste. A collective opinion by the Radioactive Waste Management Committee (RWMC) of the OECD Nuclear Energy Agency

    International Nuclear Information System (INIS)

    1995-01-01

    The report presents a consensus position of the national authorities in their search for appropriate solutions in the safe disposal of radioactive wastes in the form of a Collective Opinion of the Radioactive waste Management Committee (RWMC) of the OECD Nuclear Energy Agency. The Collective Opinion addresses the strategy for the final disposal of long-lived radioactive wastes seen from an environmental and ethical perspective, including considerations of equity and fairness within and between generations. (7 refs.)

  18. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

    2010-01-01

    Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

  19. Report of the review committee on evaluation of the R and D subjects in the field of high-temperature engineering and research

    International Nuclear Information System (INIS)

    2000-09-01

    On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on High-Temperature Engineering and Research composed of nine experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY 2000 in the Departments of HTTR Project and Advanced Nuclear Heat Technology. The Ad Hoc Review Committee meeting was held on December 27, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

  20. CERN scientists take part in the Tevatron Run II performance review committee

    CERN Multimedia

    Maximilien Brice

    2002-01-01

    Tevatron Run II is under way at Fermilab, exploring the high-energy frontier with upgraded detectors that will address some of the biggest questions in particle physics.Until CERN's LHC switches on, the Tevatron proton-antiproton collider is the world's only source of top quarks. It is the only place where we can search for supersymmetry, for the Higgs boson, and for signatures of additional dimensions of space-time. The US Department of Energy (DOE) recently convened a high-level international review committee to examine Fermilab experts' first-phase plans for the accelerator complex. Pictured here with a dipole magnet in CERN's LHC magnet test facility are the four CERN scientists who took part in the DOE's Tevatron review. Left to right: Francesco Ruggiero, Massimo Placidi, Flemming Pedersen, and Karlheinz Schindl. Further information: CERN Courier 43 (1)

  1. Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review

    Science.gov (United States)

    Peña-Rosas, Juan Pablo; Saxena, Abha; Zamora, Gerardo

    2017-01-01

    Background The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc.) contexts. Aim The goal of this scoping review is to delineate and “map” the range of ethical issues in nutrition-related public health interventions, as well as the range of the various fields in which they may arise. Methods A scoping review of empirical research and conceptual literature was conducted following the framework of Arksey and O’Malley. Searches using PubMed with Medical Subject Headings (MeSH) categories and Advanced Search Builder as well as in the Global Health Library were performed. The final sample consists of 169 publications. Results The ethics of public health prevention or treatment of obesity and non-communicable diseases is the most explicitly and frequently discussed subject. In comparison, ethical issues raised by public health interventions in the fields of undernutrition, breastfeeding, vitamin/mineral supplementation and food fortification, food security, food sustainability and food safety are addressed in a lower proportion of the sample. The results illustrate the various natures, types, and scopes of existing public health nutrition-related interventions, and the various ethical issues that may be raised by these interventions, in addition to the numerous and different contexts in which they may be implemented. Discussion The ethical issues faced in the development and implementation of nutrition-related public health interventions are varied and cannot be equated with, nor generalized about, when dealing with specific activities in this

  2. Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review.

    Science.gov (United States)

    Hurlimann, Thierry; Peña-Rosas, Juan Pablo; Saxena, Abha; Zamora, Gerardo; Godard, Béatrice

    2017-01-01

    The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc.) contexts. The goal of this scoping review is to delineate and "map" the range of ethical issues in nutrition-related public health interventions, as well as the range of the various fields in which they may arise. A scoping review of empirical research and conceptual literature was conducted following the framework of Arksey and O'Malley. Searches using PubMed with Medical Subject Headings (MeSH) categories and Advanced Search Builder as well as in the Global Health Library were performed. The final sample consists of 169 publications. The ethics of public health prevention or treatment of obesity and non-communicable diseases is the most explicitly and frequently discussed subject. In comparison, ethical issues raised by public health interventions in the fields of undernutrition, breastfeeding, vitamin/mineral supplementation and food fortification, food security, food sustainability and food safety are addressed in a lower proportion of the sample. The results illustrate the various natures, types, and scopes of existing public health nutrition-related interventions, and the various ethical issues that may be raised by these interventions, in addition to the numerous and different contexts in which they may be implemented. The ethical issues faced in the development and implementation of nutrition-related public health interventions are varied and cannot be equated with, nor generalized about, when dealing with specific activities in this field. More importantly, these ethical issues

  3. Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review.

    Directory of Open Access Journals (Sweden)

    Thierry Hurlimann

    Full Text Available The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc. contexts.The goal of this scoping review is to delineate and "map" the range of ethical issues in nutrition-related public health interventions, as well as the range of the various fields in which they may arise.A scoping review of empirical research and conceptual literature was conducted following the framework of Arksey and O'Malley. Searches using PubMed with Medical Subject Headings (MeSH categories and Advanced Search Builder as well as in the Global Health Library were performed. The final sample consists of 169 publications.The ethics of public health prevention or treatment of obesity and non-communicable diseases is the most explicitly and frequently discussed subject. In comparison, ethical issues raised by public health interventions in the fields of undernutrition, breastfeeding, vitamin/mineral supplementation and food fortification, food security, food sustainability and food safety are addressed in a lower proportion of the sample. The results illustrate the various natures, types, and scopes of existing public health nutrition-related interventions, and the various ethical issues that may be raised by these interventions, in addition to the numerous and different contexts in which they may be implemented.The ethical issues faced in the development and implementation of nutrition-related public health interventions are varied and cannot be equated with, nor generalized about, when dealing with specific activities in this field. More importantly, these

  4. Reporting of ethical committee approval and patient consent in the Portuguese Journal of Pulmonology and in the other Portuguese medical journals with impact factor

    Directory of Open Access Journals (Sweden)

    M.J. Bernardes

    2012-11-01

    Full Text Available Introduction: Reporting of ethical committee (EC approval and patient consent in publications involving human subjects may be lower than recommended. In this paper this ethical issue was analysed in the Portuguese Journal of Pulmonology and in the other two Portuguese medical journals with impact factor indexed in the ISI Web of Knowledge. Methods: Reporting of EC approval and patient consent was searched in all publications involving human subjects published in the Acta Médica Portuguesa, Acta Reumatológica Portuguesa and Portuguese Journal of Pulmonology, from the 1st July 2010 until the 30th June 2011. The search also looked for the involvement of vulnerable and potentially identifiable subjects. Results: Most of the analysed publications, which included a considerable proportion of vulnerable (23% and of potentially identifiable case reports (14%, were case reports (49%. Overall EC approval ranged from 0% to 28%, in case reports and prospective studies, respectively, whereas overall patient consent ranged from 0% to 26%. There were not statistically significant differences in results among the selected journals. Conclusions: Reporting of EC approval and patient consent in the three leading Portuguese medical journals has been lower than in their leading world counterparts. This should be taken into account and further audited in future, not only for the protection of the research subjects but also to maintain public trust in the process. Resumo: Introdução: A referência a aprovação de comissão de ética (CE e a consentimento dos doentes, nas publicações que envolvem humanos, poderá ser inferior à recomendada. Neste artigo, esta situação foi analisada na Revista Portuguesa de Pneumologia e nas outras 2 revistas médicas portuguesas com fator de impacto indexadas na ISI Web of Knowledge. Métodos: A referência a aprovação de CE e a consentimento dos doentes foi pesquisada em todas as publicações que envolveram humanos na

  5. Submission of scientifically sound and ethical manuscripts to peer-reviewed journals - a reviewer's personal perspective on bioanalytical publications.

    Science.gov (United States)

    Weng, Naidong

    2012-11-01

    In the pharmaceutical industry, bioanalysis is very dynamic and is probably one of the few fields of research covering the entire drug discovery, development and post-marketing process. Important decisions on drug safety can partially rely on bioanalytical data, which therefore can be subject to regulatory scrutiny. Bioanalytical scientists have historically contributed significant numbers of scientific manuscripts in many peer-reviewed analytical journals. All of these journals provide some high-level instructions, but they also leave sufficient flexibility for reviewers to perform independent critique and offer recommendations for each submitted manuscript. Reviewers play a pivotal role in the process of bioanalytical publication to ensure the publication of high-quality manuscripts in a timely fashion. Their efforts usually lead to improved manuscripts. However, it has to be a joint effort among authors, reviewers and editors to promote scientifically sound and ethically fair bioanalytical publications. Most of the submitted manuscripts were well written with only minor or moderate revisions required for further improvement. Nevertheless, there were small numbers of submitted manuscripts that did not meet the requirements for publications because of scientific or ethical deficiencies, which are discussed in this Letter to the Editor. Copyright © 2012 John Wiley & Sons, Ltd.

  6. Evidence and Ethics (Editorial

    Directory of Open Access Journals (Sweden)

    Alison Brettle

    2012-12-01

    discipline the research takes place in, and should be something that we are aware of as consumers of evidence. Within LIS in the UK, ethical principles have been put to the fore within a new professional framework (CILIP Chartered Institute of Library and Information Professionals, 2012a. The framework outlines the broad range of skills required by workers across the LIS profession, placing these on a wheel with ethics and values in the centre, as they underpin the profession. Placing ethics and values at the core in this way helps us set our knowledge into a wider context and, I believe, is one of the ways that we can make a difference as LIS professionals. At the same time, our ethical values and principles help to differentiate us from other professions and help to define what we do as LIS professionals. These ethical principles are outlined in a code (CILIP Chartered Institute of Library and Information Professionals, 2012b, which sets out professional responsibilities in relation to users, colleagues, and the information community and society. The elements which are particularly relevant to EBLIP, and which are espoused in the scope and mission of the journal, include maintaining and enhancing professional knowledge and competence, sharing results of research and development, encouraging best practice, and promoting equitable access to information. There are also ethical codes of practice for journal editors, these include one for LIS editors (Library and Information Science Editorial Committee, 2010 and a more general one which originated in the medical and health domain (Committee on Publication Ethics: COPE, 2011. Both of these guide journal editors in relating to readers, authors, reviewers, and publishers, and both seek to establish best practice for journal publishing. For the EBLIP journal, these codes of practice provide a useful framework for ensuring the journal operates in a professional and ethical way. A recent example where the codes have been used in

  7. Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review.

    Science.gov (United States)

    Golder, Su; Ahmed, Shahd; Norman, Gill; Booth, Andrew

    2017-06-06

    Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an individual assessment of its own ethical issues

  8. Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments.

    Science.gov (United States)

    Schüklenk, Udo; Lowry, Christopher

    2009-01-01

    The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended--at the time--on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. Existing ethics and health policy literature on the topic of access to experimental drugs. The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients--the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods.

  9. A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making.

    Science.gov (United States)

    McCulloch, Steven P; Reiss, Michael J

    2018-06-07

    Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE, foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Council and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an "Ethics Council for Animal Policy" to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs) and examine some widely used ethical frameworks (e.g., Banner's principles and the ethical matrix). The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i) Problematisation of the policy issue, (ii) utilitarian analysis, (iii) animal rights analysis, (iv) virtue-based analysis, (v) animal welfare ethic analysis, and (vi) integrated ethical analysis. The paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

  10. Ethical implications of digital images for teaching and learning purposes: an integrative review.

    Science.gov (United States)

    Kornhaber, Rachel; Betihavas, Vasiliki; Baber, Rodney J

    2015-01-01

    Digital photography has simplified the process of capturing and utilizing medical images. The process of taking high-quality digital photographs has been recognized as efficient, timely, and cost-effective. In particular, the evolution of smartphone and comparable technologies has become a vital component in teaching and learning of health care professionals. However, ethical standards in relation to digital photography for teaching and learning have not always been of the highest standard. The inappropriate utilization of digital images within the health care setting has the capacity to compromise patient confidentiality and increase the risk of litigation. Therefore, the aim of this review was to investigate the literature concerning the ethical implications for health professionals utilizing digital photography for teaching and learning. A literature search was conducted utilizing five electronic databases, PubMed, Embase (Excerpta Medica Database), Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, and Scopus, limited to English language. Studies that endeavored to evaluate the ethical implications of digital photography for teaching and learning purposes in the health care setting were included. The search strategy identified 514 papers of which nine were retrieved for full review. Four papers were excluded based on the inclusion criteria, leaving five papers for final analysis. Three key themes were developed: knowledge deficit, consent and beyond, and standards driving scope of practice. The assimilation of evidence in this review suggests that there is value for health professionals utilizing digital photography for teaching purposes in health education. However, there is limited understanding of the process of obtaining and storage and use of such mediums for teaching purposes. Disparity was also highlighted related to policy and guideline identification and development in clinical practice. Therefore, the

  11. Innovations in research ethics governance in humanitarian settings.

    Science.gov (United States)

    Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome

    2015-02-26

    Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out

  12. Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

    Science.gov (United States)

    Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

    2015-05-08

    UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

  13. Rapid qualitative review of ethical issues surrounding healthcare for pregnant women or women of reproductive age in epidemic outbreaks.

    Science.gov (United States)

    Hummel, Patrik; Saxena, Abha; Klingler, Corinna

    2018-01-01

    This article describes, categorizes, and discusses the results of a rapid literature review aiming to provide an overview of the ethical issues and corresponding solutions surrounding pregnancies in epidemic outbreaks. The review was commissioned by the World Health Organization to inform responses to the Zika outbreak that began in 2015. Due to the urgency of the response efforts that needed to be informed by the literature search, a rapid qualitative review of the literature published in PubMed was conducted. The search and analysis were based on the operationalization of 3 key concepts: ethics, pregnancy, and epidemic outbreak. Ethical issues and solutions were interpreted within a principlist framework. The data were analyzed using qualitative content analysis. The search identified 259 publications, of which the full text of 23 papers was read. Of those, 20 papers contained a substantive part devoted to the topic of interest and were therefore analyzed further. We clustered the ethical issues and solutions around 4 themes: uncertainty, harms, autonomy/liberty, and effectiveness. Recognition of the identified ethical issues and corresponding solutions can inform and improve response efforts, public health planning, policies, and decision-making, as well as the activities of medical staff and counselors who practice before, during, or after an epidemic outbreak that affects pregnant women or those of reproductive age. The rapid review format proved to be useful despite its limited data basis and expedited review process.

  14. 76 FR 54730 - Committees on Administration and Management, Collaborative Governance, Judicial Review, and...

    Science.gov (United States)

    2011-09-02

    ... accommodations for persons with disabilities), and how to submit comments to the committee can be found in the ``Research'' section of the ACUS Web site. Go to www.acus.gov and click on Research - > Committee Meetings...

  15. 76 FR 61072 - Committees on Administration and Management, Collaborative Governance, Judicial Review, and...

    Science.gov (United States)

    2011-10-03

    ... accommodations for persons with disabilities), and how to submit comments to the committee can be found in the ``Research'' section of the ACUS Web site. Go to http://www.acus.gov and click on Research -> Committee...

  16. Report of the evaluation by the Ad Hoc Review Committee on advance science research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2003

    International Nuclear Information System (INIS)

    2003-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2002, the accomplishments of the research started in Fiscal Year 2001, and the adequacy of the programs of the research to be started in Fiscal Year 2004 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of nine specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2003. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 24, 2003, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 4, 2003. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

  17. Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. Ex-post evaluation in fiscal year 2003

    International Nuclear Information System (INIS)

    2004-06-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D results achieved for five years until Fiscal Year 2002 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from October 2003 to February 2004. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on November 14, 2003, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 8, 2004. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

  18. Report of the evaluation by the ad hoc review committee on advanced photon and synchrotron radiation research. In-advance evaluation in fiscal year 2001

    International Nuclear Information System (INIS)

    2001-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Photon and Synchrotron Radiation Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2002 at Advanced Photon Research Center and at Synchrotron Radiation Research Center in Kansai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of ten specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2001. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 21, 2001, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on July 12, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Photon and Synchrotron Radiation Research. (author)

  19. Report of the evaluation by the Ad Hoc Review Committee on Information Technology. In-advance evaluation in fiscal year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Information Technology in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs pertaining to the establishment and utilization of the Information Technology Based Laboratory (ITBL) to be implemented for five years starting in Fiscal Year 2001 at Center for Promotion of Computational Science and Engineering and Department of Environmental Sciences of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from February to March 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on February 9, 2001, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Information Technology. (author)

  20. Report of the evaluation by the Ad Hoc Review Committee on Computational Science and Engineering. Result evaluation in fiscal year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Computational Science and Engineering in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Center for Promotion of Computational Science and Engineering of JAERI. The Ad Hoc Review Committee consisted of seven specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to March 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 27, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Computational Science and Engineering. (author)

  1. Report of the evaluation by the Ad Hoc Review Committee on High-Temperature Engineering and Research. Result evaluation in fiscal year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on High-Temperature Engineering and Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of HTTR Project and Department of Advanced Nuclear Heat Technology in Oarai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of nine specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 8, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on High-Temperature Engineering and Research. (author)

  2. Report of the evaluation by the ad hoc review committee on radiation application research. In-advance evaluation in fiscal year 2001

    International Nuclear Information System (INIS)

    2001-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Radiation Application Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2002 at Department of Material Development, at Department of Ion-Beam-Applied Biology and at Advanced Radiation Technology Center in Takasaki Radiation Chemistry Research Establishment of JAERI. The Ad Hoc Review Committee consisted of ten specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 25, 2001, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on July 12, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Radiation Application Research. (author)

  3. Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. In-advance evaluation in fiscal year 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2003 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from April 2002 to August 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 5th, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5th, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

  4. Report of the evaluation by the Ad Hoc Review Committee on Advance Science Research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2001, the accomplishments of the research started in Fiscal Year 2000, and the adequacy of the programs of the research to be started in Fiscal Year 2003 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 4, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

  5. Report of the evaluation by the Ad Hoc Review Committee on Materials Science Research. In-advance evaluation in fiscal year 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Materials Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the adequacy of the R and D programs to be implemented for five years starting in Fiscal Year 2003 at Department of Materials Science in Tokai Research Establishment of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from April 2002 to August 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 5th, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5th, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Materials Science Research. (author)

  6. [Review of WHO Expert Committee on Leprosy 8th report, --comparison to 7th report].

    Science.gov (United States)

    Kitajima, Shinichi; En, Junichiro; Kitajima, Shiori; Barua, Sumana; Goto, Masamichi

    2014-03-01

    In 2012 the WHO Expert Committee on Leprosy published its 8th report, 14 years after the publication of its 7th report in 1998. This report, the first since the leprosy reduction goal was met in 2000, highlights key points such as improvements in the quality of various services available to patients and the efforts of individuals and societies, in addition to medical progress in diagnosis and treatment. This review will mainly describe the changes made since the 7th report. Some of the main modifications are the deletion of single lesion paucibacillary type, elongated treatment of patients with high bacterial indices, the introduction of promising new drugs, and a shift from reducing the statistical number of patients to a new target for disability prevention.

  7. Review of design approaches of advanced pressurized LWRs. Report of a technical committee meeting and workshop

    International Nuclear Information System (INIS)

    1996-01-01

    The Technical Committee Meeting and Workshop was devoted to review and discuss differences and commonalties in the various design approaches with the aim of increasing the understanding of the design decisions taken, and a number of general conclusions were drawn. Though many differences in design approaches were found in the presentations, a number of common features could also be identified. These included design approaches to achieve further improvements with respect to safety, design simplification, reduction in cost, incorporation of feedback from operating experience, and control room improvements regarding human factors and digitization. Design approaches to achieve further improvements in safety included consideration of severe accidents in the design process, increased thermal margins and water inventories, longer grace periods and double containments. Refs, figs and tabs

  8. Report of the Review Committee on the BNL colliding beam accelerator

    International Nuclear Information System (INIS)

    1983-01-01

    The Colliding Beam Accelerator (CBA) proposal by BNL for a pp collider of 400 GeV /times/ 400 GeV with a maximum luminosity /Brit pounds/ = 2 /times/ 10 33 was reviewed by a DOE team, including consultants, on April 11--15, 1983. No major flaws were found that would prevent, in principle, the proposed collider from reaching its design goals. BNL has made sufficient progress in their superconducting magnet RandD program that, although there is not yet a magnet of the CBA baseline design, the Committee believes the design can be achieved. However, to ensure prompt completion of the project, substantial RandD needs to be carried out in short order, particularly on the timely and cost-effective production of magnets, reliability of quench protection, and determination of cryogenic heat loads

  9. Review of design approaches of advanced pressurized LWRs. Report of a technical committee meeting and workshop

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-01

    The Technical Committee Meeting and Workshop was devoted to review and discuss differences and commonalties in the various design approaches with the aim of increasing the understanding of the design decisions taken, and a number of general conclusions were drawn. Though many differences in design approaches were found in the presentations, a number of common features could also be identified. These included design approaches to achieve further improvements with respect to safety, design simplification, reduction in cost, incorporation of feedback from operating experience, and control room improvements regarding human factors and digitization. Design approaches to achieve further imp