WorldWideScience

Sample records for ethics committee members

  1. 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,

  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. 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...

  4. 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...

  5. 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

  6. 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

  7. 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

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

    Directory of Open Access Journals (Sweden)

    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

  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. 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.

  11. 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

    Directory of Open Access Journals (Sweden)

    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

  12. [Responsibilities of ethics committees].

    Science.gov (United States)

    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.

  13. 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.

  14. 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.

  15. 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

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

    Science.gov (United States)

    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.

  17. 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.

  18. 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,…

  19. 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.

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

    Science.gov (United States)

    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.

  1. 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.

  2. [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.

  3. 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.

  4. [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.

  5. The job of 'ethics committees'.

    Science.gov (United States)

    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/

  6. Report of the Ethics Committee, 2008

    Science.gov (United States)

    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,…

  7. 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.

  8. 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…

  9. 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…

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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?

  16. 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.

  17. 77 FR 55180 - Request for Nominations of Members To Serve on the Federal Economic Scientific Advisory Committee

    Science.gov (United States)

    2012-09-07

    ... (SGEs) and are subject to ethics rules applicable to SGEs. b. Members serve three-year terms. Members... equal opportunity in the workplace and seeks diverse Committee membership. Dated: August 30, 2012...

  18. 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...

  19. 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).

  20. Ethics committees in India: Facing the challenges!

    Science.gov (United States)

    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.

  1. Ethics committees in India: Facing the challenges!

    Directory of Open Access Journals (Sweden)

    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.

  2. Interactive Poster Survey Study of ACS Members' Knowledge and Needs on Research Ethics

    Science.gov (United States)

    Mabrouk, Patricia Ann; Schelble, Susan M.

    2018-01-01

    An interactive poster exhibited at two poster sessions at the Fall 2016 American Chemical Society (ACS) National Meeting was used as a vehicle to learn about ACS members' concerns and needs related to research ethics and to identify opportunities for engagement of the Society by the Committee on Ethics (ETHX) and others in terms of ethics…

  3. Members of the Committee | Women in Science | Initiatives | Indian ...

    Indian Academy of Sciences (India)

    Members of the Committee. Rohini M Godbole; Rajinder J Hans-Gill; D. Balasubramanian. Charge of the Committee. The members of the committee were assigned to formulate the terms of reference and to define appropriate action points to be followed for its work. The committee had come up with many initiatives and ...

  4. 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.

  5. 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

  6. 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...

  7. 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…

  8. 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.

  9. 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.

  10. 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.

  11. 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 ...

  12. 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.

  13. 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.

  14. 76 FR 38348 - Notice of Appointment of Committee Members to the Advisory Committee on Biotechnology and 21st...

    Science.gov (United States)

    2011-06-30

    ... Service Notice of Appointment of Committee Members to the Advisory Committee on Biotechnology and 21st.... ACTION: Notice of Appointment of Committee Members to the Advisory Committee on Biotechnology and 21st... the appointment of members to the Advisory Committee on Biotechnology and 21st Century Agriculture...

  15. \\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.

  16. Perceptions of veterinary admissions committee members of ...

    African Journals Online (AJOL)

    2015-06-26

    Jun 26, 2015 ... including communication; sensitivities to other cultures and people; scientific and professional behavior; desire for knowledge; personal management skills; compassion for animals and people; and personal integrity and ethics. All of these factors have been identified as important in selecting for successful.

  17. Perceptions of veterinary admissions committee members of ...

    African Journals Online (AJOL)

    Veterinary admission committees are asked to create and implement a fair, reliable, and valid system to select the candidates most likely to succeed in veterinary school from a large pool of applicants. Although numerous studies have explored grade point average (GPA) as a predictive value of later academic success, ...

  18. [Food hygiene training of members of corporate public catering committees].

    Science.gov (United States)

    Quaranta, Gianluigi; Laurenti, Patrizia; Gerardo Cairo, Antonio; Ricciardi, Gualtiero

    2007-01-01

    A food hygiene training course was offered to 25 members of the public catering committees of seven corporate restaurants. In order to evaluate the effectiveness of the course and identify critical topics, participants were asked to complete a questionnaire before and after completing the training course. Results are presented in this article and underscore the importance of training members of public catering committees in addition to food handlers.

  19. 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.

  20. 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.

  1. 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…

  2. Evaluation of clinical trials by Ethics Committees in Germany – results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa

    Directory of Open Access Journals (Sweden)

    Russ, Hagen

    2015-01-01

    Full Text Available [english] Objective: The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP ordinance (German: GCP-Verordnung, GCP-V, the quality of evaluations of those applications by Ethics Committees (ECs/Investigational Review Boards (IRBs in Germany as well as the pattern of EC objections in their reasoned opinions (vote. In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008.Methods: Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared.Results: Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18 took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I–IV clinical trials submitted to the regulatory authorities (BfArM and PEI in 2011.In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007 was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007. The amount of objections increased by 21% from 1,299 (2007 to 1,574 (2011 resulting in an average of 4.5 (2007 vs. 6.3 (2011 objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent

  3. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

    Science.gov (United States)

    Russ, Hagen; Busta, Susanne; Jost, Bertfried; Bethke, Thomas D

    2015-01-01

    The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008. Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared. Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I-IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011. In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial

  4. 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...

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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…

  10. 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.

  11. 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

  12. 21 CFR 14.95 - Compensation of advisory committee members.

    Science.gov (United States)

    2010-04-01

    ... employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  13. 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.

  14. 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.

  15. Members of House Committee on Science and Astronautics Visited MSFC

    Science.gov (United States)

    1962-01-01

    The members of the House Committee on Science and Astronautics visited the Marshall Space Flight Center (MSFC) on March 9, 1962 to gather first-hand information of the nation's space exploration program. The congressional group was composed of members of the Subcommittee on Marned Space Flight. Headed by Representative Olin E. Teague of Texas, other members were James G. Fulton, Pennsylvania; Ken Heckler, West Virginia; R. Walter Riehlman, New York; Richard L. Roudebush,, Indiana; John W. Davis, Georgia; James C. Corman, California; Joseph Waggoner, Louisiana; J. Edgar Chenoweth, Colorado; and William G. Bray, Indiana.

  16. 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 ...

  17. 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/

  18. 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)

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

    Science.gov (United States)

    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.

  20. 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.

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

    Science.gov (United States)

    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

  2. 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 ...

  3. 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

  4. Need for ethics support in healthcare institutions: views of Dutch board members and ethics support staff.

    Science.gov (United States)

    Dauwerse, Linda; Abma, Tineke; Molewijk, Bert; Widdershoven, Guy

    2011-08-01

    The purpose of this article is to investigate the need for ethics support in Dutch healthcare institutions in order to understand why ethics support is often not used in practice and which factors are relevant in this context. This study had a mixed methods design integrating quantitative and qualitative research methods. Two survey questionnaires, two focus groups and 17 interviews were conducted among board members and ethics support staff in Dutch healthcare institutions. Most respondents see a need for ethics support. This need is related to the complexity of contemporary healthcare, the contribution of ethics support to the core business of the organisation and to the surplus value of paying structural attention to ethical issues. The need for ethics support is, however, not unconditional. Reasons for a lacking need include: aversion of innovations, negative associations with the notion of ethics support service, and organisational factors like resources and setting. There is a conditioned need for ethics support in Dutch healthcare institutions. The promotion of ethics support in healthcare can be fostered by focusing on formats which fit the needs of (practitioners in) healthcare institutions. The emphasis should be on creating a (culture of) dialogue about the complex situations which emerge daily in contemporary healthcare practice.

  5. 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.

  6. 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

    Full Text Available Background. There exists a need throughout the North to increase capacity to address issues of health ethics and for community members to better understand and share their perspectives on this topic. Ethics comes down to weighing rights and wrongs, evaluating differing needs and understandings, acknowledging the many shades of grey and doing our best to come up with the just, fair and moral approach to the question at hand. Northern regions must collaborate to share capacity, successes and experiences in order to meet the unique needs of northern health care institutions and move forward on this issue. While guidelines for ethical research with indigenous populations exist, little has been published about an Inuit approach to health ethics more broadly. Design . To fill a critical need and to meet accreditation standards, the Qikiqtani General Hospital (QGH in Iqaluit, Nunavut, Canada, is in the process of building an Ethics Committee. Capitalizing on partnerships with other bodies both in northern and southern Canada has proved an efficient and effective way to develop local solutions to challenges that have been experienced both at QGH and other jurisdictions. Methods . The Ottawa Hospital Ethics Office and the active ethics committee at Stanton General Hospital in Yellowknife, NT, contributed expertise and experience, and helped provide some direction for the QGH ethics committee. At the local level, based on our shared commitment to health care ethics, the Qaujigiartiit Health Research Centre is an invaluable partner whose parallel efforts to develop a northern Health Research Ethics Board (REB gives great synergy to the QGH Ethics Committee. Results . Passion and commitment, as well as administrative support and endorsement from health care leaders, are the aspects of successful initiatives that we have identified to date. Using the information from both the experiences of other partners, as well as information gathered at a retreat held in

  7. Moral Reasoning among HEC Members: An Empirical Evaluation of the Relationship of Theory and Practice in Clinical Ethics Consultation.

    Science.gov (United States)

    Wasserman, Jason Adam; Stevenson, Shannon Lindsey; Claxton, Cassandra; Krug, Ernest F

    2015-01-01

    In light of the ongoing development and implementation of core competencies in bioethics, it is important to proceed with a clear sense of how bioethics knowledge is utilized in the functioning of hospital ethics committees (HECs). Without such an understanding, we risk building a costly edifice on a foundation that is ambiguous at best. This article examines the empirical relationship between traditional paradigms of bioethics theory and actual decision making by HEC members using survey data from HEC members. The assumption underlying the standardization of qualifications and corresponding call for increased education of HEC members is that they will base imminent case decisions on inculcated knowledge. Our data suggest, however, that HEC members first decide intuitively and then look for justification, thereby highlighting the need to re-examine the pedagogical processes of ethics education in the process of standardizing and improving competencies. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  8. 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.

  9. 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...

  10. E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research Inquérito pela Internet com pesquisadores clínicos, membros de comitês de ética e patrocinadores de pesquisa clínica no Brasil: uma metodologia emergente para pesquisa científica

    Directory of Open Access Journals (Sweden)

    Sonia Mansoldo Dainesi

    2012-12-01

    Full Text Available INTRODUCTION: The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. METHODS: 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. RESULTS: 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. CONCLUSION: 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.INTRODUÇÃO: O crescimento de usuários da Internet possibilita que estudos epidemiológicos sejam conduzidos eletronicamente, representando uma promissora metodologia para coleta de dados. MÉTODOS: Membros de Comitês de Ética, pesquisadores clínicos e patrocinadores foram entrevistados com

  11. 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.

  12. 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.

  13. Ethical Leadership and Leader Member Exchange (LMX Theory

    Directory of Open Access Journals (Sweden)

    Babič Šejla

    2014-01-01

    Full Text Available The aim of this paper is to evaluate the contribution that developments in the area of ethical leadership and trust have made to our understanding of effective people management within organisations. This paper is based on a case study from Harvard Business Review (2007 called "IBM - Leading the Turnaround". The author will use Leader Member Exchange (LMX theory by Graen and Uhl-Bien (1995 and integrate the ideas of ethical leadership to critically evaluate the leadership style of the CEO of IBM Louis V. Gerstner that led to the turnaround of IBM. In particular, the author will focus on the following question: What role did trust play in the leadership style of Gerstner in the transformation of IBM?

  14. 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.

  15. 78 FR 49276 - Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members

    Science.gov (United States)

    2013-08-13

    ... 25 members, who are Special Government Employees, and 5 ex-officio, non-voting members. Members and... committees; and therefore, extends particular encouragement to nominations for appropriately qualified female...

  16. 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

  17. 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.

  18. 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.

  19. 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…

  20. 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)

  1. 5 CFR 591.243 - How many members are on each COLA Advisory Committee?

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false How many members are on each COLA Advisory Committee? 591.243 Section 591.243 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL... Areas Program Administration § 591.243 How many members are on each COLA Advisory Committee? A COLA...

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  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. [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.

  10. 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.

  11. 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.

  12. 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.

  13. 75 FR 62509 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2010-10-12

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Technical Advisory Committees; Notice of Recruitment of Private- Sector Members SUMMARY: Seven Technical Advisory Committees (TACs) advise the Department of Commerce on the technical parameters for export controls applicable to dual-use commodities and...

  14. 77 FR 2271 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2012-01-17

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Technical Advisory Committees; Notice of Recruitment of Private- Sector Members SUMMARY: Seven Technical Advisory Committees (TACs) advise the Department of Commerce on the technical parameters for export controls applicable to dual-use commodities and...

  15. 78 FR 5774 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2013-01-28

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Technical Advisory Committees; Notice of Recruitment of Private- Sector Members SUMMARY: Seven Technical Advisory Committees (TACs) advise the Department of Commerce on the technical parameters for export controls applicable to dual-use commodities and...

  16. 78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Science.gov (United States)

    2013-10-29

    ... medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco... Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women... membership, the primary contact is: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and...

  17. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. Perceptions of admission committee members: some aspects on individual admission to dental education at Karolinska Institutet.

    Science.gov (United States)

    Röding, Karin

    2005-08-01

    The aim of the study was to generate an overall impression of the admission committee's (AC) perspective on individualised admission procedures, derived from some perceived experience of the individual committee members using semi-structured interviews. Qualitative research was used and data were collected by use of interviews. The results show that the committee members are highly committed to the task and try to identify desirable, non-cognitive attributes in the applicants, such as motivation, empathy, drive, and tenacity: 'emotional intelligence'. The committee members were of the opinion that it was possible to identify these attributes in an applicant. The AC further believes that the admissions procedure influences academic achievements because students regard themselves as specially selected and therefore aspire to higher achievements.

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

    Directory of Open Access Journals (Sweden)

    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

  1. 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.

  2. 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.

  3. 7 CFR 917.122 - Qualification requirements and nominiation procedure for public members of Commodity Committees.

    Science.gov (United States)

    2010-01-01

    ... Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits... members of Commodity Committees. (a) Public members shall not have a financial interest in or be associated with production, processing, financing, or marketing (except as consumers) of the commodities...

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. Ethical Climate, Organizational Commitment, and Job Satisfaction of Full-Time Faculty Members

    Science.gov (United States)

    Moore, Heather Louise

    2012-01-01

    The purpose of this quantitative study was to better understand the relationship of perceived ethical climate on the organizational commitment and job satisfaction of full-time faculty members in institutions of higher education. Full-time faculty members are the forefront employees of any educational institution, and they have a direct impact on…

  9. 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

  10. 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.

  11. Evaluating the Training, Responsibilities, and Practices of P&T Committee Members and Nonmember Contributors.

    Science.gov (United States)

    Rodriguez, Ryan; Kelly, Brett J; Moody, Mary

    2017-08-01

    Pharmacy and therapeutics (P&T) committees are responsible for managing drug formularies in numerous health care settings. Although pharmacy practice and health care organizations provide general recommendations of responsibilities and skills for members and nonmember contributors of P&T committees, the study investigators hypothesized that there is diversity in the training, responsibilities, and practices of these members and contributors. To describe the training, responsibilities, and practices of members and nonmember contributors of P&T committees in a variety of health care settings, using an online survey. In December 2015, an online survey was delivered to clinicians who were considered likely to be involved in P&T committee service from hospitals ranked by U.S. News & World Report and a convenience sample of clinicians practicing in managed care settings. The survey instrument was designed to assess various domains and perceptions of P&T committee processes. Sixty-nine respondents representing various health care delivery settings in the United States were eligible for and completed the survey. The majority of the respondents were pharmacists (94.2%), and 72.5% of the respondents were P&T committee members. The remainder of the respondents were nonmember P&T committee contributors. Approximately 60% of the respondents had served in P&T committee roles for ≥ 10 years. Specialized postgraduate training incorporating literature evaluation and formulary management was possessed by 21.7% and 17.4% of the respondents, respectively; however, most of the respondents received on-the-job training. Approximately half of the respondents were responsible for preparation of P&T committee documents, and 58% reported that nonmember contributors typically write and prepare these documents. Skill in literature evaluation was the most important criterion in selecting authors of P&T committee documents, while 10.1% of the respondents indicated that their committees did not

  12. 20 CFR 200.9 - Selection of members of Actuarial Advisory Committee.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Selection of members of Actuarial Advisory Committee. 200.9 Section 200.9 Employees' Benefits RAILROAD RETIREMENT BOARD GENERAL ADMINISTRATION GENERAL... railroad subject to the Interstate Commerce Act which own or control more than 50 percent of the total...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. 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.

  3. Ethics and professionalism in medical physics: A survey of AAPM members

    Science.gov (United States)

    Ozturk, Naim; Armato, Samuel G.; Giger, Maryellen L.; Serago, Christopher F.; Ross, Lainie F.

    2013-01-01

    Purpose: To assess current education, practices, attitudes, and perceptions pertaining to ethics and professionalism in medical physics. Methods: A link to a web-based survey was distributed to the American Association of Physicists in Medicine (AAPM) e-mail membership list, with a follow-up e-mail sent two weeks later. The survey included questions about ethics/professionalism education, direct personal knowledge of ethically questionable practices in clinical care, research, education (teaching and mentoring), and professionalism, respondents’ assessment of their ability to address ethical/professional dilemmas, and demographics. For analysis, reports of unethical or ethically questionable practices or behaviors by approximately 40% or more of respondents were classified as “frequent.” Results: Partial or complete responses were received from 18% (1394/7708) of AAPM members. Overall, 60% (827/1377) of the respondents stated that they had not received ethics/professionalism education during their medical physics training. Respondents currently in training were more likely to state that they received instruction in ethics/professionalism (80%, 127/159) versus respondents who were post-training (35%, 401/1159). Respondents’ preferred method of instruction in ethics/professionalism was structured periodic discussions involving both faculty and students/trainees. More than 90% (1271/1384) supported continuing education in ethics/professionalism and 75% (1043/1386) stated they would attend ethics/professionalism sessions at professional/scientific meetings. In the research setting, reports about ethically questionable authorship assignment were frequent (approximately 40%) whereas incidents of ethically questionable practices about human subjects protections were quite infrequent (5%). In the clinical setting, there was frequent recollection of incidents regarding lack of training, resources and skills, and error/incident reporting. In the educational setting

  4. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  5. 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.

  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. Four Roles of Ethical Theory in Clinical Ethics Consultation.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2016-09-01

    When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  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. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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...

  20. "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…

  1. 77 FR 70182 - Reopening of Nomination Period for Members of the Advisory Committee on Climate Change and...

    Science.gov (United States)

    2012-11-23

    ... Nomination Period for Members of the Advisory Committee on Climate Change and Natural Resource Science AGENCY... published a notice announcing the establishment of the Advisory Committee on Climate Change and Natural.... ADDRESSES: Send nominations to: Robin O'Malley, Policy and Partnership Coordinator, National Climate Change...

  2. 76 FR 23644 - Solicitation of Nominations for Members of the Transit Rail Advisory Committee for Safety (TRACS)

    Science.gov (United States)

    2011-04-27

    ... communication of information from knowledgeable and independent perspectives regarding transit rail safety... evaluated mainly on academic experience but also the following factors: Leadership and organizational skills... committee member's name and organizational affiliation, a cover letter describing the nominee's...

  3. 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.

  4. 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

  5. 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.

  6. [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.

  7. 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.

  8. 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/.

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

    Directory of Open Access Journals (Sweden)

    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.

  10. 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.

  11. Implementing an interprofessional patient safety learning initiative: insights from participants, project leads and steering committee members.

    Science.gov (United States)

    Jeffs, Lianne; Abramovich, Ilona Alex; Hayes, Chris; Smith, Orla; Tregunno, Deborah; Chan, Wai-Hin; Reeves, Scott

    2013-11-01

    Effective teamwork and interprofessional collaboration are vital for healthcare quality and safety; however, challenges persist in creating interprofessional teamwork and resilient professional teams. A study was undertaken to delineate perceptions of individuals involved with the implementation of an interprofessional patient safety competency-based intervention and intervention participants. The study employed a qualitative study design that triangulated data from interviews with six steering committee members and five members of the project team who developed and monitored the intervention and six focus groups with clinical team members who participated in the intervention and implemented local patient safety projects within a large teaching hospital in Canada. Our study findings reveal that healthcare professionals and support staff acquired patient safety competencies in an interprofessional context that can result in improved patient and work flow processes. However, key challenges exist including managing projects amidst competing priorities, lacking physician engagement and sustaining projects. Our findings point to leaders to provide opportunities for healthcare teams to engage in interprofessional teamwork and patient safety projects to improve quality of patient care. Further research efforts should examine the sustainability of interprofessional safety projects and how leaders can more fully engage the participation of all professions, specifically physicians.

  12. Mr Huidong LI Deputy Chairman and Secretary-General, Rev. Committee of Chinese Nationalist Party Vice President, Sun Yat-Sen Culture Interchange Association of China Member, Committee for Internal and Judicial Affairs of the National People's Congress of China

    CERN Multimedia

    Bennett, Sophia Elizabeth

    2017-01-01

    Mr Huidong LI Deputy Chairman and Secretary-General, Rev. Committee of Chinese Nationalist Party Vice President, Sun Yat-Sen Culture Interchange Association of China Member, Committee for Internal and Judicial Affairs of the National People's Congress of China

  13. 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

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

    Directory of Open Access Journals (Sweden)

    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.

  15. 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.

  16. Ethics in research

    International Nuclear Information System (INIS)

    Grass, Guido

    2014-01-01

    Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.

  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. 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...

  19. 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...

  20. 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

  1. 76 FR 11195 - Request for Nominations of Members To Serve on the Census Scientific Advisory Committee

    Science.gov (United States)

    2011-03-01

    ... technical expertise from the following disciplines: demography, economics, geography, psychology, statistics... Advisory Committee are essential for sustained Advisory Committee membership as well as submission of... must have scientific and technical expertise in such areas as demography, economics, geography...

  2. 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

  3. [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.

  4. 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

  5. 77 FR 61007 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Science.gov (United States)

    2012-10-05

    ... knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture... practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any...

  6. 76 FR 54777 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Science.gov (United States)

    2011-09-02

    ..., medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products..., pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. III. Nomination...

  7. 21 CFR 14.80 - Qualifications for members of standing policy and technical advisory committees.

    Science.gov (United States)

    2010-04-01

    ... with interested organizations. Nonvoting members— (i) Shall be selected by the interested organizations... cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that...

  8. The first twenty years of the ASME Committee on nuclear air and gas treatment - a retrospective by a founding member

    Energy Technology Data Exchange (ETDEWEB)

    Jacox, J. [Jacox Associates, Columbus, OH (United States)

    1997-08-01

    Since the 1996 Winter Meeting of CONAGT was the twentieth anniversary of CONAGT a review of the Committee and its members seems in order. This Paper will cover the background and formation of CONAGT as well as the history to date. This history will include not only the basic accomplishments but some of the less successfully met goals and a look at some of the personalities involved in the Committee work. General future plans will be included. The intent of the Paper is less a formal history than a personal recollection of the Committee and those who worked so hard to create the best possible Codes and Standards for the industry to use. 10 refs.

  9. 75 FR 29311 - Solicitation of Nominations for Members of the USDA Grain Inspection Advisory Committee

    Science.gov (United States)

    2010-05-25

    ... the nominations of men and women of all racial and ethnic groups. The Advisory Committee meets twice... or regular places of business in performance of Advisory Committee service (see 5 U.S.C. 5703). A..., individuals with demonstrated ability and experience to represent the interests of racial and ethnic...

  10. Revisiting Financial (Accounting) Literacy: A Comparison of Audit Committee Members and Business Students

    Science.gov (United States)

    Giacomino, Don E.; Wall, Joseph; Akers, Michael D.

    2009-01-01

    While financial literacy is important for an audit committee in discharging its duties there is no authoritative guidance or definition and limited empirical research as to what constitutes financial literacy of audit committees and business students. Coates et al. conducted a study that examined the financial literacy of corporate board members…

  11. 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.

  12. [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

  13. 76 FR 80949 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2011-12-27

    .... Orthopedic and Rehabilitation Devices Panel. Jamie Waterhouse, Center for Devices Circulatory System Devices... Advisory Committee--Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain... ophthalmic clinical trials. Orthopaedic and 2 September 1, 2012. Rehabilitation Devices Panel of the Medical...

  14. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Science.gov (United States)

    2011-07-29

    ... committees and, therefore, extends particular encouragement to nominations for appropriately qualified female... each nominee, current business and/or home address, telephone number, and e-mail address if available...

  15. 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.

  16. 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.

  17. [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.

  18. 75 FR 57807 - Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members

    Science.gov (United States)

    2010-09-22

    ... consists of up to 25 members, who are Special Government Employees, and 5 ex-officio, non-voting members... for appropriately qualified female, minority, or disabled candidates. Dated: September 15, 2010...

  19. 77 FR 61004 - Request for Nominations for Voting Members on Public Advisory Committees

    Science.gov (United States)

    2012-10-05

    ..., engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... specific Committee questions, contact the following persons listed in Table 1 of this document: Table 1...

  20. 75 FR 25844 - Federal Advisory Committee; National Security Education Board Members Meeting

    Science.gov (United States)

    2010-05-10

    ... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; National Security... June 23, 2010, from 8 a.m. to 12:30 p.m. ADDRESSES: The meeting will be held at the National Security.... Kevin Gormley, Program Officer, National Security Education Program, 1101 Wilson Boulevard, Suite 1210...

  1. 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.

  2. 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/.

  3. [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.

  4. Committees

    Science.gov (United States)

    2012-11-01

    -RESIGA Politehnica University of Timisoara Romania Kazuhiro TANAKA Kyushu Institute of Technology Japan Yoshinobu TSUJIMOTO Osaka University Japan Local Organizing Committee Chairman Yulin WU Tsinghua University Beijing Executive Chairman Zhengwei WANG Tsinghua University Beijing Members Shuliang CAO Tsinghua University Beijing Cichang CHEN South West University of Petroleum Chengdu Hongxun CHEN Shanghai University Shanghai Jiang DAI China Sanxia General Co Yichang Huashu DOU National University of Singapore Singapore Fengqin HAN Huanan University of Sci & Tech Guangzhou Kun LI Hefei Inst of General Machinery Hefei Rennian LI Lanzhou University of Sci & Tech Lanzhou Wanhong LI National Natural Science Foundation of China Beijing Chao LIU Yangzhou University Yangzhou Li LU China Inst of Water Resources and Hydropower Research Beijing Xingqi LUO Xi'an University of Tech Xi'an Zhenyue MA Dalian University of Sci & Tech Dalian Jiegang MU Zhejiang University of Tech Hangzhou Daqing QIN Harbin Electric Machinery Group Harbin Fujun WANG China Agriculture University Beijing Guoyu WANG Beijing Institute of Technology (BIT) Beijing Leqin WANG Zhejiang University Hangzhou Yuzhen WU NERCSPV Beijing Hongyuan XU Tsinghua University Beijing Jiandong YANG Wuhan University Wuhan Minguan YANG Jiangsu University Zhenjiang Shouqi YUAN Jiangsu University Zhenjiang Lefu ZHANG Harbin Electric Machinery Group Harbin Lixiang ZHANG Yunnan University of Sci & Tech Kunming Shengchang ZHANG Zhejiang University of Tech Hangzhou Kun ZHAO China Water & Electric Consulting Corp Beijing Yuan ZHENG Hehai University Nanjing Jianzhong ZHOU Huazhong University of Sci & Tech Wuhan Lingjiu ZHOU China Agriculture University Beijing Hongwu ZHU China Petroleum University Beijing Zuchao ZHU Zhejiang Sci-Tech University Hangzhou Secretaries Shuhong LIU (Academic), liushuhong@tsinghua.edu.cn Xianwu LUO (Registration), luoxw@tsinghua.edu.cn Baoshan ZHU (Finance), bszhu@mail.tsinghua.edu.cn

  5. 78 FR 29757 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2013-05-21

    ... views of women and men, members of all racial and ethnic groups, and individuals with and without... contracts to permit evaluation of possible sources of conflicts of interest. This notice is issued under the...

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

    Directory of Open Access Journals (Sweden)

    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.

  7. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Science.gov (United States)

    2012-02-23

    ... in ensuring that women, minority groups, and individuals with disabilities are adequately represented... who use FDA-regulated products. The latter may include patients and patients' family members, health... business address and/or home address, telephone number, and email address if available. Nominations must...

  8. Open letter to all Member State Delegates to CERN Finance Committee and CERN Council

    CERN Multimedia

    Staff Association

    2014-01-01

    Geneva, 17 September 2014 Dear Delegate, We are surprised to read that the “Terms of reference of a Council Working Group on the CERN Pension Fund” is on the agenda of the Council Session of 18 September 2014. Once more the transformation of the current defined benefit scheme into a defined contribution scheme, as well as the question of how to “re-define” the pension conditions for members and beneficiaries will be investigated. Already in the framework of the Working Group 2 (WG2) studies, two legal experts demonstrated that the political and administrative bodies of an international organization which are responsible as employer for managing the staff, must respect the general principles inherent in the law of the international civil service in all their actions, especially when proposing changes in employment conditions. In particular Council must respect the principle of acquired rights of active or retired members of personnel. To reach full funding on a 30-...

  9. 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.

  10. [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.

  11. 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.

  12. Ethics in research; Ethik in der Forschung

    Energy Technology Data Exchange (ETDEWEB)

    Grass, Guido [Koeln Univ. (Germany). Ethik-Kommission der Medizinischen Fakultaet

    2014-07-01

    Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.

  13. 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...

  14. Hiring Diverse Faculty Members in Community Colleges: A Case Study in Ethical Decision Making

    Science.gov (United States)

    Fujimoto, Eugene Oropeza

    2012-01-01

    As the diversity of students on college campuses continues to increase, the racial and ethnic diversity among faculty members continues to lag (Jayakumar, Howard, Allen, & Han, 2009; Turner, Myers, & Creswell, 1999). An often overlooked segment of this problem is the 2-year-college setting. With increasing numbers of students of color achieving…

  15. Faculty Members' Ethical Behaviors: "A Survey Based on Students' Perceptions at Universities in Turkey"

    Science.gov (United States)

    Ozcan, Kenan; Balyer, Aydin; Servi, Tayfun

    2013-01-01

    As members of academic team, faculty behaviors have vital influence on students' lives at universities. This study purposes to discover students' perceptions about faculty behaviors concerning their professional responsibilities, dating/sexual harassment, behaviors inside and behaviors outside the classroom and relationship based on self-interest.…

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 75 FR 42270 - Adoption of Supplemental Standards of Ethical Conduct for Members and Employees of the Securities...

    Science.gov (United States)

    2010-07-20

    ...-specific supplemental regulations necessary to implement their respective ethics programs. \\6\\ See 57 FR... transaction. Currently, the Commission is clearing transactions through the Ethics Program System (``EPS... of disciplinary, loyalty, or other personnel administrative proceedings in connection with those...

  1. 75 FR 42269 - Adoption of Supplemental Standards of Ethical Conduct for Members and Employees of the Securities...

    Science.gov (United States)

    2010-07-20

    ...-specific supplemental regulations necessary to implement their respective ethics programs. \\6\\ See 57 FR... transaction. Currently, the Commission is clearing transactions through the Ethics Program System (``EPS... of disciplinary, loyalty, or other personnel administrative proceedings in connection with those...

  2. 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.

  3. 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.

  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. 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

  6. Effect of Professional Ethics on Reducing Medical Errors from the Viewpoint of Faculty Members in Medical School of Tabriz University of Medical Sciences

    Directory of Open Access Journals (Sweden)

    Fatemeh Donboli Miandoab

    2017-12-01

    Full Text Available Background: Professionalism and adherence to ethics and professional standards are among the most important topics in medical ethics that can play a role in reducing medical errors. This paper examines and evaluates the effect of professional ethics on reducing medical errors from the viewpoint of faculty members in the medical school of the Tabriz University of Medical Sciences. Methods: in this cross-sectional descriptive study, faculty members of the Tabriz University of Medical Sciences were the statistical population from whom 105 participants were randomly selected through simple random sampling. A questionnaire was used, to examine and compare the self-assessed opinions of faculty members in the internal, surgical, pediatric, gynecological, and psychiatric departments. The questionnaires were completed by a self-assessment method and the collected data was analyzed using SPSS 21. Results: Based on physicians’ opinions, professional ethical considerations and its three domains and aspects have a significant role in reducing medical errors and crimes. The mean scores (standard deviations of the managerial, knowledge and communication skills and environmental variables were respectively 46.7 (5.64, 64.6 (8.14 and 16.2 (2.97 from the physicians’ viewpoints. The significant factors with highest scores on the reduction of medical errors and crimes in all three domains were as follows: in the managerial skills variable, trust, physician’s sense of responsibility against the patient and his/her respect for patients’ rights; in the knowledge and communication skills domain, general competence and eligibility as a physician and examination and diagnosis skills; and, last, in the environmental domain, the sufficiency of trainings in ethical issues during education and their satisfaction with basic needs. Conclusion: Based on the findings of this research, attention to the improvement of communication, management and environment skills should

  7. INDIAN ACADEMY OF SCIENCES Scientific Values: Ethical ...

    Indian Academy of Sciences (India)

    vedamurthy

    Science has many applied ... activities pursued by the Fellows not only involve conducting research and publishing its results, but ... See for example, the announcements on “ethical guidelines for biomedical research on human .... therefore it is important for the selection committee members to study each case carefully.

  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. The value of respect in human research ethics: a conceptual analysis and a practical guide.

    Science.gov (United States)

    Pieper, I J; Thomson, C J H

    2014-01-01

    In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

  10. Ethical Leadership, Leader-Member Exchange and Feedback Seeking: A Double-Moderated Mediation Model of Emotional Intelligence and Work-Unit Structure

    Science.gov (United States)

    Qian, Jing; Wang, Bin; Han, Zhuo; Song, Baihe

    2017-01-01

    This research elucidates the role of ethical leadership in employee feedback seeking by examining how and when ethical leadership may exert a positive influence on feedback seeking. Using matched reports from 64 supervisors and 265 of their immediate employees from a hotel group located in a major city in China, we proposed and tested a moderated mediation model that examines leader-member exchange (LMX) as the mediator and emotional intelligence as well as work-unit structure as double moderators in the relationships between ethical leadership and followers’ feedback-seeking behavior from supervisors and coworkers. Our findings indicated that (1) LMX mediated the positive relationship between ethical leadership and feedback seeking from both ethical leaders and coworkers, and (2) emotional intelligence and work-unit structure served as joint moderators on the mediated positive relationship in such a way that the relationship was strongest when the emotional intelligence was high and work-unit structure was more of an organic structure rather than a mechanistic structure. PMID:28744251

  11. [Implementation of ethics services. Opportunities and obstacles].

    Science.gov (United States)

    Salomon, F

    2015-04-01

    Medical success in the last century has caused situations, in which the question arises whether therapy is right. In the same time autonomy has become more and more important. Furthermore, human beings want to decide on health, life and dying. Experience of limitations of life and desire of autonomy in healthcare lead to ethical questions. Different ethical services were established to deal with and to solve problems. Ethics committees with multiprofessional members and different qualifications will give guidance in critical decision making. Ethics services do not receive responsibility for the decision, but helps those who are responsible by structured reflection, estimation of values and including all concerned. Implementing ethics services also encounters obstructions and scepticism. Time, responsibility for therapy and criticism of customs and structures must be considered to perpetuate success. Instructions for implementing ethics services are presented.

  12. 09 September 2013 - Japanese Members of Internal Affairs and Communications Committee House of Representatives visiting the ATLAS experimental cavern with ATLAS Spokesperson D. Charlton. T. Kondo and K. Yoshida present.

    CERN Multimedia

    Jean-Claude Gadmer

    2013-01-01

    09 September 2013 - Japanese Members of Internal Affairs and Communications Committee House of Representatives visiting the ATLAS experimental cavern with ATLAS Spokesperson D. Charlton. T. Kondo and K. Yoshida present.

  13. 29th November 2011 - Czech Parliament Members of the Social Committee of the Lower Chamber visiting CERN permanent exhibition Microcosm and ATLAS visitor centre with Senior Czech Physicist and ILO I. Lehraus.

    CERN Multimedia

    Jean-Claude Gadmer

    2011-01-01

    29th November 2011 - Czech Parliament Members of the Social Committee of the Lower Chamber visiting CERN permanent exhibition Microcosm and ATLAS visitor centre with Senior Czech Physicist and ILO I. Lehraus.

  14. 78 FR 21908 - Request for Nominations of Members To Serve on the National Advisory Committee on Racial, Ethnic...

    Science.gov (United States)

    2013-04-12

    ... National Advisory Committee on Racial, Ethnic, and Other Populations AGENCY: Bureau of the Census, Commerce..., students and youth, aging populations, American Indian and Alaska Native tribal considerations, new... technology and video/web conferencing to reduce meeting and travel costs, and to more fully engage local and...

  15. Perceptions of veterinary admissions committee members of undergraduate credits earned from community colleges or online compared to traditional 4-year institutions.

    Science.gov (United States)

    Kogan, L R; Stewart, S M; Schoenfeld-Tacher, R; Hellyer, P W

    2015-01-01

    Veterinary admission committees are asked to create and implement a fair, reliable, and valid system to select the candidates most likely to succeed in veterinary school from a large pool of applicants. Although numerous studies have explored grade point average (GPA) as a predictive value of later academic success, there has been little attention paid to how and where an applicant acquires his/her undergraduate coursework. Quality of academic program is an important component of applicant files, and it is suggested that the source of a candidate's coursework might influence admissions committee decisions, perhaps even outside of the committee's immediate awareness. Options for undergraduate education include taking classes at a traditional four-year institution, a community college, or online. This study provides an overview of the current state of online courses and community colleges in the US as a foundation to explore the views of veterinary admissions committee members pertaining to coursework completed at traditional residential 4-year schools or at community colleges and whether they are delivered on campus or online (at either type of institution). Survey participants reported a pattern of preference for traditional four-year residential coursework compared to online or community college courses. These results are interesting given the exponential growth of students taking online courses and data showing community colleges are providing a successful gateway to obtaining a four-year degree. This also points to the need for admission committees to discuss potential biases since the information about type of school and/or course may not be consistently available for all applicants. Finally, at a time when admitting a diverse class of students is a goal of many programs, it is of special concern that there are potential biases against courses taken online or from community colleges - venues that tend to draw a more diverse population than traditional 4-year

  16. 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.

  17. 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.

  18. 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.

  19. 78 FR 19191 - Request for Nominations of Members to Serve on the Federal Economic Statistics Advisory Committee

    Science.gov (United States)

    2013-03-29

    ... pleasure of the Secretary of Commerce. 2. Members are nominated by the Department of Commerce, in...., Senior Advisor Performing the Duties of the Director, Bureau of the Census. [FR Doc. 2013-07344 Filed 3...

  20. Perceptions of veterinary admissions committee members of undergraduate credits earned from community colleges or online compared to traditional 4-year institutions

    Directory of Open Access Journals (Sweden)

    L.R. Kogan

    2015-06-01

    Full Text Available Veterinary admission committees are asked to create and implement a fair, reliable, and valid system to select the candidates most likely to succeed in veterinary school from a large pool of applicants. Although numerous studies have explored grade point average (GPA as a predictive value of later academic success, there has been little attention paid to how and where an applicant acquires his/her undergraduate coursework. Quality of academic program is an important component of applicant files, and it is suggested that the source of a candidate’s coursework might influence admissions committee decisions, perhaps even outside of the committee’s immediate awareness. Options for undergraduate education include taking classes at a traditional four-year institution, a community college, or online. This study provides an overview of the current state of online courses and community colleges in the US as a foundation to explore the views of veterinary admissions committee members pertaining to coursework completed at traditional residential 4-year schools or at community colleges and whether they are delivered on campus or online (at either type of institution. Survey participants reported a pattern of preference for traditional four-year residential coursework compared to online or community college courses. These results are interesting given the exponential growth of students taking online courses and data showing community colleges are providing a successful gateway to obtaining a four-year degree. This also points to the need for admission committees to discuss potential biases since the information about type of school and/or course may not be consistently available for all applicants. Finally, at a time when admitting a diverse class of students is a goal of many programs, it is of special concern that there are potential biases against courses taken online or from community colleges - venues that tend to draw a more diverse population than

  1. 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.

  2. 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...

  3. Justice and care: decision making by medical school student promotions committees.

    Science.gov (United States)

    Green, Emily P; Gruppuso, Philip A

    2017-06-01

    The function of medical school entities that determine student advancement or dismissal has gone largely unexplored. The decision making of 'academic progress' or student promotions committees is examined using a theoretical framework contrasting ethics of justice and care, with roots in the moral development work of theorists Kohlberg and Gilligan. To ascertain promotions committee members' conceptualisation of the role of their committee, ethical orientations used in member decision making, and student characteristics most influential in that decision making. An electronic survey was distributed to voting members of promotions committees at 143 accredited allopathic medical schools in the USA. Descriptive statistics were calculated and data were analysed by gender, role, institution type and class size. Respondents included 241 voting members of promotions committees at 55 medical schools. Respondents endorsed various promotions committee roles, including acting in the best interest of learners' future patients and graduating highly qualified learners. Implementing policy was assigned lower importance. The overall pattern of responses did not indicate a predominant orientation toward an ethic of justice or care. Respondents indicated that committees have discretion to take individual student characteristics into consideration during deliberations, and that they do so in practice. Among the student characteristics with the greatest influence on decision making, professionalism and academic performance were paramount. Eighty-five per cent of participants indicated that they received no training. Promotions committee members do not regard orientations of justice and care as being mutually exclusive and endorse an array of statements regarding the committee's purpose that may conflict with one another. The considerable variance in the influence of student characteristics and the general absence of committee member training indicate a need for clear delineation of the

  4. 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.

  5. 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.

  6. 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.

  7. [The role of bioethics committees in the systems protecting scientific biomedical research participants in France and in Poland].

    Science.gov (United States)

    Czarkowski, Marek; Sieczych, Alicja

    2013-08-01

    Bioethics committees are along with ethic regulations and rules of law one of three main pillars in the system of protection of scientific biomedical research participants. Although principal directives for bioethics committees are established by international guidelines, detailed regulations may differ in particular states. The aim of this article was to compare two bioethic committees systems: French and Polish one. Historical beginnings of the bioethics committees system in France and in Poland are briefly mentioned, Subsequently, the networks of bioethics committees in both countries are compared. Although the number of bioethics committees (Research Ethic Committees) in both countries is comparable, the procedure of their establishment varies. French committees are based on administrative division of the country and divide on regional and interregional committees. In Poland, bioethics committees are established by medical universities, medical research and development units or regional chambers of physicians and dentists. In France there is no equivalent of Appeal Bioethics Committee, however one could appeal from the negative bioethics committee's opinion. The composition of French bioethics committees is more diverse and half of the members are not related to medical professions. Members of French committees are named on indefinite term by headmaster of Regional Health Agency after having been chosen in competition for the post. In Poland members are called on three-year-term but the rotation of members is not overwhelming since there is no limit of terms for one member. French legal solutions seems more secure for scientific bioethics research participants. For this reason, a detailed research on legislation in other countries is necessary before introducing any new regulations in Polish law.

  8. 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.

  9. Computational physics and applied mathematics capability review June 8-10, 2010 (Advance materials to committee members)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Stephen R [Los Alamos National Laboratory

    2010-01-01

    differential equations (broadly defined) in a variety of settings, including particle transport, solvers, and plasma physics; (3) Monte Carlo - Monte Carlo was invented at Los Alamos, and this theme discusses these vitally important methods and their application in everything from particle transport, to condensed matter theory, to biology; (4) Molecular Dynamics - This theme describes the widespread use of molecular dynamics for a variety of important applications, including nuclear energy, materials science, and biological modeling; (5) Discrete Event Simulation - The technical scope of this theme represents a class of complex system evolutions governed by the action of discrete events. Examples include network, communication, vehicle traffic, and epidemiology modeling; and (6) Integrated Codes - This theme discusses integrated applications (comprised of all of the supporting science represented in Themes 1-5) that are of strategic importance to the Laboratory and the nation. The laboratory has in approximately 10 million source lines of code in over 100 different such strategically important applications. Of these themes, four of them will be reviewed during the 2010 review cycle: Themes 1, 2, 3, and 6. Because these capability reviews occur every three years, Themes 4 and 5 will be reviewed in 2013, along with Theme 6 (which will be reviewed during each review, owing to this theme's role as an integrator of the supporting science represented by the other 5 themes). Yearly written status reports will be provided to the Capability Review Committee Chair during off-cycle years.

  10. The science of ethics: Deception, the resilient self, and the APA code of ethics, 1966-1973.

    Science.gov (United States)

    Stark, Laura

    2010-01-01

    This paper has two aims. The first is to shed light on a remarkable archival source, namely survey responses from thousands of American psychologists during the 1960s in which they described their contemporary research practices and discussed whether the practices were "ethical." The second aim is to examine the process through which the American Psychological Association (APA) used these survey responses to create principles on how psychologists should treat human subjects. The paper focuses on debates over whether "deception" research was acceptable. It documents how members of the committee that wrote the principles refereed what was, in fact, a disagreement between two contemporary research orientations. The paper argues that the ethics committee ultimately built the model of "the resilient self" into the APA's 1973 ethics code. At the broadest level, the paper explores how prevailing understandings of human nature are written into seemingly universal and timeless codes of ethics. © 2010 Wiley Periodicals, Inc.

  11. 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

  12. [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.

  13. 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...

  14. [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.

  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. 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

  17. Evidence and Ethics (Editorial

    Directory of Open Access Journals (Sweden)

    Alison Brettle

    2012-12-01

    Full Text Available Welcome to the December issue of EBLIP, the final issue of my first year as Editor-in-Chief. A year which I have thoroughly enjoyed and one where the fears over what to write in my editorials haven’t materialised. This quarter, ethics has featured quite heavily in my working life so I decided to make this the topic of the editorial, sharing some of my thoughts regarding evidence, ethics and how ethical principles are implemented within the EBLIP journal.Ethics are “principles of conduct or standards of behaviour governing an individual or profession” (Library and Information Science Editorial Committee, 2010, and as individuals or professionals we may be governed by various ethical codes. As I'm sure you know, EBLIP originated in the health domain, where ethical values and ethical research feature strongly. Indeed, by its formal definition, research cannot take place unless “ethical approval” from an appropriate committee has been granted. The practicalities of taking research through the ethical approval process can often be time consuming, and those involved in research need to bear this in mind when planning a project. Each committee will have a slightly different form and process (which can add to the frustration of the researcher, but basically will make their decision to approve on the basis that the research includes obtaining informed consent from participants (i.e., participants know what the research is about and what their involvement will mean; that the research will not cause harm to participants; that confidentiality will be maintained; and that the research undertaken is methodologically rigorous and worthwhile. Preparing a proposal for ethical approval, whilst time consuming, makes the researcher think about all aspects of the research and how it is going to be operationalized, which can save lots of time and effort in the long run and may well also improve the research design. These principles are the same whatever

  18. Survey of gadolinium-based contrast agent utilization among the members of the Society for Pediatric Radiology: a Quality and Safety Committee report

    International Nuclear Information System (INIS)

    Blumfield, Einat; Moore, Michael M.; Drake, Mary K.; Goodman, Thomas R.; Lewis, Kristopher N.; Meyer, Laura T.; Ngo, Thang D.; Sammet, Christina; Stanescu, Arta Luana; Iyer, Ramesh S.; Swenson, David W.; Slovis, Thomas L.

    2017-01-01

    Gadolinium-based contrast agents (GBCAs) have been used for magnetic resonance (MR) imaging over the last three decades. Recent reports demonstrated gadolinium retention in patients' brains following intravenous administration. Since gadolinium is a highly toxic heavy metal, there is a potential for adverse effects from prolonged retention or deposition, particularly in children. For this reason, the Society (SPR) for Pediatric Radiology Quality and Safety committee conducted a survey to evaluate the current status of GBCAs usage among pediatric radiologists. To assess the usage of GBCAs among SPR members. An online 15-question survey was distributed to SPR members. Survey questions pertained to the type of GBCAs used, protocoling workflow, requirement of renal function or pregnancy tests, and various clinical indications for contrast-enhanced MRI examinations. A total of 163 survey responses were compiled (11.1% of survey invitations), the majority of these from academic institutions in the United States. Ninety-four percent reported that MR studies are always or usually protocoled by pediatric radiologists. The most common GBCA utilized by survey respondents were Eovist (60.7%), Ablavar (45.4%), Gadovist (38.7%), Magnevist (34.4%) and Dotarem (32.5%). For several clinical indications, survey responses regarding GBCA administration were concordant with American College of Radiology (ACR) Appropriateness Criteria, including seizures, headache and osteomyelitis. For other indications, including growth hormone deficiency and suspected vascular ring, survey responses revealed potential overutilization of GBCAs when compared to ACR recommendations. Survey results demonstrate that GBCAs are administered judiciously in children, yet there is an opportunity to improve their utilization with the goal of reducing potential future adverse effects. (orig.)

  19. Survey of gadolinium-based contrast agent utilization among the members of the Society for Pediatric Radiology: a Quality and Safety Committee report.

    Science.gov (United States)

    Blumfield, Einat; Moore, Michael M; Drake, Mary K; Goodman, Thomas R; Lewis, Kristopher N; Meyer, Laura T; Ngo, Thang D; Sammet, Christina; Stanescu, Arta Luana; Swenson, David W; Slovis, Thomas L; Iyer, Ramesh S

    2017-05-01

    Gadolinium-based contrast agents (GBCAs) have been used for magnetic resonance (MR) imaging over the last three decades. Recent reports demonstrated gadolinium retention in patients' brains following intravenous administration. Since gadolinium is a highly toxic heavy metal, there is a potential for adverse effects from prolonged retention or deposition, particularly in children. For this reason, the Society (SPR) for Pediatric Radiology Quality and Safety committee conducted a survey to evaluate the current status of GBCAs usage among pediatric radiologists. To assess the usage of GBCAs among SPR members. An online 15-question survey was distributed to SPR members. Survey questions pertained to the type of GBCAs used, protocoling workflow, requirement of renal function or pregnancy tests, and various clinical indications for contrast-enhanced MRI examinations. A total of 163 survey responses were compiled (11.1% of survey invitations), the majority of these from academic institutions in the United States. Ninety-four percent reported that MR studies are always or usually protocoled by pediatric radiologists. The most common GBCA utilized by survey respondents were Eovist (60.7%), Ablavar (45.4%), Gadovist (38.7%), Magnevist (34.4%) and Dotarem (32.5%). For several clinical indications, survey responses regarding GBCA administration were concordant with American College of Radiology (ACR) Appropriateness Criteria, including seizures, headache and osteomyelitis. For other indications, including growth hormone deficiency and suspected vascular ring, survey responses revealed potential overutilization of GBCAs when compared to ACR recommendations. Survey results demonstrate that GBCAs are administered judiciously in children, yet there is an opportunity to improve their utilization with the goal of reducing potential future adverse effects.

  20. Survey of gadolinium-based contrast agent utilization among the members of the Society for Pediatric Radiology: a Quality and Safety Committee report

    Energy Technology Data Exchange (ETDEWEB)

    Blumfield, Einat [Jacobi Medical Center, Department of Radiology, Albert Einstein College of Medicine, South Bronx, NY (United States); Moore, Michael M. [The Pennsylvania State University College of Medicine, Department of Radiology, Penn State Hershey Children' s Hospital, Hershey, PA (United States); Drake, Mary K. [University of Nebraska Medical Center, Department of Radiology, Children' s Hospital and Medical Center, Omaha, NE (United States); Goodman, Thomas R. [Yale School of Medicine, Department of Radiology and Biomedical Imaging, New Haven, CT (United States); Lewis, Kristopher N. [Augusta University, Department of Radiology, Children' s Hospital of Georgia, Augusta, GA (United States); Meyer, Laura T. [Wake Radiology, Raleigh, NC (United States); Ngo, Thang D. [Nemours Children' s Hospital, Department of Medical Imaging, Orlando, FL (United States); Sammet, Christina [Ann and Robert H. Lurie Children' s Hospital of Chicago, Department of Radiology, Chicago, IL (United States); Stanescu, Arta Luana; Iyer, Ramesh S. [Seattle Children' s Hospital, University of Washington School of Medicine, Department of Radiology, Seattle, WA (United States); Swenson, David W. [Warren Alpert Medical School of Brown University, Department of Diagnostic Imaging, Providence, RI (United States); Slovis, Thomas L. [Children' s Hospital of Michigan, Wayne State University School of Medicine, Department of Radiology, Detroit, MI (United States)

    2017-05-15

    Gadolinium-based contrast agents (GBCAs) have been used for magnetic resonance (MR) imaging over the last three decades. Recent reports demonstrated gadolinium retention in patients' brains following intravenous administration. Since gadolinium is a highly toxic heavy metal, there is a potential for adverse effects from prolonged retention or deposition, particularly in children. For this reason, the Society (SPR) for Pediatric Radiology Quality and Safety committee conducted a survey to evaluate the current status of GBCAs usage among pediatric radiologists. To assess the usage of GBCAs among SPR members. An online 15-question survey was distributed to SPR members. Survey questions pertained to the type of GBCAs used, protocoling workflow, requirement of renal function or pregnancy tests, and various clinical indications for contrast-enhanced MRI examinations. A total of 163 survey responses were compiled (11.1% of survey invitations), the majority of these from academic institutions in the United States. Ninety-four percent reported that MR studies are always or usually protocoled by pediatric radiologists. The most common GBCA utilized by survey respondents were Eovist (60.7%), Ablavar (45.4%), Gadovist (38.7%), Magnevist (34.4%) and Dotarem (32.5%). For several clinical indications, survey responses regarding GBCA administration were concordant with American College of Radiology (ACR) Appropriateness Criteria, including seizures, headache and osteomyelitis. For other indications, including growth hormone deficiency and suspected vascular ring, survey responses revealed potential overutilization of GBCAs when compared to ACR recommendations. Survey results demonstrate that GBCAs are administered judiciously in children, yet there is an opportunity to improve their utilization with the goal of reducing potential future adverse effects. (orig.)

  1. Assessment of orientation practices for ethics consultation at Harvard Medical School-affiliated hospitals.

    Science.gov (United States)

    Zaidi, Danish; Kesselheim, Jennifer C

    2018-02-01

    Few studies have been conducted to assess the quality of orientation practices for ethics advisory committees that conduct ethics consultation. This survey study focused on several Harvard teaching hospitals, exploring orientation quality and committee members' self-evaluation in the American Society of Bioethics and Humanities (ASBH) ethics consultation competencies. We conducted a survey study that involved 116 members and 16 chairs of ethics advisory committees, respectively (52% and 62.5% response rates). Predictor variables included professional demographics, duration on committees and level of training. Outcome variables included familiarity with and preparedness in the ASBH competencies and satisfaction with orientations. We hypothesised that responses would be associated with both the aforementioned predictors and whether or not participants had encountered the ASBH competencies in training. A majority of respondents found their orientation curricula to be helpful (62%), although a significant portion of respondents did not receive any orientation (24%) or were unsatisfied with their orientation (14%). Familiarity with ASBH competencies was a statistically significant predictor of respondents' self-evaluation in particular categories (54% had heard of the competencies). Standard educational materials were reported as offered during orientation, such as readings (50%) and case studies (41%); different medium resources were less evidenced such as videos on ethics consultation (19%). Institutions should re-evaluate orientation practices for ethics committee members that perform ethics consultation. Integrating ASBH competencies and useful methods into a resourceful pedagogy will help improve both member satisfaction with orientation and preparation in consultation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Reasoning Backwards by Design: Commentary on "Moral Reasoning among HEC Members".

    Science.gov (United States)

    Stephens, Ashley L; Heitman, Elizabeth

    2015-01-01

    Empirical assessment of the practice of clinical ethics is made difficult by the limited standardization of settings, structures, processes, roles, and training for ethics consultation, as well as by whether individual ethics consultants or hospital ethics committees (HECs) provide consultation. Efforts to study the relationship between theory and practice in the work of HECs likewise require the spelling out of assumptions and definition of key variables, based in knowledge of the core concepts of clinical ethics and logistics of clinical consultation. The survey of HEC members reported by Wasserman and colleagues illustrates the difficulty of such research and calls attention to need for studies of real-time, complex decision making to inform conclusions about how theory affects practice. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  3. [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.

  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. 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.

  6. 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...

  7. 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.

  8. 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

  9. 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.)

  10. The role of national ethics commissions in Finland.

    Science.gov (United States)

    Halila, Ritva

    2003-08-01

    There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub-Committee on Medical Research Ethics in 1999. The Co-operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub-Committee on Medical Research Ethics acts a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi-professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years.

  11. Ethical leadership outcomes in nursing.

    Science.gov (United States)

    Barkhordari-Sharifabad, Maasoumeh; Ashktorab, Tahereh; Atashzadeh-Shoorideh, Foroozan

    2017-01-01

    Leadership style adopted by nursing managers is a key element in progress and development of nursing and quality of healthcare services received by the patients. In this regard, the role of ethical leadership is of utmost importance. The objective of the study was to elaborate on the ethical leadership and its role in professional progress and growth of nurses in the light of work condition in health providing institutes. The study was carried out as a qualitative study following conventional content analysis method. In total, 14 nursing faculty members and nursing managers at different levels were selected through purposive sampling method. Semi-structured interviews were used for data gathering. The data were analyzed using latent content analysis and constant comparison analysis. Ethical considerations: This study was conducted in accordance with ethical issues in research with human participants and national rules and regulations related to informed consent and confidentiality. The study was approved by the Committee of Ethics in Research at the Shahid Beheshti University of Medical Sciences in Tehran, Iran, under the code: sbmu.rec.1393.695 on 15 February 2015. Five subcategories were obtained based on the analysis, which constituted two main categories including "all-inclusive satisfaction" and "productivity." Nursing leaders highlighted the point that their ethical behavior creates "inner satisfaction of the leader," "employees' job satisfaction," and "patients' satisfaction." Improvement of productivity was another outcome of ethical behavior of the leaders. This kind of behavior resulted in "providing better services" and "inspiring ethical behavior in the employees." It has great influence on progress and growth of the nursing profession. By creating an ethical climate, ethical leadership leads to positive and effective outcomes-for the patients as well as for the nurses and the leaders-and professional progress and development of the nursing profession

  12. 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....

  13. Institutional Ethics Resources: Creating Moral Spaces.

    Science.gov (United States)

    Hamric, Ann B; Wocial, Lucia D

    2016-09-01

    Since 1992, institutions accredited by The Joint Commission have been required to have a process in place that allows staff members, patients, and families to address ethical issues or issues prone to conflict. While the commission's expectations clearly have made ethics committees more common, simply having a committee in no way demonstrates its effectiveness in terms of the availability of the service to key constituents, the quality of the processes used, or the outcomes achieved. Beyond meeting baseline accreditation standards, effective ethics resources are requisite for quality care for another reason. The provision of care to the sick is a practice with profound moral dimensions. Clinicians need what Margaret Urban Walker has called "moral spaces," reflective spaces within institutions in which to explore and communicate values and ethical obligations as they undergird goals of care. Walker proposed that ethicists needed to be concerned with the design and maintenance of these moral spaces. Clearly, that concern needs to extend beyond ethicists to institutional leaders. This essay uses Walker's idea of moral space to describe individuals and groups who are actual and potential ethics resources in health care institutions. We focus on four requisite characteristics of effective resources and the challenges to achieving them, and we identify strategies to build them. In our view, such moral spaces are particularly important for nurses and their colleagues on interprofessional teams and need to be expanded and strengthened in most settings. © 2016 The Hastings Center.

  14. 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

  15. Evaluation of Pharmacy and Therapeutic (P&T) Committee member knowledge, attitudes and ability regarding the use of comparative effectiveness research (CER) in health care decision-making.

    Science.gov (United States)

    Tang, D H; Warholak, T L; Hines, L E; Hurwitz, J; Brown, M; Taylor, A M; Brixner, D; Malone, D C

    2014-01-01

    Comparative effectiveness research (CER) is a constellation of research methods designed to improve health care decision making. Educational programs that improve health care decision makers' CER knowledge and awareness may ultimately lead to more cost-effective use of health care resources. This study was conducted to evaluate changes in CER knowledge, attitudes, and ability among Pharmacy and Therapeutics (P&T) Committee members and support staff after attending a tailored educational program. Physicians and pharmacists from two professional societies and the Indian Health Service who participated in the P&T process were invited via email to participate in this study. Participants completed a questionnaire, designed specifically for this study, prior to and following the 4-hour live, educational program on CER to determine the impact on their related knowledge, attitudes, and ability to use CER in decision-making. Rasch analysis was used to assess validity and reliability of subsections of the questionnaire and regression analysis was used to assess programmatic impact on CER knowledge, attitude, and ability. One hundred and forty of the 199 participants completed both the pre- and post-CER session questionnaires (response rate = 70.4%). Most participants (>75%) correctly answered eight of the ten knowledge items after attending the educational session. More than 60% of the respondents had a positive attitude toward CER both before and after the program. Compared to baseline (pretest), participants reported significant improvements in their perceived ability to use CER after attending the session in these areas: using CER reviews, knowledge of CER methods, identifying problems with randomized controlled trials, identifying threats to validity, understanding of evidence synthesis approaches, and evaluating the quality of CER (all P values CER educational program was effective in increasing participants' CER knowledge and self-perceived ability to evaluate

  16. 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...

  17. IS ETHICAL HACKING ETHICAL?

    OpenAIRE

    MUHAMMAD NUMAN ALI KHAN; DANISH JAMIL,

    2011-01-01

    This paper explores the ethics behind ethical hacking and whether there are problems that lie with this new field of work. Since ethical hacking has been a controversial subject over the past few years, the question remains of the true intentions of ethical hackers. The paper also looks at ways in which future research could be looked intoto help keep ethical hacking, ethical.

  18. 78 FR 55692 - Electricity Advisory Committee

    Science.gov (United States)

    2013-09-11

    ... amended, 5 U.S.C., App. 2, to provide advice to the U.S. Department of Energy (DOE) in implementing the....-1:00 p.m. Swearing in Ceremony and Ethics Briefing--For New EAC Members 12:00 p.m.-1:00 p.m. EAC Leadership Committee Meeting 12:00 p.m.-1:00 p.m. Registration 1:00 p.m.-1:15 p.m. Welcome and Developments...

  19. 76 FR 29722 - Elko Resource Advisory Committee

    Science.gov (United States)

    2011-05-23

    ... (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The...- Determination Act; (2) Review roles of RAC committee members and Committee Chairman; (3) Overview of project...

  20. Building research capacity with members of underserved American Indian/Alaskan Native communities: training in research ethics and the protection of human subjects.

    Science.gov (United States)

    Jetter, Karen M; Yarborough, Mark; Cassady, Diana L; Styne, Dennis M

    2015-05-01

    To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training. © 2014 Society for Public Health Education.

  1. Educating for ethical leadership.

    Science.gov (United States)

    Gallagher, Ann; Tschudin, Verena

    2010-04-01

    In this article we consider the nature of ethical leadership in nursing. An appreciation of the basis of such leadership requires an understanding of responsibility and of key intellectual and ethical qualities or virtues. We examine some of the educational and practice strategies to promote ethical leadership. We argue that there are different levels of ethical leadership. All members of the nursing workforce are ethical leaders in so far as they demonstrate a commitment to ethical practice in their everyday work and act as ethical role models for others. Nurse managers are responsible for influencing their team and for acting as arbiters between organisational and professional values. Nurse educators are role models and ethical leaders as they ensure that the explicit and hidden curriculum demonstrate a commitment to professional values. Nurses who assume political roles have an obligation to lead on ethical agenda compatible with the values of nursing.

  2. 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.

  3. 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

  4. [Research Ethics in Partnership with Benin : A call for Solidarity].

    Science.gov (United States)

    Bergeron, Michel

    2017-05-22

    Over the last decade, research ethics has developed in Benin partly through a partnership with Quebec. This partnership has evolved using TCPS2, the Canadian framework in research ethics. In doing so, three main values were put forward : respect for human dignity, respect for cultural diversity and solidarity. Over that time period, research ethics in Benin has structured through new Research Ethics Committees (REC) and though participation of those involved in research with human beings. REC members, researchers and students have acquired the needed tools to resolve most of the ethical dilemmas that could arise in the future making it one of the positive results of this partnership. Retrospectively, it has also been a situation where the Van Rensselaer Potter's perspective on bioethics has emerged in a French-speaking context where the spoken language and the French cultural approach is of great importance.

  5. [Project for the Creation of a Medical or Hospital Ethical Committee at a Local Level in the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama. Year 2013].

    Science.gov (United States)

    Díaz Rivera, Yashiro A

    2015-01-01

    The next project was based on the design on the creation of a medical ethical Committee at a hospital. It was developed at the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama, in 2013. Insomuch as the creation of social projects requires unified international parameters, format is taken from the Unesco's guides for the establishing and working of bioethics committees; adapted to the socio-economic, political and cultural context of the San Miguelito District, Panama Province. Furthermore to adapting to socio-ecological aspect where the research project is carried out, the theoretical aspect includes from the ontological personalistic bioethics, where the cornerstone is the dignity of the human person. A study of perceptions of medical staff and nursing was developed on the management of the most common ethical dilemmas in the Hospital San Miguel Arcángel. The instrument used was a previously validated perception survey through a pilot test. Reliability was measured using Cronbach's alpha coefficient, and validity was obtained from the content. Satisfactory statistical results, that verify the working hypotheses on the recognition of the importance of autonomy, confidentiality, protection of vulnerable population, occupational health staff welfare and integration of bioethics at the institutional agenda, were obtained. However, there were particular aspects that indicate some doubt as to the management of some realities that are presented in the context of health care.

  6. Real-time Responsiveness for Ethics Oversight During Disaster Research.

    Science.gov (United States)

    Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew

    2015-11-01

    Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.

  7. Einstein, Ethics and the Atomic Bomb

    Science.gov (United States)

    Rife, Patricia

    2005-03-01

    Einstein voiced his ethical views against war as well as fascism via venues and alliances with a variety of organizations still debated today. In 1939, he signed a letter to President Roosevelt (drafted by younger colleagues Szilard, Wigner and others) warning the U.S.government about the danger of Nazi Germany gaining control of uranium in the Belgian-controlled Congo in order to develop atomic weapons, based on the discovery of fission by Otto Hahn and Lise Meitner. In 1945, he became a member of the Princeton-based ``Emergency Committee for Atomic Scientists'' organized by Bethe, Condon, Bacher, Urey, Szilard and Weisskopf. Rare Einstein slides will illustrate Dr.Rife's presentation on Albert Einstein's philosophic and ethical convictions about peace, and public stance against war (1914-1950).

  8. 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

  9. Brief report : ethical problems in research practice

    OpenAIRE

    Colnerud, Gunnel

    2013-01-01

    Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral ...

  10. 'We're in the sandwich': Aged care staff members' negotiation of constraints and the role of the organisation in enacting and supporting an ethic of care.

    Science.gov (United States)

    Petriwskyj, Andrea; Gibson, Alexandra; Webby, Glenys

    2015-12-01

    Aged care staff are often seen as holding power in care relationships, particularly in client engagement. Such a perception, however, may limit our understanding and analysis of the dynamics and politics within care spaces. This paper uses interview and focus group data from both staff and clients of an Australian aged care provider to identify the positions given to, and taken up by, staff in client engagement. Focusing on one of these positions, in which staff are seen as managing and negotiating constraints, the paper uses an ethic of care lens to examine the context in which engagement - and this position taking - occurs. Findings reflect the importance of the organisational and systemic context to the practice of care ethics and the potential vulnerability and disempowerment of care giving staff. Implications for the support of staff in client engagement and the role of care organisations beyond structures and processes to an active participant in an ethic of care are discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Family members' expectations regarding nurses' competence in care homes: a qualitative interview study.

    Science.gov (United States)

    Kiljunen, Outi; Kankkunen, Päivi; Partanen, Pirjo; Välimäki, Tarja

    2017-11-22

    Structural and cultural changes in the care of older people have influenced nursing practice, creating a need to identify current competency requirements for nurses working in care homes. Family members have an important role in ensuring the well-being of older people living in care homes, and family members' can provide valuable information about competence requirements. To explore the expectations of the care home residents' family members regarding the competence of nurses in care homes for older people. A qualitative descriptive design was used. Semi-structured interviews were conducted with 18 care home residents' family members between March and September 2016. Participants were recruited with help from regional associations and member associations of The Central Association of Carers in Finland and from regional associations of The Alzheimer's Society of Finland. The snowball technique was also used. The data were analysed using inductive content analysis. Ethics committee approval was obtained from the university committee on research ethics, and written informed consent was obtained from participants. The care home residents' family members expected that nurses would be able to interact with and treat people respectfully. Reflective collaboration between the nurse and a family member was also emphasised. Family members expected nurses to provide high-quality basic care and nursing and support residents' well-being individually and holistically. Family members' expectations reflect the need for ethical and interactional competence in the care home. In addition, evidence-based practice competencies are required to provide high-quality care. Nurses' ability to provide person-centred, individual and holistic care is vital to ensure care home residents' well-being. © 2017 Nordic College of Caring Science.

  12. The rose of Sharon: what is the ideal timing for palliative care consultation versus ethics consultation?

    Science.gov (United States)

    La Via, Jennifer; Schiedermayer, David

    2012-01-01

    Ethics committees and palliative care consultants can function in a complementary fashion, seamlessly and effectively. Ethics committees can "air" and help resolves issues, and palliative care consultants can use a low-key, longitudinal approach.

  13. Engineer Ethics

    International Nuclear Information System (INIS)

    Lee, Dae Sik; Kim, Yeong Pil; Kim, Yeong Jin

    2003-03-01

    This book tells of engineer ethics such as basic understanding of engineer ethics with history of engineering as a occupation, definition of engineering and specialized job and engineering, engineer ethics as professional ethics, general principles of ethics and its limitation, ethical theory and application, technique to solve the ethical problems, responsibility, safety and danger, information engineer ethics, biotechnological ethics like artificial insemination, life reproduction, gene therapy and environmental ethics.

  14. Screening Out Controversy: Human Genetics, Emerging Techniques of Diagnosis, and the Origins of the Social Issues Committee of the American Society of Human Genetics, 1964-1973.

    Science.gov (United States)

    Mitchell, M X

    2017-05-01

    In the years following World War II, and increasingly during the 1960s and 1970s, professional scientific societies developed internal sub-committees to address the social implications of their scientific expertise (Moore, Disrupting Science: Social Movements, American Scientists, and the Politics of the Military, 1945-1975. Princeton: Princeton University Press, 2008). This article explores the early years of one such committee, the American Society of Human Genetics' "Social Issues Committee," founded in 1967. Although the committee's name might suggest it was founded to increase the ASHG's public and policy engagement, exploration of the committee's early years reveals a more complicated reality. Affronted by legislators' recent unwillingness to seek the expert advice of human geneticists before adopting widespread neonatal screening programs for phenylketonuria (PKU), and feeling pressed to establish their relevance in an increasingly resource-scarce funding environment, committee members sought to increase the discipline's expert authority. Painfully aware of controversy over abortion rights and haunted by the taint of the discipline's eugenic past, however, the committee proceeded with great caution. Seeking to harness interest in and assert professional control over emerging techniques of genetic diagnosis, the committee strove to protect the society's image by relegating ethical and policy questions about their use to the individual consciences of member scientists. It was not until 1973, after the committee's modest success in organizing support for a retrospective public health study of PKU screening and following the legalization of abortion on demand, that the committee decided to take a more publicly engaged stance.

  15. [Ethical issue in animal experimentation].

    Science.gov (United States)

    Parodi, André-Laurent

    2009-11-01

    In the 1970s, under pressure from certain sections of society and thanks to initiatives by several scientific research teams, committees charged with improving the conditions of laboratory animals started to be created, first in the United States and subsequently in Europe. This led to the development of an ethical approach to animal experimentation, taking into account new scientific advances. In addition to the legislation designed to provide a legal framework for animal experimentation and to avoid abuses, this ethical approach, based on the concept that animals are sentient beings, encourages greater respect of laboratory animals and the implementation of measures designed to reduce their suffering. Now, all animal experiments must first receive ethical approval--from in-house committees in the private sector and from regional committees for public institutions. Very recently, under the impetus of the French ministries of research and agriculture, the National committee for ethical animal experimentation published a national ethical charter on animal experimentation, setting the basis for responsible use of animals for scientific research and providing guidelines for the composition and functioning of ethics committees. Inspired by the scientific community itself this ethical standardization should help to assuage--but not eliminate--the reticence and hostility expressed by several sections of society.

  16. SENIOR STAFF ADVANCEMENT COMMITTEE (SSAC)

    CERN Document Server

    2000-01-01

    Composition and mandateThe Senior Staff Advancement Committee is composed of members nominated ad persona by the Director-General.The Committee examines proposals from Divisions concerning promotions to grade 13 in Career Path IX, changes of career path to Career Path IX and advancements to the exceptional grade in Career path VIII.The Director-General may consult the Committee on any matter related to senior staff careers.The Committee makes its recommendations to the Director-General.

  17. UNESCO's Ethics Education Programme.

    NARCIS (Netherlands)

    Have, H.A.M.J. ten

    2008-01-01

    Unesco initiated the Ethics Education Programme in 2004 at the request of member states to reinforce and increase the capacities in the area of ethics teaching. The programme is focused on providing detailed information about existing teaching programmes. It also develops and promotes teaching

  18. The ethics of contacting family members of a subject in a genetic research study to return results for an autosomal dominant syndrome.

    Science.gov (United States)

    Taylor, Holly A; Wilfond, Benjamin S

    2013-01-01

    This case explores the ethical landscape around recontacting a subject's relatives to return genetic research results when the informed consent form signed by the original cohort of subjects is silent on whether investigators may share new information with the research subject's family. As a result of rapid advances in genetic technology, methods to identify genetic markers can mature during the life course of a study. In this case, the investigators identified the genetic mutation responsible for the disorder after a number of their original subjects had died. The researchers now have the ability to inform relatives of the subject about their risk of developing the same disease. Mark Rothstein, JD, from the University of Louisville School of Medicine, provides an overview of the medical/scientific, legal, and ethical issues underlying this case. Lauren Milner, PhD, and colleagues at Stanford University explore how the relationship between researcher and subject affect this debate. Seema Shah, JD, and colleagues at the National Institutes of Health and University of California, Los Angeles (UCLA) discuss whether and how requirements of the duty to warn are applicable in this case.

  19. Listening to professional voices: draft 2 of the ACM code of ethics and professional conduct

    OpenAIRE

    Flick, Catherine; Brinkman, Bo; Gotterbarn, D. W.; Miller, Keith; Vazansky, Kate; Wolf, Marty J.

    2017-01-01

    The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link. For the first time since 1992, the ACM Code of Ethics and Professional Conduct (the Code) is being updated. The Code Update Task Force in conjunction with the Committee on Professional Ethics is seeking advice from ACM members on the update. We indicated many of the motivations for changing the Code when we shared Draft 1 of Code 2018 with the ...

  20. Changes in lifestyle habits and behaviours are associated with weight loss maintenance in members of a commercial weight loss organisation

    OpenAIRE

    Stubbs, RJ; McConnon, A; Gibbs, M; Raats, M; Whybrow, S

    2012-01-01

    This analysis examined the lifestyle correlates of weight loss maintenance in 1428 participants of a slimming organisation, who had been members for a mean SD of 16 16 months, had lost 13.8% 9.2% weight and were trying to maintain, or increase, their weight loss during a subsequent 6 month study period. Data were collected as part of the DiOGenes study(1). Ethical approval was given by the University of Surrey Ethics Committee. Adults were recruited between August 2006 and July 2008 from Slim...

  1. 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.

  2. Ethical Issues in Cross-Cultural Research

    Science.gov (United States)

    Honan, Eileen; Hamid, M. Obaidul; Alhamdan, Bandar; Phommalangsy, Phouvanh; Lingard, Bob

    2013-01-01

    The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and…

  3. Ethics Education and Adjudication within Psychology.

    Science.gov (United States)

    Mills, David H.

    1984-01-01

    Provides an overview of the formal ethics system within psychology. Describes the structure of the American Psychological Association (APA) and state ethics systems, functions of APA's Committee on Scientific and Professional Ethics and Conduct, and its procedures for handling complaints. (Author/CMG)

  4. DUBNA: Member States

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    The political upheaval in what was the Soviet Union was reflected in an Extraordinary Plenipotentiaries Committee of Joint Institute for Nuclear Research (JINR) Member States, held in Dubna, near Moscow, on 10-13 December, with representatives of eleven sovereign republics of the former Soviet State taking part

  5. The ethics of in vivo calibrations in oral health surveys.

    Science.gov (United States)

    Andrade, Flávia Reis de; Narvai, Paulo Capel; Montagner, Miguel Ângelo

    2016-01-01

    To analyze the ethics of in vivo calibration, using the discourse of the administrators of the National Oral Health Survey (SBBrasil 2010) as a starting point. This is a qualitative research involving semi-structured individual interviews with 12 members of the Steering Group and Technical Advisory Committee of the Ministry of Health, and two coordinators, one State and the other Municipal. The discourse of the collective subject technique was used for data analysis. When asked about the experiences of SBBrasil 2010, which included ethical aspects, respondents identified the forms of standardization and training of teams who collected field data. For them, there is little scientific evidence to ethically support the way the training stage, including calibration, is carried out in oral health epidemiological surveys, as a certain unease can be predicted in participants of these studies. The ethics of a research also derives from its methodological rigor; the training process; and calibration in particular, is a fundamental technical and ethical requirement in surveys such as the SBBrasil 2010. The unease of the volunteers in face of test repetition does not ethically invalidate the in vivo calibration, but mechanisms to minimize it must be developed.

  6. Abiding by codes of ethics and codes of conduct imposed on members of learned and professional geoscience institutions and - a tiresome formality or a win-win for scientific and professional integrity and protection of the public?

    Science.gov (United States)

    Allington, Ruth; Fernandez, Isabel

    2015-04-01

    In 2012, the International Union of Geological Sciences (IUGS) formed the Task Group on Global Geoscience Professionalism ("TG-GGP") to bring together the expanding network of organizations around the world whose primary purpose is self-regulation of geoscience practice. An important part of TG-GGP's mission is to foster a shared understanding of aspects of professionalism relevant to individual scientists and applied practitioners working in one or more sectors of the wider geoscience profession (e.g. research, teaching, industry, geoscience communication and government service). These may be summarised as competence, ethical practice, and professional, technical and scientific accountability. Legal regimes for the oversight of registered or licensed professionals differ around the world and in many jurisdictions there is no registration or licensure with the force of law. However, principles of peer-based self-regulation universally apply. This makes professional geoscience organisations ideal settings within which geoscientists can debate and agree what society should expect of us in the range of roles we fulfil. They can provide the structures needed to best determine what expectations, in the public interest, are appropriate for us collectively to impose on each other. They can also provide the structures for the development of associated procedures necessary to identify and discipline those who do not live up to the expected standards of behaviour established by consensus between peers. Codes of Ethics (sometimes referred to as Codes of Conduct), to which all members of all major professional and/or scientific geoscience organizations are bound (whether or not they are registered or hold professional qualifications awarded by those organisations), incorporate such traditional tenets as: safeguarding the health and safety of the public, scientific integrity, and fairness. Codes also increasingly include obligations concerning welfare of the environment and

  7. The Ethical Problems of Reserach : An empirical study of ethics in research practice

    OpenAIRE

    Colnerud, Gunnel

    2013-01-01

    Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts and problems in research. They were all researchers at the post-doctoral l...

  8. Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation.

    Science.gov (United States)

    Northway, Ruth; Howarth, Joyce; Evans, Lynne

    2015-02-01

    The aim of this paper is to explore how making reasonable adjustments to the process of securing ethical approval for research can facilitate the meaningful involvement of people with intellectual disabilities as members of a research team. This is achieved through critical reflection upon the approach taken within one participatory research study whose objective was to explore how people with intellectual disabilities understand abuse. Internationally participatory research studies (in which active involvement of community members in all stages of the research process is sought) are becoming increasingly common in the context of health care and, more specifically, within research involving people with intellectual disabilities. However, whilst it is acknowledged that participatory research gives rise to specific ethical challenges, how (or if) involvement in securing ethical approval is facilitated, is not discussed in most research reports. The significance of this paper is that it seeks to address this gap by exploring how meaningful participation can be promoted by making reasonable adjustments. Within the study, the research team worked in collaboration with the ethics committee to identify potential barriers that could prevent the participation of members of the research team who had intellectual disabilities. Reasonable adjustments (such as redesigning forms) were made to the processes involved in securing ethical approval. This study demonstrated that it is possible to ensure that ethical standards are upheld and the requirements of ethics committees met whilst also facilitating the meaningful involvement of people with intellectual disabilities. The reasonable adjustments approach explored within this paper can be translated into the context of clinical practice: making changes to the way that services are delivered can promote greater involvement of people with intellectual disabilities in their own health care. © 2014 John Wiley & Sons Ltd.

  9. 75 FR 28543 - GMUG Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ...) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to gather the... about the roles of members, support of the committee and other pertinent information, elect a...

  10. 76 FR 7531 - Yavapai County Resource Advisory Committee

    Science.gov (United States)

    2011-02-10

    ...) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to orientate new committee members to the Secural Rural Schools Act, roles of members, guidelines for Title II, and...

  11. Association of Finnish Members of Parliament and Researchers: Social Democratic Parliamentary group MP K. Olin, Former Finnish MP M. Tiuri, Finnish Centre Party MP P. Vilkuna, Senior Assistant Professor I. Ruostetsaari and Finnish Parliament Committee of Future Researcher U. Gabrielsson at ATLAS experiment with P. Jenn, M. Nordberg and M. Kotamaki on 15 September 2006.

    CERN Document Server

    Maximilien Brice

    2006-01-01

    Association of Finnish Members of Parliament and Researchers: Social Democratic Parliamentary group MP K. Olin, Former Finnish MP M. Tiuri, Finnish Centre Party MP P. Vilkuna, Senior Assistant Professor I. Ruostetsaari and Finnish Parliament Committee of Future Researcher U. Gabrielsson at ATLAS experiment with P. Jenn, M. Nordberg and M. Kotamaki on 15 September 2006.

  12. Activities of an ethics consultation service in a Tertiary Military Medical Center.

    Science.gov (United States)

    Waisel, D B; Vanscoy, S E; Tice, L H; Bulger, K L; Schmelz, J O; Perucca, P J

    2000-07-01

    The Joint Commission on Accreditation of Healthcare Organizations requires hospitals to have a mechanism to address issues of medical ethics. Most hospitals, especially those in the military, have an ethics committee composed solely of members who serve as an additional duty. To enhance the ethics consultation service, the 59th Medical Wing created a position under the chief of the medical staff for a full-time, fellowship-trained, medical ethicist. After establishment of this position, the number of consultations increased, a systematic program for caregiver education was developed and delivered, and an organizational presence was achieved by instituting positions on the institutional review board, the executive committee of the medical staff, and the credentials committee. Issues in medical care are becoming increasingly complicated, due in large part to financial stresses and technological advancements. Ethics consultation can help prevent and resolve many of these problems. This report discusses the activities of the first year of a full-time ethicist in a tertiary military medical center.

  13. 76 FR 19176 - Shipping Coordinating Committee; Notice of Committee Meeting

    Science.gov (United States)

    2011-04-06

    ...) Maritime Safety Committee (MSC 89) to be held May 11-20, 2011. The primary matters to be considered at MSC... --Technical assistance sub-programme in maritime safety and security --Capacity-building for the... business --Report of the Maritime Safety Committee Members of the public may attend these two meetings up...

  14. 78 FR 32699 - Shipping Coordinating Committee; Notice of Committee Meeting

    Science.gov (United States)

    2013-05-31

    ... Session of the International Maritime Organization's (IMO) Sub-Committee on Safety of Navigation to be... --Report to the Maritime Safety Committee Members of the public may attend this meeting up to the seating... system ``BeiDou'' in the maritime field --International Telecommunication Union (ITU) matters, including...

  15. 77 FR 47491 - Shipping Coordinating Committee; Notice of Committee Meeting

    Science.gov (United States)

    2012-08-08

    ... to the Maritime Safety Committee Members of the public may attend this meeting up to the seating... Session of the International Maritime Organization's (IMO) Sub-Committee on Dangerous Goods, Solid Cargoes... --Amendment 37-14 to the International Maritime Dangerous Goods (IMDG) Code and supplements, including...

  16. Moral Fitness: Ethical Education for Marines

    Science.gov (United States)

    2013-04-16

    ethics through the key virtues of honor, courage, and commitment early in a Marine’s career. This ethos is enforced during the indoctrination process...thinking about the right thing to do. A basic introduction into moral reasoning, virtue ethics and ethical standards educate new members on ethics and...one must practice the physical fitness test to be successful, ethics must be demonstrated by action and practice. Finally, Aristotle states that

  17. Ethics in marketing communication

    OpenAIRE

    Silvia MUHCINA; Veronica POPOVICI

    2008-01-01

    As well as the entire business world, marketing has its own ethics problems. Numerous marketing specialists or their representatives have consciously declared and adopted different engagements, declarations or codes of rules regarding the necessity that marketing people consider ethics regulations and values, so that they become much more responsible towards the members of society. These declarations or rules concern marketing practices in their ensemble or are guided towards certain specific...

  18. Power supply and ethics

    International Nuclear Information System (INIS)

    Anon.

    2004-01-01

    The 'Power Supply and Ethics' workshop was designed on the basis of a recommendation by the Nuclear Technology Committee (FA-KT) of VDI-GET. The topic is part of a series of events and publications by VDI in an area where engineering and the humanities converge. The Workshop comprised presentations and thorough discussions of seven papers on 'Power Supply and Ethics', reflecting a variety of contents and points of view of the different disciplines participating. The Workshop offered another opportunity to take the initiative and influence the public, especially politics. Other activities are planned which also the participants increasingly consider an obligation to the public. (orig.) [de

  19. ¿Por qué auditar a los comités de ética en investigación? Why to audit to research ethics committees?

    Directory of Open Access Journals (Sweden)

    Estela Quiroz

    2010-09-01

    Full Text Available Los comités de ética en investigación biomédica tienen como responsabilidad asegurar la protección de los participantes humanos en las investigaciones. Para mejorar la calidad de su trabajo deben someterse a procedimientos de auditoría, encargadas por los patrocinadores, y de inspecciones por parte de la autoridad regulatoria. A través de dichos procedimientos se garantizaría que mejoren sus funciones, y así puedan perfeccionar su labor y cumplir de manera óptima con el objetivo para el que fueron creados.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.

  20. 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.

  1. 78 FR 49260 - Trademark Public Advisory Committee

    Science.gov (United States)

    2013-08-13

    ... office automation.'' 35 U.S.C. 5(b)(3). The Committee also includes three (3) non-voting members.... While away from home or regular place of business, each member shall be allowed travel expenses...

  2. 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

  3. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

  4. 7 CFR 983.42 - Initial members and nomination of successor members.

    Science.gov (United States)

    2010-01-01

    ...) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF... alternate is selected shall serve in place of that member on the committee, and shall have and be able to... members of the committee shall serve for terms of two years: Provided, That four of the initially selected...

  5. The ESO Scientific and Technical Committee.

    Science.gov (United States)

    Léna, P.

    1982-03-01

    Since 1978, the structure of ESO involves a Scientific and Technical Committee (STC) which advises the Council on scientific and technical matters. This committee meets twice a year, usually at Garehing; its members are nominated by the Council and their term is 4 years. The STC has 10 members, who are as evenly distributed as possible among member countries, although indeed mainly chosen for their scientific abilities. The chairman is invited to attend Council meetings and to report to the members.

  6. Committee on Scientific Values | Initiatives | Indian Academy of ...

    Indian Academy of Sciences (India)

    Academy Committee on Scientific Values. The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should follow. The Committee submitted its report to the Council, which at its meeting in December 2005 approved this report ...

  7. 76 FR 31299 - Northern New Mexico Resource Advisory Committee

    Science.gov (United States)

    2011-05-31

    ... members, conduct ethics training for NNM RAC members, revisit Operation Guidelines to add language on... following business will be conducted: review of agenda, make presentation of appointment certificates to NNM RAC members, conduct ethics training for NNM RAC members, revisit Operation Guidelines to add language...

  8. AGU Committees

    Science.gov (United States)

    Administrative Committees are responsible for those functions required for the overall performance or well-being of AGU as an organization. These committees are Audit and Legal Affairs, Budget and Finance*, Development, Nominations*, Planning, Statutes and Bylaws*, Tellers.Operating Committees are responsible for the policy direction and operational oversight of AGU's primary programs. The Operating Committees are Education and Human Resources, Fellows*, Information Technology, International Participation*, Meetings, Public Affairs, Public Information, Publications*.

  9. 1976 compilation of national nuclear data committees

    International Nuclear Information System (INIS)

    1977-01-01

    This list of currently existing National Nuclear Data Committees, and their memberships, is published with the object of promoting the interaction and enhance the awareness of nuclear data activities in IAEA Member States. The following Member States have indicated the existence of a nuclear data committee in their countries: Bangladesh, Bolivia, Bulgaria, France, Hungary, India, Japan, Romania, Sweden, USSR, United Kingdom, USA, Yugoslavia

  10. Ethics in Early Childhood Special Education.

    Science.gov (United States)

    Bowe, Frank G.

    1995-01-01

    This article discusses ethical questions in providing prenatal services, including testing and genetic engineering, and medical interventions with neonates and other very young children who have severe disabilities. It explores ways to enhance ethical decision making, including recruitment for multidisciplinary teams or other committees of adults…

  11. 45 CFR 703.9 - Reimbursement of members.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Reimbursement of members. 703.9 Section 703.9... AND FUNCTIONS OF STATE ADVISORY COMMITTEES § 703.9 Reimbursement of members. (a) Advisory Committee members may be reimbursed by the Commission by a per diem subsistence allowance and for travel expenses at...

  12. Viewpoint: Decision-making in committees

    OpenAIRE

    Li Hao; Wing Suen

    2009-01-01

    This article reviews recent developments in the theory of committee decision-making. A committee consists of self-interested members who make a public decision by aggregating imperfect information dispersed among them according to a pre-specified decision rule. We focus on costly information acquisition, strategic information aggregation, and rules and processes that enhance the quality of the committee decision. Seeming inefficiencies of the committee decision-making process such as over-cau...

  13. Physician-Rating Web Sites: Ethical Implications.

    Science.gov (United States)

    Samora, Julie Balch; Lifchez, Scott D; Blazar, Philip E

    2016-01-01

    To understand the ethical and professional implications of physician behavior changes secondary to online physician-rating Web sites (PRWs). The American Society for Surgery of the Hand (ASSH) Ethics and Professionalism Committee surveyed the ASSH membership regarding PRWs. We sent a 14-item questionnaire to 2,664 active ASSH members who practice in both private and academic settings in the United States. We received 312 responses, a 12% response incidence. More than 65% of the respondents had a slightly or highly unfavorable impression of these Web sites. Only 34% of respondents had ever updated or created a profile for PRWs, although 62% had observed inaccuracies in their profile. Almost 90% of respondents had not made any changes in their practice owing to comments or reviews. One-third of respondents had solicited favorable reviews from patients, and 3% of respondents have paid to improve their ratings. PRWs are going to become more prevalent, and more research is needed to fully understand the implications. There are several ethical implications that PRWs pose to practicing physicians. We contend that it is morally unsound to pay for good reviews. The recourse for physicians when an inaccurate and potentially libelous review has been written is unclear. Some physicians have required patients to sign a waiver preventing them from posting negative comments online. We propose the development of a task force to assess the professional, ethical, and legal implications of PRWs, including working with companies to improve accuracy of information, oversight, and feedback opportunities. It is expected that PRWs will play an increasing role in the future; it is unclear whether there will be a uniform reporting system, or whether these online ratings will influence referral patterns and/or quality improvement. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  14. Research Ethics in Sign Language Communities

    Science.gov (United States)

    Harris, Raychelle; Holmes, Heidi M.; Mertens, Donna M.

    2009-01-01

    Codes of ethics exist for most professional associations whose members do research on, for, or with sign language communities. However, these ethical codes are silent regarding the need to frame research ethics from a cultural standpoint, an issue of particular salience for sign language communities. Scholars who write from the perspective of…

  15. Public Perceptions of Journalists' Ethical Motivations.

    Science.gov (United States)

    Voakes, Paul S.

    1997-01-01

    Finds starkly different conceptions of journalistic ethics, with members of the public believing the journalists' ethics are guided primarily by occupational norms and competitive pressures, whereas journalists themselves cited organizational policies, the relevant law, and their individual reasoning as primary influences on their ethical decision…

  16. Business Ethics

    OpenAIRE

    Duong, Thi

    2016-01-01

    The goal of this paper is to present examples of business ethics issues. What is business ethics, things concerned in this field are and why it is needed and important when doing business? The concept of business ethics has connotations to provision, rules and standards in directing the behavior of actors in the business. Business ethics involves compliance with the law, the implementation of ethical responsibilities of a business, the protection of the rights of those who are related to the ...

  17. Nurses' attitudes towards euthanasia in conflict with professional ethical guidelines.

    Science.gov (United States)

    Terkamo-Moisio, Anja; Kvist, Tarja; Kangasniemi, Mari; Laitila, Teuvo; Ryynänen, Olli-Pekka; Pietilä, Anna-Maija

    2017-02-01

    Despite the significant role of nurses in end-of-life care, their attitudes towards euthanasia are under-represented both in the current literature and the controversial debate that is ongoing in several countries. What are the attitudes towards euthanasia among Finnish nurses? Which characteristics are associated with those attitudes? Cross-sectional web-based survey. Participants and research context: A total of 1003 nurses recruited via the members' bulletin of the Finnish Nurses Association and social media. Ethical considerations: Ethical approval was obtained from the Committee on Research Ethics of the university to which the authors were affiliated. The majority (74.3%) of the participants would accept euthanasia as part of Finnish healthcare, and 61.8% considered that Finland would benefit from a law permitting euthanasia. Most of the nurses (89.9%) thought that a person must have the right to decide on his or her own death; 77.4% of them considered it likely that they would themselves make a request for euthanasia in certain situations. The value of self-determination and the ability to choose the moment and manner of one's death are emphasized in the nurses' attitudes towards euthanasia. A continuous dialogue about euthanasia and nurses' shared values is crucial due to the conflict between nurses' attitudes and current ethical guidelines on nursing.

  18. The ethics in qualitative health research: special considerations.

    Science.gov (United States)

    Peter, Elizabeth

    2015-09-01

    A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1) participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2) naturalistic observation can raise concerns regarding privacy and consent; 3) the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.

  19. ISPOR Code of Ethics 2017 (4th Edition).

    Science.gov (United States)

    Santos, Jessica; Palumbo, Francis; Molsen-David, Elizabeth; Willke, Richard J; Binder, Louise; Drummond, Michael; Ho, Anita; Marder, William D; Parmenter, Louise; Sandhu, Gurmit; Shafie, Asrul A; Thompson, David

    2017-12-01

    As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. Retrospective research: What are the ethical and legal requirements?

    Science.gov (United States)

    Junod, V; Elger, B

    2010-07-25

    Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.

  1. The ethics in qualitative health research: special considerations

    Directory of Open Access Journals (Sweden)

    Elizabeth Peter

    2015-09-01

    Full Text Available Abstract A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1 participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2 naturalistic observation can raise concerns regarding privacy and consent; 3 the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.

  2. 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 ...

  3. 76 FR 72204 - Renewal of Advisory Committee Charter

    Science.gov (United States)

    2011-11-22

    .... II. Structure The Committee shall consist of 17 members appointed by the Bank's Board of Directors on..., services, and State government, with not less than three members being representative of the small business... members being representative of the [[Page 72205

  4. How American Nurses Association Code of Ethics informs genetic/genomic nursing.

    Science.gov (United States)

    Tluczek, Audrey; Twal, Marie E; Beamer, Laura Curr; Burton, Candace W; Darmofal, Leslie; Kracun, Mary; Zanni, Karen L; Turner, Martha

    2018-01-01

    Members of the Ethics and Public Policy Committee of the International Society of Nurses in Genetics prepared this article to assist nurses in interpreting the American Nurses Association (2015) Code of Ethics for Nurses with Interpretive Statements (Code) within the context of genetics/genomics. The Code explicates the nursing profession's norms and responsibilities in managing ethical issues. The nearly ubiquitous application of genetic/genomic technologies in healthcare poses unique ethical challenges for nursing. Therefore, authors conducted literature searches that drew from various professional resources to elucidate implications of the code in genetic/genomic nursing practice, education, research, and public policy. We contend that the revised Code coupled with the application of genomic technologies to healthcare creates moral obligations for nurses to continually refresh their knowledge and capacities to translate genetic/genomic research into evidence-based practice, assure the ethical conduct of scientific inquiry, and continually develop or revise national/international guidelines that protect the rights of individuals and populations within the context of genetics/genomics. Thus, nurses have an ethical responsibility to remain knowledgeable about advances in genetics/genomics and incorporate emergent evidence into their work.

  5. The ESO Observing Programmes Committee

    Science.gov (United States)

    Westerlund, B. E.

    1982-06-01

    Since 1978 the ESO Observing Programmes Committee (OPC) has "the function to inspect and rank the proposals made for observing programmes at La Silla, and thereby to advise the Director General on the distribution of observing time". The members (one from each member country) and their alternates are nominated by the respective national committees for five-year terms (not immediately renewable). The terms are staggered so that each year one or two persons are replaced. The Chairman is appointed annually by the Council. He is invited to attend Council meetings and to report to its members.

  6. Antibody Scientific Committee | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The Antibody Scientific Committee provides scientific insight and guidance to the NCI's Antibody Characterization Program. Specifically, the members of this committee evaluate request from the external scientific community for development and characterization of antibodies by the program. The members of the Antibody Scientific Committee include:

  7. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...

  8. UNESCO's activities in ethics.

    NARCIS (Netherlands)

    Have, H.A.M.J. ten

    2010-01-01

    UNESCO is an intergovernmental organization with 193 Member States. It is concerned with a broad range of issues regarding education, science and culture. It is the only UN organisation with a mandate in science. Since 1993 it is addressing ethics of science and technology, with special emphasis on

  9. Ethics in family vs nonfamily owned businesses.

    Science.gov (United States)

    Hebert, Frederic J; Bass, Kenneth E; Tomkiewicz, Joseph

    2002-12-01

    This study investigated the ethical judgments in family vs nonfamily owned businesses. Respondents rated their ethical evaluations of 5 scenarios which involved ethical issues, e.g., promotion of a family member ahead of an equally qualified nonfamily employee. Analysis of responses from 120 participants yielded no statistically significant differences between the ethical judgment ratings of owner/managers of family and nonfamily owned firms.

  10. Ethics Leadership in Research, Healthcare and Organizational Systems: Commentary and Critical Reflections

    Science.gov (United States)

    Gabriele, Edward F.

    2011-01-01

    In the last decades there has arisen a greater awareness of the ever present need for critical academic reflection on the nature of ethics leadership and committees in research, healthcare, and organizational systems. Yet what is meant by ethics itself? How is ethics understood as a historical phenomenon? What challenges must ethics leaders face…

  11. Experts, meta-expertise and mediators. Ethical oversight of research in multidisciplinary scenarios

    Directory of Open Access Journals (Sweden)

    Wilfredo Betancourt Mosquera

    2016-07-01

    Full Text Available Based on a case study drawn from the written records of a Colombian Research Ethics Committee (rec, this article discusses the impact that its multidisciplinary nature has on its decision-making processes. recs are analyzed as “boundary organizations” in which experts from different disciplines can meet. Additionally, recs are viewed as contemporary socio-epistemic arenas in which research ethics are produced. It was found that multiple expertise is often seen by some of its members as an «anomaly» which impedes ordinary work and ideally should be avoided. During the assessment of research projects the rec sought to manage this task through homogenizing decision-making processes in accordance with the expertise of some of its members, avoiding the convergence of «communities of practice.» Furthermore, the members of the rec frequently base their decisions either on their own ethical judgments, or by mirroring those of more qualified reviewers. This dynamic is largely a consequence of «meta-expertise,» that is to say, rec members’ ability or legitimacy to judge expert knowledge which they do not possess. It is concluded that researchers have wide possibilities to interpret and define the ethical dimension of their work. Within local practices of ethical reviews, researchers act as «interactional» actors able to assess and communicate recs about their own ethics. Paradoxically, despite their character as a public setting for multidisciplinary dialogue, recs end up being spaces in which the professional esotericism of disciplinary communities is reaffirmed and the socio-epistemic authority of experts reinforced.

  12. Perspectives on Applied Ethics

    OpenAIRE

    2007-01-01

    Applied ethics is a growing, interdisciplinary field dealing with ethical problems in different areas of society. It includes for instance social and political ethics, computer ethics, medical ethics, bioethics, envi-ronmental ethics, business ethics, and it also relates to different forms of professional ethics. From the perspective of ethics, applied ethics is a specialisation in one area of ethics. From the perspective of social practice applying eth-ics is to focus on ethical aspects and ...

  13. The end of the nuclear power generation. On the recommendations of the ethics committee according to the 13th amendment to the Atomic Energy Act; Das Ende der Atomverstromung. Zu den Empfehlungen der Ethik-Kommission, zur 13. Atomgesetz-Novelle

    Energy Technology Data Exchange (ETDEWEB)

    Becker, Peter [Kanzlei Becker Buettner Held, Berlin (Germany)

    2011-11-15

    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.

  14. Project ethics

    CERN Document Server

    Jonasson, Haukur Ingi

    2013-01-01

    How relevant is ethics to project management? The book - which aims to demystify the field of ethics for project managers and managers in general - takes both a critical and a practical look at project management in terms of success criteria, and ethical opportunities and risks. The goal is to help the reader to use ethical theory to further identify opportunities and risks within their projects and thereby to advance more directly along the path of mature and sustainable managerial practice.

  15. Why ethics?

    OpenAIRE

    Wolfgang, Huber

    2015-01-01

    In this address, the author explores the necessity of ethical reflection on our moral responsibility regarding the challenges of today's globalized world and the future of humankind in the midst of God's creation. In this context, the differentiation of modern ethics is seen as accompanied by the task to reintegrate the ethical discourse by means of an interdisciplinary exchange and to further especially the dialogue between theological and philosophical ethics. By agreeing on Hans-Richard Re...

  16. Annex 5. Monitoring committee

    OpenAIRE

    2013-01-01

    Head of monitoring committee: the Research Commission of the govern­ment of French Polynesia. Panel members Representatives of the following organisations: IRD centre in Papeete Oceanologic Center of the Pacific/Ifremer Investment Promotion Authority Environment Division EPIC Vanille Institut Louis-Malardé Gepsun “Natural Substances process engineering” technology platform (cf. Abbreviations) Fisheries Division Economic Affairs Division External Trade Division Development of Industry and the...

  17. Standing Concertation Committee

    CERN Document Server

    HR Department

    2009-01-01

    Main points examined at the meeting of 24 June 2009 Results of the 2009 MARS exercise The Committee took note of the results of the 2009 MARS exercise presented by the Head of the HR Department, expressing satisfaction for the early availability of the statistics and for the fact that the analysis of the results covered the last three years. Status report on the work on the five-yearly review The Committee took note of a presentation by P. Gildemyn on the data collection procedure for the 2010 five-yearly review (staff, fellows, associate members of the personnel, CHIS) and of the proposed work schedule. Implications for employment conditions of the discussions at the Finance Committee and Council on 17 and 18 June 2009 The Chairman briefly reported on the discussions at the meetings of the Finance Committee and Council in June 2009, on the 2010-2014 medium-term plan and the 2010 preliminary draft budget, as well as on the modified strategy and goals for 2009. The Committee ...

  18. Ethical considerations in biomedical research: a personal view.

    Science.gov (United States)

    Dahlöf, Carl

    2013-06-01

    Ethical considerations are made when an experiment is planned and take a regulatory system of moral principles into account. Ethical considerations should first and foremost be made in order to protect the individual subject/animal from being exposed to any unethical and perhaps even illegal intervention and to ensure that the experimental conditions used are appropriate. The main role of research ethics committees is to assess the scientific and ethical aspects of submitted protocols and follow up the trial until its closure.

  19. 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

  20. 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...

  1. Medical Ethics

    Science.gov (United States)

    ... area in medicine that doesn't have an ethical aspect. For example, there are ethical issues relating to End of life care: Should ... orders? Abortion: When does life begin? Is it ethical to terminate a pregnancy with a birth defect? ...

  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. The environmental and ethical basis of the geological disposal of long-lived radioactive waste

    International Nuclear Information System (INIS)

    Vuori, S.

    1995-01-01

    This partial translation into Finnish of the recently issued Collective Opinion of the Radioactive Waste Management Committee (RWMC) of the OECD Nuclear Energy Agency is published here to provide general information to the members of the Finnish Nuclear Society. Full translation will be published later by the Ministry of Trade and Industry. 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

  4. Update of technical coordinating committee activities

    International Nuclear Information System (INIS)

    Alvarado, R.A.

    1995-01-01

    The Technical Coordinating Committee has its origins in the earliest days of implementing the Low-Level Radioactive Waste Policy Act. Between 1982 and 1985, individuals in several of the states felt that coordination among the states would be beneficial to all by affording states a cost-effective method for sharing ideas, discussing alternatives, and presenting solutions to common problems. At the current time, the committee comprises members from each of the sited states. Various compacts, federal agencies, and industry groups participate in committee activities. The Low-Level Management Program provides support for the committee through the provision of logistical support and limited manpower allocation. Activities of the committee have recently focused on waste treatment and minimization technologies. The committee also has worked diligently to see the review of the 3RSTAT computer code completed. The committee has taken a position on various regulatory proposals the past year. The committee expects to continue its work until new sites are brought online

  5. Update of technical coordinating committee activities

    Energy Technology Data Exchange (ETDEWEB)

    Alvarado, R.A.

    1995-12-31

    The Technical Coordinating Committee has its origins in the earliest days of implementing the Low-Level Radioactive Waste Policy Act. Between 1982 and 1985, individuals in several of the states felt that coordination among the states would be beneficial to all by affording states a cost-effective method for sharing ideas, discussing alternatives, and presenting solutions to common problems. At the current time, the committee comprises members from each of the sited states. Various compacts, federal agencies, and industry groups participate in committee activities. The Low-Level Management Program provides support for the committee through the provision of logistical support and limited manpower allocation. Activities of the committee have recently focused on waste treatment and minimization technologies. The committee also has worked diligently to see the review of the 3RSTAT computer code completed. The committee has taken a position on various regulatory proposals the past year. The committee expects to continue its work until new sites are brought online.

  6. 77 FR 40323 - Notice of Invitation for Nominations to the Advisory Committee on Agriculture Statistics

    Science.gov (United States)

    2012-07-09

    ... Nominations to the Advisory Committee on Agriculture Statistics AGENCY: National Agricultural Statistics..., State agriculture representatives, and agriculture-related business and marketing experts. Members serve... annually. All meetings are open to the public. Committee members are reimbursed for official travel...

  7. The Ethics of Doing Ethics.

    Science.gov (United States)

    Hansson, Sven Ove

    2017-02-01

    Ethicists have investigated ethical problems in other disciplines, but there has not been much discussion of the ethics of their own activities. Research in ethics has many ethical problems in common with other areas of research, and it also has problems of its own. The researcher's integrity is more precarious than in most other disciplines, and therefore even stronger procedural checks are needed to protect it. The promotion of some standpoints in ethical issues may be socially harmful, and even our decisions as to which issues we label as "ethical" may have unintended and potentially harmful social consequences. It can be argued that ethicists have an obligation to make positive contributions to society, but the practical implications of such an obligation are not easily identified. This article provides an overview of ethical issues that arise in research into ethics and in the application of such research. It ends with a list of ten practical proposals for how these issues should be dealt with.

  8. 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

  9. Navigating the Process of Ethical Approval: A methodological note

    Directory of Open Access Journals (Sweden)

    Eileen Carey, RNID, BSc. (hons, MSc.

    2010-12-01

    Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

  10. 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.

  11. [Ethic rounds in intensive care. Possible instrument for a clinical-ethical assessment in intensive care units].

    Science.gov (United States)

    Scheffold, N; Paoli, A; Gross, J; Riemann, U; Hennersdorf, M

    2012-10-01

    Ethical problems, such as medical end-of-life decisions or withdrawing life-sustaining treatment are viewed as an essential task in intensive care units. This article presents the ethics rounds as an instrument for evaluation of ethical problems in intensive care medicine units. The benchmarks of ethical reflection during the ethics rounds are considerations of ethical theory of principle-oriented medical ethics. Besides organizational aspects and the institutional framework, the role of the ethicist is described. The essential evaluation steps, as a basis of the ethics rounds are presented. In contrast to the clinical ethics consultation, the ethicist in the ethics rounds model is integrated as a member of the ward round team. Therefore ethical problems may be identified and analyzed very early before the conflict escalates. This preventive strategy makes the ethics rounds a helpful instrument in intensive care units.

  12. Eliciting ethical and social values in health technology assessment: A participatory approach.

    Science.gov (United States)

    Bombard, Yvonne; Abelson, Julia; Simeonov, Dorina; Gauvin, Francois-Pierre

    2011-07-01

    Despite a growing consensus that ethical and social values should be addressed in health technology assessment (HTA) processes, there exist a variety of methods for doing so. There is growing interest in involving citizens in policy development to ensure that decisions are legitimate, and reflect the broad social values of the public. We sought to bring these issues together by employing a participatory approach to elicit ethical and social values in HTA. Our primary objective was to elicit a set of ethical and social values from citizens that could be used to guide Ontario's HTA evidentiary review and appraisal process. A secondary objective was to explore the feasibility of using participatory approaches to elicit these values. A 14-person Citizens' Reference Panel on Health Technologies was established to provide input to the Ontario Health Technology Advisory Committee in developing its recommendations. A mixed methods approach was used where informed, deliberative discussions were combined with pre- and post-questionnaires, which assessed the relative importance of various ethical and social values as well as their stability over time. Over the course of five meetings, panel members progressed toward the identification of a set of core values -universal access, choice and quality care. These values were consistently prioritized as the core values that should be considered in the evaluation of health technologies and ensuing recommendations. Sustained and deliberative methods, like a citizens' panel, offer a promising approach for eliciting ethical and social values into HTA. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Ethnographic analysis of everyday ethics in the care of nursing home residents with dementia: a taxonomy.

    Science.gov (United States)

    Powers, B A

    2001-01-01

    The concept of everyday ethics was used to emphasize the moral basis of ordinary issues of daily living affecting quality of life for nursing home residents with dementia. To critically examine ethical issues of daily living affecting nursing home residents with dementia and to construct a descriptive taxonomy inductively derived from ethnographic fieldwork data. Combined anthropological methods of participant observation and in-depth interviewing were used in the natural setting of a 147-bed, voluntary, not-for-profit nursing home. Experiences of 30 residents, their family members, and nursing home staff were explored. In addition, the records of 10 ethics committee cases involving residents with dementia further enlarged the database. The taxonomy of everyday ethical issues includes the following four domains: (a) learning the limits of intervention; (b) tempering the culture of surveillance and restraint; (c) preserving the integrity of the individual; and (d) defining community norms and values. Each is representative of constellations of concerns that are grounded in the cultural and moral environment of the nursing home. Results highlight the challenges of recognizing the ethical in the ordinary, and of resolving everyday issues in ways that enhance quality of life for residents with dementia and those (family and staff) who care for them.

  14. 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.

  15. Ethics of Liver Transplantation: The Role of the Anesthesiologist.

    Science.gov (United States)

    West, James M

    2018-06-01

    Anesthesiologists have clearly established their place in the history of medical ethics. Our involvement goes back to 1966 when Henri Beecher published his landmark paper on research and informed consent. Participation in the ethics of transplantation is no less important than our previous work. Organ transplant has been life saving for many but also has given rise to many misunderstandings not just from the public but also among our own colleagues. These include methods of allocation and donation, the role that affluence may play in receiving an organ, the definition of death and donation after circulatory death. As perioperative physicians and important members of the transplant team, anesthesiologists are expected to participate in all aspects of care including ethical judgments. This article discusses some of the issues that seem to cause the most confusion and angst for those of us involved in both liver transplantation and in the procurement of organs. It will discuss the definition of death, donation after circulatory death, the anesthesiologists' role on the selection committee, living donor liver transplantation, and transplantation of patients with alcohol-related liver disease.

  16. Introductory materials for committee members: 1) instructions for the Los Alamos National Laboratory fiscal year 2010 capability reviews 2) NPAC strategic capability planning 3) Summary self-assessment for the nuclear and particle physics, astrophysics an

    Energy Technology Data Exchange (ETDEWEB)

    Redondo, Antonio [Los Alamos National Laboratory

    2010-01-01

    Los Alamos National Laboratory (LANL) uses external peer review to measure and continuously improve the quality of its science, technology and engineering (STE). LANL uses capability reviews to assess the STE quality and institutional integration and to advise Laboratory Management on the current and future health of the STE. Capability reviews address the STE integration that LANL uses to meet mission requirements. STE capabilities are define to cut across directorates providing a more holistic view of the STE quality, integration to achieve mission requirements, and mission relevance. The scope of these capabilities necessitate that there will be significant overlap in technical areas covered by capability reviews (e.g., materials research and weapons science and engineering). In addition, LANL staff may be reviewed in different capability reviews because of their varied assignments and expertise. LANL plans to perform a complete review of the Laboratory's STE capabilities (hence staff) in a three-year cycle. The principal product of an external review is a report that includes the review committee's assessments, commendations, and recommendations for STE. The Capability Review Committees serve a dual role of providing assessment of the Laboratory's technical contributions and integration towards its missions and providing advice to Laboratory Management. The assessments and advice are documented in reports prepared by the Capability Review Committees that are delivered to the Director and to the Principal Associate Director for Science, Technology and Engineering (PADSTE). This report will be used by Laboratory Management for STE assessment and planning. The report is also provided to the Department of Energy (DOE) as part of LANL's Annual Performance Plan and to the Los Alamos National Security (LANS) LLC's Science and Technology Committee (STC) as part of its responsibilities to the LANS Board of Governors.

  17. Research ethics in physical education

    Directory of Open Access Journals (Sweden)

    Júlio César Schmitt Rocha

    2009-06-01

    Full Text Available The objective here is to point out ethics in Physical Education research against a backdrop of individual and collective human conduct. Since Plato, the question of ethics in the Western world has been an incessant search for the virtues to harmonize personal and social wellbeing and for the absolute principles of conduct: Autonomy, Beneficence and Justice. Physical Education cannot exempt itself from these and its countless areas of research. In addition to the moral education that develops and solidifies within social groups, the characteristic of which is action on an individual level, we must also consider ethical principles such as those defended by the Physical Education World Manifesto and those that regulate the professional activities of Physical Education professionals. Irrespective of the area investigated, Research in Physical Education will always clash with institutionalized ethical principles enforced by ethics committees, councils and the values accepted by the researchers. Committees strive to preserve the integrity and dignity of the people enrolled on research studies while the researchers challenge the limits of knowledge at an uncomfortable frontier between the acceptable and the unacceptable within a given context of academic vision and needs.

  18. After Ethics

    DEFF Research Database (Denmark)

    Shepherd, Nick; Haber, Alejandro

    While books on archaeological and anthropological ethics have proliferated in recent years, few attempt to move beyond a conventional discourse on ethics to consider how a discussion of the social and political implications of archaeological practice might be conceptualized differently....... The conceptual ideas about ethics posited in this volume make it of interest to readers outside of the discipline; in fact, to anyone interested in contemporary debates around the possibilities and limitations of a discourse on ethics. The authors in this volume set out to do three things. The first is to track...... the historical development of a discussion around ethics, in tandem with the development and “disciplining” of archaeology. The second is to examine the meanings, consequences and efficacies of a discourse on ethics in contemporary worlds of practice in archaeology. The third is to push beyond the language...

  19. Standing Concertation Committee

    CERN Document Server

    HR Department

    2007-01-01

    ORDINARY MEETING ON 27 FEBRUARY 2007 The main items discussed at the meeting of the Standing Concertation Committee on 27 February 2007 included: Saved Leave Scheme (SLS): It was announced that a Management/Staff Association working group had been set up to discuss the Saved Leave Scheme (SLS): Members : M. Büttner, E. Chiaveri (chair), Ph. Defert, D. Klem, M. Vitasse, J.-M. Saint-Viteux. It was noted that the Staff Association was launching a questionnaire on SLS and distributed to all members of the personnel. Merit Recognition Guidelines: In the context of the new Merit Appraisal and Recognition Scheme (MARS), the committee took note of the CERN-wide 2007 Merit Recognition Guidelines, including the Frequently Asked Questions on HR Department's dedicated website. Information on CERN's medium and long-term plans (MTP-LTP)/Contract renewals/ External mobility The Committee took note of the information provided on CERN's MTP-LTP and of documentation distributed at the meeting by the Staff ...

  20. Ethical considerations

    International Nuclear Information System (INIS)

    Knoppers, B.M.

    1996-01-01

    Some ethical questions about molecular biology and human radiation studies are raised. The questions relate to the following: genetic epidemiology leading to possible stigmatization of certain groups; protection of medical information, including samples, and respect for privacy; effect of genetic characterization on standards and procedures relating to occupational exposure; exclusion of vulnerable groups from research studies. On the positive side, there is increased funding within Canada for studies of ethical, legal and social issues, and internationally ethical standards are being developed

  1. ETHICS AND COMMUNICATION IN MANAGEMENT

    OpenAIRE

    Reta CONDEI; Ioana NICULAE; Petrica STEFAN; Agatha POPESCU

    2014-01-01

    Management ethics, the determination at what means “fair”, ”correct” and “just” in decisions and action that affect the others, passes the simple problems like corruption, steal and swindle. It is focused on human interrelations such as between employers and employees, sellers and clients, shareholders, creditors, distributors, community members. The solving of the ethics dilemmas in management do not represent just a delimitation between good and bad, correct and incorrect, but also it is a ...

  2. Medical ethics and ethical dilemmas.

    Science.gov (United States)

    Iyalomhe, G B S

    2009-01-01

    Ethical problems routinely arise in the hospital and outpatient practice settings and times of dilemma do occur such that practitioners and patients are at cross-roads where choice and decision making become difficult in terms of ethics. This paper attempts a synopsis of the basic principles of medical ethics, identifies some ethical dilemmas that doctors often encounter and discusses some strategies to address them as well as emphasizes the need for enhanced ethics education both for physicians and patients particularly in Nigeria. Literature and computer programmes (Medline and PsychoInfo databases) were searched for relevant information. The search showed that the fundamental principles suggested by ethicists to assist doctors to evaluate the ethics of a situation while making a decision include respect for autonomy, beneficence, non-maleficence and justice. Although the above principles do not give answers as to how to handle a particular situation, they serve as a guide to doctors on what principles ought to apply to actual circumstances. The principles sometimes conflict with each other leading to ethical dilemmas when applied to issues such as abortion, contraception, euthanasia, professional misconduct, confidentiality truth telling, professional relationship with relatives, religion, traditional medicine and business concerns. Resolution of dilemmas demand the best of the doctor's knowledge of relevant laws and ethics, his training and experience, his religious conviction and moral principles as well as his readiness to benefit from ethics consultation and the advice of his colleagues. Ethics education should begin from the impressionable age in homes, continued in the medical schools and after graduation to ensure that doctors develop good ethical practices and acquire the ability to effectively handle ethical dilemmas. Also, education of patients and sanction of unethical behaviour will reduce ethical dilemmas.

  3. 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.

  4. Ethical issues related to computerised family medical histories in sickle cell disease: Inforare.

    Science.gov (United States)

    Franrenet, Sandra; Duchange, Nathalie; Galactéros, Fréderic; Quantin, Catherine; Cohen, Olivier; Nzouakou, Ruben; Sudraud, Sophie; Hervé, Christian; Moutel, Grégoire

    2010-10-01

    The Inforare project aims to set up a system for the sharing of clinical and familial data, in order to study how genes are related to the severity of sickle cell disease. While the computerisation of clinical records represents a valuable research goal, an ethical framework is necessary to guarantee patients' protection and their rights in this developing field. Issues relating to patient information during the Inforare study were analysed by the steering committee. Several major concerns were discussed by the committee and formalized in the patients' information letter: educating patients to aid the recruitment of family members, rules of confidentiality and the disclosure of aggregate, individual and unexpected research results. This paper presents the main issues addressed.

  5. 75 FR 28542 - Superior Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ... Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to orient the new Superior Resource Advisory Committee members on their roles... following business will be conducted: Overview of the roles and responsibilities of the Superior Resource...

  6. 12 CFR 620.30 - Audit committees.

    Science.gov (United States)

    2010-01-01

    ... shareholders; review the impact of any significant accounting and auditing developments; review accounting policy changes relating to preparation of financial statements; and review annual and quarterly reports..., financial reporting and disclosure, or accounting procedures. (b) Independence. Every audit committee member...

  7. 41 CFR 105-54.204 - Advisory committee membership.

    Science.gov (United States)

    2010-07-01

    ... particular individual or group to obtain different points of view relevant to committee business. The... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting...

  8. 77 FR 47490 - Shipping Coordinating Committee; Notice of Committee Meeting

    Science.gov (United States)

    2012-08-08

    ...: --Adoption of the agenda --Decisions of other IMO bodies --Global Maritime Distress and Safety System (GMDSS... facilities --Consideration of operational and technical coordination provisions of maritime safety... Vice-Chairman for 2014 --Any other business --Report to the Maritime Safety Committee Members of the...

  9. 77 FR 72431 - Shipping Coordinating Committee; Notice of Committee Meeting

    Science.gov (United States)

    2012-12-05

    ... other IMO bodies --Global Maritime Distress and Safety System (GMDSS): --Review and modernization of the... operational and technical coordination provisions of maritime safety information (MSI) services, including the... business --Report to the Maritime Safety Committee Members of the public may attend this meeting up to the...

  10. Ethical considerations in implementing a biometric co-enrol- ment ...

    African Journals Online (AJOL)

    The biometrics co-enrolment prevention system (BCEPS) is a novel ... capture participant's identification details in real time was approved by the SAMRC Ethics Committee. ... for guidelines and standard operating procedures (SOPs) for the.

  11. 78 FR 42945 - Health Information Technology Policy Committee Vacancy

    Science.gov (United States)

    2013-07-18

    ... GOVERNMENT ACCOUNTABILITY OFFICE Health Information Technology Policy Committee Vacancy AGENCY... American Recovery and Reinvestment Act of 2009 (ARRA) established the Health Information Technology Policy... its 20 members. ARRA requires that one member have expertise in health information privacy and...

  12. "The President" Was a Committee

    Science.gov (United States)

    Corcoran, George C.

    1976-01-01

    From 1970 until 1974, the Seattle Community College District was directed by a four-member executive committee, rather than by one chief executive officer. The history of this period is recounted, and advantages and disadvantages of the management system are identified. In sum, the system is satisfactory only in the short-run. (NHM)

  13. Research Ethics

    Science.gov (United States)

    Dooly, Melinda; Moore, Emilee; Vallejo, Claudia

    2017-01-01

    Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…

  14. Large ethics.

    Science.gov (United States)

    Chambers, David W

    2008-01-01

    This essay presents an alternative to the traditional view that ethics means judging individual behavior against standards of right and wrong. Instead, ethics is understood as creating ethical communities through the promises we make to each other. The "aim" of ethics is to demonstrate in our own behavior a credible willingness to work to create a mutually better world. The "game" of ethics then becomes searching for strategies that overlap with others' strategies so that we are all better for intending to act on a basis of reciprocal trust. This is a difficult process because we have partial, simultaneous, shifting, and inconsistent views of the world. But despite the reality that we each "frame" ethics in personal terms, it is still possible to create sufficient common understanding to prosper together. Large ethics does not make it a prerequisite for moral behavior that everyone adheres to a universally agreed set of ethical principles; all that is necessary is sufficient overlap in commitment to searching for better alternatives.

  15. BUSINESS ETHICS

    Directory of Open Access Journals (Sweden)

    Nelu BURCEA

    2014-12-01

    Full Text Available Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the elements that will form the basis of this scientific study. Lately, business ethics has been becoming an increasingly popular topic. Set against the global economic crisis, the companies’ credibility could become a major concern. Business ethics also becomes a challenge for training and informing employees and employers, in order to make not only economical, but also ethical decisions regarding their profits. In the study we shall also address the ethical standards required in a business world interested in fundamental values that can make the difference in 21st century business. Also, according to a study conducted by the authors, we shall address the two most important ethical values that prove to be essential to a business.

  16. Intelligence Ethics:

    DEFF Research Database (Denmark)

    Rønn, Kira Vrist

    2016-01-01

    Questions concerning what constitutes a morally justified conduct of intelligence activities have received increased attention in recent decades. However, intelligence ethics is not yet homogeneous or embedded as a solid research field. The aim of this article is to sketch the state of the art...... of intelligence ethics and point out subjects for further scrutiny in future research. The review clusters the literature on intelligence ethics into two groups: respectively, contributions on external topics (i.e., the accountability of and the public trust in intelligence agencies) and internal topics (i.......e., the search for an ideal ethical framework for intelligence actions). The article concludes that there are many holes to fill for future studies on intelligence ethics both in external and internal discussions. Thus, the article is an invitation – especially, to moral philosophers and political theorists...

  17. 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.

  18. 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

  19. 78 FR 71706 - Advisory Committee for Aviation Consumer Protection

    Science.gov (United States)

    2013-11-29

    ... Committee for Aviation Consumer Protection AGENCY: Office of the Secretary (OST), Department of... fifth meeting of the Advisory Committee for Aviation Consumer Protection. DATES: The fifth meeting of... Aviation Consumer Protection (ACACP) and announced those persons appointed as members. The committee's...

  20. 78 FR 55327 - Advisory Committee for Aviation Consumer Protection

    Science.gov (United States)

    2013-09-10

    ... Committee for Aviation Consumer Protection AGENCY: Office of the Secretary (OST), Department of... fifth meeting of the Advisory Committee for Aviation Consumer Protection. DATES: The fifth meeting of... Consumer Protection and announced those persons appointed as members. The committee's charter, drafted in...

  1. 76 FR 46279 - Smart Grid Advisory Committee

    Science.gov (United States)

    2011-08-02

    ...The Smart Grid Advisory Committee (SGAC or Committee) will hold a meeting via teleconference on Tuesday, August 23, 2011 from 11 a.m. to 2 p.m. Eastern Time (E.T.). The primary purpose of this meeting is to review sections of the Committee's draft report to the NIST Director. The sections of the draft report that the Committee will consider at the meeting will be posted on the SGAC Web site at http:// www.nist.gov/smartgrid. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number.

  2. Ethics issues in security hospitals.

    Science.gov (United States)

    Weinstein, Henry C

    2002-01-01

    The term 'security hospital' is used for a variety of facilities including forensic hospitals and prison hospitals, which, because of their mission, the nature of their work, and the populations they serve-or because of the authority under which they operate-place the staff at considerable risk of ethical violations related to either clinical care or to forensic activities. The problem of divided loyalties is of special concern in security hospitals. Ethics principles particularly at risk are confidentiality and informed consent. Where there are cultural disparities between the staff and the patients, differences in background, socioeconomic class, education, and other types of diversity, cultural awareness is required and must be reflected in appropriate treatment and evaluation. To counteract the risks of ethical violations, a security hospital should create an ethical climate and develop means to anticipate, prevent, and deal with ethical violations. These might include detailed and specific policies and procedures, programs of orientation, education, consultation, and liaison as well as its own ethics committee. Copyright 2002 John Wiley & Sons, Ltd.

  3. 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.

  4. 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.

  5. Ethics of Qualitative Interviewing with Grieving Families.

    Science.gov (United States)

    Rosenblatt, Paul C.

    1995-01-01

    Illustrations from a recent study of farm families who had lost a family member are used to illuminate some of the ethical challenges in qualitative bereavement research. Included in the exploration are ethics involved in interview recruitment, causing pain, informed consent, the boundaries of research and therapy, family dysfunction, and…

  6. An Ethics Challenge for School Counselors

    Science.gov (United States)

    Froeschle, Janet G.; Crews, Charles

    2010-01-01

    Ethical issues arise more often for school counselors than for those who work in other settings (Remley, 2002). The challenge of working not only with minors but also with other stakeholders including parents, teachers, school administrators, and community members sets the stage for potential legal and ethical dilemmas. Awareness and adherence to…

  7. VA Education Benefits: Actions Taken, but Outreach and Oversight Could Be Improved. Report to the Ranking Member, Subcommittee on Military Personnel, Committee on Armed Services, House of Representatives. GAO-11-256

    Science.gov (United States)

    Bertoni, Daniel

    2011-01-01

    The U.S. Department of Veterans Affairs (VA) provided $9 billion in education benefits to service-members and veterans in fiscal year 2010, mostly through the new Post-9/11 GI Bill. In providing education benefits, VA relies on State Approving Agencies (SAA) to approve schools; and on schools to report students' enrollment status. US Government…

  8. Vietnam Education Foundation: Recent Improvements Made in Internal Controls, but Weaknesses Persist. Report to the Chairman and Ranking Member, Committee on Foreign Relations, U.S. Senate. GAO-10-442

    Science.gov (United States)

    Ford, Jess T.

    2010-01-01

    The Vietnam Education Foundation (VEF) Act of 2000 established VEF as an independent agency of the executive branch. A 13-member board of directors provides primary oversight. VEF also receives guidance from other entities in carrying out its mission to further bilateral relations between the United States and Vietnam through educational exchanges…

  9. Ethics in Science.

    Science.gov (United States)

    Sharma, Om P

    2015-09-01

    Ethics are a set of moral principles and values a civilized society follows. Doing science with principles of ethics is the bedrock of scientific activity. The society trusts that the results and the projected outcome of any scientific activity is based on an honest and conscientious attempt by the scientific community. However, during the last few decades, there has been an explosion of knowledge and the advent of digital age. We can access the publications of competitors with just a "click". The evaluation parameters have evolved a lot and are based on impact factors, h-index and citations. There is a general feeling that the scientific community is under a lot of pressure for fulfilling the criteria for upward growth and even retention of the positions held. The noble profession of scientific research and academics has been marred by the temptation to falsify and fabricate data, plagiarism and other unethical practices. Broadly speaking, the breach of ethics involves: plagiarism, falsification of data, redundant (duplicate) publication, drawing far-fetched conclusions without hard data, for early publicity, gift authorship (receiving as well as giving), not giving sufficient attention and consideration to scholars and post-docs as per the norms, self promotion at the cost of team-members, treating colleagues (overall all juniors) in a feudal way and Machiavellianism (cunningness and duplicity in general conduct and push to positions of power and pelf). Misconduct in Indian academics and science is also under a lot of focus. It is important and urgent that science, engineering, and health departments and institutions in our country have in place systems for education and training in pursuit of science with ethics by sound and professional courses in Responsible Conduct of Research. All research and academic institution must have the Office of Ethics for information, guidelines, training and professional oversight of conduct of research with the ethos and ethics

  10. 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…

  11. Historical Roots and Future Perspectives Related to Nursing Ethics.

    Science.gov (United States)

    Freitas, Lorraine

    1990-01-01

    This article traces the evolution of the development and refinement of the professional code from concerns about the ethical conduct of nurses to its present state as a professional code for all nurses. The relationship of the Ethics Committee of the American Nurses' Association to the development of the code is also discussed. (Author/MLW)

  12. 76 FR 21382 - Pediatric Ethics Subcommittee; Notice of Meeting

    Science.gov (United States)

    2011-04-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0184] Pediatric Ethics Subcommittee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Ethics Subcommittee of...

  13. BUSINESS ETHICS

    OpenAIRE

    Nelu BURCEA; Ion CROITORU

    2014-01-01

    Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the eleme...

  14. Organizing Committee Advisory Committee 187

    Indian Academy of Sciences (India)

    Organizing Committee. V M Datar (Chairman). Bhabha Atomic Research Centre, Mumbai, India. D C Biswas (Convener). Bhabha Atomic Research Centre, Mumbai, India. K Mahata (Secretary). Bhabha Atomic Research Centre, Mumbai, India. Z Ahmed. Bhabha Atomic Research Centre, Mumbai, India. P V Bhagwat.

  15. Ethics curriculum for emergency medicine graduate medical education.

    Science.gov (United States)

    Marco, Catherine A; Lu, Dave W; Stettner, Edward; Sokolove, Peter E; Ufberg, Jacob W; Noeller, Thomas P

    2011-05-01

    Ethics education is an essential component of graduate medical education in emergency medicine. A sound understanding of principles of bioethics and a rational approach to ethical decision-making are imperative. This article addresses ethics curriculum content, educational approaches, educational resources, and resident feedback and evaluation. Ethics curriculum content should include elements suggested by the Liaison Committee on Medical Education, Accreditation Council for Graduate Medical Education, and the Model of the Clinical Practice of Emergency Medicine. Essential ethics content includes ethical principles, the physician-patient relationship, patient autonomy, clinical issues, end-of-life decisions, justice, education in emergency medicine, research ethics, and professionalism. The appropriate curriculum in ethics education in emergency medicine should include some of the content and educational approaches outlined in this article, although the optimal methods for meeting these educational goals may vary by institution. Copyright © 2011 Elsevier Inc. All rights reserved.

  16. Ethical issues in pediatric emergency mass critical care.

    Science.gov (United States)

    Antommaria, Armand H Matheny; Powell, Tia; Miller, Jennifer E; Christian, Michael D

    2011-11-01

    As a result of recent events, including natural disasters and pandemics, mass critical care planning has become a priority. In general, planning involves limiting the scope of disasters, increasing the supply of medical resources, and allocating scarce resources. Entities at varying levels have articulated ethical frameworks to inform policy development. In spite of this increased focus, children have received limited attention. Children require special attention because of their unique vulnerabilities and needs. In May 2008, the Task Force for Mass Critical Care published guidance on provision of mass critical care to adults. Acknowledging that the critical care needs of children during disasters were unaddressed by this effort, a 17-member Steering Committee, assembled by the Oak Ridge Institute for Science and Education with guidance from members of the American Academy of Pediatrics, convened in April 2009 to determine priority topic areas for pediatric emergency mass critical care recommendations.Steering Committee members established subgroups by topic area and performed literature reviews of MEDLINE and Ovid databases. Draft documents were subsequently developed and revised based on the feedback from the Task Force. The Pediatric Emergency Mass Critical Care Task Force, composed of 36 experts from diverse public health, medical, and disaster response fields, convened in Atlanta, GA, on March 29-30, 2010. This document reflects expert input from the Task Force in addition to the most current medical literature. The Ethics Subcommittee recommends that surge planning seek to provide resources for children in proportion to their percentage of the population or preferably, if data are available, the percentage of those affected by the disaster. Generally, scarce resources should be allocated on the basis of need, benefit, and the conservation of resources. Estimates of need, benefit, and resource utilization may be more subjective or objective. While the

  17. 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.

  18. 12 CFR 1710.14 - Code of conduct and ethics.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Code of conduct and ethics. 1710.14 Section... Code of conduct and ethics. (a) General. An Enterprise shall establish and administer a written code of conduct and ethics that is reasonably designed to assure the ability of board members, executive officers...

  19. Aesthetic Relationships and Ethics in "The Oh Fuck Moment"

    Science.gov (United States)

    Breel, Astrid

    2015-01-01

    This article explores the aesthetics and ethics of participatory performance through "The Oh Fuck Moment" by Hannah Jane Walker and Chris Thorpe, a performance that aesthetically explores ethically troubling material and manipulation. Ethical criticism of participatory art in recent years has focused on the way the audience member is…

  20. An overview of the major changes in the 2002 APA Ethics Code.

    Science.gov (United States)

    Knapp, Samuel; VandeCreek, Leon

    2003-06-01

    This article summarizes the major changes that were made to the 2002 Ethical Principles and Code of Conduct of the American Psychological Association. The 2002 Ethics Code retains the general format of the 1992 Ethics Code and does not radically alter the obligations of psychologists. One goal of the Ethics Committee Task Force was to reduce the potential of the Ethics Code to be used to unnecessarily punish psychologists. In addition, the revised Ethics Code expresses greater sensitivity to the needs of cultural and linguistic minorities and students. Shortcomings of the 2002 Ethics Code are discussed.

  1. Machine Ethics: Creating an Ethical Intelligent Agent

    OpenAIRE

    Anderson, Michael; Anderson, Susan Leigh

    2007-01-01

    The newly emerging field of machine ethics (Anderson and Anderson 2006) is concerned with adding an ethical dimension to machines. Unlike computer ethics -- which has traditionally focused on ethical issues surrounding humans' use of machines -- machine ethics is concerned with ensuring that the behavior of machines toward human users, and perhaps other machines as well, is ethically acceptable. In this article we discuss the importance of machine ethics, the need for machines that represent ...

  2. 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.

  3. Abusing ethics

    DEFF Research Database (Denmark)

    Olivares Bøgeskov, Benjamin Miguel

    This paper presents the result from our research on how nurse managers use and occasionally misuse inconclusive ethical arguments to engage their personnel in current reforms. The Danish health care system has undergone a series of reforms inspired by New Public Management theories, which have......, paying special attention to the way in which ethical arguments are used in relation to engagement. Our research shows that ethical arguments are extremely common, and they are used either to elicit engagement, or to demand engagement considering the result of a duty. However, most interestingly...... it was possible for us to find recurrence of fallacious arguments of different kinds. Based on these findings, I will argue that the use of fallacious arguments in order to generate engagement is in reality an abusive use of ethics, which raises important questions. I argue that depending on the degree...

  4. Transplant Ethics.

    Science.gov (United States)

    Altınörs, Nur; Haberal, Mehmet

    2016-11-01

    The aim of this study was to review and discuss the great variety of ethical issues related to organ donation, organ procurement, transplant activities, and new ethical problems created as a result of technologic and scientific developments. An extensive literature survey was made, and expert opinions were obtained. The gap between demand and supply of organs for transplant has yielded to organ trafficking, organ tourism, and commercialism. This problem seems to be the most important issue, and naturally there are ethical dilemmas related to it. A wide number of ideas have been expressed on the subject, and different solutions have been proposed. The struggle against organ trafficking and commercialism should include legislation, efforts to increase deceased-donor donations, and international cooperation. China's policy to procure organs from prisoners sentenced to death is unethical, and the international community should exert more pressure on the Chinese government to cease this practice. Each particular ethical dilemma should be taken separately and managed.

  5. Ethics fundamentals.

    Science.gov (United States)

    Chambers, David W

    2011-01-01

    Ethics is about studying the right and the good; morality is about acting as one should. Although there are differences among what is legal, charitable, professional, ethical, and moral, these desirable characteristics tend to cluster and are treasured in dentistry. The traditional approach to professionalism in dentistry is based on a theory of biomedical ethics advanced 30 years ago. Known as the principles approach, general ideals such as respect for autonomy, nonmaleficence, beneficence, justice, and veracity, are offered as guides. Growth in professionalism consists in learning to interpret the application of these principles as one's peers do. Moral behavior is conceived as a continuous cycle of sensitivity to situations requiring moral response, moral reasoning, the moral courage to take action when necessary, and integration of habits of moral behavior into one's character. This essay is the first of two papers that provide the backbone for the IDEA Project of the College--an online, multiformat, interactive "textbook" of ethics for the profession.

  6. Ethical leadership.

    Science.gov (United States)

    Keselman, David

    2012-01-01

    In today's climate and environment, the conventional relationship between caring, economic, and administrative practices no longer serves the interest of patients, clinicians, or systems. A shift toward human caring values and an ethic of authentic healing relationships is required as systems now have to value human resources and life purposes, inner meaning, and processes for providers and patients alike. The costs of unethical behavior can be even greater for followers. When we assume the benefits of leadership, we also assume ethical burdens. It is the assertion and experience of the author that the triangle of ethics and ethical behavior, followers, and patient's outcomes are closely interrelated and affect each other in a very intimate and direct way. Unethical leadership may lead to follower disappointment and distrust, leading to lack of interest and commitment, consequently negatively impacting patient outcomes and organizational effectiveness.

  7. Implicit and explicit clinical ethics support in The Netherlands: a mixed methods overview study

    NARCIS (Netherlands)

    Dauwerse, L.; Weidema, F.C.; Abma, T.; Molewijk, A.C.; Widdershoven, G.

    2014-01-01

    Internationally, the prevalence of clinical ethics support (CES) in health care has increased over the years. Previous research on CES focused primarily on ethics committees and ethics consultation, mostly within the context of hospital care. The purpose of this article is to investigate the

  8. Report on the PWR-radiation protection/ALARA Committee

    Energy Technology Data Exchange (ETDEWEB)

    Malone, D.J. [Consumers Power Co., Covert, MI (United States)

    1995-03-01

    In 1992, representatives from several utilities with operational Pressurized Water Reactors (PWR) formed the PWR-Radiation Protection/ALARA Committee. The mission of the Committee is to facilitate open communications between member utilities relative to radiation protection and ALARA issues such that cost effective dose reduction and radiation protection measures may be instituted. While industry deregulation appears inevitable and inter-utility competition is on the rise, Committee members are fully committed to sharing both positive and negative experiences for the benefit of the health and safety of the radiation worker. Committee meetings provide current operational experiences through members providing Plant status reports, and information relative to programmatic improvements through member presentations and topic specific workshops. The most recent Committee workshop was facilitated to provide members with defined experiences that provide cost effective ALARA performance.

  9. Ethical dilemmas

    DEFF Research Database (Denmark)

    Aabro, Christian

    2015-01-01

    What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter.......What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter....

  10. Capability ethics

    OpenAIRE

    Robeyns, Ingrid

    2012-01-01

    textabstractThe capability approach is one of the most recent additions to the landscape of normative theories in ethics and political philosophy. Yet in its present stage of development, the capability approach is not a full-blown normative theory, in contrast to utilitarianism, deontological theories, virtue ethics, or pragmatism. As I will argue in this chapter, at present the core of the capability approach is an account of value, which together with some other (more minor) normative comm...

  11. Comités de ética independientes para la investigación clínica en la Argentina: Evaluación y sistema para garantizar su independencia Independent ethics committees for clinical research in Argentina: An evaluation and a system to guarantee their independence

    Directory of Open Access Journals (Sweden)

    Sergio E. Gonorazky

    2008-04-01

    Full Text Available La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT exige para la ejecución de protocolos de investigación de nuevos fármacos en seres humanos, que éstos sean previamente evaluados y aprobados por un denominado comité de ética independiente de los patrocinadores e investigadores. Sin embargo, esta evaluación es lucrativa y la elección del comité de ética independiente es realizada por el patrocinador y/o investigador, lo que convierte la supuesta independencia en una relación del tipo "prestador de servicio - cliente". El Consejo de Revisión Institucional de Estudios de Investigación del Hospital Privado de Comunidad de Mar del Plata evaluó, entre los años 2005 y 2006, treinta y tres protocolos (con sus correspondientes hojas de información al paciente y consentimientos informados aprobados previamente por un comité de ética independiente no institucional. La mediana de objeciones relevantes realizadas por este Consejo de Revisión a los mencionados protocolos, que obligaron a que sean modificados para luego ser aprobados, fue de tres por protocolo. La acreditación de los Comités de Ética Independiente exige un sistema que garantice la real independencia de éstos de los patrocinadores y/o investigadores a la vez que mecanismos de control de gestión que incluyan una eventual pérdida de la acreditación. Este trabajo propone algunas medidas concretas para corregir las deficiencias del sistema actual.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

  12. BUSINESS ETHICS FOR BUSINESS SUSTAINABILITY IN MUHAMMADIYAH HOSPITAL: EVIDENCE FROM PONOROGO, INDONESIA

    OpenAIRE

    Anna Marina; Sentot Imam Wahjono

    2017-01-01

    The purpose of this study is to examine how business ethics can support business sustainability in hospitals. Business ethics is associated with: Hospital professional ethics, medical professional ethics, professional accounting ethics, and Islamic business ethics. This study used a qualitative approach with phenomenological analysis techniques to process the data collected from key informants, through Focus Group Discussions (FGD) with 20 supervisors, in-depth interviews with six members of ...

  13. Written institutional ethics policies on euthanasia: an empirical-based organizational-ethical framework.

    Science.gov (United States)

    Lemiengre, Joke; Dierckx de Casterlé, Bernadette; Schotsmans, Paul; Gastmans, Chris

    2014-05-01

    As euthanasia has become a widely debated issue in many Western countries, hospitals and nursing homes especially are increasingly being confronted with this ethically sensitive societal issue. The focus of this paper is how healthcare institutions can deal with euthanasia requests on an organizational level by means of a written institutional ethics policy. The general aim is to make a critical analysis whether these policies can be considered as organizational-ethical instruments that support healthcare institutions to take their institutional responsibility for dealing with euthanasia requests. By means of an interpretative analysis, we conducted a process of reinterpretation of results of former Belgian empirical studies on written institutional ethics policies on euthanasia in dialogue with the existing international literature. The study findings revealed that legal regulations, ethical and care-oriented aspects strongly affected the development, the content, and the impact of written institutional ethics policies on euthanasia. Hence, these three cornerstones-law, care and ethics-constituted the basis for the empirical-based organizational-ethical framework for written institutional ethics policies on euthanasia that is presented in this paper. However, having a euthanasia policy does not automatically lead to more legal transparency, or to a more professional and ethical care practice. The study findings suggest that the development and implementation of an ethics policy on euthanasia as an organizational-ethical instrument should be considered as a dynamic process. Administrators and ethics committees must take responsibility to actively create an ethical climate supporting care providers who have to deal with ethical dilemmas in their practice.

  14. The Just War Tradition: A Model for Healthcare Ethics.

    Science.gov (United States)

    Connolly, Chaplain John D

    2018-06-01

    Healthcare ethics committees, physicians, surgeons, nurses, families, and patients themselves are constantly under pressure to make appropriate medically ethical decisions concerning patient care. Various models for healthcare ethics decisions have been proposed throughout the years, but by and large they are focused on making the initial ethical decision. What follows is a proposed model for healthcare ethics that considers the most appropriate decisions before, during, and after any intervention. The Just War Tradition is a model that is thorough in its exploration of the ethics guiding a nation to either engage in or refuse to engage in combatant actions. In recent years, the Just War Tradition has expanded beyond the simple consideration of going to war or not to include how the war is conducted and what the post-war phase would look like ethically. This paper is an exploration of a healthcare ethics decision making model using the tenets of the Just War Tradition as a framework. It discusses the initial consult level of decision making prior to any medical intervention, then goes further in considering the ongoing ethical paradigm during medical intervention and post intervention. Thus, this proposal is a more holistic approach to healthcare ethics decision making that encourages healthcare ethics committees to consider alternate models and ways of processing so that ultimately what is best for patient, family, staff, and the environment is all taken into consideration.

  15. 29 October 2013 - Former Director-General of IAEA H. Blix on the occasion of the Thorium Energy Conference at CERN with Chair of the ThEC13 Organization Committee E. Lillestol and Author of the book “Atome Vert” (Green Atom) J.-C. de Mestral; in the LHC tunnel at Point 1 with Technology Department, Machine Protection & Electrical Integrity Group, Performance Evaluation Section Member A. Verweij.

    CERN Multimedia

    Anna Pantelia

    2013-01-01

    29 October 2013 - Former Director-General of IAEA H. Blix on the occasion of the Thorium Energy Conference at CERN with Chair of the ThEC13 Organization Committee E. Lillestol and Author of the book “Atome Vert” (Green Atom) J.-C. de Mestral; in the LHC tunnel at Point 1 with Technology Department, Machine Protection & Electrical Integrity Group, Performance Evaluation Section Member A. Verweij.

  16. 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

  17. 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

  18. 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

  19. The educational aspects of ethics

    Directory of Open Access Journals (Sweden)

    Probucka Dorota

    2016-12-01

    Full Text Available The purpose of my article is to show the importance of normative ethics for the education of young people in three areas: individual, social and natural. In the first case, ethics answers the question how we should treat ourselves. Thus, it teaches responsibility for oneself, for one’s life and individual development. In the second case, ethics answers the question how we should treat other people in order to minimize the risk of harming them. Thus, it teaches responsibility to other members of society. In the third case, normative ethics reminds us of moral obligations towards non-human beings, stressing that suffering has an interspecies character, and doesn’t pertain only to representatives of Homo sapiens.

  20. [Physicians' strikes--ethical considerations].

    Science.gov (United States)

    Glick, Shimon; Schwarzfuchs, Dan

    2012-01-01

    Strikes in general represent a solution based on a form of coercion. Historically, the striker caused direct damage to his employer, who was responsible for the perceived unfair treatment of the employee. In the case of strikes in the public sector, the employer is generally not harmed, but innocent citizens suffer in order to pressure the government agencies, a questionable practice from an ethical viewpoint. Physicians' strikes have more serious ethical problems. They cause suffering and death to innocent citizens. They violate the ethical codes to which physicians have committed themselves as professionals, and they seriously impair the trust of the public in physicians. Better and more ethical ways to provide fair compensation for physicians must be employed, perhaps like those used for judges and members of the IDF.

  1. Ética e investigación Ethics and investigation

    Directory of Open Access Journals (Sweden)

    Salomón Zavala

    2011-12-01

    Full Text Available Los autores hacen una evaluación crítica de los aspectos éticos de la investigación en base a su experiencia como docentes universitarios y como miembros de Comités de Ética en Investigación. Invitan a la discusión de temas que consideran polémicos. Comienzan mencionando el rol regulador de las Normas Éticas Internaciones y Locales y de los Comités de Ética en Investigación. Comentan la postura de bioeticistas sudamericanos respecto del llamado "doble estándar" ético y sobre la liberalización del uso del placebo. Critican el perjuicio que ocasiona a los pacientes de bajos recursos el sistema de patentes así como la falta de interés en el desarrollo de nuevos medicamentos para tratar enfermedades raras o propias de países pobres, y la excesiva extensión de los Consentimientos Informados. Terminan opinando acerca de la distribución de los ensayos clínicos entre los investigadores, los problemas que afectan a los Comités de Ética en Investigación y sobre algunos contenidos del Reglamento de Ensayos Clínicos del Instituto Nacional de Salud.The authors make a critical evaluation of the ethical aspects of research based on their experience as university teachers and members of Ethics Committees. They invite to the discussion on topics that they consider polemic. They begin by mentioning the regulatory role of the International and Local Ethical Norms and of the Ethics Committees. They comment on the position of South American bioethicists regarding the so-called ethical "double standard" and on the liberalization of the use of the placebo. They criticize the damage that the system of patents causes on low- resources patients, as well as the lack of interest in the development of new medications to treat neglected diseases or those diseases which are only prevalent in poor countries, and the excessive length of the Informed Consents. They finish giving their opinion about the distribution of the clinical trials among the

  2. Routine HIV Testing of Family Members of Hospitalized Patients in Nigeria

    Directory of Open Access Journals (Sweden)

    Olusegun Busari

    2012-04-01

    Full Text Available Background: HIV testing for family members of HIV-positive patients may enhance disclosure of status of spouses, encourage family social support and improve access to HIV services. Objective was to employ the approach of routine HIV testing to determine the prevalence of HIV among family members of both HIV positive and negative patients on admission in a federal HIV treatment designated hospital in Western Nigeria Methodology: This prospective study was conducted between January 2006 and June 2009. Ethical clearance was obtained from the Research and Ethics committee of the hospital prior to the study. Informed consent was obtained from each participant. HIV testing was offered to consenting family members of HIV positive and negative patients on admission. The family members included spouses, children of patients, parents of paediatric patients and other family members. Analysis was done in frequencies and percentages Results: 162 family members of 184 patients were tested. Spouses were, 81 (50.0%; fathers, 14 (8.6%; mothers, 20 (12.3%; children, 19 (11.7% and others family members, 28 (17.3%. 151 (93.2% of testers were first timers. Majority of those tested (82.1% had post-test counseling. The overall HIV prevalence was 12.3% (20/162. HIV prevalence within different family members was 14.8% (12/81, 20% (4/20, 7.1% (1/14, 10.5% (2/19 and 3.6% (1/28 for spouses, mothers, fathers, children and others respectively.In addition, the prevalence of HIV among family members of HIV positive and negative patients was 15.6% (14/90 and 8.3% (6/72 respectively. Of 12 spouses that were positive, 7 (13.5% were HIV-discordant; and in 71.4% (5/7 of discordant couples, the spouse was positive while the patient on admission was negative. Conclusion: The results indicate that routine HIV testing of family members of patients on admission is a strategy for identification of vast number of HIV infected persons. This method is not only innovative, but also a novel

  3. 77 FR 22297 - Renewal of Department of Defense Federal Advisory Committees

    Science.gov (United States)

    2012-04-13

    ... the exception of travel and per diem for official Committee related travel, Committee members shall... point of view and in a manner that is free from conflict of interest. The Department, when necessary... exception of travel and per diem for official Committee related travel, subcommittee members shall serve...

  4. 77 FR 68747 - Reestablishment of Department of Defense Federal Advisory Committees

    Science.gov (United States)

    2012-11-16

    ... establishment of wage schedules for all appropriated fund and non-appropriated fund wage areas of blue-collar... per diem for official Committee related travel, Committee members shall serve without compensation... per diem for official Committee-related travel, Subcommittee members shall serve without compensation...

  5. Ethical Orientations for Understanding Business Ethics.

    Science.gov (United States)

    Lewis, Phillip V.; Speck, Henry E., III

    1990-01-01

    Argues that history provides the necessary framework in which both to discuss and to seek answers to the three necessary and sequential questions about business ethics: (1) What is ethics and what does it mean to be ethical? (2) Why be ethical?; and (3) How can one be ethical? (SG)

  6. 76 FR 13436 - National Advisory Committee for Labor Provisions of U.S. Free Trade Agreements

    Science.gov (United States)

    2011-03-11

    ... point of contact for the NAALC and the Labor Provisions of U.S. Free Trade Agreements. The committee is... Labor Affairs serves as the U.S. point of contact under the FTAs listed above. The committee shall... Committee. Members of the Committee will not be compensated for their services or reimbursed for travel...

  7. 76 FR 2686 - Video Programming and Emergency Access Advisory Committee; Announcement of Establishment and...

    Science.gov (United States)

    2011-01-14

    ... FEDERAL COMMUNICATIONS COMMISSION [DA 10-2320] Video Programming and Emergency Access Advisory... appointment of members of the Video Programming and Emergency Access Advisory Committee (``Committee'' or... change of the Committee's popular name to the Video Programming Accessibility Advisory Committee (``VPAAC...

  8. [Ethics and ritual circumcision].

    Science.gov (United States)

    Castagnola, C; Faix, A

    2014-12-01

    Circumcision dates back to ancient times, nowadays, this ritual is practiced mainly in the context of Jewish and Muslim religions. The purpose of this article is to give urologists elements of reflection on the act according to the ethical principles of autonomy, beneficence, non-maleficence and justice. According to a Kantian vision, priority should be given to the respect and wishes of the individuals. In contrast, for the utilitarian theory, circumcision can be justified by a contribution to the happiness of the majority of community members at the expense of a given few. In the event of a request for ritual circumcision, urologists find themselves in the middle, uncomfortable for some, questioning the ethics of its meaning. The main pitfall for the surgeon remains in respecting the child's autonomy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  9. Goals of clinical ethics support: perceptions of dutch healthcare institutions

    NARCIS (Netherlands)

    Dauwerse, L.; Abma, T.A.; Molewijk, A.C.; Widdershoven, G.

    2013-01-01

    In previous literature, ethicists mention several goals of Clinical Ethics Support (CES). It is unknown what key persons in healthcare institutions see as main- - and sub-goals of CES. This article presents the goals of CES as perceived by board members and members of ethics support staff. This is

  10. Ecological Ethics

    International Nuclear Information System (INIS)

    Oughton, Deborah

    2013-01-01

    Deborah Oughton started with a view of the work in progress by the ICRP TG 94 on ethics, from the historical context and the principles-based ethics in RP, to continue with an overview of the ethical theories and with the main area of elaboration which concerns the common values, to conclude with considerations about the implementation in different area such as biomedicine, nuclear safety and workers, ecological aspects, and environmental health and society. By reading again the ICRP and IAEA publications on the ethical aspects in the protection of environment from the effects of ionizing radiation, the presentation covers the various and different cultures within the history of environmental ethics, the perception of Nature and the theories of environmental ethics, in particular by focusing on anthropocentrism, biocentrism and ecocentrism, as philosophical worldwide views, and on conservation, biodiversity, sustainability, environmental justice and human dignity, as primary principles of environmental protection. The influence of western Christianity, with a view of man dominating over every creeping thing on earth, and of the non-western ideas, the human perception of Nature has been analyzed and discussed to conclude that, in reality then, the anthropocentrism, biocentrism and ecocentrism, as reflected in many cultures and religions, they all support the need to protect the environment and to recognise and preserve the diversity. Three challenges were then discussed in the presentation: the ecosystem approach and ecological economics, for example in the case of Fukushima by asking what is the economic cost of marine contamination; the ecosystem changes with attention to what harms, as in the case of the environment in the contaminated areas around Chernobyl; and the environmental consequences of remediation, which can be considered a source of controversy for environmental ethics and policy

  11. 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.

  12. 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.

  13. Ethical codes. Fig leaf argument, ballast or cultural element for radiation protection?

    International Nuclear Information System (INIS)

    Gellermann, Rainer

    2014-01-01

    The international association for radiation protection (IRPA) adopted in May 2004 a Code of Ethics in order to allow their members to hold an adequate professional level of ethical line of action. Based on this code of ethics the professional body of radiation protection (Fachverband fuer Strahlenschutz) has developed its own ethical code and adopted in 2005.

  14. Should Professional Ethics Education Incorporate Single-Professional or Interprofessional Learning?

    Science.gov (United States)

    Caldicott, Catherine V.; Braun, Eli A.

    2011-01-01

    Since ethical issues in the contemporary delivery of health care involve doctors, nurses, technicians, and members of other health professions, the authors consider whether members of diverse health care occupations might benefit from studying ethics in a single classroom. While interprofessional courses may be better at teaching the ethics of the…

  15. Comissões de ética de enfermagem em instituições de saúde de Ribeirão Preto Comisiones de ética de enfermería en instituciones de salud del interior del estado de São Paulo -- Brasil Nursing ethics committees in Ribeirão Preto's healthcare institutions

    Directory of Open Access Journals (Sweden)

    Cátia Ducati

    2001-05-01

    Full Text Available O estudo teve como objetivo identificar hospitais de Ribeirão Preto que possuem Comissões de Ética de Enfermagem, estabelecidas de acordo com a Decisão do Conselho Regional de Enfermagem, verificar suas atividades e atribuições, os motivos da criação e observância à Legislação. Os resultados mostram que dos 11 hospitais visitados oito teriam obrigatoriedade de instituir Comissões e destes, apenas três a possuem, sendo que somente uma encontra-se efetivamente em atividade. O estudo possibilitou também identificar infrações éticas mais freqüentes assim como punições eventualmente aplicadas e evidenciou despreparo dos profissionais da Enfermagem em relação ao seu posicionamento perante essas Comissões.El estudio tuvo como objetivo identificar que hospitales de Ribeirão Preto tienen Comisiones de Ética de Enfermería, establecidas de acuerdo con la decisión del COREN; verificar sus actividades y atribuciones, los motivos de la creación y el cumplimiento de la legislación. Los resultados muestran que de los once hospitales visitados, 8 deberían conformar obligatoriamente Comisiones. De estos solamente 3 la poseen y solo una se encuentra en actividad. El estudio posibilitó también identificar algunas infracciones éticas más frecuentes así como los castigos eventualmente aplicados y mostró la falta de preparación de los profesionales de Enfermería en relación con su posición frente a las Comisiones.The aim of this study was to identify hospitals in Ribeirão Preto, Brazil which have a Nursing Ethics Committee established according to the Decision of the Nursing Regional Council, to examine their activities and attributions, the reasons why they were created and the enforcement of legislation. The results have shown that from the eleven hospitals visited, eight ought to have instituted their Committees; however, only three had done it and only one of them was effectively active. The study made it possible to

  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. Data Ethics

    DEFF Research Database (Denmark)

    Hasselbalch, Gry; Tranberg, Pernille

    Respect for privacy and the right to control one’s own data are becoming key parameters to gain a competitive edge in today’s business world. Companies, organisations and authorities which view data ethics as a social responsibility, giving it the same importance as environmental awareness...... and respect for human rights, are tomorrow’s winners. Digital trust is paramount to digital growth and prosperity. This book combines broad trend analyses with case studies to examine companies which use data ethics to varying degrees. The authors make the case that citizens and consumers are no longer just...... concerned about a lack of control over their data, but they also have begun to act. In addition, they describe alternative business models, advances in technology and a new European data protection regulation, all of which combine to foster a growing market for data-ethical products and services...

  18. 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.

  19. Code of Ethics for Electrical Engineers

    Science.gov (United States)

    Matsuki, Junya

    The Institute of Electrical Engineers of Japan (IEEJ) has established the rules of practice for its members recently, based on its code of ethics enacted in 1998. In this paper, first, the characteristics of the IEEJ 1998 ethical code are explained in detail compared to the other ethical codes for other fields of engineering. Secondly, the contents which shall be included in the modern code of ethics for electrical engineers are discussed. Thirdly, the newly-established rules of practice and the modified code of ethics are presented. Finally, results of questionnaires on the new ethical code and rules which were answered on May 23, 2007, by 51 electrical and electronic students of the University of Fukui are shown.

  20. Practice paper of the Academy of Nutrition and Dietetics abstract: ethical and legal issues of feeding and hydration.

    Science.gov (United States)

    Schwartz, Denise Baird; Posthauer, Mary Ellen; O'Sullivan Maillet, Julie

    2013-07-01

    It is the position of the Academy of Nutrition and Dietetics that individuals have the right to request or refuse nutrition and hydration as medical treatment. Registered dietitians should work collaboratively as part of an interprofessional team to make recommendations on providing, withdrawing, or withholding nutrition and hydration in individual cases and serve as active members of institutional ethics committees. This practice paper provides a proactive, integrated, systematic process to implement the Academy's position. The position and practice papers should be used together to address the history and supporting information of ethical and legal issues of feeding and hydration identified by the Academy. Elements of collaborative ethical deliberation are provided for pediatrics and adults and in different conditions. The process of ethical deliberation is presented with the roles and responsibilities of the registered dietitian and the dietetic technician, registered. Understanding the importance and applying concepts dealing with cultural values and religious diversity is necessary to integrate clinical ethics into nutrition care. Incorporating screening for quality-of-life goals is essential before implementing the Nutrition Care Process and improving health literacy with individual interactions. Developing institution-specific policies and procedures is necessary to accelerate the practice change with artificial nutrition, clinical ethics, and quality improvement projects to determine best practice. This paper supports the "Position of the Academy of Nutrition and Dietetics: Ethical and Legal Issues of Feeding and Hydration" published in the June 2013 issue of the Journal of the Academy of Nutrition and Dietetics. Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  1. The effect of nurses' ethical leadership and ethical climate perceptions on job satisfaction.

    Science.gov (United States)

    Özden, Dilek; Arslan, Gülşah Gürol; Ertuğrul, Büşra; Karakaya, Salih

    2017-01-01

    The development of ethical leadership approaches plays an important role in achieving better patient care. Although studies that analyze the impact of ethical leadership on ethical climate and job satisfaction have gained importance in recent years, there is no study on ethical leadership and its relation to ethical climate and job satisfaction in our country. This descriptive and cross-sectional study aimed to determine the effect of nurses' ethical leadership and ethical climate perceptions on their job satisfaction. The study sample is composed of 285 nurses who agreed to participate in this research and who work at the internal, surgical, and intensive care units of a university hospital and a training and research hospital in İzmir, Turkey. Data were collected using Ethical Leadership Scale, Hospital Ethical Climate Scale, and Minnesota Satisfaction Scale. While the independent sample t-test, analysis of variance, Mann-Whitney U test, and Kruskal-Wallis test were used to analyze the data, the correlation analysis was used to determine the relationship between the scales. Ethical considerations: The study proposal was approved by the ethics committee of the Faculty of Medicine, Dokuz Eylül University. The nurses' mean scores were 59.05 ± 14.78 for the ethical leadership, 92.62 ± 17 for the ethical climate, and 62.15 ± 13.46 for the job satisfaction. The correlation between the nurses' ethical leadership and ethical climate mean scores was moderately positive and statistically significant (r = +0.625, p = 0.000), was weak but statistically significant between their ethical leadership and job satisfaction mean scores (r = +0.461, p = 0.000), and was moderately positive and statistically significant between their ethical climate and job satisfaction mean scores (r = +0.603, p = 0.000). The nurses' ethical leadership, ethical climate, and job satisfaction levels are moderate, and there is a positive relationship between them. The nurses' perceptions of ethical

  2. 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.

  3. Neuroscientists' everyday experiences of ethics: the interplay of regulatory, professional, personal and tangible ethical spheres.

    Science.gov (United States)

    Brosnan, Caragh; Cribb, Alan; Wainwright, Steven P; Williams, Clare

    2013-11-01

    The ethical issues neuroscience raises are subject to increasing attention, exemplified in the emergence of the discipline neuroethics. While the moral implications of neurotechnological developments are often discussed, less is known about how ethics intersects with everyday work in neuroscience and how scientists themselves perceive the ethics of their research. Drawing on observation and interviews with members of one UK group conducting neuroscience research at both the laboratory bench and in the clinic, this article examines what ethics meant to these researchers and delineates four specific types of ethics that shaped their day-to-day work: regulatory, professional, personal and tangible. While the first three categories are similar to those identified elsewhere in sociological work on scientific and clinical ethics, the notion of 'tangible ethics' emerged by attending to everyday practice, in which these scientists' discursive distinctions between right and wrong were sometimes challenged. The findings shed light on how ethical positions produce and are, in turn, produced by scientific practice. Informing sociological understandings of neuroscience, they also throw the category of neuroscience and its ethical specificity into question, given that members of this group did not experience their work as raising issues that were distinctly neuro-ethical. © 2013 The Authors. Sociology of Health & Illness © 2013 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

  4. 34 CFR 350.35 - What are the requirements for the composition of an advisory committee?

    Science.gov (United States)

    2010-07-01

    ... DISABILITY AND REHABILITATION RESEARCH PROJECTS AND CENTERS PROGRAM What Rehabilitation Engineering Research... committee? The majority of a Rehabilitation Engineering Research Center advisory committee's members must be comprised of individuals with disabilities who are users of rehabilitation technology, or their parents...

  5. Ethics consultation on demand: concepts, practical experiences and a case study

    OpenAIRE

    Reiter-Theil, S.

    2000-01-01

    Despite the increasing interest in clinical ethics, ethics consultation as a professional service is still rare in Europe. In this paper I refer to examples in the United States. In Germany, university hospitals and medical faculties are still hesitant about establishing yet another "committee". One of the reasons for this hesitation lies in the ignorance that exists here about how to provide medical ethics services; another reason is that medical ethics itself is not yet institutionalised at...

  6. Ethical considerations related to participation and partnership: an investigation of stakeholders' perceptions of an action-research project on user fee removal for the poorest in Burkina Faso.

    Science.gov (United States)

    Hunt, Matthew R; Gogognon, Patrick; Ridde, Valéry

    2014-02-20

    Healthcare user fees present an important barrier for accessing services for the poorest (indigents) in Burkina Faso and selective removal of fees has been incorporated in national healthcare planning. However, establishing fair, effective and sustainable mechanisms for the removal of user fees presents important challenges. A participatory action-research project was conducted in Ouargaye, Burkina Faso, to test mechanisms for identifying those who are indigents, and funding and implementing user fee removal. In this paper, we explore stakeholder perceptions of ethical considerations relating to participation and partnership arising in the action-research. We conducted 39 in-depth interviews to examine ethical issues associated with the action-research. Respondents included 14 individuals identified as indigent through the community selection process, seven members of village selection committees, six local healthcare professionals, five members of the management committees of local health clinics, five members of the research team, and four regional or national policy-makers. Using constant comparative techniques, we carried out an inductive thematic analysis of the collected data. The Ouargaye project involved a participatory model, included both implementation and research components, and focused on a vulnerable group within small, rural communities. Stakeholder perceptions and experiences relating to the participatory approach and reliance on multiple partnerships in the project were associated with a range of ethical considerations related to 1) seeking common ground through communication and collaboration, 2) community participation and risk of stigmatization, 3) impacts of local funding of the user fee removal, 4) efforts to promote fairness in the selection of the indigents, and 5) power relations and the development of partnerships. This investigation of the Ouargaye project serves to illuminate the distinctive ethical terrain of a participatory public

  7. Inferred referendum: a rule for committee decisions

    Energy Technology Data Exchange (ETDEWEB)

    Wolsky, A; Sanathanan, L

    1979-01-01

    A new method of social choice is presented. The result of the method coincides with that of majority voting when it does not produce an intransitivity among the alternatives under consideration. When majority voting would produce an intransitivity, the method orders the alternatives in the same way as the transitive constituency would whom the committee members are most likely to represent. Analysis of the application of the method to three alternatives shows that the resulting order depends only on the committee members' votes between pairs of alternatives; the resulting order is less sensitive to irrelevant alternatives than the orders provided by other schemes; when majority voting provides an intransitivity, the hypothesis that, in fact, the committee's constituency is as assumed is almost as likely as the hypothesis that it precisely mirrors the committee.

  8. Ethical considerations: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

    Science.gov (United States)

    Biddison, Lee Daugherty; Berkowitz, Kenneth A; Courtney, Brooke; De Jong, Col Marla J; Devereaux, Asha V; Kissoon, Niranjan; Roxland, Beth E; Sprung, Charles L; Dichter, Jeffrey R; Christian, Michael D; Powell, Tia

    2014-10-01

    Mass critical care entails time-sensitive decisions and changes in the standard of care that it is possible to deliver. These circumstances increase provider uncertainty as well as patients' vulnerability and may, therefore, jeopardize disciplined, ethical decision-making. Planning for pandemics and disasters should incorporate ethics guidance to support providers who may otherwise make ad hoc patient care decisions that overstep ethical boundaries. This article provides consensus-developed suggestions about ethical challenges in caring for the critically ill or injured during pandemics or disasters. The suggestions in this article are important for all of those involved in any pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. We adapted the American College of Chest Physicians (CHEST) Guidelines Oversight Committee's methodology to develop suggestions. Twenty-four key questions were developed, and literature searches were conducted to identify evidence for suggestions. The detailed literature reviews produced 144 articles. Based on their expertise within this domain, panel members also supplemented the literature search with governmental publications, interdisciplinary workgroup consensus documents, and other information not retrieved through PubMed. The literature in this field is not suitable to support evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process. We report the suggestions that focus on five essential domains: triage and allocation, ethical concerns of patients and families, ethical responsibilities to providers, conduct of research, and international concerns. Ethics issues permeate virtually all aspects of pandemic and disaster response. We have addressed some of the most pressing issues, focusing on five essential domains: triage and allocation, ethical

  9. 17 CFR 200.735-8 - Practice by former members and employees of the Commission.

    Science.gov (United States)

    2010-04-01

    ... EXCHANGE COMMISSION ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Regulation Concerning... with section 11 of the Public Utility Holding Company Act (15 U.S.C. 79k), this paragraph shall not be... interests of the Commission. 21 This definition is taken from Formal Opinion 342 of the ABA Ethics Committee...

  10. Transgressive ethics

    DEFF Research Database (Denmark)

    Hoeyer, Klaus; Jensen, Anja Marie Bornø

    2013-01-01

    of treatment norms, we must move close to everyday work practices and appreciate the importance of material–technical treatment options as well as the interplay of professional ethics and identity. The cardiac treatment of brain-dead donors may thereby illuminate how treatment norms develop on the ground...

  11. Animal ethics

    DEFF Research Database (Denmark)

    Palmer, Clare; Sandøe, Peter

    2011-01-01

    This chapter describes and discusses different views concerning our duties towards animals. First, we explain why it is necessary to engage in thinking about animal ethics and why it is not enough to rely on feelings alone. Secondly, we present and discuss five different kinds of views about...

  12. Capability ethics

    NARCIS (Netherlands)

    I.A.M. Robeyns (Ingrid)

    2012-01-01

    textabstractThe capability approach is one of the most recent additions to the landscape of normative theories in ethics and political philosophy. Yet in its present stage of development, the capability approach is not a full-blown normative theory, in contrast to utilitarianism, deontological

  13. Preliminary ethical appraisal of a trial - what's it all about?

    Science.gov (United States)

    Siipi, Helena

    Preliminary ethical appraisal of medical trials is often based on the following four principles: respect for autonomy, beneficence, non-maleficence, and justice. Preliminary ethical appraisal should, however, not be understood solely as application of these four principles to practice. Ethical committees will inevitably interpret the principles and make decisions about their reciprocal importance in connection with each trial. Reasoning does not always proceed from above towards practical recommendations of action, but can instead also be based on a moral rule or practice relating to a certain action. A good preliminary ethical appraisal will also take into account everyday standards of morality, law and shared moral values of the society.

  14. 76 FR 77778 - Amendment to Notice of Establishment of the Advisory Committee on Supply Chain Competitiveness...

    Science.gov (United States)

    2011-12-14

    ... Operation The Committee shall consist of a maximum of 40 private sector members appointed by the Secretary... private sector members, the Secretary of Transportation and the Administrator of the Environmental... as appropriate in making appointments of private sector members. The Committee chair and vice chair...

  15. THE INFLUENCE OF AUDIT COMMITTEE CHARACTERISTICS ON REAL EARNINGS MANAGEMENT

    Directory of Open Access Journals (Sweden)

    Supriyaningsih Supriyaningsih

    2016-05-01

    Full Text Available Current study tests the impact of audit committees to the real earnings management.Using the manufacturing public listed companies from Indoensia Stock Exchange from 2012 until 2014, we found that that financial and accounting expertise of audit committee members and audit committee size have positive effect on real earnings management. Furthermore, we also found that the dual positions of the audit committee chairman have a negative effect on earnings management. The Tenure of audit committee chairman however, has no impact on real earnings management.

  16. Work of ICRP Committee 4 on the implementation of the new ICRP recommendations

    International Nuclear Information System (INIS)

    Lochard, J.

    2010-01-01

    ICRP Mission was founded in 1928 by the international Society of Radiology to advance for the public benefit the science of radiological protection, in particular by providing recommendations and guidance on all aspects of protection against ionizing radiation. The commission has five committees, plus a scientific secretariat. It has task groups and working parties which are established either by the main commission or by the committees. It consists of 82 members from 24 countries and six continents. It has 7 approximately 100 external experts participating in task groups. It also has an international community of experts in radiological protection. Committee 4 is concerned with providing advice on the application of the recommended system of protection in all its facets for occupational and public exposure. It also acts as the major point of contact with other international organizations and professional societies concerned with protection against ionizing radiation. The priorities of Committee 4 (2009 -2013) are to: . Develop advice on the implementation of the new recommendations and contribute to their dissemination . Review the ethics and values (precautionary principles, tolerability of risk, equity, sustainable development¡¦) underlying the principles and concepts of the radiation protection system . Enhance the dialogue and cooperation with international organizations and professionals The programme of work for Committee 4 was outlined: a) Task Group N¡Æ 76 : Application of the Commission.s Recommendations to NORM b) Task Group N¡Æ 80 : Application of the Commission.s Recommendations as applied to the geological disposal of long-lived solid radioactive waste c) Task Group N¡Æ 81 : Application of the Commission.s Recommendations to radon exposure d) Committee 4 programme of work (4): Task Group (to be established): Application of the Commission.s Recommendations to the protection of aircraft crew to cosmic rays e) Committee 4 programme of work (5

  17. [The Editorial Advisory Committee].

    Science.gov (United States)

    Reyes, H

    1996-12-01

    Since 1970, Revista Médica de Chile applies the peer review system as a main step in the selection and improvement of the manuscripts to be published. Over 150 experts participate in this process annually, reviewing up to 5 manuscripts per year. The final decision with regards to to the acceptability of a manuscript remains a responsibility of the Editor. The reviewers are selected by the Editor and his Associates among clinical investigators, prominent subspecialits and basic scientists, according to the nature of the manuscript. Most of them work in Chile. Their names are published and their confidential work is acknowledged in a special chronicle published in the Revista once a year. A small number of these reviewers appears in every issue of the journal identified as Members of its Editorial Advisory Committee. They have been selected by the Editors among those reviewers who deal with a greater number of manuscripts and also those experienced specialists whose opinion is requested when an exceptional conflict of opinions is raised by the authors and their reviewers. After 5 to 10 years of a highly praised collaboration, the previous Committee has been changed and new names were included, starting in this issue of Revista Médica de Chile.

  18. Scientific Integrity and Professional Ethics at AGU - The Establishment and Evolution of an Ethics Program at a Large Scientific Society

    Science.gov (United States)

    McPhaden, Michael; Leinen, Margaret; McEntee, Christine; Townsend, Randy; Williams, Billy

    2016-04-01

    The American Geophysical Union, a scientific society of 62,000 members worldwide, has established a set of scientific integrity and professional ethics guidelines for the actions of its members, for the governance of the union in its internal activities, and for the operations and participation in its publications and scientific meetings. This presentation will provide an overview of the Ethics program at AGU, highlighting the reasons for its establishment, the process of dealing ethical breaches, the number and types of cases considered, how AGU helps educate its members on Ethics issues, and the rapidly evolving efforts at AGU to address issues related to the emerging field of GeoEthics. The presentation will also cover the most recent AGU Ethics program focus on the role for AGU and other scientific societies in addressing sexual harassment, and AGU's work to provide additional program strength in this area.

  19. Do Ethics Classes Teach Ethics?

    Science.gov (United States)

    Curzer, Howard J.; Sattler, Sabrina; DuPree, Devin G.; Smith-Genthôs, K. Rachelle

    2014-01-01

    The ethics assessment industry is currently dominated by the second version of the Defining Issues Test (DIT2). In this article, we describe an alternative assessment instrument called the Sphere-Specific Moral Reasoning and Theory Survey (SMARTS), which measures the respondent's level of moral development in several respects. We describe eight…

  20. 76 FR 18800 - NASA Advisory Council; Information Technology Infrastructure Committee; Meeting

    Science.gov (United States)

    2011-04-05

    ... Network Support IT Security Risk Management Ethics Briefing IT Committee Work Plan Actions/Assignments..., company affiliation (if applicable) to include address, telephone number, and their title, place of birth...

  1. 76 FR 20354 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)

    Science.gov (United States)

    2011-04-12

    ... Interventions as well as on Ethical Considerations for Decision Making Regarding Allocation of Mechanical... strategic and other broad issues facing CDC. Matters to Be Discussed: The Advisory Committee to the Director...

  2. International Project Management Committee: Overview and Activities

    Science.gov (United States)

    Hoffman, Edward

    2010-01-01

    This slide presentation discusses the purpose and composition of the International Project Management Committee (IMPC). The IMPC was established by members of 15 space agencies, companies and professional organizations. The goal of the committee is to establish a means to share experiences and best practices with space project/program management practitioners at the global level. The space agencies that are involved are: AEB, DLR, ESA, ISRO, JAXA, KARI, and NASA. The industrial and professional organizational members are Comau, COSPAR, PMI, and Thales Alenia Space.

  3. Desenvolvimento da dimensão educacional dos Comitês de Ética em Pesquisa (CEPs Desarrollo de la dimensión educacional de los Comités de Ética en Investigación (CEPs Development of the educational dimension of ethics of research committees (ERCs

    Directory of Open Access Journals (Sweden)

    Adriana Silva Barbosa

    2012-06-01

    66,7% de los investigadores participantes tuvieron alguna aproximación ética en su trayectoria académica. Estos datos indican que los CEIs necesitan mayor apoyo institucional e inversión para la consolidación de su dimensión educativo-consultiva.The importance of the educational and consulting nature of ethics of research committees (ERCs highlights the value of research which studies these dimensions in the committees. Aims: to analyze how ERCs have carried out their educational and consulting role; to learn whether advisors have some training in research ethics; to identify whether researchers had guidance about research ethics in their academic career. This is a quantitative and descriptive study approved by CEP/UESB under protocol 134/2009, carried out with 95 informants and analyzed by Software Sphinx. According to data obtained, nearly 71.5% research participants consider educational and consulting activities carried out by ERC infrequent or lacking; 60% participants have some ethical training in their academic career. These data show that ERCs need greater institutional support and funding in order to consolidate their educational-consulting dimension.

  4. Scientific Publication Ethics

    Directory of Open Access Journals (Sweden)

    Osman İnci

    2015-06-01

    showing conscious deceptive intention. Duplication, salamislicing, publications aiming partiality, partiality in choice of sources, authorship rights violations (Author concealment, Gift Autorship, Honory Autorship or Ghost Autorship,author addition changing the order of author list, and not thanking to the contributers are other irregular applications. Innocent faults and carelessness should not be evaluated as irregular applications. It is the task and responsibility of administrators of academic committee, editors and publication committees, referees, supporting institutions, and mainly academic readers and writers to avoid irregular applications in academic publications. It is of vital importance to give ‘an academic ethics’ instructions just at the very beginning of academic life. The ones who do not know principles and rules of academic ethics are not efficient for academic research and publications. Besides sanctions should be applied against approved irregular applications.

  5. Environmental ethics

    International Nuclear Information System (INIS)

    Pautassi G, Jorge

    1994-01-01

    When the Homo Faber; to the beginning of the humanization, overcame the instinct that established a relationship balanced in the ecosphere between the animal and the nature, an interference it began in the relationship man-nature; since that was not adapted this but rather it began its transformation adapting the environment to its necessities. During miles of years the development of this production technique of the Homo Faber could be considered like a progressive and innocuous exploitation of the natural resources. At the present time, kind of a dialectical transformation of the quantity in a new quality characterizes the critical stadium of the new phase of the evolution inaugurated by the Homo Faber. We arrive this way today to that the production force, by means of the science and the technique, outlines us the problem of if for a bigger development in the productivity is necessary a progressive destruction of the ecosphere. That is to say, so that there is progress and will civilization be necessary a progressive interference of the natural balance, with the consequent setting in danger of the life? Moreover this article treats topics about their location and focuses, environmental ethics framed in the talkative ethics and virtues of the environmental ethics, among other topics

  6. Immortal ethics.

    Science.gov (United States)

    Harris, John

    2004-06-01

    This article draws on ideas published in my "Intimations of Immortality" essay in Science (Vol. 288, No. 5463, p. 59, April 7, 2000) and my "Intimations of Immortality-The Ethics and Justice of Life Extending Therapies" in editor Michael Freeman's Current Legal Problems (Oxford University Press 2002: 65-97). This article outlines the ethical issues involved in life-extending therapies. The arguments against life extension are examined and found wanting. The consequences of life extension are explored and found challenging but not sufficiently daunting to warrant regulation or control. In short, there is no doubt that immortality would be a mixed blessing, but we should be slow to reject cures for terrible diseases that may be an inextricable part of life-extending procedures even if the price we have to pay for those cures is increasing life expectancy and even creating immortals. Better surely to accompany the scientific race to achieve immortality with commensurate work in ethics and social policy to ensure that we know how to cope with the transition to parallel populations of mortals and immortals as envisaged in mythology.

  7. Resolving the ethical dilemma of nurse managers over chemically-dependent colleagues.

    Science.gov (United States)

    Chiu, W; Wilson, D

    1996-12-01

    This paper addresses the nurse manager's role regarding chemically-dependent nurses in the workplace. The manager may intervene by: terminating the contract of the impaired colleague; notifying a disciplinary committee; consulting with a counselling committee; or referring the impaired nurse to an employee assistance programme. A dilemma may arise about which of these interventions is ethically the best. The ethical theories relevant to nursing involve ethical relativism, utilitarianism, Kantian ethics, Kohlberg's justice, and Gilligan's ethic of care. Nurse managers first need to understand these theories in order to clarify their own perceptions and attitudes towards chemical dependency, and then satisfactorily resolve this ethical dilemma. Education and social learning are routes to a better understanding of chemical dependency and to broadening the ethical dimensions of nurse managers.

  8. 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...

  9. Faculty ethics: ideal principles with practical applications.

    Science.gov (United States)

    Reybold, L Earle

    2009-01-01

    Ethics in higher education is the subject of intense public attention, with considerable focus on faculty roles and responsibilities. Media reports and scholarly research have documented egregious misconduct that includes plagiarism, falsification of data, illicit teacher-student relationships, and grading bias. These accounts of wrongdoing often portray faculty ethicality as only a legal issue of obeying rules and regulations, especially in the teaching and research roles. My discussion challenges this narrow perspective and argues that characterizations of faculty ethicality should take into account broader expectations for professionalism such as collegiality, respect, and freedom of inquiry. First, I review the general principles of faculty ethics developed by the American Association of University Professors, as well as professional codes of ethics in specific professional fields. Second, I juxtapose the experiences of women and minority faculty members in relation to these general codes of ethics. This section examines three issues that particularly affect women and minority faculty experiences of ethicality: "chilly and alienating" academic climates, "cultural taxation" of minority identity, and the snare of conventional reward systems. Third, I suggest practical strategies to reconcile faculty practice with codes of ethics. My challenge is to the faculty as a community of practice to engage professional ethics as social and political events, not just legal and moral failures.

  10. Can ethics survive the onslaught of science?

    Science.gov (United States)

    Lupton, Michael

    2013-09-01

    core of ethics which is sacrosanct or is every ethical frontier fair game for invasion? Are the Ethics Committees, which approve and monitor research in the field of bioethics in Universities. Hospitals and laboratories failing in their duty as gatekeepers? They are after all the first line of defence for the survival of crucial ethical values. Can we continue to indulge the whims and needs of every individual under the guise of human rights or patient autonomy? Can a civilised society endure as such with an ever diminishing mass of ethical values?

  11. 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.

  12. Code of Ethics for the American Association of Physicists in Medicine: report of Task Group 109.

    Science.gov (United States)

    Serago, Christopher F; Adnani, Nabil; Bank, Morris I; BenComo, Jose A; Duan, Jun; Fairobent, Lynne; Freedman, D Jay; Halvorsen, Per H; Hendee, William R; Herman, Michael G; Morse, Richard K; Mower, Herbert W; Pfeiffer, Douglas E; Root, William J; Sherouse, George W; Vossler, Matthew K; Wallace, Robert E; Walters, Barbara

    2009-01-01

    A comprehensive Code of Ethics for the members of the American Association of Physicists in Medicine (AAPM) is presented as the report of Task Group 109 which consolidates previous AAPM ethics policies into a unified document. The membership of the AAPM is increasingly diverse. Prior existing AAPM ethics polices were applicable specifically to medical physicists, and did not encompass other types of members such as health physicists, regulators, corporate affiliates, physicians, scientists, engineers, those in training, or other health care professionals. Prior AAPM ethics policies did not specifically address research, education, or business ethics. The Ethics Guidelines of this new Code of Ethics have four major sections: professional conduct, research ethics, education ethics, and business ethics. Some elements of each major section may be duplicated in other sections, so that readers interested in a particular aspect of the code do not need to read the entire document for all relevant information. The prior Complaint Procedure has also been incorporated into this Code of Ethics. This Code of Ethics (PP 24-A) replaces the following AAPM policies: Ethical Guidelines for Vacating a Position (PP 4-B); Ethical Guidelines for Reviewing the Work of Another Physicist (PP 5-C); Guidelines for Ethical Practice for Medical Physicists (PP 8-D); and Ethics Complaint Procedure (PP 21-A). The AAPM Board of Directors approved this Code or Ethics on July 31, 2008.

  13. Different concepts and models of information for family-relevant genetic findings: comparison and ethical analysis.

    Science.gov (United States)

    Lenk, Christian; Frommeld, Debora

    2015-08-01

    Genetic predispositions often concern not only individual persons, but also other family members. Advances in the development of genetic tests lead to a growing number of genetic diagnoses in medical practice and to an increasing importance of genetic counseling. In the present article, a number of ethical foundations and preconditions for this issue are discussed. Four different models for the handling of genetic information are presented and analyzed including a discussion of practical implications. The different models' ranges of content reach from a strictly autonomous position over self-governed arrangements in the practice of genetic counseling up to the involvement of official bodies and committees. The different models show a number of elements which seem to be very useful for the handling of genetic data in families from an ethical perspective. In contrast, the limitations of the standard medical attempt regarding confidentiality and personal autonomy in the context of genetic information in the family are described. Finally, recommendations for further ethical research and the development of genetic counseling in families are given.

  14. Some Basics about Ethics.

    Science.gov (United States)

    Dean, Peter J.

    1994-01-01

    Discussion of ethics focuses on the role of human performance technology professionals in helping corporate ethicists. Highlights include definitions of ethics, morals, values, and business ethics; ethics in academia and in business; and application of the knowledge of ethics to decision-making. (Contains 18 references.) (LRW)

  15. Ethics for life scientists

    NARCIS (Netherlands)

    Korthals, M.J.J.A.A.; Bogers, R.J.

    2004-01-01

    In this book we begin with two contributions on the ethical issues of working in organizations. A fruitful side effect of this start is that it gives a good insight into business ethics, a branch of applied ethics that until now is far ahead of ethics for life scientists. In the second part, ethics

  16. The Ethic of Community

    Science.gov (United States)

    Furman, Gail C.

    2004-01-01

    This article proposes the concept of an ethic of community to complement and extend other ethical frames used in education e.g. the ethics of justice, critique, and care. Proceeding from the traditional definition of ethics as the study of moral duty and obligation, ethic of community is defined as the moral responsibility to engage in communal…

  17. 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.

  18. Ethics of reproductive technology: AFS recommendations, dissent.

    Science.gov (United States)

    McCormick, R A

    1987-03-01

    The Ethics Committee of the American Fertility Society recently released its report, "Ethical Considerations of the New Reproductive Technologies." The report examines general ethical, legal, and biological aspects of and makes ethical recommendations on procreative technologies, from standard in vitro fertilization, through all its possible variations and accompaniments, including donor gametes and preembryos, surrogate mothers, and cryopreservation. The judgment of ethical acceptability of third-party involvement in reproductive technology is the report's weakest aspect. The potential impact of such participation was not sufficiently weighed because of primacy given to a single value: the provision of a baby to an individual couple, or even an individual, who could not otherwise have one. A dissent to the report is based on two analyses: Third-party involvement itself violates the marriage covenant, independent of any potential damaging effects or benefits, and relaxation of marital exclusivity could harm the marriage (and marriage in general) and the prospective child. The committee also failed to resolve the problem of preembryo status. Instead, it recommended that local programs offering reproductive assistance draw up their own policies.

  19. Understanding doctors' ethical challenges as role virtue conflicts.

    Science.gov (United States)

    McDougall, Rosalind

    2013-01-01

    This paper argues that doctors' ethical challenges can be usefully conceptualised as role virtue conflicts. The hospital environment requires doctors to be simultaneously good doctors, good team members, good learners and good employees. I articulate a possible set of role virtues for each of these four roles, as a basis for a virtue ethics approach to analysing doctors' ethical challenges. Using one junior doctor's story, I argue that understanding doctors' ethical challenges as role virtue conflicts enables recognition of important moral considerations that are overlooked by other approaches to ethical analysis. © 2011 Blackwell Publishing Ltd.

  20. 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