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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. The importance of the training of Ethics Committee members.

    Science.gov (United States)

    Ricci, Giovanna; Cannovo, Nunzia

    2009-12-01

    Research Ethics Committees (RECs) carry out the important task of humanizing clinical trials. While current Italian and international legislation dedicates considerable attention to REC composition, with consensus on several vital guidelines, no such univocal guidelines are available for REC training in Europe. In Italy, the activity of RECs is subject to moral, civil and criminal responsibility, but the issue of their preparation has been addressed only marginally. This article deals with the Italian situation, thus aims at exploring the question of REC training and trying to identify solutions. Committee members need both initial and continuing education and training in research ethics, methodology and governance.

  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. Training needs assessment in research ethics evaluation among research ethics committee members in three African countries: Cameroon, Mali and Tanzania.

    Science.gov (United States)

    Ateudjieu, Jérôme; Williams, John; Hirtle, Marie; Baume, Cédric; Ikingura, Joyce; Niaré, Alassane; Sprumont, Dominique

    2010-08-01

    As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally. To assess training needs for biomedical research ethics evaluation among targeted countries. Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French. A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC. Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.

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

    Science.gov (United States)

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

    2016-01-01

    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 taken to ensure that

  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. 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.

  10. Ethics committees in Catholic hospitals. A new study assesses their role, impact, and future in CHA-member hospitals.

    Science.gov (United States)

    Bernt, Francis; Clark, Peter; Starrs, Josita; Talone, Patricia

    2006-01-01

    The role, effectiveness, and even existence of hospital ethics committees (HECs) are not universally agreed upon. Over the past 20 years, the study of HECs has focused mainly on their structure, scope, and function, making the results more descriptive than anything. In an effort to present study results that could help HECs better serve the needs of their organizations, the authors of this article recently set out to survey HEC chairs at CHA-member hospitals, asking questions about four key areas: 1) primary functions of an HEC, 2) selection criteria of HEC members, 3) strategies for success, and 4) the importance of HEC member training. The results of this survey provide some important food for thought.

  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. 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).

    Science.gov (United States)

    Russ, Hagen; Busta, Susanne; Riedel, Axel; Zöllner, Gereon; Jost, Bertfried

    2009-07-16

    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 12(th) 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 section sign 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

  13. Ethics committees in Croatia

    NARCIS (Netherlands)

    Borovecki, Ana

    2007-01-01

    In this thesis the work of ethics committees in Croatia is being investigated for the first time. The 1997 Law on Health Protection introduced legal standards for the establishment of the so-called 'mixed' type of ethics committees in healthcare institutions. Our study aims to examine whether this

  14. Views of the process and content of ethical reviews of HIV vaccine trials among members of US institutional review boards and South African research ethics committees.

    Science.gov (United States)

    Klitzman, Robert

    2008-12-01

    Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for 'major changes' in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were 'self-taught' in ethics. This study, the first we know of to offer quantitative data comparing US vs. non-US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy-makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.

  15. 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.

  16. 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.

    Science.gov (United States)

    Bhowmick, Subhrojyoti; Banerjee, Koyel; Sikdar, Shreya; Chatterjee, Tapan Kumar

    2014-07-01

    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. 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. 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. The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the

  17. 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.

  18. [Ethics in committees].

    Science.gov (United States)

    Hottois, Gilbert

    2007-01-01

    The management of techno-scientific and multicultural societies, open and evolving, can neither be conceived nor carried out on the basis of fundamentalist, essentialist rules that are characteristic of closed, immobile societies. Within a global civilisation, fundamentalisms are only acceptable as individual or community beliefs. Against the background of our civilisation on the chaotic road to globalisation described here, what are the methodological rules for bioethics committees? A first rule concerns the composition of the committees: it must be multidisciplinary and pluralist. The second rule concerns the distinction of types, which is less evident at a time which cultivates postmodernism. The "types" which absolutely must be distinguished are: science, ethics, morals, law, politics. The third rule concerns the concluding procedures. A majority vote procedure after information and limited discussion makes it possible to conclude easily and rapidly. But it generally seems not to be very ethical, especially if it does not allow minorities to have their divergent opinions appear among the conclusions in an explicit argued manner. The "lazy dissensus" must, however also be avoided: it consists in not really engaging the interdisciplinary, pluralist discussion, simply exposing and explaining each position, on the pretext that pluralism is respecting diversity, the freedom to believe, to think and to express oneself either each for himself or in the name of one's community or tradition. This sort of "postmodern" methodology, individualistic and communitarian to an extreme, is precariously balanced in relation to the committee's ethical vocation. It is therefore very important that an ethics committee really engages in discussion and expresses, let's say, a preference for consensus. This preference is the expression of its "ethical" nature: in this word (as in the word "moral", in fact), there is a reference to what is common, to what unites and makes social life

  19. 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.

  20. Accreditation of ethics committees: experience of an ethics committee.

    Science.gov (United States)

    Kulkarni, Ragini; Saraiya, Usha

    2015-01-01

    Many ethics committees (ECs) approving clinical trials in India have got themselves registered with the Drugs Controller General of India as per regulatory requirements. However, there is still scope to improve their functioning. Accreditation, which entails adherence to national and international standards, helps an EC to protect the rights, safety and well-being of research participants. The National Institute for Research in Reproductive Health (NIRRH) ethics committee for clinical studies has received recognition, or accreditation, from the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). An EC receives recognition from SIDCER if it meets five standards related to its structure and composition; adherence to specific policies; completeness of the review process; after-review process; and documentation and archiving. The extent to which these standards have been met is assessed in various ways, such as review of the EC's records, interviews of selected EC members and observation of a full board meeting of the EC. This paper describes the experiences of the NIRRH EC during and after the process of receiving recognition.

  1. 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,…

  2. 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.

  3. [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.

  4. Collaborative ethics: a standing renal dialysis ethics committee.

    Science.gov (United States)

    Grochowski, E C; Blacksher, E

    2000-10-01

    We describe a unique, award-winning, multidisciplinary, standing committee focused on ethical issues associated with chronic dialysis. The committee was formed as a collaboration between the National Kidney Foundation of Kansas and Western MO affiliate and the Midwest Bioethics Center, Kansas City, MO in June 1995 to serve the local nephrology community. The committee is comprised of experienced nephrologists, dialysis nurses, and social workers, as well as clergy, medical ethicists, and patient representatives. Committee membership has remained relatively stable over the 4 years of its existence, creating a collaborative spirit among members, which is noteworthy because members are otherwise competing with each other for patients. The committee provides education in a variety of forms, from case consultations to organized seminars. We believe this committee is valuable to the care of patients on dialysis in our local community and that similar committees can be created in other affiliates. We can envision a national network of such committees that together could work on issues in ways that serve both the local and national level. Copyright 2000 by the National Kidney Foundation, Inc.

  5. 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.

  6. Enhancing capacity of research ethics review committees

    African Journals Online (AJOL)

    local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards. Methods. The Kenya AIDS ... activities in Kenya, the NCST is responsible for ethical approval of all studies involving human ..... concept of 'ethics committee shopping'. The way forward.

  7. [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.

  8. Jurisdiction of the Medical Ethics Committees.

    Science.gov (United States)

    Voljč, Božidar

    2017-10-01

    Ethical principles of assessing medical research are to the greatest extent defined by the Nuremberg Code, the Declarations of Geneva and Helsinki, and the Oviedo Convention. Pursuant to their directives various national Medical Ethics Committees (MECs) were established which assess the ethics of research according to the risk and benefit ratio of the persons involved. Following the example of other countries, medical ethics committees eventually appeared also in hospitals and some medical and educational institutions around Slovenia. Due to an increased number of ethical challenges, it is of great importance to define the jurisdiction of the Slovenian MECs in order to ensure their coordinated operation. Exclusive jurisdiction of the national MEC includes multicentre and multi-national research, drug research (phases 1-3), high-risk research and research related to doctoral theses. The jurisdiction of the sectoral MECs includes testing the conditions for research, monitoring the execution and overviewing the final reports. A more significant jurisdiction of the sectoral MEC is preserving an ethical environment in their institutions. A network of Slovenian MECs is to be organised in the form of a jurisdiction pyramid where each member has its own obligations and responsibilities and plays an important role in relation to the entire structure.

  9. Report of the Ethics Committee, 2015.

    Science.gov (United States)

    2016-01-01

    The Report of the Ethics Committee, 2015, provides information on activities of the Ethics Committee and Ethics Office during that year. In 2015, the Ethics Office and Committee continued their work of adjudication, ethics education, and ethics consultations. The Ethics Committee adopted minor changes to its "Rules and Procedures" to increase the efficiency of the adjudication process. These changes were approved by the APA Board of Directors to become effective on March 1, 2016. The Independent Review Report by David H. Hoffman was released in July. The ethics office director also departed in July, and an interim ethics director was appointed. The process for establishing a Commission on Ethics Processes was also begun. The Commission has the charge of evaluating and recommending changes to the American Psychological Association's current ethics program. Data for adjudication processing in 2015 as well as comparisons to the previous 4 years are provided. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  10. Evaluation of research ethics committees in Turkey

    OpenAIRE

    Arda, B.

    2000-01-01

    In Turkey, there was no legal regulation of research on human beings until 1993. In that year "the amendment relating to drug researches" was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control.There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees (RECs) play a central educational role by helping physicians to be ...

  11. 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.

  12. Report of the Ethics Committee, 2010

    Science.gov (United States)

    American Psychologist, 2011

    2011-01-01

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

  13. 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.

  14. Current role of research ethics committees in health research in ...

    African Journals Online (AJOL)

    2014-05-01

    May 1, 2014 ... to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee (NHREC), was ... responsibility to submit enough hard copies of their proposals for all members of the ... Most HREC members understood the concepts of autonomy and consent in ...

  15. 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.

  16. 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?

  17. Let's Not Forget about Clinical Ethics Committees!

    Science.gov (United States)

    Carnevale, Franco A

    2016-01-01

    The aim of this article is to highlight the under-recognized merits of clinical ethics committees (CECs), to help ensure that the development of roles for clinical ethics consultants do not unwittingly compromise the valuable contributions that CECs can continue to provide. I argue that CECs can offer distinctive contributions to the clinical ethics consultation process that can complement and enrich the input provided by a clinical ethics consultant. These distinctions and complementarities should be further examined and developed. This will help to optimize the synergistic contributions that CECs and clinical ethics consultants can make to promote the ethical treatment of patients and their families. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  18. 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.

  19. 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...

  20. 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 ...

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

    Science.gov (United States)

    Cusveller, Bart

    2012-05-01

    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 to three fourth-year (bachelor) nursing students conducted 8 to 11 semi-structured interviews each with nurses in ethics committees. The question was what competencies these nurses themselves say they need to participate in such committees. This article reports the aggregate of the 52 interviews in these five studies. Regarding knowledge, the article reports on health law, ethics and professional knowledge. Regarding skills, communication is mentioned, as are professional skills and skills for 'doing ethics'. An open and respectful attitude towards patients and fellow committee members is required, as well as commitment to patient care, committee work and professional ethics. The right attitude for a nurse in an ethics committee is said to include a reflective and perceptive attitude, along with an awareness of one's own limitations and convictions. A detailed competency profile for nurses' participation in ethics committees as outlined in the recommendations may serve nursing education, institutional committees and nurses themselves to meet the demands of nurses' preparation for clinical ethics consultations.

  2. 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

  3. [Why to audit to research ethics committees?].

    Science.gov (United States)

    Quiroz, Estela

    2010-09-01

    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.

  4. 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…

  5. 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.

  6. 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.

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

    African Journals Online (AJOL)

    EB

    Abstract. 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 ...

  8. Capacity mapping of national ethics committees in the Eastern Mediterranean Region.

    Science.gov (United States)

    Abou-Zeid, Alaa; Afzal, Mohammad; Silverman, Henry J

    2009-07-04

    Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

  9. Capacity mapping of national ethics committees in the Eastern Mediterranean Region

    Directory of Open Access Journals (Sweden)

    Afzal Mohammad

    2009-07-01

    Full Text Available Abstract Background Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs in the Eastern Mediterranean (EM region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. Methods We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. Results We obtained responses from 77% (17/22 of the EM countries; 88% (15/17 of the countries stated they had NECs. Of these NECs, 40% (6/15 were involved in the ethics of science and technology, 73% (11/15 in medical ethics, and 93% (14/15 in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15 met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15 of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15 received financial support and 60% (9/15 had administrative support. Conclusion While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

  10. Ethics Committees in India: Past, present and future

    Science.gov (United States)

    Thatte, Urmila M.; Marathe, Padmaja A.

    2017-01-01

    Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward. The Past: The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency. The Present: A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen. Way Forward: A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future. Conclusions: Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees. PMID:28194334

  11. [Difficulties and possibilities of ethics committees in a Latin-American perspective].

    Science.gov (United States)

    Franca-Tarragó, Omar

    2007-01-01

    Although ethics committees in Latin America have become an essential element in the development and appropriation of bioethics on the continent, the experience of the reality of the working of the diverse existing committees nevertheless shows a certain structural weakness due in particular to the lack of involvement of the health and research institutions, the doctors themselves and the lack of training and methodology in the committees' work. Consequently it is especially necessary to develop strategies to allow the committees and their members to fulfil the missions for which they have been set up.

  12. Research ethics committee auditing: the experience of a university hospital.

    Science.gov (United States)

    Marchetti, Daniela; Spagnolo, Angelico; Cicerone, Marina; Cascini, Fidelia; La Monaca, Giuseppe; Spagnolo, Antonio G

    2013-09-01

    The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.

  13. \\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.

  14. 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…

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

    OpenAIRE

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

    2018-01-01

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

  16. Enhancing capacity of research ethics review committees in ...

    African Journals Online (AJOL)

    Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards. Methods. The Kenya AIDS Vaccine Initiative ...

  17. [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.

  18. 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, ...

  19. The Special Educator and the Hospital Ethics Committee.

    Science.gov (United States)

    Lowenthal, Barbara; And Others

    With the advent of Public Law 99-457, special educators may be expected to observe and/or serve on Hospital Ethics Committees (HECs) in order to better assist families who have seriously ill and handicapped infants and children. Issues considered by such committees include alternative viewpoints on infant euthanasia and their right to life, the…

  20. The untimely death of the UK Donation Ethics Committee.

    Science.gov (United States)

    Shaw, David

    2017-01-01

    This brief report describes the contribution of the UK Donation Ethics Committee to organ donation and transplantation in the UK, and explains why the committee has met an early demise. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. 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

  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).

    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

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

    Science.gov (United States)

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

    2012-09-01

    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 observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively and categorised these codes in two repertoires of evaluation: a repertoire of rules and a repertoire of production. In the repertoire of rules the REC applies rules, weighs scientific value and burdens to the participants and makes a final judgment on a research proposal in a meeting. In the repertoire of production, REC members check documents and forms and advise researchers on how to improve their proposals and can use informal communication. Based on these findings, we think that evaluations of the practice of ethical review should take into account the fact that RECs can use a repertoire of rules and a repertoire of production to evaluate research proposals. Combining these two repertoires can be a viable option so that the REC gives researchers advice on how to improve their proposals to prevent rejection of valuable research. © 2012 The Authors. Sociology of Health & Illness © 2012 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

  4. What is the role of ethics committees after Regulation (EU) 536/2014?

    Science.gov (United States)

    Petrini, Carlo

    2016-03-01

    EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a 'single decision'. This raises the problem of identifying: (1) the facility designated to express this 'single decision' and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a 'single decision' by the Member State concerned. Three possible approaches to the procedures for expressing that 'single decision' and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option. 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/

  5. 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.

  6. 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…

  7. 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

  8. 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.

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

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

    ACRE) to guide Centre employees who encounter ethical issues in the research we ... Concern for the welfare of participants: researchers should act to benefit or promote the wellbeing of participants (beneficence) and should do no harm ...

  10. Assessing Institutional Ethics Committees in India Using the IRB-RAT.

    Science.gov (United States)

    Chenneville, Tiffany; Menezes, Lynette; Bylsma, Lauren M; Mann, Angela; Kosambiya, Jayendrakumar; Baxi, Rajendra

    2014-10-01

    Institutional ethics committees (IECs) are currently still in their infancy in low- to middle-income countries (LMICs), which may have important implications with regard to the oversight of the protection of human participants. Understanding how these IECs currently function is a critical first step in helping LMICs build infrastructures that support the protection of research participants and improve the scientific quality of health research worldwide. We assessed the functioning of the IECs at two medical colleges in Gujarat, India, by administering the Institutional Review Board Researcher's Assessment Tool (IRB-RAT) to 42 IEC and faculty members. The IRB-RAT includes eight scales assessing various domains related to how investigators and members perceive their ethics committees. Results from t tests revealed significant differences between ideal ratings and descriptive ratings on each of the IRB-RAT scales with ideal ratings being higher than current descriptive ratings on all of the scales (values of Indian IECs. © The Author(s) 2014.

  11. [Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].

    Science.gov (United States)

    Wessler, I; Burger, R; Doppelfeld, E

    2005-02-01

    Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).

  12. 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/

  13. An Evaluation of the Middle East Research Training Initiative Tool in Assessing Effective Functioning of Research Ethics Committees.

    Science.gov (United States)

    Jaoko, Walter; Bukusi, Elizabeth; Davis, Arlene M

    2016-10-01

    The effective functioning of a research ethics committee (REC) can be evaluated using self-assessment tools. The Middle East Research Ethics Training Initiative (MERETI) tool can be used by one member, typically the Chair, to score an REC. The consistency of these scores across several members of an REC has never been evaluated. This study examined whether results would be consistent irrespective of who conducts the assessment. One REC's effective functioning was assessed by several members ( n = 13). The Chair's scores were compared with scores of other members in relation to their duration of REC membership, research ethics training, gender, and employer's institutional affiliation to the REC. The Chair's overall score was higher than the other members' scores by 11%. No significant differences in scores were obtained in relation to duration of REC membership ( p = .72), interval since last research ethics training ( p = .94), and gender ( p = .27). The MERETI tool is thus consistent irrespective of who performs the assessment.

  14. 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)

  15. 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

  16. 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.

  17. Assessing physicians' roles on health care ethics committees.

    Science.gov (United States)

    McDaniel, Charlotte

    2010-12-01

    The purpose of this study was to examine the role of physicians on HEC including structural and process features. Four committees were selected from among 12 volunteering to participate with 12 sessions observed. Power analysis (0.8) confirmed an adequate number of communication exchanges, and no statistical significant difference (p role effectiveness lower than other occupations and lower than overall committee effectiveness. Communication exchanges representing process revealed three positive communication types, and consistent attempts to aid committee functions through consensual processes that also were substantiated by non-physician members. Findings suggested more attention to both structural and process functions of HEC and their members.

  18. Research Award: Advisory Committee on Research Ethics

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

    IDRC CRDI

    Canada. Candidates should possess: • Demonstrated interest in research ethics in international development or global health. • Knowledge of research for development. • Strong research and analytical skills. • Proficiency in English; French language skills an asset. • Strong verbal and written communication skills.

  19. 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

  20. How to make an ethics review process more effective and efficient? : A proposal of Ethics Review Worksheet for REC members

    OpenAIRE

    田代, 志門; 松井, 健志

    2016-01-01

    A research ethics committee (REC) has its paramount function in protecting human subjects in medical research. In this article, we propose and explain how to use the Ethics Review Worksheet that we have developed in order to make ethics review process more effective and efficient. Characteristically, the Worksheet is composed of a comprehensive checklist of important viewpoints based on research ethics theories, and also carefully designed to follow the actual process of ethics review. With t...

  1. 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.

  2. 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

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

    Science.gov (United States)

    Cole, Madeleine; Healey, Gwen

    2013-01-01

    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. 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. 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. 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 Iqaluit in September 2011, we are working to develop a

  4. 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.

  5. 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.

  6. Intra-Hospital Committee for Donation of Organs and Tissues for Transplant: ethical issues

    Directory of Open Access Journals (Sweden)

    Josiane Cappellaro

    2015-02-01

    Full Text Available The objective of this study was to demonstrate ethical aspects involved in the donation, collection and transplantation of organs and tissues through the experiences of workers in an intra-hospital committee for donation of organs and tissues for transplant. Exploratory qualitative research developed with eleven health workers. Data collection was performed at a university hospital in Pelotas, RS, Brazil, in the period of January-March 2010, through interviews. Data analysis resulted in the following categories: understanding of brain death diagnosis as an ethical issue; and, ethical issues experienced by workers in the relationship established with the family. It was concluded that such situations instigate workers to reflect on their attitudes, values, and their role as a health team member and protector of lives.

  7. 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...

  8. 7 CFR 917.25 - Selection of members of various commodity committees.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Selection of members of various commodity committees....25 Selection of members of various commodity committees. (a) The Secretary shall select the members of each commodity committee from nominations made by growers, as provided in §§ 917.21 through 917.24...

  9. 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.

  10. 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.

  11. [Ethical justification for human stem cell research. The view of the German Central Ethics Committee for Stem Cell Research].

    Science.gov (United States)

    Siep, L

    2008-09-01

    According to the German Stem Cell Act the Central Ethics Committee for Stem Cell Research (ZES) advices the competent authority (Robert Koch Institute) as to whether an application to import human embryonic stem-cells for research is "ethically justifiable" ("ethisch vertretbar"). The law does indeed specify some conditions of this justification, but without precisely defining them. This article clarifies the committee's understanding of ethically justifiable research. It deals with misunderstandings of the law and problems involved in its application.

  12. Identifying structures, processes, resources and needs of research ethics committees in Egypt

    Directory of Open Access Journals (Sweden)

    Sleem Hany

    2010-06-01

    Full Text Available Abstract Background Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results We obtained responses from 67% (12/18 of the identified RECs. Most RECs (10/12 have standard operating procedures and many (7/12 have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members with little lay representation (13.7%. Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc; none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members

  13. 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.

  14. The new system of review by multicentre research ethics committees: prospective study.

    Science.gov (United States)

    Tully, J; Ninis, N; Booy, R; Viner, R

    2000-04-29

    To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. A single multicentre research ethics committee and 125 local ethics committees from six regions of England. Time to reply, time to approval, and number of non-local changes to the application requested. Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

  15. Impact of recent regulatory notifications on an institutional ethics committee.

    Science.gov (United States)

    Bhide, Shruti S; Jalgaonkar, Sharmila V; Katkar, Janhavi V; Shetty, Yashashri C; Tripathi, Raakhi K; Marathe, Padmaja A; Thatte, Urmila M

    2016-01-01

    The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.

  16. 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?

  17. A new role for psychologists--hospital ethics committees.

    Science.gov (United States)

    Mozdzierz, G J; Snodgrass, R W; DeLeon, P H

    1992-12-01

    Over the past decade psychology has begun to appreciate that it represents more than "merely mental health care" and has become increasingly involved in the generic health care arena. The participation of psychologists in Hospital Ethics Committees (HECs) is presented as a professional activity for which psychologists are particularly well suited. The clinical mission of HECs, the historical importance of ethical considerations to psychology, and the field's specific training and psycho-social expertise suggest valuable contributions that psychologists can make in this particular area. Further, as psychology actively increases its participation in HECs, other professional disciplines outside of the mental health field will systematically have the opportunity to become more familiar with psychology and its clinical and research expertise.

  18. 7 CFR 917.22 - Nomination of Peach Commodity Committee members.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Nomination of Peach Commodity Committee members. 917.22 Section 917.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL... Nomination of Peach Commodity Committee members. Nominations for membership on the Peach Commodity Committee...

  19. 7 CFR 917.21 - Nomination of Pear Commodity Committee members.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Nomination of Pear Commodity Committee members. 917.21 Section 917.21 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING... Pear Commodity Committee members. Nominations for membership on the Pear Commodity Committee shall be...

  20. The role of ethics committees and ethics consultation in allocation decisions: a 4-stage process.

    Science.gov (United States)

    Strech, Daniel; Hurst, Samia; Danis, Marion

    2010-09-01

    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. 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. 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. 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 intraindividual 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.

  1. 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

  2. The role of the child and adolescent psychiatrist on health care institutional ethics committees.

    Science.gov (United States)

    Sexson, Sandra B; Sexson, William R

    2008-01-01

    Over the past 30 years, institutional ethics committees have become the standard vehicle for addressing ethical issues in health care institutions. Early in this development, general psychiatrists became integrally involved; however, child and adolescent psychiatry roles on institutional ethics committees have been delineated less clearly. This article provides an overview of the functioning of institutional ethics committees, including composition and a definition of the roles across education, policy development, and case consultation. Within the context of the various roles of the institutional ethics committee, the potential contributions of a child and adolescent psychiatrist are defined and specific areas of expertise are delineated. Case examples are cited to demonstrate the unique contributions in the areas of developmental understanding, enhanced understanding of communication styles and failures, as well as an understanding of specific psychiatric factors and cultural issues that a child and adolescent psychiatrist may bring to the institutional ethics committee.

  3. Health care chaplains and their role on institutional ethics committees: an Australia study.

    Science.gov (United States)

    Carey, Lindsay B; Cohen, Jeffrey

    2010-06-01

    This paper presents the results of the largest Australian pastoral study concerning the perceptions of health care chaplains about their involvement on hospital research ethics committees (also known in some contexts as institutional ethics committees). Survey results from over 300 Australian health care chaplains indicated that nearly 90% of chaplains believed there was merit in chaplains serving on hospital research ethics committees, yet only a minority (22.7%) had ever participated on such committees. Data from in-depth interviews is also presented exploring the reasons for the lack of participation and the varying opinions regarding the role, appropriateness, and value of chaplains on ethics committees. Some implications of this study with respect to chaplaincy, hospital research ethics committees, health care institutions, ecclesiastical institutions, and government responsibilities are discussed.

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

    Science.gov (United States)

    Moodley, Keymanthri; Myer, Landon

    2007-01-25

    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. 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. 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. 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.

  5. 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.

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

    OpenAIRE

    Bouësseau Marie-Charlotte; Coleman Carl H

    2008-01-01

    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 ...

  7. Evaluation of Research Ethics Committees: Criteria for the Ethical Quality of the Review Process.

    Science.gov (United States)

    Scherzinger, Gregor; Bobbert, Monika

    2017-01-01

    Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.

  8. Ethics and new reproductive technologies: an international review of committee statements.

    Science.gov (United States)

    Walters, LeRoy

    1987-06-01

    Walters examines the statements of advisory committees in eight countries on new practices involving human reproduction: clinical in vitro fertilization; surrogate motherhood; and human embryo research. He analyzes the positions taken by the committees on the general acceptability of the new technologies, as well as on specific issues involved in assisted human reproduction. In chronological order, the statements examined are those of the U.S. Ethics Advisory Board; the Waller committee in Victoria, Australia; a South Australian committee; the Demack committee in Queensland; Britain's Council for Science and Society; Britain's Warnock committee; a Tasmania, Australia, committee; the Ontario Law Reform Commission; Australia's Family Law Council; West Germany's Benda committee; the American Fertility Society; a Western Australia committee; the Dutch Health Council; and the National Ethics Committee of France.

  9. Research ethics committees and community values: Devlin, Dworkin, Hart and beyond.

    Science.gov (United States)

    Salako, Solomon E

    2010-03-01

    Two fundamental requirements ought to be met in any selection to research ethics committees: (i) professional scientific competence, and (ii) the understanding of moral values which prevail in any community. The question is: Should the verdicts of research ethics committees be based on community values? This article critically examines theories of community as were propounded by Devlin, Dworkin and Hart in answer to this question. It is argued that community values are complementary rather than conflicting, and that Dworkin's theory of community provides an analytical framework for research ethics on the new genetic technologies. Finally, it is submitted that the verdicts of research ethics committees should be based on community values.

  10. THE ROLE OF GOOD PRACTICES IN THE MANAGEMENT OF ETHICAL PROGRAMS IN HOSPITAL ESTABLISHMENTS. A FURTHER STEP FROM ETHICS COMMITTEES

    Directory of Open Access Journals (Sweden)

    AGHEORGHIESEI (CORODEANU DANIELA-TATIANA

    2012-09-01

    Full Text Available This article is a review of both the functions and roles played by ethics committees in hospital establishments,and respectively of the challenges they are confronted with, in the general context of activities concerned withorganizational ethics. Furthermore, we analyse international good practices, such as they intervene in the organizationof ethical programs, and also the place the committees take up within these programs. Our qualitative research isbased on the analysis of the websites of 144 hospitals from Romania, classified within the first three competence levels,and aims at highlighting the fact that ethics committees do not have sufficient visibility, which is certainly notbeneficial to patients. In this context, our research demonstrates that there is plenty space for improvement in quality ofcare based on ethics program and its tools and the experience of other countries could serve as a viable guide.

  11. Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?

    Science.gov (United States)

    Shabani, Mahsa; Dove, Edward S; Murtagh, Madeleine; Knoppers, Bartha Maria; Borry, Pascal

    2017-10-01

    Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is warranted. In this article, we review these oversight practices and argue that they reveal a compelling need to clarify the scope of ethical considerations by oversight bodies and to delineate core elements such as "objectionable" data uses. Ethical oversight of genomic data sharing would be considerably improved if the relevant ethical considerations by research ethics and DACs were coordinated. We therefore suggest several mechanisms to achieve greater clarification of ethical considerations by these committees, as well as greater communication and coordination between both to ensure robust and sustained ethical oversight of genomic data sharing.

  12. Requirements for ethics committee review for studies submitted to Implementation Science.

    Science.gov (United States)

    Eccles, Martin P; Weijer, Charles; Mittman, Brian

    2011-03-31

    The requirement for ethics review of studies submitted to Implementation Science has been unclear. Therefore, in this editorial, we set out our requirements for ethics committee review of experimental and non-experimental studies. For any study that meets the criteria of human subject research (which includes research on healthcare providers), irrespective of study design, we will require proof of either satisfactory ethics committee review or of the granting of an official exemption or waiver.

  13. Are Research Ethics Committees Prepared for Community-Based Participatory Research?

    Science.gov (United States)

    Tamariz, Leonardo; Medina, Heidy; Taylor, Janielle; Carrasquillo, Olveen; Kobetz, Erin; Palacio, Ana

    2015-12-01

    Community-based participatory research (CBPR) is challenging to research ethics committees (RECs). We reviewed the REC preparedness when reviewing CBPR projects. We searched the MEDLINE database and included qualitative studies of CBPR researchers or REC members about their experiences with RECs. The search yielded 107 studies, of which 10 met our criteria. Barriers were that the community is not prepared to conduct research, the reluctance of RECs to work outside the university, the difficulty RECs have understanding CBPR, and that REC forms evaluate individual rather than community risk. Facilitators were having a CBPR expert as an REC member and educating RECs. Therefore, RECs are not prepared to evaluate CBPR projects leading to unnecessary delays in the approval process. © The Author(s) 2015.

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

    Science.gov (United States)

    Mitchell, Theresa; Fletcher, Ian

    1998-01-01

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

  15. 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.

  16. 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.

  17. Roles and responsibilities of clinical ethics committees in priority setting.

    Science.gov (United States)

    Magelssen, Morten; Miljeteig, Ingrid; Pedersen, Reidar; Førde, Reidun

    2017-12-01

    Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees (CECs) be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs (2003-2015) were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs' work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests.

  18. 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.

  19. 78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Science.gov (United States)

    2013-10-29

    ... for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and.../default.htm . SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Tobacco... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration...

  20. 7 CFR 917.20 - Designation of members of commodity committees.

    Science.gov (United States)

    2010-01-01

    ... members of each said committees shall be selected biennially for a term ending on the last day of February of odd numbered years, and such members shall serve until their respective successors are selected... Date Note: At 59 FR 10055, Mar. 3, 1994, in § 917.20, the words “a Pear Commodity Committee and” were...

  1. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Science.gov (United States)

    2011-07-29

    ...] Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory... Administration (FDA) is requesting nominations for 12 members to serve on the Medical Imaging Drugs Advisory... final rule adding the Medical Imaging Drugs Advisory Committee to the list of FDA standing advisory...

  2. 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.

  3. Protected Lists of Members : Experiment Committees, Research Board and LHC-RRBs

    CERN Document Server

    Mage-Granados, Patricia

    2016-01-01

    Defines the use of the Sharepoint Site : http://cern.ch/scientific-committees/, where all members of any CERN Scientific Committee are listed. Different views shhow 'active' or 'all' (history). The end date of a mandate automatically removes an entry from the 'active' view but keeps it under 'all'. Some entries are double, e.g. if a member becomes ex-officio or changes from one committee to another.

  4. 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.

  5. Establishment and work of ethics committees in central and eastern European countries.

    Science.gov (United States)

    Glasa, Jozef

    2002-01-01

    The genuine reform efforts in medicine and health care in Central and East European (CEE) countries have continued to pose important and thought-provoking challenges to the newly reborn disciplines of medical ethics (or bioethics). They are embodied in the bulk of new ethical problems, concepts and quandaries brought about by the developments, changes, clashes, and "real life" issues of the CEE countries' health care systems and biomedical sciences. Certain part, quite variable from country to country, of this bio-ethical endeavour has been confined to the work and activities of ethics committees (ECs) or similar bodies. They have emerged in varying number, shape, composition, competence, legal status, responsibility and time of appearance, in almost all transition countries of CEE. They may be considered as a kind of "field workplaces" of medical ethics/bioethics within the countries' HCSs or biomedical research structures. Despite some shortcomings and drawbacks, a lot has already been achieved. In some countries the progress has been quick and systematic. The major pitfalls were mostly due to the missing, weak or unclear legal backing of ECs' establishment and work; lack of education and training of their members; insufficient support from health care administrators; misconceptions concerning their mission, procedures, scope of responsibility, and reporting; insufficient or missing funding; low profile societal esteem for ECs' work; but some drawbacks were due also to the underdeveloped 'dialogic' culture of the impartial discussion and democratic discourse in the 'post-totalitarian' CEE transition countries. The future of ECs in CEE will be connected to the countries' integration and harmonization efforts towards research, health systems, and other international structures in Europe and beyond. This should need an extensive and non-discriminatory international partnership, exchange and co-operation.

  6. 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

  7. [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.

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    Sanish Davis

    2017-01-01

    Conclusion: Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

  10. The role of a pediatric ethics committee in the newborn intensive care unit.

    Science.gov (United States)

    Mercurio, M R

    2011-01-01

    Institutional Ethics Committees are commonly available in hospitals with newborn intensive care units, and may serve as a valuable resource for staff and parents dealing with difficult ethical decisions. Many clinicians may be unaware of when the committee might be helpful, or how it functions. After a brief historical introduction, two cases are presented as illustrations of pediatric ethics committee function. The first involves consideration of cardiac surgery for an infant with ventricular septal defect and Trisomy 13. The second involves disagreement between staff and parents regarding possible provision of cardio-pulmonary resuscitation in a terminally ill newborn. Principles and considerations often brought to bear in committee deliberations are reviewed for each case. Neonatologists, staff and families should be aware of this potentially valuable resource, and are encouraged to use it for situations of moral distress, conflict resolution or ethical uncertainty.

  11. 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.

  12. A perinatal ethics committee on abortion: process and outcome in thirty-one cases.

    Science.gov (United States)

    La Puma, J; Darling, C M; Stocking, C B; Schiller, K

    1992-01-01

    The US Supreme Court's June 1992 decision to uphold most of Pennsylvania's law restricting access to abortion confirms that while abortion is still permitted in the US, it is being increasingly regulated. Individual institutions may, however, find ways to permit access to abortion. One hospital formed a mandatory, prospective perinatal ethics committee (PEC) in May 1987 to develop clinical guidelines with which to consider and decide requests by physicians for their patients seeking abortions. The authors obtained the consent of this PEC to study its membership, processes, case outcomes, and clinical decision making. Understanding PEC processes and outcomes may help other institutions to decide whether to institute similar mechanisms. Specifically, the investigators determined the backgrounds and abortion-related beliefs of PEC members and obstetric and gynecology department members, whether the PEC affects the number of abortions performed, how PEC members decide in individual cases, and whether requesting physicians find the PEC helpful. All eleven PEC members and 58 of the 65 medical staff ob/gyn physicians returned background surveys. Study results are presented. Overall, the PEC appeared to function as an affirming regulatory body for second-trimester, medically-indicated terminations and for certain personal choice terminations. Institutional interests were well-served by the PEC and with the assurance of informed consent, the interests of some patients were also well served.

  13. In the lion's den? Experiences of interaction with research ethics committees

    OpenAIRE

    Fistein, Elizabeth; Quilligan, Sally

    2011-01-01

    Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethical review process that would alert researchers to the committee's concerns and allow them to give a m...

  14. The Effect of the SOLINET Data Base Quality Control Committee on Member Libraries' Input.

    Science.gov (United States)

    Caster, Lillie

    This committee advises and makes recommendations on matters relating to quality control. During the first year of operation, the committee concentrated on the quality of retrospective records input by member libraries, the need for OCLC to give high priority to deferred records, and the definition of a unique record. The establishment of an OCLC…

  15. 10 CFR 7.20 - Conflict of interest reviews of advisory committee members' outside interests.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Conflict of interest reviews of advisory committee members' outside interests. 7.20 Section 7.20 Energy NUCLEAR REGULATORY COMMISSION ADVISORY COMMITTEES § 7.20... that such appointment is consistent with the laws and regulations on conflict of interest applicable to...

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

    Science.gov (United States)

    Coleman, Carl H; Bouësseau, Marie-Charlotte

    2008-03-28

    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. 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. 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 studies? Second, does the process affect prospective

  17. 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

  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. 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.

  20. Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review.

    Science.gov (United States)

    Adams, Pornpimon; Prakobtham, Sukanya; Limpattaracharoen, Chanthima; Suebtrakul, Sumeth; Vutikes, Pitchapa; Khusmith, Srisin; Wilairatana, Polrat; Adams, Paul; Kaewkungwal, Jaranit

    2017-08-14

    The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase

  1. 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...

  2. 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.

  3. 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.

  4. 21 CFR 14.84 - Nominations and selection of nonvoting members of standing technical advisory committees.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Nominations and selection of nonvoting members of... Advisory Committees § 14.84 Nominations and selection of nonvoting members of standing technical advisory... Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 1503...

  5. 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.

  6. [What a surgeon needs to know of the work of a medical ethics committee/institutional review board].

    Science.gov (United States)

    Beck, N

    2015-02-01

    Ethical committees or institutional review boards are interdisciplinary committees to assess the ethical, social, legal and medical aspects of research involving human subjects. The ethics commission is to protect both the patient as well as the investigators and other personnel involved in the implementation of scientific projects. According to the professional code (Berufsordnung) every physician is obliged to consult an ethics committee to get a an approval before carrying out a research project. Concerning the Declaration of Helsinki, the advice of physicians is an international standard before carrying out a research project. In addition to the advisory function the ethics committee has an authorisation function within the pharmaceutical and medical device law. In the present publication the advisory and authorisation functions of an German ethics committee are briefly explained. Georg Thieme Verlag KG Stuttgart · New York.

  7. 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

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

    African Journals Online (AJOL)

    Most of the respondents do agree that the REC functions include Protocol review 86%, protection of research participants 84.3%, and monitoring of ongoing research. During ethical review, the RECpays special attention to scientific design [79.7%] and ethical issues [75.3%], but less to the budget and literature review.

  9. 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…

  10. 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...

  11. 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...

  12. 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...

  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. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 76 FR 23644 - Solicitation of Nominations for Members of the Transit Rail Advisory Committee for Safety (TRACS)

    Science.gov (United States)

    2011-04-27

    ... 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...

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

    Science.gov (United States)

    Halila, Ritva

    2014-12-01

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

  20. 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

  1. 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

  2. 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

  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

    2013-04-01

    To assess current education, practices, attitudes, and perceptions pertaining to ethics and professionalism in medical physics. 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." 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, incidents of unethical or ethically

  4. 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 research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Researchers and the REC did not adequately address the inter-related 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.

  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. 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…

  7. 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.

  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. [About the genesis of the first Polish local research ethics committee].

    Science.gov (United States)

    Paprocka-Lipinska, Anna

    2014-12-01

    From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.

  10. 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...

  11. Are the votes of ethics committees in Germany for the protection of clinical study trial subjects "sovereign acts?".

    Science.gov (United States)

    Graf, Hans-Peter

    2013-06-01

    A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called "revaluation" of the Medical Device Law Deutsches Medizinproduktegesetz-MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then "sovereign acts" or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee's vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult.

  12. Biomedical Research Ethics Committees in sub-Saharan Africa: a collective review of their structure, functioning, and outcomes.

    Science.gov (United States)

    Silaigwana, Blessing; Wassenaar, Douglas

    2015-04-01

    Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs. © The Author(s) 2015.

  13. Global summit of national ethics committees: an essential tool for international dialogue and consensus-building.

    Science.gov (United States)

    Bouësseau, Marie-Charlotte; Reis, Andreas; Ho, W Calvin

    2011-01-01

    July 2010, important decisions were taken to ensure the continuity Held for the first time in 1996, the Global Summit of National of activities between the Summits. This article intends to briefly Ethics Committees (NECs) is a key platform for dialogue and retrace the history and analyse the role and functioning of the fostering consensus on ethical issues at a global level. At the Global Summit. It also discusses future challenges for international Eighth Global Summit meeting, which took place in Singapore in collaboration of NECs.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

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

    Science.gov (United States)

    Jalgaonkar, Sharmila V; Bhide, Shruti S; Tripathi, Raakhi K; Shetty, Yashashri C; Marathe, Padmaja A; Katkar, Janhavi; Thatte, Urmila M

    2016-01-01

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

  20. Research Ethics 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.

  1. Committee Opinion No. 695: Sterilization of Women: Ethical Issues and Considerations.

    Science.gov (United States)

    2017-04-01

    Sterilization is the most common method of contraception among married couples, with nearly twice as many couples choosing female partner sterilization over male sterilization. Although sterilization is among the most straightforward surgical procedures an obstetrician-gynecologist performs, it is enormously complex when considered from a historical, sociological, or ethical perspective. Sterilization practices have embodied a problematic tension, in which some women who desired fertility were sterilized without their knowledge or consent, and other women who wanted sterilization to limit their family size lacked access to it. An ethical approach to the provision of sterilization must, therefore, promote access for women who wish to use sterilization as a method of contraception, but at the same time safeguard against coercive or otherwise unjust uses. This Committee Opinion reviews ethical issues related to the sterilization of women and outlines an approach to providing permanent sterilization within a reproductive justice framework that recognizes that all women have a right to pursue and to prevent pregnancy.

  2. Committee Opinion No 695 Summary: Sterilization of Women: Ethical Issues and Considerations.

    Science.gov (United States)

    2017-04-01

    Sterilization is the most common method of contraception among married couples, with nearly twice as many couples choosing female partner sterilization over male sterilization. Although sterilization is among the most straightforward surgical procedures an obstetrician-gynecologist performs, it is enormously complex when considered from a historical, sociological, or ethical perspective. Sterilization practices have embodied a problematic tension, in which some women who desired fertility were sterilized without their knowledge or consent, and other women who wanted sterilization to limit their family size lacked access to it. An ethical approach to the provision of sterilization must, therefore, promote access for women who wish to use sterilization as a method of contraception, but at the same time safeguard against coercive or otherwise unjust uses. This Committee Opinion reviews ethical issues related to the sterilization of women and outlines an approach to providing permanent sterilization within a reproductive justice framework that recognizes that all women have a right to pursue and to prevent pregnancy.

  3. 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

  4. 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...

  5. "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…

  6. 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.

  7. Playing, sitting out, and observing the game: an investigation of faculty members' perspectives on political behavior in ethical decision making.

    Science.gov (United States)

    Medeiros, Kelsey E; Gibson, Carter; Mecca, Jensen T; Giorgini, Vincent; Connelly, Shane; Mumford, Michael D

    2015-01-01

    Ethical dilemmas are inherently ambiguous, complex, and ill-defined. Additionally, these dilemmas involve multiple stakeholders. These characteristics may induce political behavior as a resolution tactic. Thus, the goal of the present effort was to investigate perspectives on politics among researchers in an ethical decision-making context. A qualitative analysis of interviews with university faculty members revealed that faculty members' perspectives on political behavior in an ethical decision-making context fall into a number of categories, including positive, negative, and realistic views of political activity. The implications of these varying perspectives on ethical decision making are discussed.

  8. 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

  9. 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.

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

    Science.gov (United States)

    Jeong, Ihn Sook

    2015-06-01

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

  11. 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.

  12. 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/.

  13. 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...... and 2010. Two queries drive this article: First, how are spaces made for ethical review –politically, infrastructurally, materially – as committee members campaign for attention to ethics and access to resources in which to conduct their meetings? Second, how are the limits of ‘local circumstance......’ negotiated during a review of the committee’s work: what does the implementation of standards in the area of ethics look like? I then discuss what standards of ethics practice mean for more fraught questions of the universal in bioethics. Rather than regarding ethics systems as backgrounds to global health...

  14. 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.

  15. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

    NARCIS (Netherlands)

    Lent, M.J. van; Rongen, G.A.; Out, H.J.

    2014-01-01

    BACKGROUND: Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC

  16. 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.

  17. 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.

  18. The reporting of research ethics committee approval and informed consent in otolaryngology journals.

    Science.gov (United States)

    Murphy, S; Nolan, C; O'Rourke, C; Fenton, J E

    2015-02-01

    Medical research involving human subjects must follow ethical standards as outlined in the Declaration of Helsinki of the World Medical Association. The aim of this study was to assess the frequency of reporting of informed consent and regional ethical committee (REC) approval in all reports of trials published in the major European Otolaryngology journals. Review of all clinical research articles published online in the calendar year 2012. Three leading European Otolaryngology journals. Clinical Otolaryngology, The Journal of Laryngology and Otology and The European Achieves of Oto-Rhino-Laryngology. Evaluate the incidence of reporting of REC approval and informed consent. Of the 767 articles reviewed, 401 met the inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research which require ethical approval). 49.9% lacked a statement of REC approval and 42.9% lacked disclosure of informed consent. Articles that did not state REC approval were associated with not stating informed consent (P < 0.05). Articles that lack explicit statements of REC approval and informed consent are frequent and continue to be published in major otolaryngology journals. © 2014 John Wiley & Sons Ltd.

  19. 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.

  20. 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

  1. 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.

  2. Ethics committees in Italy: a survey on a sample of oncologists.

    Science.gov (United States)

    Mosconi, Paola; Apolone, Giovanni; Cattaneo, Giovanna; Pomodoro, Livia; Garattini, Silvio

    2003-01-01

    The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This

  3. Health research ethics review and needs of institutional ethics ...

    African Journals Online (AJOL)

    for their time, but this was reported to be as a token and was not proportion to the workload. Monitoring of research undertaking was identified as a problem in all the research ethics committees. Sixty-nine percent of the committee members reported lack of mechanisms for monitoring of approved research while 33% did not ...

  4. [Update of the work of the ethics research in evaluating genetic research and its role as an external ethics committee biobank].

    Science.gov (United States)

    Alfonso Farnós, Iciar; Hernández Gil, Arantza; Rodríguez Velasco, María

    2013-01-01

    Research on human genome and its applications open great perspectives to improve human beings' health. However, these advances must never endanger the respect of dignity, freedom and rights of the participants in medical research, assuring prohibition of any way of discrimination because of genetic features. The Independent Research Boards (IRB), responsible for safeguarding rights, safety and well-being of the subjects taking part in the biomedical research, assess independently submitted genetic studies, clinical trials whose primary objective is obtaining genetic information and genetic sub-studies of clinical trials with drugs. Biobanks, as safeguarding means to preserve biological samples in suitable quality conditions, must be assigned to two external committees, a scientific one and an ethics one. External ethics committees of biobanks have to make the ethical assessment of the submissions of samples transfers and associated data, in order to carry out research projects. On the other hand, they have to advise biobanks on the compliance of ethical and legal principles, which, in many committees, has turned into the performance of informed consent forms which are in accordance with current laws.

  5. Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries

    Science.gov (United States)

    Moerman, C J; Haafkens, J A; Söderström, M; Rásky, É; Maguire, P; Maschewsky‐Schneider, U; Norstedt, M; Hahn, D; Reinerth, H; McKevitt, N

    2007-01-01

    Background Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. Objective To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation? Methods Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003). Results All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender‐specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. Conclusions The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. PMID:17264199

  6. 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

  7. [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.

  8. 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...

  9. 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...

  10. 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

  11. Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs.

    Science.gov (United States)

    Ballantyne, Angela J; Rogers, Wendy A

    2008-06-02

    To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research. Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007. Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research. In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair. Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.

  12. 76 FR 72954 - Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the...

    Science.gov (United States)

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug...

  13. [Revista Médica de Chile: A new member in the "International Committee of Medical Journal Editors"].

    Science.gov (United States)

    Reyes, Humberto

    2010-06-01

    After a worldwide call for applications that took place in 2009, two medical journals were selected to become new members of the "International Committee of Medical Journal Editors (ICMJE)": Chinese Medical Journal and Revista Médica de Chile. Both Editors: Getu Zhaori, MD, and Humberto Reyes, MD, respectively, attended the ICMJE Meeting, 12-14 April 2010, in Queenstown, New Zealand. The meeting agenda included several topics that had been studied in advance by the attendants: editors or deputy editors of the 14 journals integrating this Committee plus a representative for the U.S. National Library of Medicine and another one for the World Association of Medical Journal Editors (WAME). The Committee agreed in new recommendations tending to safeguard the integrity and transparency of every manuscript published in all journals that adhere to the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM)". These recommendations will be published shortly in ICMJE member journals. An important issue discussed refers to improvements in the "ICMJE Uniform Disclosure Form for Potential Conflicts of Interest"' that had some changes, a glossary of terms will be attached to it and the Instructions will be accompanied by translations into the official WHO languages as well as other languages used by ICMJE member journals. For our journal it is an honor and a great responsibility to become a member of this highly qualified Committee, the only journal published in Spanish and the first one from Latin America.

  14. 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

  15. The Ethics of Breast Surgery.

    Science.gov (United States)

    Throckmorton, Alyssa; VanderWalde, Lindi; Brackett, Craig; Dominici, Laura; Eisenhauer, Thomas; Johnson, Nathalie; Kong, Amanda; Ludwig, Kandice; O'Neill, Jennifer; Pugliese, Matthew; Teller, Paige; Sarantou, Terry

    2015-10-01

    Breast surgery has evolved as a subspecialty of general surgery and requires a working knowledge of benign and malignant diseases, surgical techniques, shared decision-making with patients, collaboration with a multi-disciplinary team, and a basic foundation in surgical ethics. Ethics is defined as the practice of analyzing, evaluating, and promoting best conduct based upon available standards. As new information is obtained or as cultural values change, best conduct may be re-defined. In 2014, the Ethics Committee of the ASBrS acknowledged numerous ethical issues, specific to the practice of breast surgery. This independent review of ethical concerns was created by the Ethics Committee to provide a resource for ASBrS members as well as other surgeons who perform breast surgery. In this review, the professional, clinical, research and technology considerations that breast surgeons face are reviewed with guidelines for ethical physician behavior.

  16. [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

  17. An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India.

    Science.gov (United States)

    Bhide, Shruti S; Katkar, Jahnavi V; Maurya, Mitesh; Gogtay, Nithya Jaideep; Thatte, Urmila M

    2016-01-01

    The present study is an audit of the communiqués issued by the Drugs Controller General of India [DCGI] to Ethics Committees [ECs] for content and directives after the mandatory notification of registration of Ethics Committees issued on 8 th February 2013. All letters were downloaded from the website of the Central Drugs Standard Control Organization [CDSCO] and evaluated for the date of issue, number of directives, domains covered by the directives [general instructions, administrative requirements and quorum requirements], median time to approval for registration and time elapsed between date of application and issue of the approval letter. There were a total of 1036 EC letters listed on the website, from which 854 [82.4%] could be downloaded. A working denominator of 841 was arrived at after discarding repeat letters and those that had an incorrect address. The state of Maharashtra had the highest number of ECs registered (209/841, 24.9%) followed by Gujarat [97/841, 11.5%) and Karnataka [96/841, 11.4%]. The number of directives within each letter ranged from 8-22. The overall time to approval was 77.5 [24-919] days and the time to approval between Institutional and Independent Ethics Committees was significantly different. The office of the DCGI had a very wide time range for approving registration of Ethics Committees that ranged from less than a month to more than two years. The quality and nature of the directives improved with time. As the country moves towards accreditation, letters issued by the DCGI should have uniformity. The large number of ECs in a single state and lack of even a single one in several others is something that needs to be addressed by policy makers.

  18. 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…

  19. 78 FR 29757 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2013-05-21

    ... consideration for membership on the Food Advisory Committee. Nominations received after July 22, 2013 will be... importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating... information concerning such matters related to financial holdings, employment, and research grants and/or...

  20. 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.

  1. 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.

  2. What doesn’t work with Phase IV studies? A real experience from an Ethics Committee

    Directory of Open Access Journals (Sweden)

    F. Grigoletto

    2013-05-01

    Full Text Available Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and safety of an approved drug. Carried out either in hospital or general practice setting, they can be distinguished in Phase IV trials and post-marketing surveillance studies. Limited information is available in Italy about their characteristics as the proportion of observational studies, the average size and the importance of the non-sponsored research. In order to investigate these and other features, we analysed 1,881 protocols presented to the Ethics Committee of a large size University Hospital in the decade 1999-2008. Out of the 188 (10% Phase IV studies, about three fourths were controlled clinical trials, 48.4% had an active drug and 16.0% a placebo as comparator; only 8.5% was presented as observational. Most of the Phase IV studies could be classifiable as Phase IIIb. The median sample size value was 200 patients, while the Phase III studies reported a median of 360 patients, this contradicting the “large-scale” characteristic of the Phase IV studies reported in the literature.

  3. [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.

  4. 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... 30, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc...

  5. 76 FR 80949 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2011-12-27

    ... site at http://www.fda.gov/AdvisoryCommittees/default.htm . FOR FURTHER INFORMATION CONTACT: For..., biomedical engineers or microbiologists/infection control practitioners or experts. Microbiology Devices..., gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive...

  6. 75 FR 62509 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2010-10-12

    ... send a copy of your resume to Ms. Yvette Springer at [email protected] . Deadline: This Notice of... INFORMATION CONTACT: Ms. Yvette Springer on (202) 482-2813. Dated: October 6, 2010. Yvette Springer, Committee...

  7. 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/.

  8. 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.

  9. Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review.

    Science.gov (United States)

    Clark, Timothy; Berger, Ursula; Mansmann, Ulrich

    2013-03-21

    To assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees. Review of original research protocols. Unpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009. Completeness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size. 446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced. Most research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to

  10. Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China.

    Science.gov (United States)

    Zeng, Lingfeng; Liang, Weixiong; Pan, Jianke; Cao, Ye; Liu, Jun; Wang, Qi; Wang, Lu; Zou, Yuanping; Wang, Kezhu; Kong, Lingshuo; Xie, Hui; Xu, Weihua; Li, Weirong; Zhao, Wei; Mi, Suiqing; Chen, Yunbo; Cheng, Shuyi; Li, Xiaoyan; Cao, Qian; Zeng, Xing; Wang, Ningsheng

    2016-03-25

    Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

  11. 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..., 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012...

  12. 7 CFR 917.115 - Nomination of shipper members for the Control Committee.

    Science.gov (United States)

    2010-01-01

    ...) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF... then current year, have not advised the manager of the Control Committee in writing of their participation in the formation of an elective body shall be notified promptly by the manager after that date, by...

  13. 78 FR 9060 - Request for Nominations for Voting Members on Public Advisory Panels or Committees

    Science.gov (United States)

    2013-02-07

    ... site at http://www.fda.gov/AdvisoryCommittees/default.htm . FOR FURTHER INFORMATION CONTACT: For.../infection control practitioners or experts. Hematology and Pathology of 4 March 1, 2013. the Medical Devices..., embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy...

  14. 78 FR 5774 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2013-01-28

    ... send a copy of your resume to Ms. Yvette Springer at Yvette.Springer@bis.doc.gov . Deadline: This... FURTHER INFORMATION CONTACT: Ms. Yvette Springer on (202) 482-2813. Dated: January 22, 2013. Yvette Springer, Committee Liaison Officer. BILLING CODE 3510-JT-P ...

  15. 77 FR 2271 - Technical Advisory Committees; Notice of Recruitment of Private-Sector Members

    Science.gov (United States)

    2012-01-17

    ... send a copy of your resume to Ms. Yvette Springer at Yvette.Springer@bis.doc.gov . Deadline: This... FURTHER INFORMATION CONTACT: Ms. Yvette Springer on (202) 482-2813. Dated: January 11, 2012. Yvette Springer, Committee Liaison Officer. BILLING CODE 3510-JT-P ...

  16. Mapping African ethical review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa.

    Science.gov (United States)

    IJsselmuiden, Carel; Marais, Debbie; Wassenaar, Douglas; Mokgatla-Moipolai, Boitumelo

    2012-08-01

    Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. © 2012 Blackwell Publishing Ltd.

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

    Science.gov (United States)

    Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

    2017-01-01

    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.

  18. 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

  19. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Science.gov (United States)

    2012-02-23

    ... authorities knowledgeable in fields such as social marketing, health literacy, and other relevant areas... members will be selected to provide experiential insight on the communication needs of the various groups...

  20. 77 FR 14591 - Open Meeting of the Federal Advisory Committee on Insurance

    Science.gov (United States)

    2012-03-12

    [email protected] . Paper Statements Send paper statements in triplicate to the Federal Advisory... meeting Committee members will be introduced and briefed on applicable ethics standards as well as the...

  1. 78 FR 23827 - Veterans' Advisory Committee on Rehabilitation, Notice of Meeting

    Science.gov (United States)

    2013-04-22

    ... annual report. On May 2, the Committee members will receive an annual ethics briefing and discuss meeting... NW., Washington, DC 20420, or via email at [email protected] . In the communication with the...

  2. 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-...

  3. 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)

    Adams, Pornpimon; Wongwit, Waranya; Pengsaa, Krisana; Khusmith, Srisin; Fungladda, Wijitr; Chaiyaphan, Warissara; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Kaewkungwal, Jaranit

    2013-09-11

    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. 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. 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. Delays in the approval or non-approval of studies involving minorities were

  4. Los comités de ética clínica en México: la ambigua frontera entre la ética asistencial y la ética en investigación clínica Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics

    Directory of Open Access Journals (Sweden)

    Edith Valdez-Martínez

    2008-08-01

    functions. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. A survey of ethical issues surrounding supply of information to members of the public by hospital pharmacy medicines information centres.

    Science.gov (United States)

    Wills, Simon; Brown, David; Astbury, Sarah

    2002-04-01

    To examine ways in which medicines information pharmacists approach ethical dilemmas encountered in information supply, to appreciate the factors affecting any observed variation in responses, and to identify and training deficits among medicines information (MI) pharmacists in this area. A questionnaire was circulated to all medicines information pharmacists working in the hospital pharmacy service in the United Kingdom. The survey presented ten realistic scenarios involving requests for information on a variety of topics from 'lay' callers. Respondents were asked to identify any perceived ethical dilemmas presented by the scenarios and to indicate their preferred replies. Details on training given or received in this area were also requested. The overall response rate was 151 of 286 questionnaires mailed (52.8%), representing 137 discrete DI centres throughout the UK. Postgraduate clinical qualifications were possessed by 71% of respondents. Just 32 (21.2%) indicated that they gave training on ethical issues surrounding information supply while 57 (37.1%) said they had received such training. Over half (54.3%) had neither received nor delivered training on ethical issues. Of the 32 who said they gave training, 21 had received training themselves. Only 4 (2.6%) said they had a protocol in place for dealing with enquiries from members of the public. There was considerable variation in how respondents thought the scenarios might be resolved, emphasising the varying levels of appreciation of the issues and lack of a uniform approach to management. An interesting dichotomy emerged between liberal and conservative approaches. Liberal pharmacists clearly believed that all MI data is in the public domain and should be produced and evaluated on request because patients have a "right" to it. The conservative pharmacists had a more protective attitude toward the patient and believed that patients should not be given information by MI pharmacists directly; rather that it

  6. Can I trust them to do everything? The role of distrust in ethics committee consultations for conflict over life-sustaining treatment among Afro-Caribbean patients.

    Science.gov (United States)

    Romain, Frederic; Courtwright, Andrew

    2016-09-01

    Distrust in the American healthcare system is common among Afro-Caribbeans but the role of this distrust in conflict over life-sustaining treatment is not well described. To identify the ways that distrust manifests in ethics committee consultation for conflict over life-sustaining treatment among Afro-Caribbean patients. This was a retrospective cohort study at a large academic hospital of all ethics committee consultations for life-sustaining treatment among Afro-Caribbean patients and their surrogates. We reviewed medical records and identified cases in which ethics consultants described distrust as playing a role in the conflict over life-sustaining treatment. Of the 169 ethics committee consultation cases for conflict over life-sustaining treatment, 11 (6.5%) involved patients who self-identified as Afro-Caribbean. Distrust played a role in several of these cases, with surrogates of three patients, in particular, illustrating the way that perceived heath disparities, past labelling and concerns about continued maltreatment generated distrust leading to conflict over life-sustaining treatment. Exploring issues of distrust may help ethics consultants identify the source of conflict over life-sustaining treatment among Afro-Caribbean patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. 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.

  8. 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…

  9. The impact of ethical and despotic leadership on the emotions and team work engagement perceptions of individual members within work teams

    OpenAIRE

    Simões, João Gonçalo Madeira Fraga Fernandes

    2016-01-01

    The purpose of this thesis is the study of the impact of two different leadership styles, ethical and despotic, on three different variables of members of a team: positive emotions, negative emotions and perception of team work engagement. Data was collected from both real world companies and through a laboratory study. The results show that ethical leadership seems to positively impact team work engagement perceptions and positive emotions and to negatively impact negative emotions. Despotic...

  10. Dialysis Withdrawal: Impact and Evaluation of a Multidisciplinary Deliberation Within an Ethics Committee as a Shared-Decision-Making Model.

    Science.gov (United States)

    Maurizi Balzan, Jocelyne; Cartier, Jean Charles; Calvino-Gunther, Silvia; Carron, Pierre Louis; Baro, Patrice; Palacin, Pedro; Vialtel, Paul

    2015-08-01

    Since dialysis withdrawal in maintenance dialysis patients with limited life expectancy results always in short-term death, nephrologists need a referenced process to make their decision. This study reviews 8 years of operation of an Ethics Committee in Nephrology (ECN). The ECN, within a multidisciplinary team, once a month explores cases reported by caregivers when maintaining dialysis seems not to be in the patient's best interest. Discussion is required when the vital prognosis is engaged by the evolution of the chronic kidney disease (CKD) or the occurrence of an acute medical event. Data are analyzed using a discussion guide. The informed decision is completed with an appropriated palliative care project involving the patient, and recorded in their file. Since 2006, the ECN has deliberated yearly for 10 sessions on 6-18 cases, concerning 380 identified maintenance dialysis patients. Characteristics of the population, cases, sessions and proposals are recorded and analyzed. The only variable associated with dialysis withdrawal was having at least one new comorbid condition. End of life is supported with the help of the palliative care team in the hospital or exceptionally at home. The ECN, through a multidisciplinary deliberation and resolution process, proposes an ethical shared-decision-making model ensuring that dialysis withdrawal follows professional guidelines, and is registered as a method for evaluating professional practice (EPP). Annual activity reports are submitted to the Hospital's Medical Evaluation and Quality Unit. Benefits are individual and collective for patients, relatives and caregivers. Prospects for reducing non-implemented decisions and identifying cases earlier would improve the Committee effectiveness. © 2015 The Authors. Therapeutic Apheresis and Dialysis © 2015 International Society for Apheresis.

  11. Building Capacity in Ethical Review

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    Capacity building in biomedical research ethics review has been a European priority since the early 2000s. Prompted by the increase in data originating in internationally sponsored trials in emerging economies, a range of capacity building initiatives were put in place in the field of ethical...... 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...

  12. 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.

  13. Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

    Science.gov (United States)

    Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

    2014-01-01

    Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics" was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010-September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with

  14. Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand

    Science.gov (United States)

    Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

    2014-01-01

    Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with

  15. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

    Science.gov (United States)

    van Lent, Marlies; Rongen, Gerard A; Out, Henk J

    2014-12-10

    Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and

  16. 77 FR 16535 - Request for Nominations of Members To Serve on the Census Bureau National Advisory Committee on...

    Science.gov (United States)

    2012-03-21

    ... Committee addresses census policies, research and methodology, tests, operations, communications/messaging..., considering such factors as race, ethnicity, geography, gender, technical expertise, community involvement... to equal opportunity in the workplace and seeks diverse Advisory Committee membership. Dated: March...

  17. ACOG Committee Opinion No. 510: Ethical ways for physicians to market a practice.

    Science.gov (United States)

    2011-11-01

    It is ethical for physicians to market their practices provided that the communication is truthful and not misleading, deceptive, or discriminatory. All paid advertising must be clearly identified as such. Producing fair and accurate advertising of medical practices and services can be challenging. It often is difficult to include detailed information because of cost and size restrictions or the limitations of the media form that has been selected. If the specific advertising form does not lend itself to clear and accurate description, an alternative media format should be selected. Advertising that seeks to denigrate the competence of other individual professionals or group practices is always unethical.

  18. 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.

  19. 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

  20. ACOG Committee Opinion No. 341. Ethical ways for physicians to market a practice.

    Science.gov (United States)

    2006-07-01

    It is ethical for physicians to market their practices through any form of public communication provided that the communication is truthful and not misleading or deceptive. Communications should not convey discriminatory attitudes involving race, ethnicity, gender; or sexual orientation.All paid advertising must be clearly identified as such. Producing fair and accurate advertising of medical practices and services can be challenging. It often is difficult to include detailed information because of cost and size restrictions or the limitations of the media form that has been selected. If the specific advertising form does not lend itself to clear and accurate description, an alternative media format should be selected. Finally, any advertising that seeks to denigrate the competence of other individual professionals or group practices is always considered unethical.

  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

    ... Climate Change and Natural Resource Science AGENCY: U.S. Geological Survey, Interior. ACTION: Notice... Advisory Committee on Climate Change and Natural Resource Science (Committee), and inviting nominations for... Partnership Coordinator, National Climate Change and Wildlife Science Center, U.S. Geological Survey, 12201...

  2. 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.

  3. Locating Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2013-01-01

    , 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...... 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......, and development anthropology. Drawing on material from ethnographic fieldwork with the NGO in Sri Lanka, Thailand, the Philippines, Taiwan and mainland China over 12 months between March 2009 and November 2010, it advances an argument that the uptake of ethics through forms such as the Ethics Review Committee...

  4. 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

    ... factors as geography, age, gender, race, ethnicity, technical expertise, community involvement, knowledge...), who are selected for their personal expertise with the topics highlighted above and/or representatives..., but not limited to regular meeting attendance, committee meeting discussant responsibilities, review...

  5. 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

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

    Directory of Open Access Journals (Sweden)

    Jing Qian

    2017-07-01

    Full Text Available 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.

  7. 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.

  8. 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.

  9. Members of the International Cryogenic Engineering Committee visit the CMS experiment at Point 5 during the Nineteenth International Cryogenic Engineering Conference (ICEC 19) in Grenoble, France (22-26 July 2002).

    CERN Multimedia

    Maximilien Brice

    2002-01-01

    Members of the International Cryogenic Engineering Committee visit the CMS experiment at Point 5 during the Nineteenth International Cryogenic Engineering Conference (ICEC 19) in Grenoble, France (22-26 July 2002).

  10. 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.

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

    Science.gov (United States)

    Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-04-20

    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. 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. 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.

  12. Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members.

    Science.gov (United States)

    Perumal-Pillay, Velisha Ann; Suleman, Fatima

    2017-01-07

    The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams. Qualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January - April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data. The interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines. This is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.

  13. 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

  14. 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

  15. 75 FR 64736 - Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the...

    Science.gov (United States)

    2010-10-20

    ... the following fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, epidemiology, product safety, product manufacturing sciences and quality or other scientific areas relevant to..., nanotechnology, and combination products. Members shall be chosen from academia and industry. The Science Board...

  16. 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.

  17. 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.

  18. 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...

  19. 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.

  20. [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.

  1. 75 FR 42270 - Adoption of Supplemental Standards of Ethical Conduct for Members and Employees of the Securities...

    Science.gov (United States)

    2010-07-20

    ... remain in effect. The Commission encourages its members and employees to engage in teaching, lecturing.... (3) Professional services means practicing a profession as the term ``profession'' is defined in 5...). Employees who wish to engage in teaching, writing or speaking for compensation should review the provisions...

  2. 75 FR 42269 - Adoption of Supplemental Standards of Ethical Conduct for Members and Employees of the Securities...

    Science.gov (United States)

    2010-07-20

    ... remain in effect. The Commission encourages its members and employees to engage in teaching, lecturing.... (3) Professional services means practicing a profession as the term ``profession'' is defined in 5...). Employees who wish to engage in teaching, writing or speaking for compensation should review the provisions...

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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…

  8. Under the shelter of ethics.

    Science.gov (United States)

    Lichterman, Boleslav L

    2005-01-01

    Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

  9. 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.)

  10. 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.)

  11. 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...

  12. 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

  13. 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...

  14. 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.

  15. 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...

  16. 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.

  17. 77 FR 10033 - Advisory Committee International Postal and Delivery Services

    Science.gov (United States)

    2012-02-21

    ... a meeting of the Advisory Committee on International Postal and Delivery Services. This Committee... and delivery services of interest to Advisory Committee members and the public. For further... DEPARTMENT OF STATE [Public Notice: 7762] Advisory Committee International Postal and Delivery...

  18. Committee Reports, May 2008

    Science.gov (United States)

    2008-08-01

    The Division's Executive Committee conducted several items of business at the New Orleans meeting. Elsewhere in this issue [see p 1032] is a listing of the candidates for Division offices for Fall 2008 election, approved by the Committee and later affirmed at the Division business meeting. Among items of specific interest to Division members is a plan to have the Journal of Chemical Education send an announcement to members when each issues goes online, and the Committee approved this use of the Division email list. It also approved plans presented by Amina El-Ashmawy and the BCCE committee to proceed with a bid from Pennsylvania State University for the 2012 BCCE.

  19. 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.

  20. 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

  1. [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.

  2. [Ethics code of the Chilean Biological Society].

    Science.gov (United States)

    de Etica, C; Valenzuela, C; Cruz-Coke, R; Ureta, T; Bull, R

    1997-01-01

    The Chilean Biological Society has approved an ethics code for researchers, elaborated by its Ethic Committee. The text, with 16 articles, undertakes the main ethical problems that researchers must solve, such as institutional, professional or societal ethics, scientific fraud, breaches in collaborative work, relationships between researchers, participation in juries and committees, ethical breaches in scientific publications, scientific responsibility and punishments. This code declares its respect and valorization of all life forms and adheres to international biomedical ethical codes. It declares that all knowledge, created or obtained by researchers is mankind's heritage.

  3. [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.

  4. 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.

  5. 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).

  6. Ethical Perspectives on Advertising

    OpenAIRE

    SOJKOVÁ, Eva

    2008-01-01

    In my paper I examine the practice of advertising from ethical perspective. The paper informs about the ethical regulation of advertising practice in Czech Republic and highlights its interconnection with legislative regulation. It also introduces the work of the Committee for advertising - the first organization for auto-regulation of advertising in Eastern Europe - whose goal is to ensure honest, legal, decent, truthful practice of advertising in Czech Republic. In the main part of my paper...

  7. Engineer Ethics

    Energy Technology Data Exchange (ETDEWEB)

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

    2003-03-15

    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.

  8. 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.

  9. Professional ethics: an overview from health research ethics point of view.

    Science.gov (United States)

    Nyika, Aceme

    2009-11-01

    The advancement of the medical field has been to a large extent made possible by the hard work contributed by researchers all over the world. The pool of knowledge generated through research is the basis for diagnostic methods, therapeutic interventions and policies that continue to improve the quality of life for mankind. Health researchers are the ones who interact directly with research participants as they implement research protocols. Although other players involved in health research such as Ethics Review Committees, Regulatory Authorities, Data Safety and Monitoring Boards, and sponsors help to ensure that the health research meets internationally acceptable scientific and ethical standards, researchers could be considered to be the major determining factor as to whether the research is actually done properly. Although professional associations of health researchers help to uphold the integrity of their members, there is need to complement the efforts of such associations and sensitize researchers on the ethical implications of some acts of commission or omission, done inadvertently or knowingly, that may not be adequately addressed by requirements of the associations. This paper gives an overview of professional ethics from the point of view of health research ethics, and concludes that alerting health researchers about these issues is not only good for the protection of the welfare of research participants, but is also critical for the carrier development of the researchers, be they junior or senior.

  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. [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.

  12. 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.

  13. 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.

  14. [Ethical assessment of biomedical experiments in The Netherlands].

    Science.gov (United States)

    Noach, E L

    1995-01-01

    The ethical evaluation of biomedical experiments is loyally accepted in the Netherlands. It was introduced everywhere during the last 15 years. Among the targets we find not only the protection of the experimental objects--animals and humans--but also the protection of researchers who may find moral support in the approval of their projects by a Committee of Ethical Evaluation. Concerning experiments in animals, the legal framework is provided by the Law on Animal Experiments. This law was drawn up in accordance with the directive of the E.U. To be allowed to practice experiments in animals, an institute must possess a licence; the researchers are moreover obliged to be appropriately trained with regard to experiments in animals. To that end an adequately functioning organization has been set up. The intensive supervision is widely decentralized and effected for the greater part by experts working within the institutes. The "intra muros" Committees supervising the experiments in animals play an important part in the ethical evaluation. More than 50 of those Committees are active at this time. Setting the ethical standards is done in close collaboration between the Authorities and the researchers. Researchers and animal protection associations have established a "Platform for the Replacement of Experiments in Animals", in which they support development of alternative methods for research. The legislation concerning medical experiments in humans is not yet completely enforced, but in practice the ethical evaluation has been effected for many years in every hospital of the Netherlands. At present about 150 "Committees for medico-ethical evaluation" are at work. Their task may be very heavy, especially in the academic hospitals, where, mostly, over 150 projects are advised on every year. Adequate training facilities are provided for the members of the committees. The passing of the bill on experiments in humans is stagnating owing to political reasons. Besides the

  15. SENIOR STAFF ADVANCEMENT COMMITTEE (SSAC)

    CERN Multimedia

    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.

  16. 41 CFR 105-54.204 - Advisory committee membership.

    Science.gov (United States)

    2010-07-01

    ... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and Civil Rights for review and forwarding to the Administrator. (b) Discrimination is prohibited on the... cleared by the Designated Agency Ethics Official. ...

  17. 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.

  18. 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…

  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. Assigning ethical weights to clinical signs observed during toxicity testing.

    Science.gov (United States)

    Ringblom, Joakim; Törnqvist, Elin; Hansson, Sven Ove; Rudén, Christina; Öberg, Mattias

    2017-01-01

    Reducing the number of laboratory animals used and refining experimental procedures to enhance animal welfare are fundamental questions to be considered in connection with animal experimentation. Here, we explored the use of cardinal ethical weights for clinical signs and symptoms in rodents by conducting trade-off interviews with members of Swedish Animal Ethics Committees in order to derive such weights for nine typical clinical signs of toxicity. The participants interviewed represent researchers, politically nominated political nominees and representatives of animal welfare organizations. We observed no statistically significant differences between these groups with respect to the magnitude of the ethical weights assigned, though the political nominees tended to assign lower weights. Overall, hunched posture was considered the most severe clinical sign and body weight loss the least severe. The ethical weights assigned varied considerably between individuals, from zero to infinite value, indicating discrepancies in prioritization of reduction and refinement. Cardinal ethical weights may be utilized to include both animal welfare refinement and reduction of animal use in designing as well as in retrospective assessment of animal experiments. Such weights may also be used to estimate ethical costs of animal experiments.

  1. 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...

  2. 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.

  3. 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

  4. 78 FR 8160 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2013-02-05

    ... SECURITY President's National Security Telecommunications Advisory Committee AGENCY: National Protection... Committee Teleconference. SUMMARY: The President's National Security Telecommunications Advisory Committee... telecommunications policy. Agenda: The NSTAC members will review and discuss the draft NSTAC Report to the President...

  5. 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

  6. MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

    Science.gov (United States)

    Gysels, Marjolein; Evans, Catherine J; Lewis, Penney; Speck, Peter; Benalia, Hamid; Preston, Nancy J; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Todd, Chris J; Higginson, Irene J

    2013-12-01

    There is little guidance on the particular ethical concerns that research raises with a palliative care population. To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

  7. Challenges in the Ethical Review of Peer Support Interventions

    Science.gov (United States)

    Simmons, David; Bunn, Christopher; Nakwagala, Fred; Safford, Monika M.; Ayala, Guadalupe X.; Riddell, Michaela; Graffy, Jonathan; Fisher, Edwin B.

    2015-01-01

    PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the “4+1 ethical framework” (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees’ reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of “light touch” consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support. PMID:26304976

  8. Ethical Guidelines and Practices for US Military Medical Professionals

    Science.gov (United States)

    2015-03-03

    symposium has brought together the Walter Reed-Bethesda Ethics Committee and the Department of Pastoral Care to provide education and training...University of the Health Sciences;2006. 138. Walter Reed-Bethesda Ethics Committee and Department of Pastoral Care . Annual Healthcare Ethics...Association, Council on Ethical and Judicial Affairs  CAPT Roosevelt Brown, Chaplain of Navy Medicine, Pastoral Care Office, Bureau of Medicine and

  9. The use of an online comment system in clinical ethics consultation.

    Science.gov (United States)

    Hauschildt, Katrina; Paul, Trisha K; De Vries, Raymond; Smith, Lauren B; Vercler, Christian J; Shuman, Andrew G

    2017-01-01

    Although a mechanism for resolving ethical issues in patient care is required for accreditation of American hospitals, there are no formal qualifications for providing clinical ethics consultation (CEC), and there remains great variability in the composition of ethics committees and consult services. Consequently, the quality of CEC also varies depending on the qualifications of those performing CEC services and the format of CEC utilized at an institution. Our institution implemented an online CEC comment system to build upon existing practices to promote consistency and broad consensus in CEC services and enable quality assurance. This qualitative study explored the use of an online comment system in ethics consultation and its impact on consensus building and quality assurance. All adult ethics consultations recorded between January 2011 and May 2015 (n = 159) were analyzed for themes using both open and directed coding methods. We found that comments broadly reflected three categories: expressions of approval/agreement (87% of consults), comments about the case (89%), and comments about the written record (72%). More than one-third of consults included responses to other comments (37%). The most common types of "comments about the case" included requests for additional information (36%), recommendations for additional services (21%), and references to formal policies/standards (28%). Comments often spanned multiple categories and themes. Comments about the written record emphasized accessibility, clarity, and specificity in ethics consultation communication. We find the online system allows for broad committee participation in consultations and helps improve the quality of CEC provided by allowing for substantive discussion and consensus building. Further, we find the use of an online comment system and subsequent records can serve as an educational tool for students, trainees, and ethics committee members.

  10. Public affairs committee actions

    Science.gov (United States)

    The AGU Public Affairs Committee will create an ad hoc committee to consider possible AGU position statements concerning the effects of nuclear war.The action was taken at the May 31, 1983, meeting of the Committee at the AGU Spring Meeting in Baltimore. Present were Carroll Ann Hodges, Chairman, and members Thomas J. Ahrens, David Cauffman, Jared Cohon, Stamatios Krimigis, Robert Murphy, Raymond Roble, and George Shaw. Also attending were the current Congressional Fellow Arthur Weissman and SPR—Cosmic Rays Section Secretary Miriam Forman.

  11. Executive committee

    Science.gov (United States)

    Xiao, Guoqing; Cai, Xiaohong; Ding, Dajun; Ma, Xinwen; Zhao, Yongtao

    2014-04-01

    ChairVice Chair Toshiyuki AzumaRoberto Rivarola Atomic, Molecular & Optical Physics LabUniversidad Nacional de Rosario and Advanced Science InstituteInstituto de Fisica Rosario RIKEN, JapanRosario, Argentina SecretaryMembers Dominique VernhetJoachim Burgdörfer, Austria Institut des NanoSciences de Paris Birgit Lohmann, Australia Université Pierre et Marie Curie Hossein Sadeghpour, USA Paris, FranceThomas Stöhlker, Germany Past ChairJim McCann, UK Barry DunningGuoqing Xiao, China Physics & AstronomyXiaohong Cai, China Rice University, HoustonXinwen Ma, China Texas, USAYongtao Zhao, China TreasurerFernando Martin, Spain Henrik CederquistLuis Mendez, Spain Alba Nova University CenterAnatoli Kheifets, Australia Stockholm University Stockholm, Sweden Details of the general committee are available in the PDF

  12. 37 CFR 11.23 - Committee on Discipline.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Committee on Discipline. 11... Committee on Discipline. (a) The USPTO Director shall appoint a Committee on Discipline. The Committee on Discipline shall consist of at least three employees of the Office. None of the Committee members shall...

  13. 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 Multimedia

    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.

  14. 3 February 2011 - British Members of the Science and Technology Committee (Commons)led by A. Miller MP signing the guest book with CERN Director for Accelerators and Technology S. Myers; in the ATLAS experimental cavern at LHC Point 1 with Spokesperson F. Gianotti and Deputy D. Charlton.

    CERN Multimedia

    Maximilien Brice

    2011-01-01

    3 February 2011 - British Members of the Science and Technology Committee (Commons)led by A. Miller MP signing the guest book with CERN Director for Accelerators and Technology S. Myers; in the ATLAS experimental cavern at LHC Point 1 with Spokesperson F. Gianotti and Deputy D. Charlton.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. Publication ethics for researchers

    OpenAIRE

    Banerjee, Probir K.

    2013-01-01

    The community of researchers unanimously agrees that a code of ethics must be followed when engaging in research and consenting to publication of research findings in academic journals. However, unethical research practice continues to cause concern. In an effort to address the concern, several researchers have prescribed remedial action. Publishers and members of the research community have also tried to raise awareness of this malady plaguing the research community. For example, Ethics in R...

  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. Ethical Issues in Research: How Harmful is Deception?

    Science.gov (United States)

    Smith, Charles P.; And Others

    One function of a Human Subjects Committee is to review the possible adverse effects of ethically problematic experiments. The concerns of an institutional review committee about the possible adverse effects of an ethically-problematic "cheating" study were examined with regard to the actual effects reported by the subjects. Retrospective…

  2. 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.

  3. Perceptions of veterinary admissions committee members of ...

    African Journals Online (AJOL)

    2015-06-26

    Jun 26, 2015 ... for undergraduate education include taking classes at a traditional four-year institution, a community college, or online. This study ... growth of students taking online courses and data showing community colleges are providing a successful gateway to ... skills required for success can often be learned, non-.

  4. 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 ...

  5. Counselors' Perceptions of Ethical Behaviors

    Science.gov (United States)

    Neukrug, Edward S.; Milliken, Tammi

    2011-01-01

    A random sample of American Counseling Association members was asked to respond to a 77-item survey of counselor behaviors and identify whether each behavior was ethical or unethical. Results are categorized by behaviors in which 90% of counselors agreed, 75% to 90% agreed, and 25% to 50% disagreed. Also, changes in ethics education were reviewed…

  6. 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*.

  7. 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…

  8. [Ethics and animal experiments.].

    Science.gov (United States)

    Schnaider, Taylor Brandão; Souza, Cláudio de

    2003-04-01

    This is a major subject since the aim is to grant human beings physical, mental, social and spiritual well-being without forgetting the sacred rights of all animals. Most international codes dealing with health-related research practices state that research developed in human beings should be based on previous lab animal experiments or on other scientific data. This article aimed at explaining ethics in animal experiments. The concepts of dissertation and thesis, experimental thesis, experimental essay or pilot experiment and experimental animal facilities are reviewed. Then, a historical retrospective is drawn about the first attempt to develop experimental research policies during the mid 19th Century, in London. It is highlighted that some criteria defined by that time still persist. The first animal research ethical committee was created in Sweden in 1979, followed by the USA in1984. In Brazil, animal research ethical committees were created as late as in the 90s. The Federal Law 6638 was passed in May 1979 and provides for the didactic-scientific practice of animal vivisection. This law, however, is still waiting for regulation. In addition, there are some drafts being analyzed by the Congress, which provide for the use of animals for teaching and research purposes. Finally, the policies adopted by the Brazilian College of Animal Experiments and the Universal Declaration of Animal Rights are presented. Professors, postgraduates, residents and graduate students of a Medical School involved in animal research should be aware of the ethical principles aiming at protecting animals selected for scientific work.

  9. Union Members Are Community Members

    Science.gov (United States)

    Gray, David

    2013-01-01

    Unions serve their members' interests. But union members are also community members, and their interests go well beyond increasing pay and benefits. A local union president has found that his members are best served by participating in a community-wide coalition. Providing eyeglasses to needy students, promoting healthy eating, and increasing…

  10. 77 FR 46426 - Renewal of Department of Defense Federal Advisory Committees

    Science.gov (United States)

    2012-08-03

    ... eminent authorities in the field of defense, management, leadership, and academia. All Committee members..., Advisory Committee Management Officer for the Department of Defense, 703-692-5952. SUPPLEMENTARY...

  11. 76 FR 63623 - President's Committee for People With Intellectual Disabilities Committee Meeting via Conference...

    Science.gov (United States)

    2011-10-13

    .... Agenda: Committee Members will review and approve the 2011 PCPID Report (Letter) to the President... disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of...

  12. 76 FR 68486 - President's Committee for People With Intellectual Disabilities: Committee Meeting via Conference...

    Science.gov (United States)

    2011-11-04

    ... after this deadline. Agenda: Committee Members will review and approve the 2011 PCPID Report (Letter) to... following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B...

  13. Business ethics

    OpenAIRE

    Csillag,Paula

    1998-01-01

    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 ...

  14. 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.

  15. The Benefits of Participating in Collaborative Committees.

    Science.gov (United States)

    Belfiore, Mary Ellen

    A study was conducted to show the effect that participation in workplace committees has on committee members. The subjects were 34 members of Workplace Education Center (WEC) projects of ABC Canada who work on establishing and maintaining workplace literacy initiatives; they were interviewed by phone or in group discussions. The study found that,…

  16. 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

  17. 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…

  18. 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…

  19. Teachers' Ethical Dilemmas: What Would You Do?

    Science.gov (United States)

    Bucholz, Jessica L.; Keller, Cassandra L.; Brady, Michael P.

    2007-01-01

    Educators will face a variety of ethical and moral dilemmas throughout their teaching careers; however, they do not have a common board that governs its members' ethical behavior. Instead, there are numerous educational organizations that have written their own specific codes for ethical behavior. The Council for Exceptional Children (CEC) has…

  20. Contribution of the ethics committee of the French society of intensive care medicine to a scenario for the implementation of organ donation after Maastricht III-type cardiac death in France.

    Science.gov (United States)

    Graftieaux, J-P; Bollaert, P-E; Haddad, L; Kentish-Barnes, N; Nitenberg, G; Robert, R; Villers, D; Dreyfuss, D

    2014-02-01

    French law allows organ donation after death due to cardiocirculatory arrest. In the Maastricht classification, type III non-heart-beating donors are those who experience cardiocirculatory arrest after the withdrawal of life-sustaining treatments. French authorities in charge of regulating organ donation (Agence de la Biomédecine, ABM) are considering organ collection from Maastricht type III donors. We describe a scenario for Maastricht type III organ donation that fully complies with the ethical norms governing care to dying patients. That organ donation may occur after death should have no impact on the care given to the patient and family. The dead-donor rule must be followed scrupulously: the organ retrieval procedure must neither cause nor hasten death. The decision to withdraw life-sustaining treatments, withdrawal modalities, and care provided to the patient and family must adhere strictly to the requirements set forth in patient-rights legislation (the 2005 Léonetti law in France) and should not be influenced in any way by the possibility of organ donation. A major ethical issue regarding the family is how best to transition from discussing treatment-withdrawal decisions to discussing possible organ retrieval for donation should the patient die rapidly after treatment withdrawal. Close cooperation between the healthcare team and the organ retrieval team is crucial to minimize the distress of family members during this transition. Modalities for implementing Maastricht type III organ donation are discussed here, including the best location for withdrawing life-sustaining treatments (operating room or intensive care unit). Copyright © 2014. Published by Elsevier SAS.

  1. 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.

  2. 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.

  3. 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 ...

  4. Ethics and originality in doctoral research in the UK.

    Science.gov (United States)

    Snowden, Austyn

    2014-07-01

    To show that the ethics governance process in the UK is not necessarily conducive to innovative investigation by doctoral students. Doctoral students need to demonstrate an original contribution to knowledge. This paper critically evaluates the concept of knowledge in relation to the concept of research paradigms. The purpose of this is to situate different claims to originality and show that original knowledge in nursing is always ethical knowledge of nursing. Academic databases, local and national policy documents. Ethics governance procedures in nurse research in the UK are summarised. These are contrasted with ethical issues embedded in day-to-day nursing practice. The author's argument is that current methods of ethics governance for doctoral research in the UK can be detrimental to the construction of original knowledge in nursing. This is because original research in nursing necessarily affects the ethics of care, but the gatekeeping function of risk-averse ethics committees tends to prevent students attempting ethically complex studies. This means less important research gets carried out. To mitigate these issues, doctoral students need to develop a solid understanding of the ethics governance process. They need to build relationships with relevant ethics committees. University ethics committees are ideally placed to help with this process. Without original research practice will remain reactive. Originality entails risk on the part of both researcher and ethics committee. Positive risk taking is more feasible in the context of collaboration and mutual understanding. Nurses should become more active in research governance.

  5. 75 FR 42680 - Agenda and Notice of Public Meeting of the Colorado Advisory Committee

    Science.gov (United States)

    2010-07-22

    ... is for the committee to participate in orientation and ethics training; discuss recent Commission and... Committee will also be briefed by the director of a city anti-discrimination agency and a representative of...

  6. 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

  7. The ACR Intersociety Committee: history, activities, and membership.

    Science.gov (United States)

    Naeger, David M; Fletcher, Thomas B; Dodd, Gerald D

    2013-05-01

    The Intersociety Committee is a freestanding committee of the ACR established to promote collegiality and improve communication among national radiology organizations. The Intersociety Committee began in 1980 with 22 member organizations and has grown to approximately 50 member organizations. Each year, the Intersociety Committee sponsors a summer conference, at which representatives from the member organizations discuss issues facing radiology. Herein, the authors review the history of the committee, its activities to date, and the results of an extensive member survey conducted in 2010. Copyright © 2013 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  8. 76 FR 72204 - Renewal of Advisory Committee Charter

    Science.gov (United States)

    2011-11-22

    .... Background and Authority The Advisory Committee was established as a non-discretionary committee pursuant to.... II. Structure The Committee shall consist of 17 members appointed by the Bank's Board of Directors on... community, not less than two members being representative of the labor community, and not less than two...

  9. 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...

  10. "The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research.

    Science.gov (United States)

    Barchi, Francis; Matlhagela, Keikantse; Jones, Nicola; Kebaabetswe, Poloko M; Merz, Jon F

    2015-08-19

    Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens. This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance. Areas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods. Education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of

  11. Assessing the animal ethics review process

    DEFF Research Database (Denmark)

    Varga, O.; Sandøe, Peter; Olsson, I.A.S.

    2012-01-01

    Although animal experiments play an important role in biomedical research, their use is ethically challenging. Primarily in Europe, North America and Australasia ethics committees are set up to control the animal use in science. Project approval is usually decided on a case-by-case basis with focus...... on ensuring that the animals are caused a minimum of harm relative to the possibility of achieving beneficial results. Even though rules in this area are reasonably uniform there seems to be significant room for differences, individual and culturally based, between ethics committees concerning how the rules...... are applied. Our aim was to conduct a review of empirical studies of the different kinds of animal ethics committees in order to clarify what is known about their operation and highlight information which is missing in their evaluation. Our main findings are that there is a significant variation in process...

  12. Critical Analysis of Assessment Studies of the Animal Ethics Review Process †

    OpenAIRE

    Varga, Orsolya

    2013-01-01

    Simple Summary In many countries, the approval of animal research projects depends on the decisions of the ethics committees which review the projects. Since the efficiency of the protection of experimental animals greatly depends on the performance of the ethics committees, its regular assessment is crucial. This paper reviews the results of studies assessing the performance of the ethics committees, and emphasizes the importance of outcome assessment in the evaluation of the performance of ...

  13. Social Workers' Participation in the Resolution of Ethical Dilemmas in Hospice Care

    Science.gov (United States)

    Csikai, Ellen L.

    2004-01-01

    Ethical dilemmas are inherent in every health care setting. A sample of hospice social workers with no direct access to a hospice ethics committee (N = 110) was surveyed regarding ethical issues in hospice care, how the issues were managed, and the extent to which social workers participated in resolution of ethical dilemmas. Common issues…

  14. 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…

  15. 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 ...

  16. 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.

  17. 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.

  18. Position of the academy of nutrition and dietetics: ethical and legal issues in feeding and hydration.

    Science.gov (United States)

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

    2013-06-01

    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 (RDs) should work collaboratively as part of the 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. RDs have an active role in determining the nutrition and hydration requirements for individuals throughout the life span. When individuals choose to forgo any type of nutrition and hydration (natural or artificial), or when individuals lack decision-making capacity and others must decide whether or not to provide artificial nutrition and hydration, RDs have a professional role in the ethical deliberation around those decisions. Across the life span, there are multiple instances when nutrition and hydration issues create ethical dilemmas. There is strong clinical, ethical, and legal support both for and against the administration of food and water when issues arise regarding what is or is not wanted by the individual and what is or is not warranted by empirical clinical evidence. When a conflict arises, the decision requires ethical deliberation. RDs' understanding of nutrition and hydration within the context of nutritional requirements and cultural, social, psychological, and spiritual needs provide an essential basis for ethical deliberation. RDs, as health care team members, have the responsibility to promote use of advanced directives. RDs promote the rights of the individual and help the health care team implement appropriate therapy. This paper supports the "Practice Paper of the Academy of Nutrition and Dietetics: Ethical and Legal Issues of Feeding and Hydration" published on the Academy website at: www.eatright.org/positions. Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  19. Ethical Impotence

    Science.gov (United States)

    Sternberg, Robert J.

    2015-01-01

    Ethical impotence occurs when one wants to act ethically but feels powerless to do anything about the perceived unethical behavior. One may feel that one's actions will have no impact or that those actions actually will have harmful consequences to oneself and/or others. Ethical impotence can be understood in terms of an eight-step model of…

  20. 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? ...

  1. 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

  2. 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.

  3. 78 FR 40444 - Amendment of the Threat Reduction Advisory Committee

    Science.gov (United States)

    2013-07-05

    ...- related matters, as requested by the USD(AT&L). The Committee shall be composed of not more than 21... affairs, WMD, nuclear physics, chemistry, and biology. The Committee members are appointed by the...

  4. [Medical ethics as professional ethics].

    Science.gov (United States)

    Kwon, Ivo

    2012-09-25

    Contemporary medical ethics is far from the traditional concept of "In-Sul (benevolent art)" or "Yul-Li (倫, ethics), which emphasizes so much the personality or the character of a doctor. Nowadays, medical ethics should be considered as "professional ethics" which regulates the acts and medical practices of ordinary doctors in their daily practice. The key concepts of the professional ethics are "autonomy", "integrity", and "professional standard" established by medical organizations such as medical societies or associations. Most of Korean doctors have not been familiar with the concept of professional ethics or professionalism, which is due to the modern history of Korea. However, the concept of professional ethics is really critical to Korean doctors from the perspective of professional dignity and social respect to this profession. The current healthcare system of Korea is suffering from many problems of both private and public sector. Nonetheless, the professional ethics is urgently demanded for that very reason.

  5. 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.

  6. Standing Concertation Committee

    CERN Multimedia

    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 ...

  7. 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.

  8. 77 FR 40947 - Motor Carrier Safety Advisory Committee (MCSAC): Membership Solicitation

    Science.gov (United States)

    2012-07-11

    ... Committee based on their education, training, or experience. Currently, the members include representatives... with specialized experience, education, or training in commercial motor vehicle safety issues. The... is balanced with appropriate consideration of background. All Committee members must be able to...

  9. 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.

  10. 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.

  11. 7 CFR 7.15 - Eligibility requirements of county committee members, community committee members, and delegates.

    Science.gov (United States)

    2010-01-01

    ... Department's policy relating to equal opportunity and civil rights, including the equal employment policy, or... with the Department's policy relating to equal opportunity and civil rights, including the equal... president of the National Association of Farmer Elected Committeemen, the limitation shall be four...

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

    Science.gov (United States)

    West, James M

    2018-03-01

    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.

  13. 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.

  14. 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

  15. 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.

  16. Contemporary medical ethics: an overview from Iran.

    Science.gov (United States)

    Larijani, Bagher; Zahedi, Farzaneh

    2008-12-01

    The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990 s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research.

  17. 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.

  18. 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.

  19. Office complaint redressal committee | About IASc | Indian Academy ...

    Indian Academy of Sciences (India)

    ... Chief Librarian, RRI, Member; Ms M. Srimathi, Executive Editor, Member; Dr T.D. Mahabaleswara, Executive Editor, Member; Ms Jai Benjamin, Editorial Assistant, Member; Ms B.R. Nalini, Administrative Assistant, Member. The tenure of the committee will be for two years with immediate effect. YouTube; Twitter; Facebook ...

  20. Defense mechanisms in ethics consultation.

    Science.gov (United States)

    Agich, George J

    2011-12-01

    While there is no denying the relevance of ethical knowledge and analytical and cognitive skills in ethics consultation, such knowledge and skills can be overemphasized. They can be effectively put into practice only by an ethics consultant, who has a broad range of other skills, including interpretive and communicative capacities as well as the capacity effectively to address the psychosocial needs of patients, family members, and healthcare professionals in the context of an ethics consultation case. In this paper, I discuss how emotion can play an important interpretive role in clinical ethics consultation and why attention to the role of defense mechanisms can be helpful. I concentrate on defense mechanisms, arguing first, that the presence of these mechanisms is understandable given the emotional stresses and communicative occlusions that occur between the families of patients and critical care professionals in the circumstances of critical care; second, that identifying these mechanisms is essential for interpreting and managing how these factors influence the way that the "facts" of the case are understood by family members; and, third, that effectively addressing these mechanisms is an important component for effectively doing ethics consultation. Recognizing defense mechanisms, understanding how and why they operate, and knowing how to deal with these defense mechanisms when they pose problems for communication or decision making are thus essential prerequisites for effective ethics consultation, especially in critical care.

  1. Ethics in action: Approving and improving medical research with human subjects

    OpenAIRE

    de Jong, J.P.

    2013-01-01

    In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for many years, with Research Ethics Committees as their cornerstone. Although these oversight systems aim to ensure that the ethical quality of research is in order, they have been criticized for imped...

  2. Standing Concertation Committee

    CERN Multimedia

    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 ...

  3. 1980 compilation of National Nuclear Data Committees

    International Nuclear Information System (INIS)

    1980-04-01

    A list of currently existing National Nuclear Data Committees, and their memberships, is compiled and published upon the request of the International Nuclear Data Committee with the objective to promote the interaction and enhance the awareness of nuclear data activities in IAEA Member States

  4. 76 FR 45570 - Consumer Advisory Committee

    Science.gov (United States)

    2011-07-29

    ... two (2) one-day plenary meetings per year. In addition, as needed, working groups or subcommittees... minimum of two (2) one-day plenary committee meetings per year in Washington, DC. Committee members are... (Chairperson) Native Public Media--Dr. Traci Morris Rochester Institute of Technology--Raja Kushalnagar Speech...

  5. Ethics education in psychoanalytic training: a survey.

    Science.gov (United States)

    Ransohoff, Paul M

    2010-02-01

    Didactic education in psychoanalytic ethics is a relatively new phenomenon. Ethics courses were offered by few institutes before they were mandated and before publication of the first Ethics Case Book in 2001. As institutes have developed ethics training, the solutions they have arrived at-formats, length and placement of courses, and preferred readings- remain unknown to other educators and analysts. This survey was undertaken to gain an overview of the current state of ethics education. Twenty-nine of the thirty-one training institutes of the American Psychoanalytic Association (93%) responded to inquiries. Most institutes (79%) offered one course, and the average number of class sessions was 6.3. Of 258 different readings used, 61 (23.6%) were used by more than one institute and 37 (14.3%) by more than two. The most frequent topics were boundaries, confidentiality, and illness, and Dewald and Clark's Case Book (2008) and Gabbard and Lester (1995) were the most common readings. These findings should be useful to instructors, curriculum committees, and ethics committees in their ethics education planning, as well as to practicing analysts in their ethical self-education. This study may also serve as a model for analogous investigations into other areas of analytic education and as an impetus to further research and educational innovation.

  6. 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…

  7. Virtue ethics.

    OpenAIRE

    Vernon, Gervase

    2003-01-01

    The Handbook of Economics and Ethics portrays an understanding of economic methodology in which facts and values, though distinct, are closely interconnected in a variety of ways. From theory building to data collection, and from modelling to policy evaluation, this encyclopaedic Handbook is at the intersection of economics and ethics.

  8. 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.

  9. 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.

  10. 77 FR 38630 - Open Internet Advisory Committee

    Science.gov (United States)

    2012-06-28

    ..., reasonable network management practices, differences in treatment of fixed and mobile broadband services... solicited applications for membership on the Committee. Members must be willing to commit to a two (2) year...

  11. Intelligence Ethics:

    DEFF Research Database (Denmark)

    Rønn, Kira Vrist

    2016-01-01

    .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......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...

  12. 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.

  13. 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...

  14. 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...

  15. 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

  16. 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.

  17. 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...

  18. "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)

  19. 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.

  20. 77 FR 65393 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2012-10-26

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Security Telecommunications Advisory Committee (NSTAC) will meet on Monday, November 5, 2012, via a... preparedness (NS/EP) telecommunications policy. Agenda: The NSTAC members will receive an update on progress...

  1. 77 FR 44641 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2012-07-30

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Security Telecommunications Advisory Committee (NSTAC) will meet on Thursday, August 16, 2012, via a... preparedness telecommunications policy. Agenda: The NSTAC members will receive an update on progress made to...

  2. 76 FR 72427 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2011-11-23

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Telecommunications Advisory Committee (NSTAC) will meet on Thursday, December 8, 2011. The meeting will be open to...) telecommunications policy. During the meeting, NSTAC members will receive feedback from the Department of Homeland...

  3. Evaluation Team Dynamics: Intragroup Ethical Challenges

    Science.gov (United States)

    Urias, David

    2009-01-01

    Ethical challenges associated with the relationships among members of an evaluative team/organization receive less attention. Examples of the kinds of ethical dilemmas that could occur within an evaluation team include an individual taking undeserved credit, transferring blame, making false promises, withholding information, breaching…

  4. 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

  5. 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...

  6. 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…

  7. 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)

  8. Documentation of ethical considerations in published articles in ...

    African Journals Online (AJOL)

    Introduction. Guidelines for biomedical research involving human subjects require that research should be conducted in accordance with accepted ethical principles. The International Committee of Medical Journal Editors guidelines require authors to indicate that they have obtained ethical approval and informed consent.

  9. 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.

  10. 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...

  11. 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.

  12. 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…

  13. 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...

  14. 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.

  15. 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....

  16. Population Ethics

    OpenAIRE

    BLACKORBY, Charles; BOSSERT, Walter; DONALDSON, David

    2006-01-01

    This paper reviews the welfarist approach to population ethics. We provide an overview of the critical-level utilitarian population principles and their generalized counterparts, examine important properties of these principles and discuss their relationships to other variable-population social-evaluation rules. We illustrate the difficulties arising in population ethics by means of an impossibility result and present characterizations of the critical-level generalized-utilitarian principles ...

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. [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.

  3. 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

  4. 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

  5. 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…

  6. Combating Gangs: Better Coordination and Performance Measurement Would Help Clarify Roles of Federal Agencies and Strengthen Assessment of Efforts. Report to the Ranking Member, Committee on Oversight and Government Reform, House of Representatives. GAO-09-708

    Science.gov (United States)

    US Government Accountability Office, 2009

    2009-01-01

    The Department of Justice (DOJ) estimates that the United States has about a million gang members. While state and local agencies have primary responsibility for combating gang crime, the federal government has key roles to enforce laws and help fund programs to provide alternatives to gang membership for at-risk youth. GAO was asked to examine…

  7. [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.

  8. 75 FR 22751 - Federal Advisory Committee; Defense Advisory Committee on Military Personnel Testing; Charter...

    Science.gov (United States)

    2010-04-30

    ... studies to ensure that the tests have utility in predicting success in technical training and on the job... employees. In addition, all Committee members, with the exception of travel and per diem for official travel...

  9. 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.

  10. Assessing the animal ethics review process

    DEFF Research Database (Denmark)

    Varga, O.; Sandøe, Peter; Olsson, I.A.S.

    2012-01-01

    on ensuring that the animals are caused a minimum of harm relative to the possibility of achieving beneficial results. Even though rules in this area are reasonably uniform there seems to be significant room for differences, individual and culturally based, between ethics committees concerning how the rules...

  11. Authorship Ethics. ERIC/AE Digest.

    Science.gov (United States)

    Syrett, Kristen L.; Rudner, Lawrence M.

    The key ethical standards for authorship of educational research are summarized, drawing on "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" developed by the International Committee of Medical Journal Editors. Adopted by more than 500 scientific and biomedical journals, these standards are effective guidelines for…

  12. Ethical Issues in Collaborative Action Research

    Science.gov (United States)

    Locke, Terry; Alcorn, Noeline; O'Neill, John

    2013-01-01

    This article begins by raising issues around the way in which ethical approval for research is managed in university settings, where committees often base their assumptions on a principlist approach making a number of assumptions that we consider to be contestable, such as a neat separation between researcher and researched. However, collaborative…

  13. Architecture towards a new ethical challenge

    Directory of Open Access Journals (Sweden)

    Joseph Rykwert

    2015-11-01

    Full Text Available The most Pressing Challenge to any architect seems to me the ethical one. Always to see the client as a person,as an interlocutor however anonymous they may seem, however committee-like the commissioning process — and to see their work as a dialogue with the client.

  14. Architecture towards a new ethical challenge

    OpenAIRE

    Joseph Rykwert

    2015-01-01

    The most Pressing Challenge to any architect seems to me the ethical one. Always to see the client as a person,as an interlocutor however anonymous they may seem, however committee-like the commissioning process — and to see their work as a dialogue with the client.

  15. 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

  16. 78 FR 44519 - Forest Resource Coordinating Committee

    Science.gov (United States)

    2013-07-24

    ... advice on the allocation of funds, including the competitive funds set-aside for Competitive Allocation of Funds Innovation Projects (Sections 8007 and 8008 of the Food, Conservation, and Energy Act of... members. The members appointed to the Committee will be fair and balanced in terms of points of view...

  17. Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

    Science.gov (United States)

    Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

    2013-04-01

    Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or

  18. 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...

  19. 78 FR 57671 - Advisory Committee on International Postal and Delivery Services; Membership Renewals

    Science.gov (United States)

    2013-09-19

    ... services. The Advisory Committee on International Postal and Delivery Services was created in accordance... Officer of the Advisory Committee on International Postal and Delivery Services has opened the application... members. Requirements: Members of the Advisory Committee on International Postal and Delivery Services...

  20. 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.

  1. 77 FR 19007 - Renewal of Department of Defense Federal Advisory Committees

    Science.gov (United States)

    2012-03-29

    ... members appointed by the Secretary of Defense who have experience with the military or with women's... voting rights on the Committee or its subcommittees, shall not count toward the Committee's total... Committee. SUMMARY: Under the provisions of the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix...

  2. 75 FR 57102 - Advisory Committee on International Postal and Delivery Services

    Science.gov (United States)

    2010-09-17

    ... a meeting of the Advisory Committee on International Postal and Delivery Services. This Committee... and delivery services of interest to Advisory Committee members and the public. Public input: Any... Committee on International Postal and Delivery Services. Dated: September 3, 2010. Dennis M. Delehanty...

  3. 76 FR 15028 - Advisory Committee on International Postal and Delivery Services

    Science.gov (United States)

    2011-03-18

    ... a meeting of the Advisory Committee on International Postal and Delivery Services. This Committee... and delivery services of interest to Advisory Committee members and the public. Public input: Any... DEPARTMENT OF STATE [Public Notice: 7324] Advisory Committee on International Postal and Delivery...

  4. 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.

  5. 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...... promised better services for lower costs. Despite the positive intention, such reforms have not always been received as such by front line nurses, who often see an opposition between these processes with their focus on efficiency and the fundamental values of nursing. In this climate, nurse managers......, 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...

  6. 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...... 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...... 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...

  7. 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...

  8. 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.

  9. 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…

  10. 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.

  11. Knowledge awareness and attitude about research ethics among dental faculties in India.

    Science.gov (United States)

    Gopinath, Nithin Manchery; John, Joseph; Senthilkumar, E; Nagappan, N

    2014-09-01

    The aim of this study was to assess the level of knowledge, awareness and attitude about research ethics and research ethics committees (RECs) among dental faculties. This cross-sectional questionnaire study incorporated a self administered questionnaire. Descriptive, Chi-square and logistic regression analysis was used to analyze the data. The overall response rate to the study was 85%. More than half were familiar with research ethics, principles and functions of the research ethics committee. Though there were some faculties whose attitude regarding research ethics principle was not optimal. The present study revealed a broad acceptance among the faculties acceptance toward RECs and training in research ethics, though there existed certain gap in knowledge about research among the faculties. This will help us to understand the knowledge, awareness and attitudes of dental faculties toward research ethics, which will help the institutional officials to develop better educational programs in the field of research ethics in order to help them conduct better research henceforth.

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. Overview on health research ethics in Egypt and North Africa.

    Science.gov (United States)

    Marzouk, Diaa; Abd El Aal, Wafaa; Saleh, Azza; Sleem, Hany; Khyatti, Meriem; Mazini, Loubna; Hemminki, Kari; Anwar, Wagida A

    2014-08-01

    Developing countries, including Egypt and North African countries, need to improve their quality of research by enhancing international cooperation and exchanges of scientific information, as well as competing for obtaining international funds to support research activities. Research must comply with laws and other requirements for research that involves human subjects. The purpose of this article is to overview the status of health research ethics in Egypt and North African countries, with reference to other Middle Eastern countries. The EU and North African Migrants: Health and Health Systems project (EUNAM) has supported the revision of the status of health research ethics in Egypt and North African countries, by holding meetings and discussions to collect information about research ethics committees in Egypt, and revising the structure and guidelines of the committees, as well as reviewing the literature concerning ethics activities in the concerned countries. This overview has revealed that noticeable efforts have been made to regulate research ethics in certain countries in the Middle East. This can be seen in the new regulations, which contain the majority of protections mentioned in the international guidelines related to research ethics. For most of the internationally registered research ethics committees in North African countries, the composition and functionality reflect the international guidelines. There is growing awareness of research ethics in these countries, which extends to teaching efforts to undergraduate and postgraduate medical students. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  17. The adequacy of the ethics review process in Malaysia: protection of the interests of mentally incapacitated adults who enrol in clinical trials

    OpenAIRE

    Kaur, S.

    2011-01-01

    The objective of this thesis is to answer the question, “does the ethics committee review process in Malaysia provide meaningful protection to mentally incapacitated adults who enrol in clinical research trials?” This question is answered by examining three important aspects of the ethics review process. First, the quality of the deliberations of ethics committees is examined by looking at the underlying principles that are meant to guide ethics decision-making. Second, the ...

  18. 17 CFR 200.57 - Relationships with other members.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Relationships with other members. 200.57 Section 200.57 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Canons of Ethics § 200.57 Relationships with...

  19. 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...

  20. 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

  1. 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

  2. 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)

    2014-01-01

    Background 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. Methods 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. Results 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. Conclusions This investigation of the Ouargaye project serves to illuminate the distinctive

  3. 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

  4. 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.

  5. 75 FR 27857 - Meeting of Advisory Committee on International Communications and Information Policy

    Science.gov (United States)

    2010-05-18

    ... issues, and international market access issues. Members of the public may submit suggestions and comments... DEPARTMENT OF STATE [Public Notice 6973] Meeting of Advisory Committee on International Communications and Information Policy The Department of State's Advisory Committee on International...

  6. 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.

  7. [Ethics and occupational physicians: ethics and mission required for occupational physicians].

    Science.gov (United States)

    Fujino, Akihiro

    2013-10-01

    The ethics of occupational physicians are considered from the following three viewpoints: (1) their legal standing and ethics in job execution; (2) ethics in research in occupational medicine; and (3) ethics in the 21st century and fundamental issues. We discuss: in (1), the contract types of occupational physicians and their independency and neutrality, the protection of health information and privacy, and the use of authority and the security measures; in (2), ethical standards of medical research in Japanese and international organizations, the significance and role of ethics committees, and issues characteristic of occupational health research; and in (3), occupational physicians and politic ethics, the practical abilities and ethics necessary for occupational physicians, and the practice and philosophy of occupational medicine as an art. These considerations suggest that occupational physicians, who have a special status based on the governmental policy of the occupational physician system, should develop an ethical consciousness at the core of their duties and perform their mission with responsibility to employees and employers, all of whom are Japanese citizens. Finally, we propose that the ultimate mission of occupational physicians is "to practice occupational medicine as a branch of the humanities."

  8. 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…

  9. Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

    Directory of Open Access Journals (Sweden)

    McRae Andrew D

    2013-01-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1 ethical challenges in CRTs; (2 the ethics review process for CRTs; and (3 the need for comprehensive ethics guidelines for CRTs. Methods Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers. Results Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees. Conclusions Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

  10. Computer and Applied Ethics

    OpenAIRE

    越智, 貢

    2014-01-01

    With this essay I treat some problems raised by the new developments in science and technology, that is, those about Computer Ethics to show how and how far Applied Ethics differs from traditional ethics. I take up backgrounds on which Computer Ethics rests, particularly historical conditions of morality. Differences of conditions in time and space explain how Computer Ethics and Applied Ethics are not any traditional ethics in concrete cases. But I also investigate the normative rea...

  11. Institutional Animal Care and Use Committee Considerations for the Use of Wildlife in Research and Education.

    Science.gov (United States)

    Sikes, Robert S; Bryan, John A

    2016-01-01

    Ethical and effective oversight of the use of wildlife species in research and education requires consideration of issues and methods not relevant to work with traditional laboratory or domesticated animals, just as the effective oversight of biomedical research requires consideration of issues and methods not germane to wildlife research. Institutional Animal Care and Use Committees or other institutional review committees can meet their responsibilities in these disparate types of animal activities only by using resources tailored to the animals and situations encountered. Here we review the issues and the resources that facilitate effective oversight of such activities in the wildlife research arena available to researchers, institutional review committees, regulatory bodies, and accrediting bodies. Issues covered include an understanding of the fundamental differences between wildlife research and biomedical research; the profound differences between wildlife species and traditional laboratory subjects, most of which are domesticated animals; and the unique issues presented when the research subjects are members of wild populations and communities. We review the resources available for effective oversight of wildlife projects and emphasize that competent oversight of wildlife research demands the use of appropriate resources. These resources include guidelines designed for the use of wild species (taxon-specific guidelines) and protocol forms tailored for the species and situations encountered. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  12. 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.

  13. A mixed-method systematic review: support for ethical competence of nurses.

    Science.gov (United States)

    Poikkeus, Tarja; Numminen, Olivia; Suhonen, Riitta; Leino-Kilpi, Helena

    2014-02-01

    The aim was to appraise and synthesize evidence of empirical studies of how nurses' ethical competence can be supported. Ethical competence is an essential element of nursing practice. Nurses increasingly need support in competence when carrying out their responsibilities towards their patients. A mixed-method systematic review of quantitative and qualitative studies was undertaken according to the University of York's Centre for Reviews and Dissemination guidelines. Searches of MEDLINE, Nursing Database and British Nursing Index databases were conducted, yielding 512 citations between 1985-2012. After a two-stage application of inclusion and exclusion criteria, 34 articles were included. The quality of the studies was assessed using STROBE or COREQ criteria. Data were analysed by content analysis. Nurses' ethical competence has been studied from different viewpoints: ethical decision-making, ethical sensitivity, ethical knowledge and ethical reflection. There was little empirical evidence of provided support, but studies offered recommendations on how to support ethical competence. The most common strategies to support ethical competence were ethics education, ethics rounds, ethics committee and consultation. Nurse leaders and colleagues have a key role in providing opportunities for nurses to gain ethical competence. There is a need to develop evidence-based support at the organizational and individual level to support nurses' ethical competence. Barriers for multiprofessional cooperation in ethical issues should be recognized and addressed as part of the development of organizational ethical practices. Research should pay more attention to the conceptual, theoretical and practical perspectives of ethical competence. © 2013 John Wiley & Sons Ltd.

  14. 17 CFR 200.735-8 - Practice by former members and employees of the Commission.

    Science.gov (United States)

    2010-04-01

    ... interests of the Commission. 21 This definition is taken from Formal Opinion 342 of the ABA Ethics Committee... EXCHANGE COMMISSION ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Regulation Concerning... in which he had substantial responsibility while he was a public employee’) from subsequent private...

  15. Environmental ethics.

    Science.gov (United States)

    Steinberg, J J

    2000-03-01

    The U.S. Environmental Protection Agency (EPA) held the first meeting on environmental ethics sponsored by the Scientific Advisory Panel and Board on 10-11 December 1998 in Arlington, Virginia (1). The report from the meeting will more completely inform scientists and the community of current issues. This editorial should serve as an initial brief of this meeting [which was held on the fiftieth anniversary of the Declaration of Human Rights (adopted by the United Nations on 10 December 1948)].

  16. 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.

  17. The Mineral Physics Committee

    Science.gov (United States)

    Mineral Physics Committee members for the period July 1, 1986, to J ne 30, 1988, have been announced. They are Murli H. Manghnani (Hawaii Institute of Geophysics, Honolulu), and Orson L. Anderson (University of California, Los Angeles), Thomas J. Ahrens (California Institute of Technology, Pasadena, Calif.), Subir K. Banerjee (University of Minnesota, Minneapolis), William A. Bassett (Cornell University, Ithaca, N.Y.), Gordon E. Brown, Jr. (Stanford University, Stanford, Calif.), Michael Brown (University of Washington, Seattle), Robert M. Hazen (Geophysical Laboratory, Washington, D.C.), Raymond F. Jeanloz (University of California, Berkeley), Robert C. Liebermann (State University of New York (SUNY),(Stony Brook), Alexandra Navrotsky (Princeton University, Princeton, N.J.), Robert N. Schock (Lawrence Livermore National Laboratory, Livermore, Calif.), and Donald J. Weidner (SUNY Stony Brook).

  18. [The biologization of ethics].

    Science.gov (United States)

    Moreno Lax, Alejandro

    2010-01-01

    Three ethics exist as a condition of possibility of any possible ethics, following a material and biological foundation. This content argument (not logical-formal) supposes a refutation of the naturalistic fallacy that the analytical philosophy attributes to Hume, in three areas of the ethical human experience: body, society and nature. These are: the ethics of the species [J. Habermas], the ethics of liberation [E. Dussel] and the ethics of the responsibility [H. Jonas]. This material argument is a philosophical foundation to considering for three types of applied ethics: medical bioethics, development ethics and environmental ethics.

  19. 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...

  20. 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?