Research ethics on the agenda - the debates preceding the establishment of the ethics committees.

PubMed

Paulsen, Nadia Shad; Lie, Anne Kveim

2016-11-01

BACKGROUND This article examines two factors that helped to trigger and drive forward the debate about research ethics committees (now the Regional Committees for Medical and Health Research Ethics) in Norway in the 1970s: the revision of the Declaration of Helsinki by a Scandinavian working group, and the unfolding of the so-called Gro case in the Norwegian national media.METHOD We have used existing literature in the form of books and articles on the history of research ethics from the University Library of the University of Oslo, the National Library of Norway, the History of Science, Technology and Medicine database, and Retriever. We have manually reviewed issues of the Dagbladet daily newspaper from 1974, and relevant volumes of the Journal of the Norwegian Medical Association from the 1960s and 1970s. Finally, we have used the archives of the Norwegian Association of Higher Education Institutions, and the Faculty of Social Sciences at the University of Oslo.RESULTS The World Medical Association's revision of the Declaration of Helsinki in 1975 stipulated the use of independent ethics committees for the assessment and supervision of research projects. The Gro case, which concerned the testing of behavioural therapeutic treatment on a young girl resident in an institution and the ensuing public debate, led to a demand from the public for closer monitoring and ethical regulation of research activity.INTERPRETATION Both of the events mentioned were used actively in the argumentation and preparatory work for the establishment of research ethics committees.

[Legal repercussions of Clinical Ethics Committees reports].

PubMed

Couceiro V, Azucena; Beca I, Juan Pablo

2006-04-01

Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.

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

PubMed Central

Tully, Joanna; Ninis, Nelly; Booy, Robert; Viner, Russell

2000-01-01

Objective To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. Design 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. Setting A single multicentre research ethics committee and 125 local ethics committees from six regions of England. Main outcome measures Time to reply, time to approval, and number of non-local changes to the application requested. Results 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. Conclusions 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. PMID:10784541

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

PubMed

Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

2015-01-01

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

The role of national ethics commissions in Finland.

PubMed

Halila, Ritva

2003-08-01

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

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

PubMed

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.

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

PubMed

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

Committees for Ethics in Research involving human subjects.

PubMed

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

2008-01-01

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

Human research ethics committees: examining their roles and practices.

PubMed

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.

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

PubMed

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.

Human research ethics committees in technical universities.

PubMed

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.

Evolution of Ethics in Clinical Research and Ethics Committee

PubMed Central

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013. PMID:28794547

Evolution of Ethics in Clinical Research and Ethics Committee.

PubMed

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013.

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

PubMed

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.

Ethics committees, organ transplantation and public policy.

PubMed

Dickens, Bernard M

1992-01-01

It is clear that ethics committees face many dilemmas in developing sound public policy on organ transplantation through their roles in serving their institutions and their communities. With conscientiousnes and good faith, different committees may adopt different approaches to the same issue, and arrive at different solutions when subscribing to the same approach. It is valuable that committee members should be aware of other committees' approaches and disclose the reasons for their own in a frank, non-defensive way. It should also be remembered that a measure of legitimacy can attach to ethics committees' decisions because of the integrity with which their decisions are reached, even when they differ from other committees' decisions. Like courts of law, their decisions carry weight because of how they are reached, not simply because of how they comport with the judgments of others. This is not to say that every or any legally permissible policy is ethically sound, but only that ethics committees can contribute to public satisfaction that institutions are under reliable control through the demonstrable integrity and competence of their processes of policy making.

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

PubMed

Bain, Luchuo Engelbert

2017-01-01

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

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

PubMed

Weber, L J

1997-01-01

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

Factors influencing the effectiveness of research ethics committees.

PubMed

Schuppli, C A; Fraser, D

2007-05-01

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

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

PubMed Central

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

Report of the Ethics Committee, 2008

ERIC Educational Resources Information Center

American Psychologist, 2009

2009-01-01

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

Rebuilding a Research Ethics Committee

ERIC Educational Resources Information Center

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,…

Ethics Committees and Mental Health.

PubMed

Yepes Delgado, Carlos Enrique; Ocampo Montoya, Andrea

Although research processes are covered by the objectivity of science, they are still influenced by the interests of those who conduct them. This is why high level committees have been tasked with defining the scope of the studies and performing a thorough assessment of them, since these imply great dilemmas. This premise leads to the emergence of Ethics Committees, where liaison psychiatry has an important place due to its communication abilities and knowledge of the human behavior. This paper attempts to provide some observations to take into account when discussing the link between ethics and mental health. In this work, the authors approach the question of ethics committees and the importance that psychiatrist performance has within them. This is done through a review of relevant papers on the subject. A detailed description on research ethics is provided in terms of justification, purpose and duties. Likewise, emphasis is placed on each of the areas in which psychiatrists are involved and bear great responsibilities in the medical decision-making process. Similarly, this description also includes the moment in which participants give their informed consent when taking part in medical research. Finally, we conclude that there are several questions regarding the relevance given to these committees in the methodological and ethical assessment of research projects. This in turn implies greater effort in the search for a culture of quality which highlights the emphasis on research subjects. Copyright © 2017 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

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

PubMed

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.

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

PubMed

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

2017-03-01

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

Report of the Ethics Committee, 2010

ERIC Educational Resources Information Center

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…

Report of the Ethics Committee, 2009

ERIC Educational Resources Information Center

American Psychologist, 2010

2010-01-01

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

The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.

PubMed

Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

2005-10-17

Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.

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

PubMed

Courtwright, Andrew; Jurchak, Martha

2016-01-01

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

The job of 'ethics committees'.

PubMed

Moore, Andrew; Donnelly, Andrew

2015-11-13

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

Institutional Ethics Committee Regulations and Current Updates in India.

PubMed

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

2017-08-01

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

[Lawyer members of a hospital ethics committee, a training in bioethics?].

PubMed

Mathieu, Géraldine; Rommelaere, Claire

2013-01-01

As lawyer members of a hospital ethics committee, we wanted to address the question if being part of such a committee allowed us to call ourselves "bioethicists". Before answering, it is important to put Belgian hospital ethics committees in context, firstly by explaining their missions: defining general ethical guidelines in order to help physicians in their practice, providing for punctual advice and assessing every clinical research protocol which is proposed to a physician of the hospital. Theoretical information concerning the missions of Belgian hospital ethics committees is the opportunity to develop some thinking elements of about the role and duties of those committees. We can then wonder who are or should be the members of hospital ethics committees: what does the law say and what to think about it? Questions about ethics committees'missions and members allow us to come to the conclusion that the mere fact of being member of a hospital ethics committee is not enough to call oneself a bioethicist. On the one hand, experience should be accompanied by proper training; on the other hand, one should always be aware that "becoming a bioethicist" is a never ending journey.

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

PubMed

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.

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

PubMed

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

2009-04-01

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

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

ERIC Educational Resources Information Center

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…

Physicians' and nurses' expectations and objections toward a clinical ethics committee.

PubMed

Jansky, Maximiliane; Marx, Gabriella; Nauck, Friedemann; Alt-Epping, Bernd

2013-11-01

The study aimed to explore the subjective need of healthcare professionals for ethics consultation, their experience with ethical conflicts, and expectations and objections toward a Clinical Ethics Committee. Staff at a university hospital took part in a survey (January to June 2010) using a questionnaire with open and closed questions. Descriptive data for physicians and nurses (response rate = 13.5%, n = 101) are presented. Physicians and nurses reported similar high frequencies of ethical conflicts but rated the relevance of ethical issues differently. Nurses stated ethical issues as less important to physicians than to themselves. Ethical conflicts were mostly discussed with staff from one's own profession. Respondents predominantly expected the Clinical Ethics Committee to provide competent support. Mostly, nurses feared it might have no influence on clinical practice. Findings suggest that experiences of ethical conflicts might reflect interprofessional communication patterns. Expectations and objections against Clinical Ethics Committees were multifaceted, and should be overcome by providing sufficient information. The Clinical Ethics Committee needs to take different perspectives of professions into account.

Legal aspects of clinical ethics committees.

PubMed

Hendrick, J

2001-04-01

In an increasingly litigious society where ritual demands for accountability and "taking responsibility" are now commonplace, it is not surprising that members of clinical ethics committees (CECs) are becoming more aware of their potential legal liability. Yet the vulnerability of committee members to legal action is difficult to assess with any certainty. This is because the CECs which have been set up in the UK are--if the American experience is followed--likely to vary significantly in terms of their functions, procedures, composition, structures and authority. As a consequence it is difficult to generalize about the legal implications. Nevertheless, despite these difficulties this article will outline the broad legal principles governing the potential liability of committee members. It will also consider the relationship between CECs and the courts. It begins, however, with a brief analysis of the relationship between ethics and law in committee deliberations, and in particular of the role of law and legal expertise on CECs.

Ethics committees in India: Facing the challenges!

PubMed Central

Kadam, Rashmi; Karandikar, Shashikant

2012-01-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves. PMID:22701820

Ethics committees in India: Facing the challenges!

PubMed

Kadam, Rashmi; Karandikar, Shashikant

2012-04-01

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

Enhancing the use of institutional ethics committees in mental health care in Israel.

PubMed

Bergman-Levy, Tal; Doron, Adiel; D Strous, Rael

2014-01-01

Institutional ethics committees were established and functioned in Israel prior to the application of the Patients Rights Act of 1996. These committees were voluntary and comprised of multidisciplinary teams in order to obtain numerous viewpoints stemming from various different fields. This intent was based on an understanding that the issue of ethics and the process of making ethical decisions inherently address moral and social considerations which are beyond the realm of medical practice. In contrast to the voluntary institutional ethics committees, the Patients Rights Act of 1996 instituted statutory ethics committees. These committees were mandated to investigate defined areas and, in contrast to the former committees that were considered to be valuable as advisory and enlightening entities, their decisions are binding. However, it appears that the utilization of these ethics committees within the domain of mental health facilities is limited in scope and their use varies greatly between institutions. The employment of these committees in mental health institutions focuses mainly around issues that relate to information management and mentally ill patients' refusal of medical treatment. Several explanations exist for this phenomenon. Suggestions as to how the situation may be remedied are addressed as well as the complementary role that these ethics committees may play in modern day clinical practice.

Knowledge about the research and ethics committee at Makerere University, Kampala.

PubMed

Ibingira, B R; Ochieng, J

2013-12-01

All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect human participants' interests, rights and welfare. To evaluate researchers' knowledge about the functions and ethical review process of the College of Health Sciences research and ethics committee. A cross sectional study. 135 researchers consented to participate in the study, but 70 questionnaires were answered giving a 52% response. Age ranged between 30 to 61 years, majority of participants 30-39 years. 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. More than 97% of the respondents believe that the REC is either average or very good, while 2.8% rank it below average. Respondents knew the major functions of the committee including protection of the rights and welfare of research participants, protocol review and monitoring of on going research, and the elements of protocol review that are given more attention include ;scientific design and ethical issues. Overall performance of the REC was ranked as average by respondents. The committee should limit delays in approval and effectively handle all functions of the committee.

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

PubMed Central

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

2016-01-01

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. PMID:26811365

[Ethics committees in the experience of the IMSS: a Latin American instance].

PubMed

Valdez-Martínez, Edith; Mata-Valderrama, Guadalupe; Bedolla, Miguel; Fajardo-Dolci, Germán Enrique

2015-01-01

The aim of this article is to identify the current state of hospital bioethics committees and local research ethics committees of the Mexican Institute of Social Security (IMSS). A descriptive cross-sectional study was performed that included all hospitals of the IMSS (N = 262). Two self-administered questionnaires were e-mailed between october and november 2014 to the hospital directors: one for hospital bioethics committees and another for local research ethics committees. Both questionnaires had five sections: committee location, date of committee set up, activity situation, composition, functions, and experience. The response rate was 85 %. It was reported 150 active hospital bioethics committees and 67 active local research ethics committees. In both groups physicians and executive directors dominated committees' membership, and lay people were reported only in seven hospital bioethics committees. The primary function of hospital bioethics committees was case consultation, and their primary goal "to improve the quality of medical care". Local Research Ethics Committees reported as primary function "to evaluate health research protocols and rule of them", and as their primary goal "to protect the rights and wellbeing of the research subjects". Both groups of committees ought to be assessed regularly through audit cycles in order to identify the educative actions that enhance their efficiency.

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

PubMed Central

Coleman, Carl H; Bouësseau, Marie-Charlotte

2008-01-01

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 studies? Second, does the

Report of the ASCA Ethics Committee: 1997-1999.

ERIC Educational Resources Information Center

Dansby-Giles, G.; Carpenter, J.; Howes, J.; Hubert, R. M.; Huss, S. Norris; Kraus, K.; Reed, S.; Thomas, R.; Whitledge, J.

Ethical inquiries processed by the Ethics Committee of the American School Counselor Association (ASCA) were reviewed for the years 1997-1999. During the first years, 38 inquiries were reported. In the following year, the Ethical Standards for School Counselors was published and that helped drop the number of inquiries. The topical areas of…

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

PubMed

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.

Hospital/clinical ethics committees' notion: an overview

PubMed Central

Hajibabaee, Fatemeh; Joolaee, Soodabeh; Cheraghi, Mohammad Ali; Salari, Pooneh; Rodney, Patricia

2016-01-01

Hospital ethics committees (HECs) help clinicians deal with the ethical challenges which have been raised during clinical practice. A comprehensive literature review was conducted to provide a historical background of the development of HECs internationally and describe their functions and practical challenges of their day to day work. This is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases. The keyword ethics committee, combined with hospital, clinic, and institution, was used without a time limitation. All original and discussion articles, as well as other scientific documents were included. Of all the articles and theses found using these keywords, only 56 were consistent with the objectives of the study. Based on the review goals, the findings were divided into three main categories; the inception of HECs in the world, the function of HECs, and the challenges of HECs. According to the results, the Americas Region and European Region countries have been the most prominent considering the establishment of HECs. However, the majority of the Eastern Mediterranean Region and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The results highlight the status and functions of HECs in different countries and may be used as a guide by health policymakers and managers who are at the inception of establishing these committees in their hospitals. PMID:28523118

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

PubMed

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.

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

PubMed

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/

Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives.

PubMed

Altavilla, A; Manfredi, C; Baiardi, P; Dehlinger-Kremer, M; Galletti, P; Pozuelo, A Alemany; Chaplin, J; Ceci, A

2012-01-01

To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research. Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials project set up an inventory of Ethics Committees existing in Europe and conducted a survey on their approach to paediatric trials. Ethics Committees operating in 22 European Countries participated in this survey. Results showed a high lack of knowledge, understanding and awareness of the current European paediatric regulatory framework and a lack of involvement of Ethics Committees in paediatric research, especially in terms of training and education, demonstrated also by the decreasing number of Ethics Committees answering exhaustively to the whole questionnaire. The majority of participating Ethics Committees expressed interest in future initiatives related to paediatric research. Despite a limited knowledge and understanding of the current paediatric regulatory framework, a significant number of Ethics Committees operating in Europe show interest in initiatives related to paediatric research. Networking may be an essential tool to be used to enhance Ethics Committees role in supporting paediatric research. Any initiative should be undertaken at European level in collaboration with European Union Institutions. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

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

PubMed

Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

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

Hospital based ethics, current situation in France: between “Espaces” and committees

PubMed Central

Guerrier, M

2006-01-01

Unlike research ethics committees, which were created in 1988, the number of functioning hospital based ethical organisations in France, such as clinical ethics committees, is unknown. The objectives of such structures are diverse. A recent law created regional ethical forums, the objectives of which are education, debate, and research in relation to healthcare ethics. This paper discusses the current situation in France and the possible evolution and conflicts induced by this law. The creation of official healthcare ethics structures raises several issues. PMID:16943328

Error reduction, patient safety and institutional ethics committees.

PubMed

Meaney, Mark E

2004-01-01

Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.

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

PubMed

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.

Ethics committees in New Zealand.

PubMed

Gillett, Grant; Douglass, Alison

2012-12-01

The ethical review of research in New Zealand after the Cartwright Report of 1988 produced a major change in safeguards for and empowerment of participants in health care research. Several reforms since then have streamlined some processes but also seriously weakened some of the existing safeguards. The latest reforms, against the advice of various ethics bodies and the New Zealand Law Society, further reduced and attenuated the role of ethics committees so that New Zealand has moved from being a world leader in ethical review processes to there being serious doubt whether it is in conformity to international Conventions and codes. The latest round of reforms, seemingly driven by narrow economic aspirations, anecdote and innuendo, have occurred without any clear evidence of dysfunction in the system nor any plans for the resourcing required to improve quality of ethical review or to audit the process. It is of serious concern both to ethicists and medical lawyers in New Zealand that such hasty and poorly researched changes should have been made which threaten the hard-won gains of the Cartwright reforms.

Institutional ethics committees as social justice advocates.

PubMed

Farley, M A

1984-10-01

The idea of involvement in social justice issues transcends the traditional responsibilities of most institutional ethics committees (IECs). Yet precedents for such an advocacy role exist in several areas: the development of regulations that protect handicapped newborns from discriminatory decisions of nontreatment and the institutional committees that review research protocols or formulate "do not resuscitate" policies. The need for IECs to take up social justice issues is based in the concepts of autonomy--the capacity for freedom of choice--and relationality--the capacity to known and to love. All the human ethical questions of freedom, well-being, and justice emerge in the health care setting, where the concepts of autonomy and relationality are intently focused on and sometimes threatened. If a health care institution is to address such questions as affirmative action policies in financing and purchasing, the just pricing of medical care, the ethics of treatment decisions, and the right to medical care, it needs a forum in which to deliberate, collaborate, and discern responsible corporate moral action. For example, an ethics committee can: Call for correction of problems of sexism, racism, and classism in health care institutions; Address government regulations in a way that enables a better understanding of professional commitments; and Lead facilities to discover ways to network with others to meet the needs of the populations they serve. Above all, IECs can help health care professionals find a new "hermeneutic" for interpreting the health care mission to allow them greater power to respond to the dignity and the needs of human persons.

APPLYING RESEARCH ETHICS GUIDELINES: THE VIEW FROM A SUB-SAHARAN RESEARCH ETHICS COMMITTEE

PubMed Central

Henderson, Gail E.; Corneli, Amy L.; Mahoney, David B.; Nelson, Daniel K.; Mwansambo, Charles

2009-01-01

Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations. PMID:19385794

Research ethical committees in Scotland.

PubMed Central

Thompson, I E; French, K; Melia, K M; Boyd, K M; Templeton, A A; Potter, B

1981-01-01

A questionnaire was sent to 41 ethical committees in Scotland requesting information about their constitution and supervision of clinical research. Thirty-four (83%) replies were received. Committees varied in size from one to 73 members, most of whom were medical. Ten had no nurse members and only three had lay members without direct NHS connections. Sixteen saw their role as advisory rather than supervisory. Thirteen had not met in the past year whereas two had held 10 or more meetings. Limited use (12) was made of standard protocols, and only six had formal procedures for monitoring research in progress. Only seven of 370 proposals were rejected outright. Risk/benefit dilemmas and difficulties relating to informed consent were the commonest problems encountered. The committees provide only limited safeguards for patients and research workers, and more effective, standardised procedures are indicated. PMID:6781629

[Clinical ethics committees in Mexico: their development in the Mexican Institute of Social Security].

PubMed

Valdez-Martínez, Edith; Bedolla, Miguel

2007-01-01

The Mexican Institute of Social Security (IMSS) considers the relevance of ethics in a similar context than other countries have developed. According to these considerations, IMSS implemented formally of system of local committees on clinical ethics (CLEC), not only to provide support when ethical dilemmas emerge, but to facilitate the development of an ethics culture among health professionals. The implementation of the CLEC network started in 2004, and since then, its number has increased across the country. Currently IMSS has 78 CLECs. Their number continues to grow due to the level of awareness about the importance of ethics for making medical decisions. In November 2006 the first CLEC national meeting was held and the need to redefine strategies to improve performance of CLECS emerged. This article reports the current situation of the CLECs in Mexico.

The Special Educator and the Hospital Ethics Committee.

ERIC Educational Resources Information Center

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…

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Justice in jeopardy: a qualitative study of institutional ethics committees in New Delhi.

PubMed

Kandhari, Rohini

2013-01-01

Protecting the safety and welfare of clinical trial subjects is the primary responsibility of the multidisciplinary ethics committee. In India, ethics committees have come under increasing criticism for functioning as "secret societies unaccountable to the public" (1). Yet, little effort has been made to undertake qualitative research on the ethics review bodies. This article describes the essential findings of a study that aimed at providing an insight into the structure and functioning of institutional ethics committees (IECs) in selected hospitals in Delhi. Importantly, the study also attempted to investigate the challenges faced by IEC members that pose barriers to IEC performance and thus jeopardise a just and effective system of protection for the human trial subject.

Medical dominance within research ethics committees.

PubMed

Humphreys, Stephen; Thomas, Hilary; Martin, Robyn

2014-01-01

Qualitative research is reported which explores the perceptions of members of the U.K.'s independent Phase I ethics committees (IECs) about key issues identified following a literature review. Audio-recorded interviews were conducted with ten expert and ten lay members from all IECs except the one to which the lead author was attached. Transcripts were thematically analyzed following a broadly hermeneutical approach. The findings-dealing with such matters as recruitment strategies and length of service; attitudes towards member categories, published ethics guidelines, and the adequacy of insurance; levels of training and views on achieving a recognised level of competence-have an intrinsic interest, but it is when the findings are considered collectively using Freidson's theory of professional dominance that they reveal the influence the medical profession can have in shaping ethics review.

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

PubMed

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.

[Ethical issue in animal experimentation].

PubMed

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.

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

PubMed

Fazly Bazzaz, Bibi Seddigheh; Sadeghi, Ramin

2012-09-01

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

The untimely death of the UK Donation Ethics Committee.

PubMed

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/.

Ethics of emergency department triage: SAEM position statement. SAEM Ethics Committee (Society for Academic Emergency Medicine).

PubMed

1995-11-01

Emergency department overcrowding, the growth of managed care, and the high cost of emergency care are creating pressures to triage patients away from U.S. EDs. Paradoxically, this pressure to limit patient access to EDs has increased in spite of federal laws that restrict patient triage and transfer. The latter regulations view EDs as the safety net for the U.S. health care system. The SAEM Ethics Committee evaluated the ethical implications of policies that triage patients out of the ED prior to complete evaluation and treatment. The committee used these implications to develop practical guidelines, which are reported.

The Israeli abortion committees' process of decision making: an ethical analysis.

PubMed

Rimon-Zarfaty, Nitzan; Jotkowitz, Alan

2012-01-01

The Israeli law of abortions (1977) legally authorises hospital committees to decide upon women's requests for selective abortion. One of the law's clauses determines that abortions can be approved in cases of an embryopathy. However, the law does not provide any clear definitions of those fetal 'physical or mental defects' in terms of severity and/or likelihood, which remain open to interpretation by the committee members. This paper aimed to determine which ethical methodologies are used by committee members and advisors as they face the dilemma of abortion approval due to mild to moderate possible embryopathy. Twenty interviews demonstrated that they use mainly a combination of deontology and a contextual-relational model. Their ethical considerations are both contextual such as the family's/woman's relational network and are influenced by the ethical principles of autonomy and in cases of late abortions the value of life. The findings reveal a paradoxical picture: on the one hand, committee members hold liberal perceptions and in practice abortion requests are very seldom rejected. On the other hand, the Israeli abortion law and practice of abortion committees is still problematical from liberal and feminist rights perspectives. This paradox is discussed further by reflecting upon the relevant theory as well as the Israeli context. The paper concludes by suggesting that within the specific Israeli sociopolitical climate the requirement for committee approval of what should be a private decision might be necessary in order to placate religious or other opposition to abortion.

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC

PubMed Central

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-01-01

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure. PMID:26343188

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC.

PubMed

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-04-14

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure.

Ethics Committee Consultation and Extracorporeal Membrane Oxygenation.

PubMed

Courtwright, Andrew M; Robinson, Ellen M; Feins, Katelyn; Carr-Loveland, Jennifer; Donahue, Vivian; Roy, Nathalie; McCannon, Jessica

2016-09-01

The clinical ethics literature on extracorporeal membrane oxygenation (ECMO) has been focused primarily on identifying hypothetical ethical dilemmas that may arise with the use of this technology. Little has been written on the actual experience with ECMO-related ethical questions. To describe the role of an ethics consultation service during the expansion of a single-center ECMO program in a cardiothoracic surgery intensive care unit (CSICU) and to identify common ethical themes surrounding the use of ECMO. We conducted a retrospective, descriptive cohort study of all ECMO ethics consultation cases in the CSICU at a large academic hospital between 2013 and 2015. During the study period, 113 patients were placed on ECMO in the CSICU, 45 (39.5%) of whom were seen by the ethics committee. In 2013, 10 of 46 (21.7%) patients received ethics consults. By 2015, 28 of 30 (93.3%) of patients were seen by ethics consultants. Initial consultation occurred at a median of 2 days (interquartile range, 1-6 d) following initiation of ECMO. The most common ethical issue involved disagreement about the ongoing use of ECMO, which included multiple axes: Disagreement among health care providers, disagreement among surrogates, and disagreement between health care providers and surrogates over stopping or continuing ECMO. In our experience with integrating ethics consultation into the routine care of ECMO patients, most of the ethical questions more closely resembled traditional concerns about the appropriate use of any life-sustaining treatment rather than the novel dilemmas imagined in the current literature.

A syllabus for research ethics committees: training needs and resources in different European countries.

PubMed

Cairoli, Ester; Davies, Hugh T; Helm, Jürgen; Hook, Georg; Knupfer, Petra; Wells, Frank

2012-03-01

This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of this approach were discussed and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states.

Psychiatric research: what ethical concerns do LRECs encounter? A postal survey. Local research ethics committees.

PubMed

Osborn, D P J; Fulford, K W M

2003-02-01

Psychiatric research can occasionally present particular ethical dilemmas, but it is not clear what kind of problems local research ethics committees (LRECs) actually experience in this field. We aimed to assess the type of problems that committees encounter with psychiatric research, using a postal survey of 211 LRECs. One hundred and seven (51%) of those written to replied within the time limit. Twenty eight (26%) experienced few problems with psychiatric applications. Twenty six (24%) emphasised the value of a psychiatric expert on the committee. The most common issues raised were informed consent (n=64, 60%) and confidentiality (n=17, 16%). The use of placebos (and washout periods) (n=18, 17%), the validity of psychiatric questionnaires (n=16, 15%) and overuse of psychiatric "jargon" (n=14, 13%) in psychiatric applications also raised concern. Our results suggest that LRECs have specific concerns regarding methodology, consent, and confidentiality in psychiatric research, and that they find psychiatric input invaluable.

The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

PubMed Central

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

[The research ethics committees: the French example of the Comités de Protection des Personnes].

PubMed

Duprat, Jean-Pierre

2012-06-01

Succeeding to the CCPPRB as created by the statute of December 20, 1988, the CPP are the ethics committees foreseen by international texts dealing with research involving human beings. They were ruled by the statute of 9 August 9, 2004 and are partly modified by the last statute of March 5, 2012, settling a new classification of research, each category under a different set of rules. To solve difficulties arising from the number of committees (40), a new National Committee for research is created, working closely with the minister. Another purpose of the reform was to include the observational research to extend the area of research with opened access to international level for publications.

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

PubMed

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

Down’s syndrome screening is unethical: views of today’s research ethics committees

PubMed Central

Reynolds, T M

2003-01-01

Background: Screening for Down’s syndrome forms part of routine obstetric practice. Ethical considerations relating to genetic screening form a major part of the workload of research ethics committees. This study investigated the attitudes of research ethics committee members to several conditions varying in clinical severity and prognosis, including Down’s syndrome. Methods: The members of 40 randomly chosen research ethics committees were surveyed. A simple questionnaire comprising 19 clinical scenarios based around four “clinical” conditions was designed to review conditions that were potentially embarrassing, affecting life span but not mental ability, premature death, and intellectual impairment with a risk of neonatal cardiac defects (Down’s syndrome). Screening tests with different degrees of effectiveness were described and the diagnostic test descriptions ranged from having no risk to an unaffected fetus to causing spontaneous abortion of two normal fetuses for each affected fetus identified. Replies were graded on a scale of 1 to 5. Results: Seventy seven replies were received from 28 different research ethics committees. Screening was supported for treatment of a life threatening condition (95% in favour) but screening for conditions of a slight increase in premature death (14% in favour) or cosmetic features (10% in favour) were considered unethical. Views were ambiguous (49% in favour) about conditions involving significant shortening of lifespan. Down’s syndrome screening was considered more ethical when described as a serious condition (56% in favour) than when the clinical features were described (44% in favour). Once increased rates of spontaneous abortion on confirmatory testing were added, 79% (21% in favour) and 86% (14% in favour) stated that screening was unethical (for “serious” and “clinical features” descriptions, respectively). Conclusions: Down’s syndrome screening raises ethical concerns about genetic testing in

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

Proportional ethical review and the identification of ethical issues

PubMed Central

Hunter, D

2007-01-01

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. PMID:17400625

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

PubMed

van Wyk, Christa

2010-06-01

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

Health Research Ethics Committees in South Africa 12 years into democracy

PubMed Central

Moodley, Keymanthri; Myer, Landon

2007-01-01

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. PMID:17254335

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

PubMed

Mello, Anahi Guedes de

2016-10-01

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

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

PubMed

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.

Ethics committees and the legality of research

PubMed Central

Douglas, T M

2007-01-01

One role of research ethics committees (RECs) is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research (“the Claim”). I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the legality of their own research. I then consider three arguments against the Claim which may over‐ride this presumption—namely, that policy should instruct RECs to assess the legality of research because (1) doing so would minimise the costs of assessing the legality of research, (2) whether research is legal may partly determine whether it is ethical and (3) whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails. PMID:18055906

Research governance: new hope for ethics committees?

PubMed

Frew, Deborah; Martlew, Ainsley

2007-01-01

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

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

PubMed

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.

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

PubMed

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.

Stimulating debate: ethics in a multidisciplinary functional neurosurgery committee

PubMed Central

Ford, Paul J; Kubu, Cynthia S

2006-01-01

Multidisciplinary healthcare committees meet regularly to discuss patients' candidacy for emerging functional neurosurgical procedures, such as Deep Brain Stimulation (DBS). Through debate and discussion around the surgical candidacy of particular patients, functional neurosurgery programs begin to mold practice and policy supported both by scientific evidence and clear value choices. These neurosurgical decisions have special considerations not found in non‐neurologic committees. The professional time used to resolve these conflicts provides opportunities for the emergence of careful, ethical practices simultaneous with the expansion of therapy applications PMID:16446416

Medical ethics surveillance in the Armed Forces.

PubMed

Pearn, J

2000-05-01

Modern defense services depend on a policy of the vigorous promotion of research to ensure that they retain an advantage in any future operational context. Research involving personnel within the armed forces, however, has certain constraints with respect to contemporary, best-practice medical ethics. Service members are one example of a class of "captive subjects" who require special protection in the context of medical research. (Prisoners, students, children, and the intellectually disabled are other such examples.) The majority of national defense forces now have ethical watchdog groups--institutional ethics committees--that oversee research involving service members. Such groups monitor the special considerations and constraints under which subjects in uniform can volunteer for biological research. These committees audit particularly the ethical themes of confidentiality, equality, and justice. Themes inherent in medical research in the military include the standard Beauchamp-Childress paradigm of autonomy, beneficence, nonmaleficence, and justice, to which are added the traditional military values of loyalty, respect, courtesy, and chivalry. Contemporary thinking is that the general principle of affording service members the opportunity to volunteer for research should be maintained within the constraints of compromised training time, national security, and operational necessity. Most biological research (and its outcome) does not in practice compromise confidentiality or military security. This paper presents an audit of the functioning of one national military medical ethics committee, the Australian Defence Medical Ethics Committee, and presents a discussion of its philosophies and influence within the broader military context. The Australian Defence Medical Ethics Committee believes that most research should, as an a priori condition of approval, be intended for open publication in peer-reviewed journals.

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

PubMed

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.

Perspectives of Egyptian research ethics committees regarding their effective functioning.

PubMed

Matar, Amal; Silverman, Henry

2013-02-01

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

75 FR 6056 - National Geospatial Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... DEPARTMENT OF THE INTERIOR Office of the Secretary National Geospatial Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of renewal of National Geospatial Advisory Committee... renewed the National Geospatial Advisory Committee. The Committee will provide advice and recommendations...

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

PubMed

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.

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

PubMed

Langat, Simon K

2005-10-01

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

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

PubMed

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

Local research ethics committees of the Mexican Institute of Social Security: results of a national survey.

PubMed

Valdez-Martinez, E; Garduño-Espinosa, J; Martinez-Salgado, H; Porter, J D H

2004-07-01

To identify the structure, composition and work of the local research ethics committees (LRECs) of the Mexican Institute of Social Security (IMSS) in Mexico. A descriptive cross-sectional study was performed that included all LRECs of the IMSS. A total of 335 questionnaires coded in advance were posted to each LREC secretary. The requested information was from January to December 2001. The response rate was 100%. Two hundred and thirty-eight (71%) LRECs were reported as 'active' during the evaluation period. Although almost all LRECs were composed of diverse professionals, physicians dominated the LRECs' membership. The rejection rate for research projects was lower than 1 per 1000, and less than half of the LRECs held meetings to issue a report of projects' evaluation. LRECs need to foster good ethical research; implementation of an audit system to examine their work might help improve LRECs' performance and accountability.

Early Childhood Special Educators and the Hospital Ethics Committee.

ERIC Educational Resources Information Center

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)

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

PubMed

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

Clinical ethics protocols in the clinical ethics committees of Madrid.

PubMed

Herreros, Benjamin; Ramnath, Venktesh R; Bishop, Laura; Pintor, Emilio; Martín, María Dolores; Sánchez-González, Miguel A

2014-03-01

Currently, The nature and scope of Clinical Ethics Protocols (CEPs) in Madrid (Spain) are not well understood. The main objective is to describe the features of 'guideline/recommendation' type CEPs that have been or are being developed by existing Clinical Ethics Committees (CECs) in Madrid. Secondary objectives include characterisation of those CECs that have been the most prolific in reference to CEP creation and implementation and identification of any trends in future CEP development. We collected CEPs produced and in process by CECs accredited in the public hospitals in Madrid, Spain, from 1996 to 2008. CECs developed 30 CEPs, with 10 more in process. The most common topic is refusal of treatment (seven CEPs developed; two in process). If CEPs addressing terminal illness, Do-Not-Resuscitate orders and advance directives are placed into a separate 'ethical problems at the end of life' category, this CEP subject emerges as the most common (eight developed; four in process). There is a relationship between the age of the CEC and the development of CEPs (the oldest CECs have developed more CEPs). CECs now seem to be more likely to engage in CEP development. The CECs in Madrid, Spain, have developed a significant number of CEPs (30 in total and 10 in process) and there is a trend towards continued development. The most frequent topics are ethical problems at the end of life and refusal of treatment by the patient.

Recent Studies of Research Ethics at the National Academy of Sciences

NASA Astrophysics Data System (ADS)

Bissell, Richard

2012-01-01

Over the last few years, the National Academy of Sciences/National Research Council has been asked to revisit some of the core ethical issues for science that had not been properly explored since the 1990s. Some of the interest in this area related to the impact of technology changes in the sciences (e.g., management of massive data bases) and some to institutional changes (e.g., globalization of research teams, emergence of new scientific powers abroad, and new models in the publishing industry). As a result, a series of authoritative reports from the Academies’ Committee on Science, Engineering and Public Policy have been developed by expert committees and published - the third edition of On Being A Scientist (2009), a report on Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009), and underway there is a new edition of Responsible Science: Ensuring the Integrity of the Research Process (first published in 1992, forthcoming in 2012). It is relevant in this age of global science that the latest edition of OBAS has been translated into multiple foreign languages, and the InterAcademy Council has launched its own project on research ethics with a report due from this multi-science academy body in the 2012-2013 period. Some of the principal findings and issues raised in these reports will be presented by Richard E. Bissell, Executive Director for Policy and Global Affairs at the National Academy of Sciences.

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.

PubMed

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.

77 FR 5820 - National Geospatial Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... DEPARTMENT OF THE INTERIOR Office of the Secretary National Geospatial Advisory Committee AGENCY... that the Secretary of the Interior has renewed the National Geospatial Advisory Committee. The Committee will provide advice and recommendations to the Federal Geographic Data Committee (FGDC), through...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

PubMed

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.

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

PubMed Central

2012-01-01

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

The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity.

PubMed

Salloch, Sabine

2018-06-05

Dual Use Research of Concern (DURC) constitutes a major challenge for research practice and oversight on the local, national and international level. The situation in Germany is shaped by two partly competing suggestions of how to regulate security-related research: The German Ethics Council, as an independent political advisory body, recommended a series of measures, including national legislation on DURC. Competing with that, the German National Academy of Sciences and the German Research Foundation, as two major professional bodies, presented a strategy which draws on the self-control of science and, inter alia, suggests expanding the scope of research ethics committees (RECs) to an evaluation of DURC. This situation is taken as an occasion to further discuss the scope and limits of professional self-control with respect to security-related research. The role of RECs as professional bodies of science is particularly analyzed, referring to the theoretical backgrounds of professionalism. Two key sociological features of professionalism - ethical orientation and professional self-control - are discussed with respect to the practice of biomedical science. Both attributes are then analyzed with respect to the assessment of DURC by RECs. In conclusion, it is stated that issues of biosecurity transcend the boundaries of the scientific community and that a more comprehensive strategy should be implemented encompassing both professional self-control and legal oversight.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

29 CFR 1960.41 - National committee duties.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.41 National committee duties. National committees...

29 CFR 1960.41 - National committee duties.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.41 National committee duties. National committees...

29 CFR 1960.41 - National committee duties.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.41 National committee duties. National committees...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

41 CFR 105-54.204 - Advisory committee membership.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting... cleared by the Designated Agency Ethics Official. ...

41 CFR 105-54.204 - Advisory committee membership.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting... cleared by the Designated Agency Ethics Official. ...

41 CFR 105-54.204 - Advisory committee membership.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting... cleared by the Designated Agency Ethics Official. ...

41 CFR 105-54.204 - Advisory committee membership.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and... basis of race, color, age, national origin, religion, sex, or mental and physical handicap in selecting... cleared by the Designated Agency Ethics Official. ...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

PubMed

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

2016-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

PubMed

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countries.

PubMed

Kojima, Somei; Waikagul, Jitra; Rojekittikhun, Wichit; Keicho, Naoto

2005-05-01

This study discusses the establishment of ethical guidelines for ethical review for biomedical research performed in Thailand, and to some extent, in neighboring countries. There are differences, from country to country, at national and institutional levels regarding guidelines for ethical review committees. Only a handbook issued by Mahidol University describes guidelines for human genetic research and on research dealing with reproductive technology. Both these areas require special consideration to avoid violating human dignity, rights, and confidentiality. This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome.

Professional Ethics for Astronomers

NASA Astrophysics Data System (ADS)

Marvel, K. B.

2005-05-01

There is a growing recognition that professional ethics is an important topic for all professional scientists, especially physical scientists. Situations at the National Laboratories have dramatically proven this point. Professional ethics is usually only considered important for the health sciences and the legal and medical professions. However, certain aspects of the day to day work of professional astronomers can be impacted by ethical issues. Examples include refereeing scientific papers, serving on grant panels or telescope allocation committees, submitting grant proposals, providing proper references in publications, proposals or talks and even writing recommendation letters for job candidates or serving on search committees. This session will feature several speakers on a variety of topics and provide time for questions and answers from the audience. Confirmed speakers include: Kate Kirby, Director Institute for Theoretical Atomic and Molecular Physics - Professional Ethics in the Physical Sciences: An Overview Rob Kennicutt, Astrophysical Journal Editor - Ethical Issues for Publishing Astronomers Peggy Fischer, Office of the NSF Inspector General - Professional Ethics from the NSF Inspector General's Point of View

French national committee celebrates.

PubMed

Dufort, B

1993-03-01

Having been established just as Ronald Reagan withdrew funds from its American equivalent, the French national bioethics committee is the longest established such committee anywhere. Unfortunately it has not had the international influence of the American President's Commission largely, on suspects, because it works in the wrong language. It has just celebrated its tenth anniversary with a meeting at the Sorbonne.

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

PubMed

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.

National and Governmental Advisory Committees: Meetings

EPA Pesticide Factsheets

Meetings and Teleconference Information for the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation,

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

PubMed

2016-04-01

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

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

PubMed

Bamber, Greg J; Sappey, Jennifer

2007-07-01

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

76 FR 7807 - National Wildlife Services Advisory Committee; Reestablishment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... Inspection Service [Docket No. APHIS-2009-0057] National Wildlife Services Advisory Committee.... SUMMARY: We are giving notice that the Secretary of Agriculture will reestablish the National Wildlife.... SUPPLEMENTARY INFORMATION: The purpose of the National Wildlife Services Advisory Committee (the Committee) is...

E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

PubMed

Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G

2015-01-01

Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

PubMed

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.

75 FR 34141 - National Vaccine Advisory Committee Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Vaccine Advisory Committee Meetings AGENCY... giving notice that the National Vaccine Advisory Committee (NVAC) will hold two teleconference meetings...-677-1385, passcode ``NVAC.'' FOR FURTHER INFORMATION CONTACT: Daniel Salmon, National Vaccine Program...

Evaluation of the National FFA Nominating Committee Training

ERIC Educational Resources Information Center

Bruce, Jacklyn; Ricketts, Kristina

2007-01-01

The purpose of this qualitative study was to evaluate if the environment of the National FFA Organization's Nominating Committee training fosters transfer of training to the job they are required to perform, selecting National FFA Officers. Nominating Committee members, advisors, National FFA staff, and National Officer candidates participated in…

[Ethics and biomedical research].

PubMed

Goussard, Christophe

2007-01-01

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.

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

PubMed

Edwards, Kyle T

2014-07-01

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

77 FR 75182 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Security Telecommunications Advisory Committee (NSTAC) will meet on Friday, January 11, 2013, via... related to national security and emergency preparedness telecommunications policy. Agenda: The NSTAC...

75 FR 29781 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...] President's National Security Telecommunications Advisory Committee AGENCY: National Protection and Programs... Security Telecommunications Advisory Committee (NSTAC) will be meeting by teleconference; the meeting will... telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public...

78 FR 65318 - National Committee on Vital and Health Statistics: Meeting Full Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... Health Statistics (NCVHS), Full Committee Meeting. Time and Date: November 13, 2013 9:00 a.m.-2:15 p.m..., National Center for Health Statistics, 3311 Toledo Road, Auditorium B & C, Hyattsville, Maryland 20782...

Bioethics and the Italian National Bioethics Committee: historical highlights.

PubMed

Conti, A A

2016-01-01

Though the term "bioethics" was coined in 1970-1, it was immediately after World War II that there emerged the idea that the voluntary consent of human beings was absolutely mandatory for medical interventions to be ethically acceptable. The 1964 Declaration of Helsinki asserted that only an explicit consent could morally and ethically justify research on human beings. In the 1978 "Encyclopedia of Bioethics", the US author Warren T. Reich defined bioethics as the systematic study of human behaviour in the fields of health care and life sciences, and carefully differentiated the epistemological profile of bioethics from that of traditional medical ethics deriving from the Hippocratic Oath. An institutional milestone in the Italian evolution of bioethical knowledge and competence was the foundation of the Italian National Bioethics Committee (NBC), established in 1990. The NBC, which answers to the Council of Ministers, provides methodological support to the Italian Government in the field of bioethical issues, elaborating legislative acts and also furnishing information and consultation for other bodies and associations and for the general public. The activity of the NBC is clearly discernible in its free and user-friendly website. Today, the Internet is often the first repository where individuals and patients look for bioethical information. Given that the quality of this information is extremely variable and not infrequently unreliable, initiatives such as that of the above mentioned NBC website are particularly useful and precious both for health care operators and the entire community.

75 FR 16159 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-31

...] President's National Security Telecommunications Advisory Committee AGENCY: National Communications System... Telecommunications Advisory Committee (NSTAC) will hold its annual meeting on May 6, 2010. The meeting will be open... preparedness telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee...

Ethical guidelines in pandemic influenza: recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention.

PubMed

Kinlaw, Kathy; Barrett, Drue H; Levine, Robert J

2009-12-01

Because of the importance of including ethical considerations in planning efforts for pandemic influenza, in February 2005 the Centers for Disease Control and Prevention requested that the Ethics Subcommittee of the Advisory Committee to the Director develop guidance that would serve as a foundation for decision making in preparing for and responding to pandemic influenza. Specifically, the ethics subcommittee was asked to make recommendations regarding ethical considerations relevant to decision making about vaccine and antiviral drug distribution prioritization and development of interventions that would limit individual freedom and create social distancing. The ethics subcommittee identified a number of general ethical considerations including identification of clear goals for pandemic planning, responsibility to maximize preparedness, transparency and public engagement, sound science, commitment to the global community, balancing individual liberty and community interests, diversity in ethical decision making, and commitment to justice. These general ethical considerations are applied to the issues of vaccine and antiviral drug distribution and use of community mitigation interventions.

Ethics of energy production and use: debate within the National Council of Churches

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harnik, P.

1979-02-01

An Energy Policy Statement emanating from a panel for the National Council of Churches (NCC) in the United States was presented in May 1978 to the governing board of the NCC. The proposed Energy Policy Statement is composed of four sections: Opinions and Perspectives, Theological Dimensions of the Energy Situation, Ecological Justice and Human choice, and A Challenge to the Churches. Controversy concerning the proposed plan was great. The controversy on nuclear energy is specifically described. While the NCC was anti-nuclear, the World Council of Churches was tilting toward nuclear power. The NCC focused on ethics of energy and themore » WCC is not focusing on ethics; its nuclear statement does not constitute policy; and another WCC committee is aggressively promoting conservation and appropriate technology. The lessons drawn from the NCC debate are summarized. (MCW)« less

Palliative sedation: the position statement of the Italian National Committee for Bioethics.

PubMed

Orsi, Luciano; Gristina, Giuseppe R

2017-05-01

In January 2016 the Italian National Bioethics Committee (NBC) published a position statement entitled Deep and continuous palliative sedation in the imminence of death, related to the use of sedation and analgesia for relief from pain and psychological distress in dying patients. In this statement the Committee points out the clinical and ethical appropriateness of palliative sedation as a therapeutic procedure. As a result, today palliative sedation has to be considered useful, scientifically safe and reliable, and acknowledged as an integral part of good clinical practice. At the same time, the position statement, once and for all, makes clear that palliative sedation cannot and must not be equated with the practice of euthanasia. Thus, this document should be known by health professionals caring for dying patients not only in palliative as well as in intensive care settings, but it should be also considered as a milestone aimed to encourage and ease a widespread implementation of this procedure in all health care settings.

Institution animal care and use committees need greater ethical diversity.

PubMed

Hansen, Lawrence Arthur

2013-03-01

In response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of animal pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare.

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

PubMed

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

2017-01-01

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

Research ethics and approval process: A guide for new GP researchers.

PubMed

Liaw, Siaw-Teng; Tam, Chun Wah Michael

2015-06-01

The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.

The ethics of HIV research in developing nations.

PubMed

Resnik, David B

1998-10-01

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

78 FR 23219 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-18

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... Federal Advisory Committee Act. The purpose of the committee is to provide advice and recommendations on...

78 FR 9883 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... Advisory Committee Act. The purpose of the committee is to provide advice and recommendations on the...

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

PubMed

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

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

PubMed Central

Hunt, Matthew; Tansey, Catherine M.

2016-01-01

Background 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. Methods 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. Results 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. Conclusion 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

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

PubMed

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.

78 FR 46565 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... Committee Act (FACA) (Pub. L. 92-463). The purpose of the Committee is to provide advice and recommendations...

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

PubMed

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.

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

PubMed

Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

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

78 FR 29145 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0022] President's National Security Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... notice of a May 22, 2013, meeting of the President's National Security Telecommunications Advisory...

78 FR 45255 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. [[Page 45256... President's National Security Telecommunications Advisory Committee (NSTAC) will meet on Tuesday, August 20... related to national security and emergency preparedness (NS/EP) telecommunications policy. Agenda: The...

78 FR 18614 - National Offshore Safety Advisory Committee

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2013-03-27

... Continental Shelf (OCS); (b) Electrical Equipment in Hazardous Areas on Foreign Flag Mobile Offshore Drilling... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2013-0182] National Offshore Safety... Advisory Committee Meetings. SUMMARY: The National Offshore Safety Advisory Committee (NOSAC) will meet on...

78 FR 34115 - National Offshore Safety Advisory Committee

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2013-06-06

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2013-0461] National Offshore Safety.... SUMMARY: The National Offshore Safety Advisory Committee (NOSAC) will meet via teleconference to receive a.... Additionally the committee will reconvene the Subcommittee on commercial diving safety to consider...

75 FR 65025 - National Offshore Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-0925] National Offshore Safety Advisory Committee AGENCY: Coast Guard, DHS. ACTION: Notice of meeting. SUMMARY: The National Offshore Safety Advisory Committee (NOSAC) will meet to discuss items related to safety of operations and other matters...

75 FR 3913 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

...] President's National Security Telecommunications Advisory Committee AGENCY: National Communications System... Telecommunications Advisory Committee (NSTAC) will be meeting by teleconference; the meeting will be open to the... implementing national security and emergency preparedness telecommunications policy. Notice of this meeting is...

77 FR 13512 - National Advisory Committee on Meat and Poultry Inspection

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2012-03-07

... Service 9 CFR Parts 381 and 500 [Docket No. FSIS-2012-0016] National Advisory Committee on Meat and... Committee Act, that the National Advisory Committee on Meat and Poultry Inspection (NACMPI) will hold a...-ROMs: Send to National Advisory Committee on Meat and Poultry Inspection, USDA, FSIS, 14th...

An analysis on the research ethics cases managed by the Committee on Publication Ethics (COPE) between 1997 and 2010.

PubMed

Foo, Jong Yong Abdiel; Wilson, Stephen James

2012-12-01

The growing emphasis on the importance of publishing scientific findings in the academic world has led to increasing prevalence of potentially significant publications in which scientific and ethical rigour may be questioned. This has not only hindered research progress, but also eroded public trust in all scientific advances. In view of the increasing concern and the complexity of research misconduct, the Committee on Publication Ethics (COPE) was established in 1997 to manage cases with ethical implications. In order to review the outcomes of cases investigated by COPE, a total of 408 cases that had been managed by COPE were successfully extracted and analysed with respect to 7 distinct criteria. The results obtained indicate that the number of ethical implications per case has not changed significantly (p > 0.01) since the year COPE was instigated. Interestingly, the number of ethical cases, and to some extent, research misconduct, is not diminishing. Therefore, journal editors and publishers need to work closely together with COPE to inculcate adoption of appropriate research ethics and values in younger researchers while discouraging others from lowering standards. It is hoped that with a more concerted effort from the academic community and better public awareness, there will be fewer incidences of ethically and scientifically challenged publications. The ultimate aim being to enhance the quality of published works with concomittant public trust in the results.

Consensus, contracts, and committees.

PubMed

Moreno, J D

1991-08-01

Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this level of analysis than about the ethics committee phenomenon itself.

Healthcare ethics: the experience after the Haitian earthquake.

PubMed

Etienne, Mill; Powell, Clydette; Amundson, Dennis

2010-01-01

On January 12, 2010, a 7.0 Richter earthquake devastated Haiti and its public health infrastructure leading to a worldwide humanitarian effort. The United States sent forces to Haiti's assistance including the USNS Comfort, a tertiary care medical center on board a ship. Besides setting a transparent triage and medical regulating system, the leadership on the Comfort instituted a multidisciplinary Healthcare Ethics Committee to assist in delivering the highest level efficient care to the largest number of victims. Allocation of resources was based on time-honored ethics principles, the concept of mass casualty triage in the setting of resource constraints, and constructs developed by the host nation's Ministry of Health. In offering aid in austere circumstances, healthcare practitioners must not only adhere to the basic healthcare ethics principles but also practice respect for communities, cultures, and traditions, as well as demonstrate respect for the sovereignty of the host nation. The principles outlined herein should serve as guidance for future disaster relief missions. This work is in accordance with BUMEDINST 6010.25, Establishment of Healthcare Ethics Committees.

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

PubMed

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

2013-05-01

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

Institution animal care and use committees need greater ethical diversity

PubMed Central

Hansen, Lawrence Arthur

2013-01-01

In response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of animal pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare. PMID:23131895

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

PubMed

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

2015-12-02

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

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

PubMed

Roa, A; Rosselot, E

1995-04-01

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

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

PubMed

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.

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

PubMed

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.

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

PubMed

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.

Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.

PubMed

Davis, Sanish

2018-01-01

Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.

77 FR 24207 - National Committee on Vital and Health Statistics: Teleconference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics...) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311...

77 FR 9660 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

..., Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics...

75 FR 52950 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... from Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers...

76 FR 20989 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the Following Advisory Committee Meeting. Name: National Committee on Vital and Health Statistics..., Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and...

75 FR 31789 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... from Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers...

75 FR 39531 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311...

76 FR 61706 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics.... Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control...

76 FR 45810 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics..., NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo...

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

PubMed

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

2018-05-23

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

A Survey of Hospital Ethics Structures in Ontario.

PubMed

Breslin, Jonathan

2017-01-01

In response to the growing recognition of the prevalence of ethical issues in clinical care, hospitals in Canada began forming ethics committees in the 1980s. Studies showed significant growth in the prevalence of ethics committees over the ensuing decade. Although the limited studies available suggest that ethics committees have become very prevalent in Canadian hospitals, hospital ethics services have evolved in recent years to include a wider range of structures. In some cases, these structures may work in conjunction with an ethics committee, but in other cases they may replace ethics committees. They include on-staff ethicists, external ethics consultants, "hub-and-spokes" structures and regional ethics programs. What is not known, however, is how prevalent these other structures are and whether ethics committees continue to function as the main delivery mechanism for ethics services in Canadian hospitals. This paper reports on the results of a survey of hospitals in Ontario to answer those questions.

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

ERIC Educational Resources Information Center

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…

77 FR 55214 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics..., National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room...

76 FR 4696 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics..., National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room...

77 FR 60507 - Voluntary Service National Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... meeting is open to the public. The Committee, comprised of 57 national voluntary organizations, advises... DEPARTMENT OF VETERANS AFFAIRS Voluntary Service National Advisory Committee; Notice of Meeting... Committee Act) that the Executive Committee of the Department of Veterans Affairs Voluntary Service (VAVS...

77 FR 47028 - National Advisory Committee on Meat and Poultry Inspection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... Inspection Service [Docket No. FSIS-2012-0030] National Advisory Committee on Meat and Poultry Inspection... Agriculture National Advisory Committee on Meat and Poultry Inspection. SUMMARY: The U.S. Department of Agriculture intends to reestablish the National Advisory Committee on Meat and Poultry Inspection. The purpose...

77 FR 26023 - President's National Security Telecommunications Advisory Committee; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0016] President's National Security Telecommunications Advisory Committee; Correction AGENCY: National Protection and Programs Directorate, DHS. [[Page... April 25, 2012, concerning the President's National Security Telecommunications Advisory Committee...

77 FR 10746 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics...; March 9, 2012: 9 a.m.-3 p.m. EST. Place: National Center for Health Statistics, 3311 Toledo Road...

75 FR 61761 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics..., 2010 9 a.m.-3 p.m. EST. Place: National Center for Health Statistics, 3311 Toledo Road, Auditorium A&B...

78 FR 34034 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... purpose of the Committee is to provide advice and recommendations on the implementation of the National...

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

PubMed

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.

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

PubMed

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

76 FR 19952 - Davy Crockett National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

... DEPARTMENT OF AGRICULTURE Davy Crockett National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of Public Meeting, Davy Crockett National Forest Resource Advisory Committee... 1972 (FACA), the U.S. Department of Agriculture, Forest Service, Davy Crockett National Forest Resource...

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

PubMed

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

76 FR 64326 - National Construction Safety Team Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

... Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team (NCST) Advisory... INFORMATION: The Committee was established pursuant to Section 11 of the National Construction Safety Team Act...

76 FR 17379 - National Tree-Marking Paint Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

... DEPARTMENT OF AGRICULTURE Forest Service National Tree-Marking Paint Committee Meeting AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Tree-Marking Paint Committee will... related to improvements in, concerns about, and the handling and use of tree-marking paint by personnel of...

77 FR 20612 - National Tree-Marking Paint Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-05

... DEPARTMENT OF AGRICULTURE Forest Service National Tree-Marking Paint Committee Meeting AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Tree-Marking Paint Committee will... related to improvements in, concerns about, and the handling and use of tree-marking paint by personnel of...

77 FR 51817 - National Maritime Security Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... the information sharing efforts of the Coast Guard and DHS. (2) Cyber-Security. The Committee will... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2012-0797] National Maritime Security Advisory...: The National Maritime Security Advisory Committee (NMSAC) will meet on September 11-12, 2012 in the...

78 FR 37817 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY: National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary... giving notice that the National Vaccine Advisory Committee (NVAC) will be holding a special meeting. This...

75 FR 25259 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a...., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, Department of Health...

78 FR 52923 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting... Independence Avenue SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office...

76 FR 81911 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... National Forest System Land Management Planning Rule AGENCY: USDA Forest Service. ACTION: Notice of intent... intends to establish the National Advisory Committee for Implementation of the National Forest System Land... (FACA), the Committee is being established to provide advice and recommendations on the implementation...

Annual report of Council, 1985-1986: medical ethics.

PubMed

1986-03-29

Recent activities of the Council of the British Medical Association related to ethical and public policy issues are described. The Council has been working to improve the network of local research ethics committees and favors the establishment of a national committee to review research proposals. It has been engaged in efforts to shape the Data Protection Act to safeguard the confidentiality of personal health records and to protect the confidentiality of minors who seek contraceptive advice without their parents' knowledge. Other Council concerns include advertising by the medical profession and the physician's role in law enforcement in Great Britain and in investigations of torture on the international scene.

75 FR 54446 - Voluntary Service National Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...-four national voluntary organizations, advises the Secretary, through the Under Secretary for Health... DEPARTMENT OF VETERANS AFFAIRS Voluntary Service National Advisory Committee; Notice of Meeting... Committee Act) that the Executive Committee of the Department of Veterans Affairs Voluntary Service (VAVS...

77 FR 34044 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Health Statistics; have a briefing on a Standards Subcommittee meeting; and hear subcommittee reports...

78 FR 34101 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Health Statistics, 3311 Toledo Road, Auditorium B & C, Hyattsville, Maryland 20782, (301) 458-4524...

75 FR 70926 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland...

76 FR 54469 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... the following advisory committee meeting. Name: National Committee on Vital and Health Statistics... Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland...

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

PubMed

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.

78 FR 68811 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... (FACA) (Pub. L. 92-463). The purpose of the Committee is to provide advice and recommendations on the...

Secret ethics business?

PubMed

Gillam, Lynn

2003-01-01

In this paper, I question the common assumption that the workings of Human Research Ethics Committees should be treated as confidential. This is actually quite a complex issue, since there are many stages in the ethics approval process, and a number of different stakeholders who might wish to claim access, or restrict access, to different sorts of information. Here I consider just one aspect--whether ethics committee members should be free to reveal in public the details of what occurs in their meetings. My approach is two-fold: first a negative argument that confidentiality does not apply to ethics committee deliberations, and then a positive argument that there is an important public good, namely accountability, to be served by making these deliberations open to the public.

77 FR 59888 - General Conference Committee of the National Poultry Improvement Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... Inspection Service [Docket No. APHIS-2012-0068] General Conference Committee of the National Poultry... the General Conference Committee of the National Poultry Improvement Plan (Committee) for a 2year... interest. FOR FURTHER INFORMATION CONTACT: Dr. C. Stephen Roney, Senior Coordinator, National Poultry...

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

78 FR 63232 - President's National Security Telecommunications Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Telecommunications Advisory Committee (NSTAC) will meet on Wednesday, November 20, 2013. The meeting will be open to... preparedness (NS/EP) telecommunications policy. During the meeting, the Industrial Internet Subcommittee Co...

78 FR 54470 - National Committee on Vital and Health Statistics: Meeting Full Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... Health Statistics (NCVHS); Full Committee Meeting. Time and Date: September 16, 2013 9:00 a.m.-2:45 p.m... Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland...

A guide to multi-centre ethics for surgical research in Australia and New Zealand.

PubMed

Boult, Maggi; Fitzpatrick, Kate; Maddern, Guy; Fitridge, Robert

2011-03-01

This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

76 FR 1592 - National Poultry Improvement Plan; General Conference Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-11

...] National Poultry Improvement Plan; General Conference Committee Meeting AGENCY: Animal and Plant Health... General Conference Committee of the National Poultry Improvement Plan. DATES: The General Conference.... FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior Coordinator, National Poultry...

Ethics and National Defense: The Timeless Issues

DTIC Science & Technology

1993-02-01

that responsibility while asserting a personal morality of pacifism is simply unconscionable. 6 A personal morality of ethical egoism , even en...contained in, Personal morality, 82 18-20, 30-31,64,80,90 of enlightened egoism , 12 professional value of, 21,29 of ethical egoism , 12 246 INDEX and...ADiiV264 467 JAM •STOJANIS DTIC 93-09884 ELECTE U, rllllllllclllilllll[) FFI I ICS .\\ N D \\)..I 0 N. X . )F F: PN S F ETHICS AND NATIONAL DEFENSE THE

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

PubMed

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.

78 FR 33799 - National Poultry Improvement Plan; General Conference Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-05

...] National Poultry Improvement Plan; General Conference Committee Meeting AGENCY: Animal and Plant Health... General Conference Committee of the National Poultry Improvement Plan. DATES: The General Conference.... Denise L. Brinson, Acting Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, 1506 Klondike...

National and Governmental Advisory Committee Advice Letters for 2014

EPA Pesticide Factsheets

Advice Letters produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

National and Governmental Advisory Committee Advice Letters for 2015

EPA Pesticide Factsheets

Advice Letters produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

78 FR 58521 - National Construction Safety Team Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

... Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, Department of Commerce ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team (NCST) Advisory... service, and their knowledge of issues affecting teams established under the NCST Act. The Committee...

National and Governmental Advisory Committee Advice Letters for 2016

EPA Pesticide Factsheets

Advice Letters and produced by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation, and EPA responses

77 FR 9651 - National Advisory Committee on Institutional Quality and Integrity (NACIQI) Teleconference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

... DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity (NACIQI) Teleconference AGENCY: National Advisory Committee on Institutional Quality and Integrity, Office of... teleconference meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI) and...

Consistency in decision making by research ethics committees: a controlled comparison.

PubMed

Angell, E; Sutton, A J; Windridge, K; Dixon-Woods, M

2006-11-01

There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of kappa = 0.286 (95% confidence interval -0.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as "slight". The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.

National and Governmental Advisory Committee Meetings Documents for 2017

EPA Pesticide Factsheets

Meetings materials,Teleconference Information produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

National and Governmental Advisory Committee Meetings Documents for 2015

EPA Pesticide Factsheets

Meetings materials,Teleconference Information produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

National and Governmental Advisory Committee Meetings Documents for 2016

EPA Pesticide Factsheets

Meetings materials,Teleconference Information produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

National and Governmental Advisory Committee Meetings Documents for 2018

EPA Pesticide Factsheets

Meetings materials,Teleconference Information produced for and/or by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation

76 FR 53134 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Preregistration... 20201. FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, U.S. Department of Health and...

77 FR 68103 - National Construction Safety Team Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team (NCST) Advisory... affecting teams established under the NCST Act. The Committee will advise the Director of NIST on carrying...

78 FR 4132 - National Climate Assessment and Development Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...-3013-0] RIN 0648-XC433 National Climate Assessment and Development Advisory Committee AGENCY: Office of... Oceanic and Atmospheric Research (OAR) publishes this notice on behalf of the National Climate Assessment and Development Advisory Committee (NCADAC) to announce the availability of a Draft Climate Assessment...

The Just War Tradition: A Model for Healthcare Ethics.

PubMed

Connolly, Chaplain John D

2018-06-01

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

Ethics in oncology: consulting for the investment industry.

PubMed

Berlin, Jordan; Bruinooge, Suanna S; Tannock, Ian F

2007-02-01

As Ethics Committee Chair, I am pleased to introduce the first in an ongoing series of ethics vignettes. These columns, which are based on true-to-life situations that arise in oncology research and practice, are intended to identify and explore important ethical issues and provide commentary that is specific to oncology. Please look for them periodically in both the Journal of Clinical Oncology and the Journal of Oncology Practice. The idea for publishing vignettes evolved through the joint efforts of the Ethics Committee and the Board of Directors. Rather than adopt a single set of ethical principles that applies vaguely to any situation and well to none, the Committee and the Board preferred to tackle ethical dilemmas individually, specifically, and directly. Because the Ethics Committee thought the ethical and legal implications of physician interactions with the investment industry were so important and timely, it chose to address this topic in both a position article, which was previously published in the January 20, 2007, issue of the Journal of Clinical Oncology (J Clin Oncol 25:338-340, 2007) and in its first vignette column. The Ethics Committee hopes this column will be the first of several that ASCO members will find helpful as they grapple with the many ethical issues that arise in daily practice in the field of oncology. Because these columns are intended to address the concerns of ASCO members, the Committee welcomes suggestions for future topics at vignettes@asco.org. Martin D. Abeloff, MD, Chair, Ethics Committee.

76 FR 72904 - National Construction Safety Team Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team (NCST) Advisory... Team Act (15 U.S.C. 7301 et seq.). The NCST Advisory Committee is comprised of ten members, appointed...

77 FR 74828 - National Construction Safety Team Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-18

... Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team (NCST) Advisory... Construction Safety Team Act (15 U.S.C. 7301 et seq.). The NCST Advisory Committee is comprised of ten members...

76 FR 64102 - Big Cypress National Preserve Off-Road Vehicle Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... Cypress National Preserve Off-Road Vehicle Advisory Committee AGENCY: National Park Service, Interior... Cypress National Preserve Off-Road Vehicle Advisory Committee to offer recommendations, alternatives and possible solutions to management of off-road vehicles at Big Cypress National Preserve. FOR FURTHER...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

PubMed

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.

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

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

PubMed

Hedgecoe, Adam

2014-02-01

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

[The clinical ethics committee (CEC) in the area of conflict between hospital certification, moral pragmatics and scientific approach].

PubMed

Bauer, Axel W

2007-01-01

During the last decade numerous consultative bodies for bioethical and medical ethical issues have been established. In this study we will introduce the clinical ethics committee (CEC), which can be mainly brought into action for three purposes: discussing moral problems in a hospital's everyday work, developing guidelines for the clinic, and giving further education to the hospital's staff. Starting with the denominational hospitals at the end of the 1990s, CECs have been established in the meantime at a large number of German clinics, often in an interrelation with hospital certification. We will describe the process of establishing a CEC at the university hospital in Mannheim (Baden-Württemberg) and examine its formal structure given by the statutes and the standing orders. An important issue of the CEC's activities consists in individual consultation, for instance concerning withholding or withdrawing life-supporting therapy from comatose patients. First and foremost it has to be clarified whether there is really an ethical problem which cannot be solved by those seeking advice or whether the CEC is just asked a rhetorical question in order to attain allies. In this case disappointment will often be the consequence. The quality of an ethical consultation cannot be treated as equivalent to the correspondence with preconceived moral attitudes. The CEC is not a "moral police" but a multi-professional body, in which scientific medical ethics should play an important but under no circumstances a dominating role. Meaningful criteria and measuring methods to study the effectiveness of clinical ethics committees will have to be evolved and tested in practice as soon as possible.

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

PubMed

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.

77 FR 48496 - Okanogan and Wenatchee National Forests Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-14

... DEPARTMENT OF AGRICULTURE Forest Service Okanogan and Wenatchee National Forests Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Wenatchee-Okanogan Resource Advisory Committee will meet on September 13 at the Okanogan-Wenatchee National Forest Headquarters Office...

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.

PubMed

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/

Transferring embryos with genetic anomalies detected in preimplantation testing: an Ethics Committee Opinion.

PubMed

2017-05-01

Patient requests for transfer of embryos with genetic anomalies linked to serious health-affecting disorders detected in preimplantation testing are rare but do exist. This Opinion sets out the possible rationales for a provider's decision to assist or decline to assist in such transfers. The Committee concludes in most clinical cases it is ethically permissible to assist or decline to assist in transferring such embryos. In circumstances in which a child is highly likely to be born with a life-threatening condition that causes severe and early debility with no possibility of reasonable function, provider transfer of such embryos is ethically problematic and highly discouraged. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?

PubMed Central

Nyika, A; Kilama, W; Chilengi, R; Tangwa, G; Tindana, P; Ndebele, P; Ikingura, J

2009-01-01

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. PMID:19251972

75 FR 69619 - Chippewa National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... DEPARTMENT OF AGRICULTURE Forest Service Chippewa National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Chippewa National Forest Resource... information on national forest projects and processes to the Chippewa National Forest Resource Advisory...

78 FR 9899 - National Committee on Foreign Medical Education and Accreditation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... DEPARTMENT OF EDUCATION National Committee on Foreign Medical Education and Accreditation AGENCY: Office of Postsecondary Education, U.S. Department of Education, National Committee on Foreign Medical Education and Accreditation. ACTION: The purpose of this notice is to announce the upcoming meeting of the...

76 FR 6136 - Solicitation for Nominations for the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation for Nominations for the National Vaccine... of advisory committees. SUMMARY: The National Vaccine Program Office (NVPO), a program office within... candidates to be considered for appointment as public members to the National Vaccine Advisory Committee...

Chinese ethics review system and Chinese medicine ethical review: past, present, and future.

PubMed

Li, En-Chang; Du, Ping; Ji, Ke-Zhou; Wang, Zhen

2011-11-01

The Chinese medical ethics committee and the ethical review system have made the following achievements: (1) enabled the institutionalization of medical ethics, (2) carried out the ethics review of Chinese medicine (CM) and integrative medicine extensively, (3) trained a large number of ethical professionals, (4) supported and protected the interests of patients and subjects, and (5) ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways: (1) to refine the relevant rules of ethical review, (2) to develop the relevant standards of the CM and integrative medicine ethical review, (3) to enhance the independence and authority of ethics committee, (4) to emphasize innovation and to discover and solve new problems, and (5) to increase international exchanges and improve relevant research.

77 FR 65190 - National Committee on Vital and Health Statistics: Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-25

... Office of the National Coordinator for Health Information Technology (ONC), and the Office for Civil Rights (OCR). The Committee will also discuss its draft report on Data Stewardship in Community Health... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting...

Evaluating the ethical acceptability of animal research.

PubMed

Bout, Henriëtte J; Fentener van Vlissingen, J Martje; Karssing, Edgar D

2014-11-01

The ethical acceptability of animal research is typically evaluated on a case-by-case basis. Legislation such as Directive 2010/63/EU on the protection of animals used for scientific purposes provides guidance for ethical evaluation of animal use proposals but does not dictate the outcome, leaving this determination to the ethical review committees of individual institutions. The authors assess different ethics models and how these are reflected in the guidelines of Directive 2010/63/EU. They also describe a matrix for carrying out harm-benefit analyses of animal use proposals, which they identified by examining the practices of three ethical review committees in the Netherlands. Finally, they discuss how this matrix can be applied by ethical review committees at other institutions.

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

PubMed

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.

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

PubMed

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 < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the 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.

77 FR 1710 - National Maritime Security Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2011-0975] National Maritime Security Advisory... notice announcing a National Maritime Security Advisory Committee (NMSAC) public meeting on January 18-19... and forward progress regarding multiple maritime security initiatives. If you have been adversely...

77 FR 17491 - National Offshore Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... from the Mobile Offshore Drilling Unit Guidance Policy, Notice of Availability, request for comments... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-0091] National Offshore Safety... Management; Notice of Federal Advisory Committee Meetings. SUMMARY: The National Offshore Safety Advisory...

11 CFR 100.56 - Office building or facility for national party committees.

Code of Federal Regulations, 2010 CFR

2010-01-01

... national party committees. A gift, subscription, loan, advance, or deposit of money or anything of value to a national party committee for the purchase or construction of an office building or facility is a...

Challenges in the Ethical Review of Peer Support Interventions

PubMed Central

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

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

ERIC Educational Resources Information Center

Mabrouk, Patricia Ann; Schelble, Susan M.

2018-01-01

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

Neuroscience, ethics, and national security: the state of the art.

PubMed

Tennison, Michael N; Moreno, Jonathan D

2012-01-01

National security organizations in the United States, including the armed services and the intelligence community, have developed a close relationship with the scientific establishment. The latest technology often fuels warfighting and counter-intelligence capacities, providing the tactical advantages thought necessary to maintain geopolitical dominance and national security. Neuroscience has emerged as a prominent focus within this milieu, annually receiving hundreds of millions of Department of Defense dollars. Its role in national security operations raises ethical issues that need to be addressed to ensure the pragmatic synthesis of ethical accountability and national security.

Neuroscience, Ethics, and National Security: The State of the Art

PubMed Central

Tennison, Michael N.; Moreno, Jonathan D.

2012-01-01

National security organizations in the United States, including the armed services and the intelligence community, have developed a close relationship with the scientific establishment. The latest technology often fuels warfighting and counter-intelligence capacities, providing the tactical advantages thought necessary to maintain geopolitical dominance and national security. Neuroscience has emerged as a prominent focus within this milieu, annually receiving hundreds of millions of Department of Defense dollars. Its role in national security operations raises ethical issues that need to be addressed to ensure the pragmatic synthesis of ethical accountability and national security. PMID:22448146

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

PubMed

Newcombe, J P; Kerridge, I H

2007-01-01

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

Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil.

PubMed

Bueno, Mariana; Brevidelli, Maria Meimei; Cocarelli, Thaís; Santos, Gianni Mara Silva dos; Ferraz, Maria Auxiliadora; Mion, Décio

2009-01-01

It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students' research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts

75 FR 49520 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-13

... DEPARTMENT OF THE INTERIOR National Park Service Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park Service, Interior. ACTION: Notice of meeting. SUMMARY: Notice...)], that a meeting of the Landmarks Committee of the National Park System Advisory Board will be held...

A national survey of U.S. internists' experiences with ethical dilemmas and ethics consultation.

PubMed

DuVal, Gordon; Clarridge, Brian; Gensler, Gary; Danis, Marion

2004-03-01

To identify the ethical dilemmas that internists encounter, the strategies they use to address them, and the usefulness of ethics consultation. National telephone survey. Doctors' offices. General internists, oncologists, and critical care/pulmonologists (N = 344, 64% response rate). Types of ethical dilemmas recently encountered and likelihood of requesting ethics consultation; satisfaction with resolution of ethical dilemmas with and without ethics consultation. Internists most commonly reported dilemmas regarding end-of-life decision making, patient autonomy, justice, and conflict resolution. General internists, oncologists, and critical care specialists reported participating in an average of 1.4, 1.3, and 4.1 consultations in the preceding 2 years, respectively (P <.0001). Physicians with the least ethics training had the least access to and participated in the fewest ethics consultations; 19% reported consultation was unavailable at their predominant practice site. Dilemmas about end-of-life decisions and patient autonomy were often referred for consultation, while dilemmas about justice, such as lack of insurance or limited resources, were rarely referred. While most physicians thought consultations yielded information that would be useful in dealing with future ethical dilemmas (72%), some hesitated to seek ethics consultation because they believed it was too time consuming (29%), might make the situation worse (15%), or that consultants were unqualified (11%). While most internists recall recent ethical dilemmas in their practices, those with the least preparation and experience have the least access to ethics consultation. Health care organizations should emphasize ethics educational activities to prepare physicians for handling ethical dilemmas on their own and should improve the accessibility and responsiveness of ethics consultation when needed.

The Ethical Dimensions of Working with Parents: Using the Code of Ethics when Faced with a Difficult Decision

ERIC Educational Resources Information Center

Freeman, Nancy K.; Swick, Kevin J.

2007-01-01

In 2000 ACEI began an exploration of the potential role that a code of professional ethics might have in the Association. The Public Affairs Committee recommended that the Executive Board appoint an ad hoc Ethics Committee. That committee, under the leadership of Nita Barbour, accepted its charge to provide guidance to colleagues who struggle to…

Clinical ethics revisited

PubMed Central

Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark

2001-01-01

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456

Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

PubMed

Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

2015-05-08

UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

Education and the improvement of clinical ethics services

PubMed Central

2013-01-01

The proliferation of clinical ethics in health care institutions around the world has raised the question about the qualifications of those who serve on ethics committees and ethics consultation services. This paper discusses some of weaknesses associated with the most common educational responses to this concern and proposes a complementary approach. Since the majority of those involved in clinical ethics are practicing health professionals, the question of qualification is especially challenging as the role of ethics committees and, increasingly, ethics consultation services are becoming increasingly important to the functioning of health care institutions. Since the challenging nature of health care finances often leads institutions to rely on voluntary participation of committed health professional with only token administrative or clerical support to provide the needed ethics services, significant challenges are created for attaining competence and functional effectiveness. The article suggests that a complementary approach should be adopted for sustaining and building capacity in clinical ethics. Ethics committees and consultation services should systematically adopt quality improvement techniques to effect designed changes in clinical ethics performance and to build ethical capacity within targeted clinical units and services. Demonstrating improvements in functioning can go a long way to build confidence and capacity for clinical ethics and can help in justifying the need for support. To do so, however, requires that ethics committees and consultation services first shift attention to those areas that demonstrate weak or questionable ethical performance, including the established practices of the ethics committee and consultation service, and second seek collaboration with the involved health care providers to pursue demonstrable change. Such an approach has a much better chance of improving the capacity for clinical ethics in health care institutions than

75 FR 42375 - Kisatchie National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

... DEPARTMENT OF AGRICULTURE Forest Service Kisatchie National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Kisatchie National Forest Resource..., Kisatchie National Forest, 2500 Shreveport Highway, Pineville, LA 71360. Comments may also be sent via e...

76 FR 9740 - Kisatchie National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

... DEPARTMENT OF AGRICULTURE Forest Service Kisatchie National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Kisatchie National Forest Resource..., Kisatchie National Forest, 2500 Shreveport Highway, Pineville, LA 71360. Comments may also be sent via e...

76 FR 60079 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-0911-8428; 2280-665] Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park Service. ACTION: Notice... U.S.C. Appendix (1988)], that a meeting of the Landmarks Committee of the National Park System...

[Review of ethical aspects in biomedical research. The experience of the Ethics Committee of the Center for Toxic Oil Syndrome and Rare Diseases [CISATER

PubMed

Martín-Arribas, M C; Posada, M; Terracini, B; Carballo, F; Abaitua, I

2003-01-01

This Field Note aims to make known the decisions taken by the Ethics Committee of the Instituto de Salud Carlos III for Toxic Oil Syndrome regarding the secondary use of research specimens in biological research when informed consent is lacking. This is a common concern in the field of biomedical research. After debating the ethical suitability of the secondary use of these samples, our main conclusion is that researchers conducting prospective studies should expressly solicit written informed consent from participants in the study about i) whether there will or could be any secondary use of the samples and, if so, ii) whether such secondary use would be conditional on the type of research.

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

PubMed Central

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

77 FR 53230 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

... DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-11084; 2200-3200-665] Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park Service, Interior. ACTION..., 5 U.S.C. Appendix (1988), that a meeting of the Landmarks Committee of the National Park System...

76 FR 15338 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-0311-6924; 2280-665] Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park Service, Interior. ACTION... [5 U.S.C. Appendix (1988)], that a meeting of the Landmarks Committee of the National Park System...

75 FR 28659 - National Advisory Committee on Occupational Safety and Health (NACOSH)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-21

... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH). SUMMARY: The National Advisory Committee on Occupational...

Ethics in Government: A National Survey of Public Administrators.

ERIC Educational Resources Information Center

Bowman, James S.

1990-01-01

Presents the results of a national survey of 750 practicing government managers regarding ethics in government and society, integrity in public agencies, and moral standards in organizational conduct. The 441 respondents agree that a compelling need exists for guidance in addressing ethical conduct in government. (JOW)

U.S. National Committee for Geochemistry

ERIC Educational Resources Information Center

Geotimes, 1974

1974-01-01

Reports highlights of the April, 1973 meeting of the U.S. National Committee for Geochemistry. Some of the topics reported on were: The Geophysics Research Board, deep drilling, exchange of geochemists with China and the activities of the Subcommittee on Geochemical Environment in Relation to Health and Disease. (BR)

78 FR 20295 - National Tree-Marking Paint Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-04

... Tree-Marking Paint Committee Meeting AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Tree-Marking Paint Committee will meet in Awendaw, SC on May 21-23, 2013. The purpose of... use of tree-marking paint by personnel of the Forest Service and the Department of the Interior...

76 FR 28949 - Kisatchie National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... DEPARTMENT OF AGRICULTURE Forest Service Kisatchie National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Kisatchie National Forest Resource... begin at 6 p.m. ADDRESSES: The meeting will be held at the Kisatchie National Forest Supervisor's Office...

A National Survey of U.S. Internists’ Experiences with Ethical Dilemmas and Ethics Consultation

PubMed Central

DuVal, Gordon; Clarridge, Brian; Gensler, Gary; Danis, Marion

2004-01-01

OBJECTIVE To identify the ethical dilemmas that internists encounter, the strategies they use to address them, and the usefulness of ethics consultation. DESIGN National telephone survey. SETTING Doctors’ offices. PARTICIPANTS General internists, oncologists, and critical care/pulmonologists (N = 344, 64% response rate). MEASUREMENTS Types of ethical dilemmas recently encountered and likelihood of requesting ethics consultation; satisfaction with resolution of ethical dilemmas with and without ethics consultation. RESULTS Internists most commonly reported dilemmas regarding end-of-life decision making, patient autonomy, justice, and conflict resolution. General internists, oncologists, and critical care specialists reported participating in an average of 1.4, 1.3, and 4.1 consultations in the preceding 2 years, respectively (P < .0001). Physicians with the least ethics training had the least access to and participated in the fewest ethics consultations; 19% reported consultation was unavailable at their predominant practice site. Dilemmas about end-of-life decisions and patient autonomy were often referred for consultation, while dilemmas about justice, such as lack of insurance or limited resources, were rarely referred. While most physicians thought consultations yielded information that would be useful in dealing with future ethical dilemmas (72%), some hesitated to seek ethics consultation because they believed it was too time consuming (29%), might make the situation worse (15%), or that consultants were unqualified (11%). CONCLUSIONS While most internists recall recent ethical dilemmas in their practices, those with the least preparation and experience have the least access to ethics consultation. Health care organizations should emphasize ethics educational activities to prepare physicians for handling ethical dilemmas on their own and should improve the accessibility and responsiveness of ethics consultation when needed. PMID:15009780

78 FR 69437 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-13730; PPWOCRADI0, PCU00RP14.R50000] Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park... Regulations, that a meeting of the Landmarks Committee of the National Park System Advisory Board will be held...

Four Roles of Ethical Theory in Clinical Ethics Consultation.

PubMed

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.

The opportunities and ethics of big data: practical priorities for a national Council of Data Ethics.

PubMed

Varley-Winter, Olivia; Shah, Hetan

2016-12-28

In order to generate the gains that can come from analysing and linking big datasets, data holders need to consider the ethical frameworks, principles and applications that help to maintain public trust. In the USA, the National Science Foundation helped to set up a Council for Big Data, Ethics and Society, of which there is no equivalent in the UK. In November 2015, the Royal Statistical Society convened a workshop of 28 participants from government, academia and the private sector, and discussed the practical priorities that might be assisted by a new Council of Data Ethics in the UK. This article draws together the views from that meeting. Priorities for policy-makers and others include seeking a public mandate and informing the terms of the social contract for use of data; building professional competence and due diligence on data protection; appointment of champions who are competent to address public concerns; and transparency, across all dimensions. For government data, further priorities include improvements to data access, and development of data infrastructure. In conclusion, we support the establishment of a national Data Ethics Council, alongside wider and deeper engagement of the public to address data ethics dilemmas.This article is part of the themed issue 'The ethical impact of data science'. © 2016 The Author(s).

78 FR 13377 - Landmarks Committee of the National Park System Advisory Board Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-12225; PPWOCRADI0, PCU00RP14.R50000] Landmarks Committee of the National Park System Advisory Board Meeting AGENCY: National Park... Committee of the National Park System Advisory Board will be held beginning at 1:00 p.m. on April 9, 2013...

77 FR 1076 - National Maritime Security Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-09

...The National Maritime Security Advisory Committee (NMSAC) will meet on January 18-19, 2012 in Washington, DC to discuss various issues relating to national maritime security. This meeting will be open to the public.

Research ethics policies and practices in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey.

PubMed

Zielinski, Chris; Kebede, Derege; Mbondji, Peter Ebongue; Sanou, Issa; Kouvividila, Wenceslas; Lusamba-Dikassa, Paul-Samson

2014-05-01

To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries. A structured questionnaire was used to solicit information on research ethics from health research institutions. Forty-two sub-Saharan African countries. Key informants from the health research institutions. Existence of institutional ethics review policies and mechanisms. About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee. There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies. © The Royal Society of Medicine.

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

PubMed

Rubinstein, Dorit; Tabak, Nili

2012-03-01

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

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

PubMed

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.

The Ethics and Politics of Ethics Approval

ERIC Educational Resources Information Center

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…

Ethical evaluation of research proposals by ethics panels advising the European Commission.

PubMed

Kolar, Roman

2004-06-01

Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.

76 FR 55939 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...The National Geospatial Advisory Committee (NGAC) will meet on October 4-5, 2011 at the National Conservation Training Center, 698 Conservation Way, Shepherdstown, WV 25443. The meeting will be held in Room 201 Instructional East. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

75 FR 30855 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

...The National Geospatial Advisory Committee (NGAC) will meet on June 22-23, 2010 at the National Conservation Training Center, 698 Conservation Way, Shepherdstown, WV 25443. The meeting will be held in Room 201 Instructional East. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

[Continuing education in ethics: from clinical ethics to institutional ethics].

PubMed

Brazeau-Lamontagne, Lucie

2012-01-01

The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

Medical ethics in pediatric critical care.

PubMed

Orioles, Alberto; Morrison, Wynne E

2013-04-01

Ethically charged situations are common in pediatric critical care. Most situations can be managed with minimal controversy within the medical team or between the team and patients/families. Familiarity with institutional resources, such as hospital ethics committees, and national guidelines, such as publications from the American Academy of Pediatrics, American Medical Association, or Society of Critical Care Medicine, are an essential part of the toolkit of any intensivist. Open discussion with colleagues and within the multidisciplinary team can also ensure that when difficult situations arise, they are addressed in a proactive, evidence-based, and collegial manner. Copyright © 2013 Elsevier Inc. All rights reserved.

Ethics and the pediatric surgeon.

PubMed

Fallat, Mary E; Caniano, Donna A; Fecteau, Annie H

2007-01-01

Care of infants and children with life-impairing or life-threatening congenital and acquired disorders often raises ethical concerns for pediatric surgeons. The purpose of this survey was to determine the level of interest in clinical ethics and how respondents would manage ethical dilemmas within several clinical case scenarios. A 12-item validated questionnaire developed by the Ethics and Advocacy Committee was provided for the American Pediatric Surgical Association (APSA; www.eapsa.org) members on the organizational website. General categories of questions included informed consent, patient privacy, and what constitutes research. The survey was completed by 235 of the 825 APSA members; a response rate of 28.4%. The majority (62%) were in academic practice, 22% had additional education or an advanced degree in ethics, and 11% were members of a hospital ethics committee. There was a clear majority response for seven questions. Topics generating the most controversy included the impact of consent by minors, decision making in the neurologically devastated child, what constitutes research in pediatric surgery, the use of interpreters for consent, and patient privacy. Respondents chose a well-referenced manuscript as the preferred modality for ethics education of the APSA members. Pediatric surgeons have a general interest in clinical ethics as it relates to the care of their patients. An important mission of the Ethics and Advocacy Committee can be to provide education that gives guidance and knowledge to the members of APSA on timely topics in surgical ethics.

78 FR 4830 - National Advisory Committee on Microbiological Criteria for Foods; Reestablishment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-23

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0040] National Advisory Committee on Microbiological Criteria for Foods; Reestablishment AGENCY: Food Safety and... Committee on Microbiological Criteria for Foods (NACMCF). The Committee is being reestablished in...

Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland

PubMed Central

2014-01-01

Background To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012. Methods Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons’ opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded. Results Based on REC chairpersons’ interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons’ assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons’ own personal view agreed with their REC. Conclusions The distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices. PMID:24666735

76 FR 28210 - Chippewa National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-16

... DEPARTMENT OF AGRICULTURE Forest Service Chippewa National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Chippewa National Forest Resource... provide advice and recommendations to the Forest Service concerning projects and funding consistent with...

76 FR 34103 - President's Committee on the National Medal of Science; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-10

... NATIONAL SCIENCE FOUNDATION President's Committee on the National Medal of Science; Notice of... Science Foundation announces the following meeting: Name: President's Committee on the National Medal of Science (1182). Date and Time: Wednesday, July 6, 2011, 8:30 a.m.-3:30 p.m. Place: National Science...

78 FR 48724 - President's Committee on the National Medal of Science; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... NATIONAL SCIENCE FOUNDATION President's Committee on the National Medal of Science; Notice of... Science Foundation announces the following meeting: Name: President's Committee on the National Medal of Science (1182). Date and Time: Tuesday, September 3, 2013, 8:30 a.m.-2 p.m. Place: National Science...

77 FR 61644 - President's Committee on the National Medal of Science Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... NATIONAL SCIENCE FOUNDATION President's Committee on the National Medal of Science Notice of... Science Foundation announces the following meeting: Name: President's Committee on the National Medal of Science (1182). Date and Time: Wednesday, October 31, 2011, 8:30 a.m.-2:00 p.m. Place: National Science...

Ethical Challenges

ERIC Educational Resources Information Center

Morris, Michael

2004-01-01

All evaluators face the challenge of striving to adhere to the highest possible standards of ethical conduct. Translating the AEA's Guiding Principles and the Joint Committee's Program Evaluation Standards into everyday practice, however, can be a complex, uncertain, and frustrating endeavor. Moreover, acting in an ethical fashion can require…

76 FR 11503 - National Offshore Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... person representing enterprises specializing in offshore drilling. To be eligible, applicants for all... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0040] National Offshore Safety... Coast Guard seeks applications for membership on the National Offshore Safety Advisory Committee. This...

What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics

PubMed Central

Garrard, E; Dawson, A

2005-01-01

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations. PMID:15994364

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

DTIC Science & Technology

1984-08-01

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

77 FR 50985 - National Advisory Committee for Implementation of the National Forest System Land Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

... National Forest System Land Management Planning Rule AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The National Advisory Committee for Implementation of the National Forest System Land... implementation of the National Forest System Land Management Rule. The meeting is open to the public. The purpose...

76 FR 14898 - Daniel Boone National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... DEPARTMENT OF AGRICULTURE Forest Service Daniel Boone National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Daniel Boone National Forest... basement floor. Written comments should be sent to Kimberly Morgan, Daniel Boone National Forest, 1700...

76 FR 39410 - National Offshore Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... energy industry; (d) One member representing enterprises specializing in offshore drilling; and, (e) One... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0539] National Offshore Safety... Coast Guard seeks applications for membership on the National Offshore Safety Advisory Committee. This...

76 FR 67429 - National Advisory Committee on Institutional Quality and Integrity (NACIQI) Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity (NACIQI) Meeting AGENCY: National Advisory Committee on Institutional Quality and Integrity, Office of... submissions comply with the requirements of Section 508 of the Rehabilitation Act, or be submitted in an...

[National Database of Genotypes--ethical and legal issues].

PubMed

Franková, Vera; Tesínová, Jolana; Brdicka, Radim

2011-01-01

National Database of Genotypes--ethical and legal issues The aim of the project National Database of Genotypes is to outline structure and rules for the database operation collecting information about genotypes of individual persons. The database should be used entirely for health care. Its purpose is to enable physicians to gain quick and easy access to the information about persons requiring specialized care due to their genetic constitution. In the future, another introduction of new genetic tests into the clinical practice can be expected thus the database of genotypes facilitates substantial financial savings by exclusion of duplicates of the expensive genetic testing. Ethical questions connected with the creating and functioning of such database concern mainly privacy protection, confidentiality of personal sensitive data, protection of database from misuse, consent with participation and public interests. Due to necessity of correct interpretation by qualified professional (= clinical geneticist), particular categorization of genetic data within the database is discussed. The function of proposed database has to be governed in concordance with the Czech legislation together with solving ethical problems.

Abortion and neonaticide: ethics, practice, and policy in four nations.

PubMed

Gross, Michael L

2002-06-01

Abortion, particularly later-term abortion, and neonaticide, selective non-treatment of newborns, are feasible management strategies for fetuses or newborns diagnosed with severe abnormalities. However, policy varies considerably among developed nations. This article examines abortion and neonatal policy in four nations: Israel, the US, the UK and Denmark. In Israel, late-term abortion is permitted while non-treatment of newborns is prohibited. In the US, on the other hand, later-term abortion is severely restricted, while treatment to newborns may be withdrawn. Policy in the UK and Denmark bridges some of these gaps with liberal abortion and neonatal policy. Disparate policy within and between nations creates practical and ethical difficulties. Practice diverges from policy as many practitioners find it difficult to adhere to official policy. Ethically, it is difficult to entirely justify perinatal policy in these nations. In each nation, there are elements of ethically sound policy, while other aspects cannot be defended. Ethical policy hinges on two underlying normative issues: the question of fetal/newborn status and the morality of killing and letting die. While each issue has been the subject of extensive debate, there are firm ethical norms that should serve as the basis for coherent and consistent perinatal policy. These include 1) a grant of full moral and legal status to the newborn but only partial moral and legal status to the late-term fetus 2) a general prohibition against feticide unless to save the life of the mother or prevent the birth of a fetus facing certain death or severe pain or suffering and 3) a general endorsement of neonaticide subject to a parent's assessment of the newborn's interest broadly defined to consider physical harm as well as social, psychological and or financial harm to related third parties. Policies in each of the nations surveyed diverging from these norms should be the subject of public discourse and, where possible

75 FR 64692 - Daniel Boone National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... DEPARTMENT OF AGRICULTURE Forest Service Daniel Boone National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Daniel Boone National Forest... Boone National Forest, 1700 Bypass Road, Winchester, KY 40391. Comments may also be sent via email to...

77 FR 8275 - National Advisory Committee on Violence Against Women; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... DEPARTMENT OF JUSTICE National Advisory Committee on Violence Against Women; Notice of Meeting AGENCY: Office on Violence Against Women, United States Department of Justice. ACTION: Notice of Meeting... National Advisory Committee on Violence Against Women (hereinafter ``NAC''). DATES: The meeting will take...

76 FR 52971 - National Advisory Committee on Violence Against Women; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

... DEPARTMENT OF JUSTICE National Advisory Committee on Violence Against Women; Notice of Meeting AGENCY: Office on Violence Against Women, United States Department of Justice. ACTION: Notice of Meeting... National Advisory Committee on Violence Against Women(hereinafter ``NAC''). DATES: The meeting will take...

75 FR 26918 - North Gifford Pinchot National Forest Resource Advisory Committee Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... DEPARTMENT OF AGRICULTURE Forest Service North Gifford Pinchot National Forest Resource Advisory Committee Meeting Notice AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The North Gifford Pinchot National Forest Resource Advisory Committee will meet on Wednesday, June 9, 2010 at the Salkum...

75 FR 70712 - General Conference Committee of the National Poultry Improvement Plan; Reestablishment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

...] General Conference Committee of the National Poultry Improvement Plan; Reestablishment AGENCY: Animal and... Poultry Improvement Plan (Committee) for a 2-year period. The Secretary of Agriculture has determined that.... Rhorer, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, Suite 101, 1498 Klondike...

77 FR 70483 - President's Committee on the National Medal of Science; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... NATIONAL SCIENCE FOUNDATION President's Committee on the National Medal of Science; Notice of... Science. Originally the meeting was scheduled for October 31, 2012. A notice was published in the Federal... Science Foundation announces the rescheduled meeting: Name: President's Committee on the National Medal of...

75 FR 57438 - Chippewa National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

... FURTHER INFORMATION CONTACT: Kay K. Getting, Public Affairs Team Leader, Chippewa National Forest... Resource Advisory Committee members on their roles and responsibilities. DATES: The meeting will be held on... following business will be conducted: Overview of the roles and responsbilities of the Chippewa National...

UNESCO's activities in ethics.

PubMed

ten Have, Henk A M J

2010-03-01

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 bioethics. One major objective of the ethics programme is the development of international normative standards. This is particularly important since many Member States only have a limited infrastructure in bioethics, lacking expertise, educational programs, bioethics committees and legal frameworks. UNESCO has recently adopted the Universal Declaration on Bioethics and Human Rights. The focus of current activities is now on implementation of this Declaration. Three activities are discussed that aim at improving and reinforcing the ethics infrastructure in relation to science and technology: the Global Ethics Observatory, the Ethics Education Programme and the Assisting Bioethics Committees project.

Resources to Support Ethical Practice in Evaluation: An Interview with the Director of the National Center for Research and Professional Ethics

ERIC Educational Resources Information Center

Goodyear, Leslie

2012-01-01

Where do evaluators find resources on ethics and ethical practice? This article highlights a relatively new online resource, a centerpiece project of the National Center for Professional and Research Ethics (NCPRE), which brings together information on best practices in ethics in research, academia, and business in an online portal and center. It…

Common ground: An environmental ethic for Los Alamos National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Menlove, F.L.

1991-01-01

Three predominant philosophies have characterized American business ethical thinking over the past several decades. The first phase is the ethics of self-interest'' which argues that maximizing self-interest coincidentally maximizes the common good. The second phase is legality ethics.'' Proponents argue that what is important is knowing the rules and following them scrupulously. The third phase might be called stake-holder ethics.'' A central tenant is that everyone affected by a decision has a moral hold on the decision maker. This paper will discuss one recent initiative of the Los Alamos National Laboratory to move beyond rules and regulations toward an environmentalmore » ethic that integrates the values of stakeholder ethics'' into the Laboratory's historical culture and value systems. These Common Ground Principles are described. 11 refs.« less

77 FR 20794 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment.... SUMMARY: This notice announces the selection of the authors for the report of the next National Climate Assessment by the National Climate Assessment and Development Advisory Committee (NCADAC). The next National...

76 FR 78944 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

...The National Geospatial Advisory Committee (NGAC) will meet on January 12, 2012, from 1 p.m. to 4 p.m. EST. The meeting will be held via Web conference and teleconference. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

77 FR 3268 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory...., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: The National Vaccine Program Office, U.S. Department...

76 FR 2910 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory...., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, Department of Health...

77 FR 63893 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... meeting to discuss National Industrial Security Program policy matters. DATES: The meeting will be held on...

78 FR 9431 - National Industrial Security Program Policy Advisory Committee (NISPPAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Information Security Oversight Office National Industrial Security Program Policy Advisory Committee (NISPPAC) AGENCY: National Archives and Records... meeting to discuss National Industrial Security Program policy matters. DATES: The meeting will be held on...

75 FR 61520 - President's Committee on the National Medal of Science; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... NATIONAL SCIENCE FOUNDATION President's Committee on the National Medal of Science; Notice of... Science Foundation announces the following meeting: Name: President's Committee on the National Medal of Science (1182). Date and Time: Wednesday, October 20, 2010, 8:30 a.m.-1:30 p.m. Place: Conference Room...

National and Governmental Advisory Committee Advice Letters and EPA Responses for 2017

EPA Pesticide Factsheets

Advice Letters and produced by the National Advisory Committee and Governmental Advisory Committee to the United States Representative to the North American Commission for Environmental Cooperation, and EPA responses

Report of the Committee on ethics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1994-01-01

On July 23, 1991, the Office of Government Ethics proposed a massive overhaul of the [open quotes]Standards of Ethical Conduct for Employees of the Executive Branch.[close quotes] The purpose of the revision was to create a uniform set of standards for the officers and employees of the federal government. The goal of this report is to heighten the awareness of energy practitioners to a few of the facets of these regulations and some of the problems that attorneys may encounter in dealing with ethical matters under the scope of these regulations. Another goal is to make the energy bar awaremore » that the federal ethical regulations have been strongly criticized by many respected commentators. After a brief introduction, section II of the article addresses compensation of appearances, teaching, speaking, or writing. Section III discusses pro bono activities. Sections IV addresses changes in financial disclosure requirements. Section V contains some concluding remarks.« less

76 FR 6761 - Daniel Boone National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-08

... DEPARTMENT OF AGRICULTURE Forest Service Daniel Boone National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Daniel Boone National Forest... National Forest, 1700 Bypass Road, Winchester, KY 40391. Comments may also be sent via e-mail to [email protected

77 FR 51536 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory... INFORMATION CONTACT: National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715-H...

78 FR 4147 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory... INFORMATION CONTACT: National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715-H...

78 FR 31553 - Meeting of the National Vaccine Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY... Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory...: National Vaccine Program Office, U.S. Department of Health and Human Services,, 200 Independence Avenue SW...

77 FR 61574 - National Climate Assessment and Development Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). DATES: Time and Date: The meeting... to dial into the call. Please check the National Climate Assessment Web site for additional...

77 FR 56191 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). DATES: The meeting will be held... dial into the call. Please check the National Climate Assessment Web site for additional information at...

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

PubMed

Rose, Klaus; Kummer, Hans

2015-05-28

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.

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

PubMed Central

Rose, Klaus; Kummer, Hans

2015-01-01

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. PMID:27417359

78 FR 942 - National Committee on Vital and Health Statistics: Meeting Standards Subcommittee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting... Health Statistics (NCVHS) Subcommittee on Standards. Time and Date: February 27, 2013 9:30 a.m.-5:00 p.m... electronic claims attachments. The National Committee on Vital Health Statistics is the public advisory body...

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

PubMed

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

76 FR 25309 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... meeting of the DOC NOAA National Climate Assessment and Development Advisory Committee (NCADAC). The... available at a location to be determined. Please check the National Climate Assessment Web site for this...

77 FR 64491 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). Time and Date: The meeting will be... One Veterans Place Silver Spring, MD 20910. Please check the National Climate Assessment Web site for...

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

PubMed

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

2018-06-01

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.

77 FR 75118 - National Advisory Committee on Meat and Poultry Inspection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0051] National Advisory Committee on Meat and Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of public meeting. SUMMARY: Pursuant to the Federal Advisory Committee Act, the Food Safety and...

Ethics, Ethical Human Research and Human Research Ethics Committees

ERIC Educational Resources Information Center

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…

75 FR 31818 - National Science Board; Committee on Strategy and Budget; Sunshine Act Meetings; Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-04

... NATIONAL SCIENCE FOUNDATION National Science Board; Committee on Strategy and Budget; Sunshine Act Meetings; Notice The National Science Board's Committee on Strategy and Budget, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the...

77 FR 42257 - General Conference Committee of the National Poultry Improvement Plan; Solicitation for Membership

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-18

...] General Conference Committee of the National Poultry Improvement Plan; Solicitation for Membership AGENCY... regional membership for the General Conference Committee of the National Poultry Improvement Plan. DATES... INFORMATION CONTACT: Dr. C. Stephen Roney, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS...

75 FR 47311 - National Offshore Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-05

... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-0489] National Offshore Safety Advisory... Offshore Safety Advisory Committee (NOSAC) will meet by teleconference to discuss items related to safety... advice and makes recommendations to the Coast Guard on [[Page 47312

75 FR 54385 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...The National Geospatial Advisory Committee (NGAC) will meet on September 22-23, 2010 at the American Institute of Architects Building, 1735 New York Avenue, NW., Washington, DC 20006. The meeting will be held in the Gallery Room. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, was established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

78 FR 16527 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

...The National Geospatial Advisory Committee (NGAC) will meet on April 3, 2013, from 1:00 p.m. to 5:00 p.m. EST. The meeting will be held via Web conference and teleconference. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

78 FR 71638 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

...The National Geospatial Advisory Committee (NGAC) will meet on December 11, 2013, from 1:00 p.m. to 5:00 p.m. EST. The meeting will be held via web conference and teleconference. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

76 FR 10914 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-28

...The National Geospatial Advisory Committee (NGAC) will meet on March 17-18, 2011 at the American Institute of Architects Building, 1735 New York Avenue, NW., Washington, DC 20006. The meeting will be held in the Gallery Room. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, was established to advise the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

76 FR 28449 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

...The National Geospatial Advisory Committee (NGAC) will meet on June 8-9, 2011 at the American Institute of Architects Building, 1735 New York Avenue, NW., Washington, DC 20006. The meeting will be held in the Gallery Room. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, was established to advise the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

75 FR 71141 - Announcement of National Geospatial Advisory Committee Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

...The National Geospatial Advisory Committee (NGAC) will meet on December 7-8, 2010 at the American Institute of Architects Building, 1735 New York Avenue, NW., Washington, DC 20006. The meeting will be held in the Gallery Room. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, was established to advise the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget (OMB) Circular A-16. Topics to be addressed at the meeting include:

78 FR 64481 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). Time and Date: The meeting will be... public will not be able to dial into the call. Please check the National Climate Assessment Web site for...

78 FR 51711 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). Time and Date: The meeting will be... public will not be able to dial into the call. Please check the National Climate Assessment Web site for...

78 FR 21598 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... National Climate Assessment and Development Advisory Committee (NCADAC). Time and Date: The meeting will be... public will not be able to dial into the call. Please check the National Climate Assessment Web site for...

Confessions of an Ethics Committee Chair

ERIC Educational Resources Information Center

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…

77 FR 3435 - General Conference Committee of the National Poultry Improvement Plan; Cancellation of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

...] General Conference Committee of the National Poultry Improvement Plan; Cancellation of Meeting AGENCY... are giving notice that the meeting of the General Conference Committee of the National Poultry.... Stephen Roney, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, 1506 Klondike Road, Suite...

76 FR 41195 - National Forests In Mississippi, Tombigbee and Holly Springs Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... DEPARTMENT OF AGRICULTURE Forest Service National Forests In Mississippi, Tombigbee and Holly Springs Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Tombigbee and Holly Springs National Forests Resource Advisory Committee will meet in Starkville, MS. The...

76 FR 41196 - National Forests in Mississippi, Tombigbee and Holly Springs Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... DEPARTMENT OF AGRICULTURE Forest Service National Forests in Mississippi, Tombigbee and Holly Springs Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Tombigbee and Holly Springs National Forests Resource Advisory Committee will meet in Starkville, MS. The...

76 FR 51014 - National Advisory Committee on Institutional Quality and Integrity, Office of Postsecondary...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity, Office of Postsecondary Education; Meeting AGENCY: National Advisory Committee on Institutional Quality and Integrity, Office of Postsecondary Education, U.S. Department of Education. ACTION: Notice of December 14-16...

78 FR 56866 - National Climate Assessment and Development Advisory Committee (NCADAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-16

... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration National Climate Assessment... open meeting. SUMMARY: The National Climate Assessment and Development Advisory Committee (NCADAC) was... synthesize and summarize the science and information pertaining to current and future impacts of climate...

75 FR 69046 - Bridger-Teton National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... DEPARTMENT OF AGRICULTURE Forest Service Bridger-Teton National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Bridger-Teton Resource Advisory... sent to Tracy Hollingshead, Bridger-Teton National Forest, 308 Hwy 189 North, Kemmerer, WY 83101...

76 FR 13975 - Bridger-Teton National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... DEPARTMENT OF AGRICULTURE Forest Service Bridger-Teton National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Bridger-Teton Resource Advisory... to Tracy Hollingshead, Bridger-Teton National Forest, 308 Hwy 189 North, Kemmerer, WY 83101. Comments...

77 FR 51753 - Daniel Boone National Forest Resource Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... DEPARTMENT OF AGRICULTURE Forest Service Daniel Boone National Forest Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Daniel Boone National Forest... relationships and to provide advice and recommendations to the Forest Service concerning projects and funding...

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

PubMed

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.

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

PubMed Central

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. PMID:28785221

From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

PubMed

Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

2013-03-01

As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.