Do Committees Ru(i)n the Bio‐Political Culture? On the Democratic Legitimacy of Bioethics Committees

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.     

Exploitation and community engagement: Can Community Advisory Boards successfully assume a role minimising exploitation in international research?

It has been suggested that community advisory boards (CABs) can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource‐poor settings – namely, where individuals join with a very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board (T‐CAB) as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T‐CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T‐CAB members have gained knowledge and developed capacities that are foundational for one‐day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short‐term CABs.     

Challenges faced by research ethics committees in El Salvador: results from a focus group study

Objective:  To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building.
Methods:  Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed.
Results:  Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight.
Conclusions:  Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.     

CONTEMPORARY MEDICAL ETHICS: AN OVERVIEW FROM IRAN

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

Duties to stakeholders amidst pressures from shareholders: lessons from an advisory panel on transplant policy

The distinction between stakeholders and shareholders frequently employed in business ethics can illuminate challenges faced by a bioethics advisory panel. I use the distinction to reflect back on the work of an advisory panel on which I served, a panel on US transplant policy. The panel hearings were akin to a shareholders' meeting, with many stakeholders absent. In addition to 'hearing out' the shareholders who were present, the panel had duties to absent stakeholders to insure their interests were included in public discussion. While panel efforts to include stakeholder perspectives rightfully framed its report, such duties should have framed its operating procedures more robustly. The stakeholder/shareholder distinction also offers a critical prism on the actual evolution of organ allocation policy, which the panel failed to influence. Current policy embodies a compromise among shareholders that obscures major stakeholder interests. This results in under-attention to likely medical benefit of transplant, compared to other allocation criteria. Recognition of duties to stakeholders amidst pressures of shareholders complicates the notion of 'consensus' for an advisory panel. Consensus framed on terms defined only by shareholders, not stakeholders, may be an inadequate measure of public interest.     

Should Consensus Be ‘The Commission Method’ in the US? The Perspective of the Federal Advisory Committee Act,Regulations, and Case Law

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA)--the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus-making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work product--including a consensus report--is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus-making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus-only bioethics commissions can learn from FACA-related legislative, agency, and judicial insights that consensus-seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus-only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision-making by government officials more than it sets back openness and accountability to a diverse public.     

Unequal protection for patient rights: The divide between university and health ethics committees

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health resarchers and their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process.     

Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi‐structured, in‐depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply‐rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.     

Ethics, evidence, and public policy

The growth of evidence-based medicine (EBM) raises a number of ethical issues that have too often been overlooked. These include issues that arise when clinicians make judgments under uncertainty, new challenges for the clinician-patient relationship, new duties for institutional review boards, issues in physician autonomy and reimbursement, and challenges for disclosure and informed consent. Ethics and EBM must be addressed by policy makers and integrated into medical education.     

Ferretting out the facts behind the H5N1 controversy

Recent recommendations by the National Science Advisory Board for Biosecurity (NSABB) to redact key methodological details of two studies involving mammal-to-mammal transmission of the H5N1 (H5) subtype influenza viruses, has led to a temporary moratorium on all research involving live H5N1 or H5 HA reassortant viruses shown to be transmissible in ferrets. Herein, I review the events which led to this impasse and comment on their impact.     

Module five: implementation of ethics review

The objective of this module is to inform you on issues of concern for Research Ethics Committee members and investigators during the review process. The many guidelines on research ethics, including those from the South African Department of Health and the World Health Organisation, will be referred to extensively to educate you on the requirements of Research Ethics Committees. The evolution of the review process in South Africa will be detailed.     

The Health Care Ethics Consultant, edited by Françoise Baylis

The Health Care Ethics Consultant marks a stage in the development of ethics consultancy. Ethics consultancy is a manifestation of a newly secularized society in which a new discipline has developed to fill a gap created by the combination of the diminishing influence of traditional moral authorities and the growth of new problems associated with the development of new technology and changes in society and culture. The stated primary objective of the book is to focus attention on an immediate practical problem: the role and responsibilities, the education and training, and the certification and accreditation of health ethics consultants. An edited collection of articles, the book originated as a research project financed by the Social Sciences and Humanities Research Council of Canada, undertaken by a Strategic Research Network which included faculty members from Dalhousie University, McGill University, the University of Toronto, McMaster University and the University of Calgary.     

Profile – Børge Diderichsen

Børge Diderichsen (Fig. 1) is the President of the European Federation of Biotechnology (EFB) and Vice President at Novo Nordisk (Denmark). After a master's degree in biochemistry, followed by a Ph.D. in microbiology, both from the University of Copenhagen, he joined Novo Industry as part of a small team of researchers who were to examine whether genetically modified organisms (GMOs) could be used in the production of insulin and industrial enzymes. Since then he has played an important role in Novo Nordisk's efforts to resolve many of the problems that arise in connection with the production of GMOs and was a pioneer in bringing some of the first industrial enzymes from GMOs onto the market. Diderichsen has many honorary titles and has served on a large number of boards and commissions. Most recently he was invited to join the Commissioner's Advisory Group for Life Sciences, Genomics and Biotechnology for Health corresponding to the 6th Framework Programme. For more than 20 years he has contributed to the public debate concerning genetic engineering and ethics, biotechnology and society, conditions for universities and public research among others. He has been a major force in reforming the EFB, of which he was elected president in January 2002.

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Fig. 1. Børge Diderichsen.     

Under-Representation of Women on Dental Journal Editorial Boards

Introduction

Each journal’s editorial and advisory board plays a critical role in resolving gender bias in the peer-review and publication process. Thus, this study aimed to quantify women’s participation in editorial and advisory boards of major dental journals. Gender data on editorial and advisory boards were extracted from major dental journals, which were then categorized by journal specialty focus. The gender of the editor-in-chief and associate editor-in-chief was noted to assess the effect of journal leadership on women’s participation in journal boards. For comparison purposes, data were also obtained regarding the percentage of women faculty for each dental specialty.

Results

Overall, in the major 69 dental journals, 14.8% of editorial board members were women. An one-way ANOVA analysis revealed statistically significant gender differences between journal specialty categories (p = 0.003) with some dental specialties’ journals demonstrating a relatively high participation of women as editorial board members. There was a significant positive correlation for various dental specialties between women’s representation in editorial and advisory boards and women in similar dental academic specialties (p = 0.02, r² = 0.55). Furthermore, there was a positive correlation between the presence of women in journal editorial leadership and the percentage of women serving as advisory board members (p = 0.03). Our results confirmed that the under-representation of women on dental journal editorial boards was significantly different between dental science specialties. When there were more women in journal editorial leadership positions, there was a higher participation of women as editorial and advisory board members. Journals should increase the numbers of women on editorial boards in order to secure diversity, improve publication quality and recognize women’s contribution to dental science.     

Pioneering Interdisciplinary Research Initiatives for Oceans and Human Health

Following the release of the report From Monsoons to Microbes by the National Research Council in 1999, efforts began to promote federal sponsorship of research and education in a new scientific discipline focusing on how the ocean affects human health. The National Institute of Environmental Health Sciences (NIEHS) and the National Science Foundation (NSF) initiated a joint program to establish and sustain several research Centers for Oceans and Human Health (COHH) at nonfederal institutions. Shortly thereafter, the National Oceanic and Atmospheric Administration (NOAA) mounted a similar initiative to establish intramural centers at existing NOAA facilities as well as an extramural grants program. This profile reviews the history and current state of these developments. The statements and opinions in this report are those of the authors only and do not necessarily represent the position of, or imply commitments by, any agency of the United States Government.     

"Walking along beside the researcher": how Canadian REBs/IRBs are responding to the needs of community-based participatory research

Research ethics boards and institutional review boards (REBs/IRBs) have been criticized for relying on conceptions of research that privilege biomedical, clinical, and experimental designs, and for penalizing research that deviates from this model. Studies that use a community-based participatory research (CBPR) design have been identified as particularly challenging to navigate through existing ethics review frameworks. However, the voices of REB/IRB members and staff have been largely absent in this debate. The objective of this article is to explore the perspectives of members of Canadian university-based REBs/IRBs regarding their capacity to review CBPR protocols. We present findings from interviews with 24 Canadian REB/IRB members, staff, and other key informants. Participants were asked to describe and contrast their experiences reviewing studies using CBPR and mainstream approaches. Contrary to the perception that REBs/IRBs are inflexible and unresponsive, participants described their attempts to dialogue and negotiate with researchers and to provide guidance. Overall, these Canadian REBs/IRBs demonstrated a more complex understanding of CBPR than is typically characterized in the literature. Finally, we situate our findings within literature on relational ethics and explore the possibility of researchers and REBs/IRBs working collaboratively to find solutions to unique ethical tensions in CBPR.     

Genetic polymorphism and linkage of the sixth and seventh complement components (C6 and C7) in the common marmoset

Using polyacrylamide gel isoelectric focusing and standard specific hemolytic detection methods, genetic polymorphisms have been found in the sixth and seventh complement components (C6 and C7) in two laboratory groups of Common marmosets. The C6 locus is highly variable and the products of six alleles were observed; three C7 alleles were found. Comprehensive breeding data indicated that both sets of alleles are inherited in an autosomal codominant manner. Many of the C6 variants differed only by a minute charge interval. The C7 variant bands differed by large charge intervals and could only be clearly seen in plasmas that had been preincubated with neuraminidase. A linkage analysis of C6 and C7 phenotypes in three, two-generation families gives reasonable evidence that the two loci are linked in marmosets as they are in humans.This work was supported by a grant from the Advisory Board to the Research Councils.     

Four forward-looking guidance points

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.     

New draft code for research involving humans proved a major challenge.

A new draft code of conduct for research involving humans aims to bring a fresh vision to the ethics field. The code is a joint endeavour of the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council and supersedes all three agencies'' earlier ethics statements. Once the draft code is revised and approved, likely by the end of the year, investigators will have a more refined understanding of the ethical limits of acceptable research.