Ethics and biomedical research

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.     

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

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively 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.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 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.ConclusionsThe 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.     

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

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

生命伦理学委员会

生命伦理学委员会是从伦理学角度审查人体试验研究,保护受试者权益的决策咨询组织。该委员会一般由来自法学、伦理学、医学、药学等领域的专家学者组成,其审查遵循的重要依据是世界医学会制订的《赫尔基辛宣言》。近年来,伦理委员会快速发展,但各伦理委员会审查质量参差不齐。因此,相关部门尚需加强对伦理委员会成员的培训,并加强对伦理委员会的监管,方能促进我国伦理委员会的良性发展。     

Assessment of the ethical review process in Sudan

The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies' requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define 'ethics committee'.     

A critical analysis of Australian clinical ethics committees and the functions they serve

The predominant function of Australian clinical ethics committees (CECs) is policy formation. Some committees have an educational role. Few committees play any direct role in advising on ethics in the management of individual patients and this occurs only in exceptional circumstances. There is a tendency to exaggerate both the number and function of committees. It is suggested that studies of ethics committees, based on questionnaire surveys, should be interpreted cautiously. An examination of ethical issues indicates that there is a role for a critical analysis of power relations in Australian hospitals that is not fulfilled by CECs.     

The rise of research ethics committees in Western Europe: some concomitant problems

The rise of research ethics committees in Western Europe has accelerated since 1975 when the World Medical Association recommended that protocols for experiments involving human subjects be submitted to independent committees for consideration, comment, and guidance. This article describes the numbers, types, composition, function, authority, and problems of institutional, regional, and national research ethics committees in the Netherlands, Great Britain, West Germany, France, Switzerland, and Sweden. Among the problems are lack of authority to require ethical review, underrepresentation of nonmedical members, inconsistencies in definitions of and standards for human experimentation, and nonconsideration of the rights of investigators as well as subjects. The author urges legislation to strengthen the self regulating mechanism of research ethics committees.     

Two models of ethics committees

A distinction is made between two models of ethics committees. According to the Mirror Model, ethics committees ought to reflect the values of society. The Critical Model says committees are to critically examine these standards rather than merely reflect them. It is argued that the Critical Model should be accepted because a society's ethical standards can be mistaken and a society that has Critical rather than merely Mirror ethics committees is more likely to have such mistakes revealed. Some implications of the Critical Model are discussed.     

Publication: an ethical imperative.

Publication of medical research is both a monitor of the researcher''s ethics and an audit of the local or regional ethics committee that approved it. Selectivity of publication or of the intention to publish lessens this audit. Opinions differ about what is ethically allowable in clinical and benchtop medical research. Ethical permission and ethical monitoring of medical research are subject to a hierarchy of pyramidal controls, starting in hospital and ending with the local, institutional, or regional ethics committee. Currently, such committees function with widely varying degrees of efficiency and quality of output, and with differing viewpoints on many ethical issues. Without an a priori insistence by institutional ethics committees that there be an intention to publish all medical research involving human subjects, ethics committees cannot routinely be subject to the scrutiny or audit which they themselves demand of researchers.     

GENDER AND ETHICS COMMITTEES: WHERE’S THE ‘DIFFERENT VOICE’?

Prominent international and national ethics commissions such as the UNESCO International Bioethics Committee rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under‐representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics committees because of relatively straightforward, if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti‐female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in eastern and western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference.     

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.     

Human Research Ethics Committees: Examining their Roles and Practices

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.     

The Role of a Hospital Ethics Consultation Service in Decision-Making for Unrepresented Patients

Despite increased calls for hospital ethics committees to serve as default decision-makers about life-sustaining treatment (LST) for unrepresented patients who lack decision-making capacity or a surrogate decision-maker and whose wishes regarding medical care are not known, little is known about how committees currently function in these cases. This was a retrospective cohort study of all ethics committee consultations involving decision-making about LST for unrepresented patients at a large academic hospital from 2007 to 2013. There were 310 ethics committee consultations, twenty-five (8.1 per cent) of which involved unrepresented patients. In thirteen (52.0 per cent) cases, the ethics consultants evaluated a possible substitute decision-maker identified by social workers and/or case managers. In the remaining cases, the ethics consultants worked with the medical team to contact previous healthcare professionals to provide substituted judgement, found prior advance care planning documents, or identified the patient’s best interest as the decision-making standard. In the majority of cases, the final decision was to limit or withdraw LST (72 per cent) or to change code status to Do Not Resuscitate/Do Not Intubate (12 per cent). Substitute decision-makers who had been evaluated through the ethics consultation process and who made the final decision alone were more likely to continue LST than cases in which physicians made the final decision (50 per cent vs 6.3 per cent, p = 0.04). In our centre, the primary role of ethics consultants in decision-making for unrepresented patients is to identify appropriate decision-making standards. In the absence of other data suggesting that ethics committees, as currently constituted, are ready to serve as substitute decision-makers for unrepresented patients, caution is necessary before designating these committees as default decision-makers.     

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.     

What is wrong with ethics review,the impact on teaching anthropology,and how to fix it: results of an empirical study

There is no empirical evidence that ethics review protects anthropologists’ research participants, but there is ample evidence that it is stifling research agendas and reshaping how we teach anthropological research methods, entrenching a positivist, clinical model of what constitutes research. This paper examines the impact of ethics review on student research in Australia, based on interviews conducted at 14 Australian universities. The data clearly show that the risks posed by student research are minor, and vastly overestimated by ethics committees. To avoid problems with ethics committees, we shepherd students into undertaking low‐risk, and consequently low‐impact, research. Many departments are abandoning research‐led teaching altogether because of the obstacle of ethics review. One solution would be to locate ethics discussions in disciplines and departments, radically restructuring the encounter to reconceptualise it as collegial debate about ethics dilemmas rather than ‘ethics review’.     

The roles and functions of hospital-based ethics committees.

Ethics committees ar becoming much more visible on the Canadian health care scene. They range from research-ethics committees that decide whether research projects are ethically sound to case-oriented committees that look at particular issues and give advice. Eike-Henner Kluge says that ethics committees are useful tools, but only when they are appropriately constituted and function in a professional manner. Otherwise, he warns, they become either useless or a liability.     

Addressing the challenge for expedient ethical review of research in disasters and disease outbreaks

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries.     

An Exploration of the Protective Effects of Investigators’ Ethical Awareness upon Subjects of Drug Clinical Trials in China

Up till now, China has not enacted any legal mechanisms governing certification or supervision for ethics committees. This article analyses deficiencies in the protection of subjects in clinical drug trials under China’s current laws and regulations; it emphasizes that investigators, as practitioners who have direct contact with subjects, play significant roles in protecting and safeguarding subjects’ rights and interests. The paper compares the status quo in China in this area to that of other countries and discusses ways China might enhance the protection of rights and interests of trial subjects, such as enhancing the ethical awareness of investigators through training, improving laws and regulations, and strengthening the communication between investigators and ethics committees.     

Who should Decide for the Unrepresented?

Unrepresented patients lack the capacity to make medical decisions for themselves, have no clear documentation of preferences for medical treatment, and have no surrogate decision maker or obvious candidate for that role. There is no consensus about who should serve as the decision maker for these patients, particularly regarding whether to continue or to limit life‐sustaining treatment. Several authors have argued that ethics committees should play this role rather than the patient's treating physician, a common current default. We argue that concerns about the adequacy of physicians as surrogates are either empirically unfounded or apply equally to ethics committees. We suggest that physicians should be the primary decision maker for the unrepresented because of their fiduciary duties toward their patients. As part of the process of fulfilling these duties, they should seek the advice of third parties such as ethic committees; but final end‐of‐life decision‐making for the unrepresented should rest with the treating physician.     

Fate of biomedical research protocols and publication bias in France: retrospective cohort study

Objectives To describe the fate of protocols approved by the French research ethics committees, a national system created by the French 1988 Huriet-Sérusclat Act; to assess publication bias at a national level.Design Retrospective cohort study.Setting Representative sample of 25/48 French research ethics committees in 1994.Protocols 649 research protocols approved by committees, with follow-up information.Main outcome measures Protocols'' initial characteristics (design, study size, investigator) abstracted from committees'' archives; follow-up information (rates of initiation, completion, and publication) obtained from mailed questionnaire to principal investigators.Results Completed questionnaires were available for 649/976 (69%) protocols. Of these, 581 (90%) studies were initiated, 501/581 (86%) were completed, and 190/501 (38%) were published. Studies with confirmatory results were more likely to be published as scientific papers than were studies with inconclusive results (adjusted odds ratio 4.59, 95% confidence interval 2.21 to 9.54). Moreover, studies with confirmatory results were published more quickly than studies with inconclusive results (hazard ratio 2.48, 1.36 to 4.55).Conclusion At a national level, too many research studies are not completed, and among those completed too many are not published. We suggest capitalising on research ethics committees to register and follow all authorised research on human participants on a systematic and prospective basis.