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.     

Review by a local medical research ethics committee of the conduct of approved research projects,by examination of patients' case notes,consent forms,and research records and by interview.

OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients'' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects approved by Tayside local medical research ethics committee. MAIN OUTCOME MEASURES: Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. RESULTS: In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. CONCLUSIONS: Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.     

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel ‘pre‐review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative 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.     

Guidelines for Community-based Ethics Review of Children’s Science Fair Projects

Low-level community based ethics committees staffed by teachers, parents and community representatives can readily review children’s science fair projects subject to the revision of two core assumptions currently governing children’s Science Fairs. The first part of the paper recasts the New Zealand Royal Society guidelines from its primary emphasis on risk to a new assumption, without benefit there can be no risk. Equally, this revision gives more prominence to the participant information sheet, allowing it to act as a quasi application form which provides ethical transparency between student researchers, participants and a community based ethics committee. A second core assumption, more accurately labeled a cult of originality, produces a random, open-ended array of student topics taking ethics review beyond the confidence level of most community based ethics review committees. This paper reins in Science Fair coordinators recommending they make community level ethics review more manageable by providing a list of preapproved topics for those students wanting to conduct research involving human participants. These revised assumptions create a workable division of labour. Teachers’ preapproved topics involving human participants are more likely to be low risk, permitting community level ethics review to focus primarily on two aspects of the minimization of harm: first, for all participants, especially those with diminished autonomy, and second, for the child researchers themselves, as some participants may be unknown to the student. These revised assumptions make science and ethics more accessible to public education thus demonstrating how Science Fairs can lead students and the community into better understanding the role and function that ethics has in all scientific research human participants. Martin Tolich chaired New Zealand’s National Health Ethics committee, the multi-region ethics committee.     

The current situation of health research and ethics in Sudan

At the beginning of the twentieth century, health research in the Sudan developed primarily as a function of the colonial British administration. Ethical issues in the medical profession in the Sudan are governed by the Sudan Medical Council. To address these issues, the Sudan Medical Council issued Medico-legal and Ethical Guidelines in 1967. This important document has focused principally on ethical issues arising in clinical medicine. Throughout the history of health research in Sudan it is very difficult to find any reference to research ethics. Nevertheless, there have been a few attempts to articulate ethics in health research. In 1979, Sudan witnessed the establishment of the first ethical review committee, which was established by the initiative of a group of doctors and scientists from the national health research laboratory. This committee got neither political nor institutional recognition. Therefore, it was not developed and came to an end shortly after its inception. Yet, in 2000 the FMOH established an ethical review committee (ERC). The functions of this committee were to review proposals of health research to be carried out in the country for ethical issues irrespective to the funding agents. Unfortunately, the committee devoted all the jobs in reviewing only externally-sponsored health research and research carried out by expatriate researchers or international organisations.     

医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

European Ethical Review Committee: the experience of an international ethics committee reviewing protocols for drug trials.

An international ethics review committee, founded seven years ago, has several unusual features: it selects its own members, who are independent of the drug industry; it includes members with no medical or paramedical background, such as lay people and lawyers; and it reviews protocols together with the study''s sponsor. Membership of 31 from nine European countries enables frequent meetings and there is a full meeting of the committee every year to review progress and consider policy. Of the first 294 protocols for phase I, II, or III trials reviewed, 37 were admitted outright, 243 were amended (usually during the discussion of the protocol), and 14 were rejected. It is suggested that, to overcome the problem of ethics review in smaller institutions, regional health authorities in Britain might consider establishing similar committees.     

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report''s assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research.     

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.     

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'.     

Research ethics capacity development in Africa: exploring a model for individual success

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees. Our data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs.     

Ethics committee recommendations for laboratory animals in private research in France

Complementary to existing legislation, non-public research companies in France have been working together voluntarily within an organization known as Grice (Interprofessional Working Group on Ethics Committees for Laboratory Animals/Groupe de Réflexion Interprofessionnel sur les Comites d'Ethique appliquée à l'animal de laboratoire) with the objective of creating institutional ethics committees in an effort to promote animal welfare and good scientific procedures. Each company's commitment to the creation of these committees has been expressed by signing the Charter. Each ethics committee is composed of at least three members, including one who is not a scientist; a veterinarian is highly desirable. The committee examines all procedures and protocols involving animals and hands down a favourable or unfavourable opinion, or requests improvements, especially concerning animal well-being. Consensual approval of the protocol is an essential requirement before the purchase or allocation of animals. The committee examines every aspect of laboratory animal housing and care, and inspects all temporary or permanent animal housing facilities. Grice will continue its efforts in relation with public research organizations as well as with groups and in other countries whose objectives are in line with its own.     

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。     

Transnational policy migration,interdisciplinary policy transfer and decolonization: Tracing the patterns of research ethics regulation in Taiwan

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on ‘principlism’ and committee‐based review were imported from the United States. Professionalisation of research ethics displaced other longer‐standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples’ rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self‐referential and attend to the social, economic and political context within which regulation operates.     

Enriching Our Views on Clinical Ethics: Results of a Qualitative Study of the Moral Psychology of Healthcare Ethics Committee Members

The contribution of healthcare ethics committee (HEC) members to HECs is fundamental. However, little is known about how HEC members view clinical ethics. We report results from a qualitative study of the moral psychology of HEC members. We found that contrary to the existing Kohlberg-based studies, HEC members hold a pragmatic non-expert view of clinical ethics based mainly on respect for persons and a commitment to the patient’s good. In general, HEC members hold deflationary views regarding moral theory. Ethical principles are not abstract foundations but the expression of moral commitments to patients that pre-exist awareness of moral theory. Emotions and proximity to patient sufferance fundamentally shape the views of HEC members on clinical ethics. Further work at the intersection of clinical ethics and qualitative research could bring to the foreground lay perspectives on moral problems that may differ from bioethics expert views.     

Inducement in research

Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.     

Investigating assumptions of vulnerability: A case study of the exclusion of psychiatric inpatients as participants in genetic research in low‐ and middle‐income contexts

Psychiatric genetic research investigates the genetic basis of psychiatric disorders with the aim of more effectively understanding, treating, or, ultimately, preventing such disorders. Given the challenges of recruiting research participants into such studies, the potential for long‐term benefits of such research, and seemingly minimal risk, a strong claim could be made that all non‐acute psychiatric inpatients, including forensic and involuntary patients, should be included in such research, provided they have capacity to consent. There are tensions, however, regarding the ethics of recruiting psychiatric inpatients into such studies. In this paper our intention is to elucidate the source of these tensions from the perspective of research ethics committee interests and decision‐making. We begin by defining inpatient status and outline some of the assumptions surrounding the structures of inpatient care. We then introduce contemporary conceptions of vulnerability, including Florencia Luna’s account of vulnerability which we use as a framework for our analysis. While psychiatric inpatients could be subject to consent‐related vulnerabilities, we suggest that a particular kind of exploitation‐related vulnerability comes to the fore in the context of our case study. Moreover, a subset of these ethical concerns takes on particular weight in the context of genetic research in low‐ and middle‐income countries. At the same time, the automatic exclusion of inpatients from research elicits justice‐related vulnerabilities.     

Composition and capacity of Institutional Review Boards,and challenges experienced by members in ethics review processes in Addis Ababa,Ethiopia: An exploratory qualitative study

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.     

How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review

We assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 full-length articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.