Composition and function of ethical committees

In this paper the need for review (ethical) committees is elaborated to include a discussion of their composition and function. In some institutions more than one such committee may be set up, a departmental ethical committee and one which studies the projects of all the departments concerned. By considering proposed research before it is started patients or volunteers are protected from injury, discomfort, and inconvenience, and the scientific validity of a clinical experiment can be scrutinized. A list of possible criteria for the work of ethical committees is given.     

Attitudes of women to fetal tissue research.

The use of human fetal tissue for scientific research has enormous potential but is subject to government legislation. In the United Kingdom the Polkinghorne Committee's guidelines were accepted by the Department of Health in 1990. These guidelines set out to protect women undergoing termination of pregnancy from exploitation but in so doing may significantly restrict potential research. Although the committee took evidence from a wide variety of experts they did not seek the views of the general public. We asked 108 women about to have a therapeutic abortion; 167 women who had had a pregnancy terminated in the past, and 419 women who had never had an abortion, their views on research using human fetal tissue. Regardless of their past experiences the women were overwhelmingly in favour of research using fetal tissue (94 per cent). They made little distinction between basic research and research with obvious clinical relevance and supported the concept of using transplanted fetal tissue for the treatment of adult disease such as Parkinsonism. Women about to undergo an abortion were significantly more likely (p < 0.001) to approve of all types of research including that aimed at improving methods of abortion and research using live fetuses in utero.     

Evaluating the work of ethical review committees: an observation and a suggestion.

Eight research protocols which had previously been approved by Ethical Research Committees (ERCs) were reviewed in simulated review committees set up during a symposium on medical ethics. Only three protocols were considered to provide fully adequate information to allow ethical review and only one protocol was thought to provide sufficient guarantees on the ethical issues raised by the proposed research. For five other protocols additional safeguards were considered necessary, in particular covering the problem of informed consent. Two protocols were considered to raise unresolvable ethical issues. This artificial exercise does not establish that review by ERCs is ineffective. It does highlight the lack of objective criteria in ethical review. Peer review by exchange of protocols between ERCs could assist in increasing the consistency in the application of ethical standards.     

Evaluation of research ethics committees in Turkey

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

Ethics committees and the legality of research

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.     

A review of ethical issues in AIDS research.

Much of the past research in AIDS concentrated in the epidemiology, virology, immunology and pathogenesis of human immunodeficiency virus (HIV) infection. However, current research activities incorporates aspects intended to modify human behaviour with a view to slowing down the spread. But a more comprehensive control of the AIDS epidemic can only be affected when a vaccine and, or effective anti HIV drugs are developed. Perspectives into AIDS research will therefore involve more vaccine and drug trials. How will these studies be conducted? To date there is no satisfactory animal model for HIV, and although chimpanzees have shown a promising role as animal models, this role which is not very good for the chimpanzees, is not entirely satisfactory for humans because of the long-incubation period and natural history of AIDS. Human subjects must therefore bear the burden of this research. Unlike in the past when ethical considerations in AIDS research in Africa and other developing countries were less stringent, these newer aspects, initiate more appropriate ethical issues to be instituted. It is also appropriate, to recognize contribution of human subjects in developing countries which should determine the pricing policy for AIDS drugs and vaccines in future.     

Delays and diversity in the practice of local research ethics committees.

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.     

中医药临床研究伦理审查发展对策思考

生物医学研究的目的在于造福人类、促进健康。为规避科学研究的风险,促进生物医学研究的健康、规范发展,涉及人体的生物医学研究需接受伦理委员会的审查和监督已经成为国际通则,中医药的临     

Factors influencing the effectiveness of research ethics committees

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.     

Therapeutic cloning research and ethical oversight

Cloning Trevor, a story about therapeutic cloning research, appeared in the June issue of The Atlantic Monthly. The story gives a human face to the people whom therapeutic cloning could benefit. It presents an argument for government funding and it puts the usual calls for a moratorium on embryonic stem cell research to allow for more debate, in a less favourable light. The story also highlights some problems with ethical oversight.     

Some ethical issues in dementia research

The ethical problems associated with dementia have been thrown into focus by the ageing population. The elderly form a disadvantaged group in society and the author wonders if it is morally justified to pursue research into ways of arresting pathology without concomitant attention being paid to the quality of life of the surviving elderly. Precise diagnosis of dementia requires invasive, and potentially injurious, brain biopsy. Recent thinking has pointed to some of the advantages of biopsy. The question of consent in a patient with impaired mental function has to be borne in mind. As for the special ethical problems associated with Huntington's chorea, it is argued there is no justification for withholding information from, or for authoritarian direction of, patients and 'at risk' relatives but the importance of full discussion before undertaking predictive procedures is stressed.