EuropaBio's ethics committee and Advisory Group on Ethics(AGE): an overview.
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Advisory Committees↗
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Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees.
With the advent of multicentre research ethics committees in the UK, local research ethics committees (LRECs) are required to advise only on issues relating to the local acceptability of a project. We looked at the handling of two commercially sponsored studies, one initiated before the change and one after, confining the analysis to 21 LRECs approached in both. As judged by the amount of paper per application, the new system for LRECs is simpler and should be less costly. However, there was an increasing tendency for LRECs to charge for their services (30% study 1, 47% study 2) and these charges varied by more than 400%. If such fees must be levied, a common scale is desirable.
Case-Control Studies↗
International variation in ethics committee requirements: comparisons across five Westernised nations.
BACKGROUND: Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. DISCUSSION: The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. SUMMARY: Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.
Behavioral Research↗
Monitoring of health research by ethics committees.
AIMS: All health related research carried out within New Zealand requires appraisal from an accredited ethics committee. The purpose of this project was to pilot an active monitoring programme and to assess the effectiveness of such a programme for future monitoring by ethics committees. METHODS: In this qualitative study interviews were undertaken by representatives from the Wellington and Manawatu-Whanganui ethics committees with principal investigators for sixteen research proposals which had been given ethical approval from the appropriate ethics committee. Issues discussed during the interviews included the protocol and any changes to the methods or research personnel, recruitment of participants, issues arising from informed consent, reporting of adverse events, funding and payment to researchers. Researchers were given the opportunity to provide feedback on the ethical review process and suggestions for improvement. RESULTS: The most significant deviation from the approved protocol concerned access to patient information. Some minor discrepancies between the approved protocols and subsequent research undertaken and the requirements for extending ethical approval of projects beyond the initial approval date were also discussed. CONCLUSIONS: The monitoring programme fulfilled an educational role, providing an opportunity for information sharing between ethics committees and researchers. An active monitoring programme by an ethics committee can detect deviations from the approved protocol beyond the current requirements for researchers to provide annual progress reports. Future monitoring should include, where relevant, access to consent forms and patients' notes.
Ethics Committees↗
Ethics-committee authorization in Germany.
On 9 August 1994 the German legislature revised the German Drug Law (AMG). Included in the revision is a passage requiring, for the first time, that the sponsors and investigators of clinical studies involving human subjects first obtain the approval of an ethics committee before carrying out such studies. According to the legislation, which takes effect on 17 August 1995, approval is to come from 'an independent ethics committee, set up and administered according to state law [emphasis added]' (1). Although it is clear according to the text that the 16 federal states have been empowered to establish ethics committees within their jurisdictions, this does not mean that the state governments are free to transfer exclusive authority in the matter to their respective medical associations, a step that would effectively abolish Germany's private ethics committees. First, the legislation does not rule out the authorization of private ethics committees. Second, as legal scholars attest, the exclusive control of ethics committees by the medical associations would constitute an illegal monopoly. Third, it is arguable that medical-association ethics committees fail to meet the one prior federal requirement, that of independence. There is a great deal of confusion in Germany today about which kinds of ethics committees (public and/or private) the states will sanction before 17 August 1995. In an attempt to sort things out we present a brief explanation of how ther came to be two kinds of ethics committees in Germany, review the legal battle between the two over the issue of authorization, point out how the German legislature, in passing the recent bill, has missed an opportunity to clarify the issue and, finally suggest why the administration of ethics committees by the medical associations may be incompatible with the requirement that ethics committees be independent.
Civil Rights↗
Criteria for decision making in local research (ethics) committees.
This paper briefly reviews the role in medical ethics of the British Medical Association and the General Medical Council. It describes the origin of local research ethics committees and then outlines the criteria which should be used in such committees to assess the ethics of research protocols, based on current best practice in the United Kingdom.
Clinical Protocols↗
Electronic communication in ethics committees: experience and challenges.
Experience with electronic communication in ethics committees at two hospitals is reviewed and discussed. A listserver of ethics committee members transmitted a synopsis of the ethics consultation shortly after the consultation was initiated. Committee comments were sometimes incorporated into the recommendations. This input proved to be most useful in unusual cases where additional, diverse inputs were informative. Efforts to ensure confidentiality are vital to this approach. They include not naming the patient in the e-mail, requiring a password for access to the listserver, and possibly encryption. How this electronic communication process alters group interactions in ethics committees is a fruitful area for future investigation.
Chicago↗
Research ethics committees--the future.
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Advisory Committees↗
Review of research ethics committees.
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Advisory Committees↗
Down's syndrome screening is unethical: views of today's research ethics committees.
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 general that need to be dealt with before the introduction of any prenatal screening test.
Attitude↗
Attitudes to research ethical committees.
A questionnaire on the attitudes towards the functions of research ethical committees was sent to members of selected research ethical committees in Wessex and some controls. Almost all respondents felt there was a need for ethical review of research projects; 42 per cent thought there was a need for some training before joining a committee; 67 per cent thought the system could be improved and 47 per cent thought that monitoring or follow-up procedures should be adopted. Ethical committees were thought to be purely advisory, as opposed to mandatory, by 33 per cent, and 63 per cent thought they should restrict their review to ethical problems as opposed to scientific or design problems. Views about the function of non-medical members ranged from 'none at all' to 'very important'. Of the 10 controls who were asked whether they would become a member of an ethical committee if asked, seven said that on balance they would and the reasons stated varied from the view that it was a 'very important committee' to the feeling that it was 'a necessary but irksome job'.
Attitude↗
Ethics committees offer helping hand to doctors caught in ethical quagmire.
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Decision Making↗
Research ethics committees at work: the experience of one multi-location study.
OBJECTIVES: To report the outcome of applications to 43 research ethics committees. SETTING: Four regional health authorities in England. FINDINGS: The research ethics committees varied considerably in their practices. The time lapse until notification of the outcome of the approval ranged from just under one week to 23 weeks with a mean of 8.6 weeks. Four research ethics committees failed to notify the research team of an outcome of their request for approval. CONCLUSION: A national research ethics committee is needed to review national and multi-location research studies in the light of the fragmented and variable practice of local research ethics committees.
Behavioral Research↗
An ethical committee for general practice in the west for Scotland: proposals received in the first year.
The particular ethical problems of research in general practice and pressure from local general practitioners and hospital ethical committees led to the development of an ethical committee for general practice in the west of Scotland. The workload of this ethical committee in its first year of existence is described.Despite the fact that many of the studies considered by the committee were sponsored by pharmaceutical companies and were often sophisticated, the ethical issues of a general practice setting had not always been fully appreciated. Of the 21 study proposals submitted over the year 13 showed areas of ethical uncertainty. However, all the studies were eventually approved. Most of the problems encountered were easily overcome and might have been avoided if the general practitioners undertaking the research had been able to seek advice from those with experience of research in general practice and in particular of the ethical issues involved. Local ethical committees for general practice, made up largely of general practitioners but with at least one lay member, might provide one such source of advice.
Ethics Committees, Research↗
Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
Clinical Protocols↗
Ethics committees, organ transplantation and public policy.
CONCLUSION: 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.
Adolescent↗
Communication deficiencies in research and monitoring by ethics committees.
AIM: To assess the range of issues that arise for researchers, research participants and ethics committee members in the setting of a hospital-based research environment and to develop a tool that could be used to assist in the process of monitoring. METHODS: A qualitative phase comprising focus group sessions and interviews involving research participants, researchers and ethics committee members of a public teaching hospital and a quantitative phase involving distribution of a questionnaire to research participants and researchers. The data from the qualitative phase were used to assist with the development of the quantitative instrument. Descriptive statistics were derived to describe the various attitudes and practices with respect to the conduct of research. RESULTS: The qualitative study identified issues concerning monitoring procedures and the quality of communication between researchers and study participants. The quantitative analysis showed that parts of the Explanatory Statement (also known as the Participant Information Statement) were incomprehensible to 21% of research participants; the Explanatory Statement was considered too long by 34% of researchers; 6% of researchers believed that explicit consent was not always necessary; of the participants who were out of pocket for attending a study, 53% were offered compensation; and 44% of research participants were unaware of the existence of the ethics committee. In addition, 12% of researchers felt that the quality of monitoring should be improved. CONCLUSIONS: Improvements are necessary in the communication between ethics committees and researchers and research participants, and there is a need for more effective monitoring by ethics committees of research practices. The questionnaire designed for this study could be applied in a prospective manner as a useful tool for monitoring the conduct of research.
Adult↗
Ethics that exclude: the role of ethics committees in lesbian and gay health research in South Africa.
Prevailing state and institutional ideologies regarding race/ethnicity, gender, and sexuality help to shape, and are influenced by, research priorities. Research ethics committees perform a gatekeeper role in this process. In this commentary, we describe efforts to obtain approval from the ethics committee of a large medical institution for research into the treatment of homosexual persons by health professionals in the South African military during the apartheid era. The committee questioned the "scientific validity" of the study, viewing it as having a "political" rather than a "scientific" purpose. They objected to the framing of the research topic within a human rights discourse and appeared to be concerned that the research might lead to action against health professionals who committed human rights abuses against lesbians and gay men during apartheid. The process illustrates the ways in which heterosexism, and concerns to protect the practice of health professionals from scrutiny, may influence the decisions of ethics committees. Ethics that exclude research on lesbian and gay health cannot be in the public interest. Ethics committees must be challenged to examine the ways in which institutionalized ideologies influence their decision making.
Behavioral Research↗