Research ethics committee audit: differences between committees.

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated.     

Research ethics committees and paternalism

In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.     

Research ethics committees: the role of ethics in a regulatory authority

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.     

Hospital ethics committees. Administrative aspects

Two physicians with experience in setting up hospital ethics committees (HECs) review some of the administrative and legal aspects of the committees' formation and operation. They identify HECs as having an advisory function rather than a regulatory or decision making role, and explore the rationale for these committees and their relationship to institutional review boards. Advice is offered to hospitals planning to establish ethics committees on defining their goals, selecting members, deciding about patient and family participation, opening meetings to all interested persons, and keeping records. Fost and Cranford also discuss the questions of access to committees, their jurisdiction, whether consultation should be optional or mandatory, and the effect of committee consultations on legal liability. They conclude that, if properly formed and administered, hospital ethics committees can help promote ethically defensible decisions about life-sustaining care.     

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.     

Natural justice and human research ethics committees: an Australia-wide survey

OBJECTIVE: To determine how familiar human research ethics committees (HRECs) are with the principles of natural justice and whether they apply these principles. DESIGN AND SETTING: A postal survey conducted between April and September 2002 of the Chairs of all HRECs registered with the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) in 2001. MAIN OUTCOME MEASURES: HRECs' reported familiarity with, and application of, three principles of natural justice: (1). the hearing rule, requiring a decision maker to allow a person affected by a decision to present his or her case; (2). the rule against bias, requiring a decision maker to be unbiased in the matter to be decided; and (3). the evidence rule, requiring that a decision be based on the evidence provided, and not irrelevant issues. RESULTS: From 201 Chairs of HRECs Australia-wide, we received 110 completed questionnaires (55% response rate). About 33% of respondents were very familiar with the principles of natural justice, and 25% completely unfamiliar. Most respondents felt that natural justice should be, and usually is, applied by HRECs. In cases of possible positive bias of an HREC member towards a research proposal, 70% of respondents said they would exclude the member from decision making. In cases of possible negative bias, 43% said they would exclude the HREC member. CONCLUSION: The degree of familiarity with principles of natural justice varies widely among Chairs of HRECs. While many respondents felt that HRECs usually apply natural justice, responses to questions about bias suggest that HRECs do not always exclude members with possible bias, contrary to NHMRC guidelines.     

Ethics and ethics committees: HIV serosurveillance in Scotland.

Knowledge of the heterosexual spread of HIV is needed to plan future health-care needs. In December 1989 we gained approval and finance for unlinked anonymous testing of neonatal Guthrie card samples in Scotland. Local ethics committee approval was required before testing could start. Twenty ethics committees were approached in the 15 Scottish health board areas. Nineteen of the committees have agreed, representing 99.6 per cent of births in Scotland. Our method of contacting ethics committees is discussed, as are the points raised.     

Research ethics committees in Europe: implementing the directive, respecting diversity

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union (EU). How four different member states-Hungary, Portugal, Sweden and the UK-have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees.     

Hospital ethics committees in Israel: structure,function and heterogeneity in the setting of statutory ethics committees

OBJECTIVES: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons. SETTING: Israel five years after the passage of the Patients' Rights Act. Main measurements: Patients' rights and informal ethics committee structure and function. RESULTS: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction. CONCLUSIONS: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement.     

Compensation for subjects of medical research: the moral rights of patients and the power of research ethics committees.

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable.     

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.     

Research involving human subjects: ethics and law in early 20th century Russia

This paper reports on the ethical and legal basis of human subjects research in Russia in the first half of the twentieth century, a part of medical history that does not appear previously to have been described. It now seems that both Russia and Germany had regulations before World War II, unlike the UK or US.