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PubMed2004

Ethical review of health research: a perspective from developing country researchers.

BACKGROUND: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). METHODS: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. RESULTS: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. CONCLUSION: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

Academic Medical Centers↗
PubMed1977

Ethical review in the pharmaceutical industry.

1. There seems no reason why clinical pharmacology studies conducted within the pharmaceutical industry should be exempt from the requirement of ethical review, and independent review in this situation reduces the vulnerability of the company and its employees, in addition to serving its primary function of protecting the volunteer subjects. 2. Experience within one company has shown that independent ethical review need not seriously influence the pace of research. 3. It is important that such committees should be seen to be independent and competent.

Drug Evaluation↗
PubMed2002

Ethical review of health service research in the UK: implications for nursing.

BACKGROUND: This paper examines the current systems and structures for ethical review of health services research in the United Kingdom (UK). Past criticisms and the adequacy of recent governance arrangements for Ethics Committees in addressing these are discussed. The implications for nurses are then considered. RATIONALE: This examination of the situation is prompted by the demand for more innovative research designs in health care evaluation, new regulations and guidance, and a climate of public anxiety regarding research conduct in the UK. FINDINGS: The evolution of Research Ethics Committees (RECs) has been slow and resulted in a lack in consistency. Criticisms made of RECs can be categorized into four main areas. New governance arrangements for RECs have emerged as potential solutions to these criticisms. This review identifies the limitations of the new governance arrangements in addressing past criticisms because of two factors. The first is insufficient funding. The second is confusion about the confidentiality and consent requirements of clinicians working in areas where research is conducted and on whom recruitment processes often rely. The current situation regarding health research ethical review has implications for nurses, whether they are working as researchers, members of Ethics Committees or clinicians where research is conducted. CONCLUSION: The new governance arrangements may go some way to addressing past problems. However, investment in RECs is required. It is also important to realize that maintaining ethical probity in health service research is a tripartite concern. It is reliant as it is on the actions of Ethics Committees and clinical research partners as well as those of the researchers themselves.

Confidentiality↗
PubMed2004

Ethics review of social, behavioral, and economic research: where should we go from here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examinees 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES--and in particular, behavioral health--research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.

Behavioral Research↗
PubMed2002

Research ethics review and the bureaucracy.

This paper suggests that the increasing bureaucracy of ethics review by committee is more about fulfilling institutional requirements than it is about ethics. It is suggested that ethics committees should not be instruments of bureaucratic regulation and control. They should be freed to play a critical role within the institution, to support and develop ethical research and researchers, and given time to discuss and explore the difficult ethical issues where they arise. To burden research ethics committees with trivial bureaucratic tasks is to miss an opportunity for healthy exchanges of views about ethics and to distort the nature and meaning of ethics.

Australia↗
PubMed1997

Clinical trial registries and ethics review boards: the results of a survey by the FICHTRE project.

Clinical trial registries could make an important contribution to research by playing a role in the avoidance of trial duplication as well as serving as a source of information on the existence of clinical trials for those wishing to perform overviews. In order to fulfil their role efficiently, these registries should contain information about all trials. However, resources of existing registries are not exhaustive. Currently, all protocols for clinical trials must be submitted to an ethics review board for approval-thus these boards could provide an invaluable source of information about what trials are being performed. One of the objectives of our project was to assess the attitudes of the ethics review boards (ERBs) to providing this type of information to clinical trial registries. We received 115 replies from 281 questionnaires sent to ERBs in seven European countries. More than 70% replied that they would be willing to communicate information about the trials they review, and there seemed to be general agreement that clinical trial registries should be funded and supported by governments. Although ERBs could provide a useful source of information, only an official body such as the Ministry of Health or a drug regulatory body could establish and run a clinical trials registry efficiently.

Clinical Trials as Topic↗
PubMed1989

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.

Ethical Review↗
PubMed2004

Participatory action research: considerations for ethical review.

This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

Community Mental Health Services↗
PubMedDate not supplied

Ethical review in community-based HIV/AIDS research.

AIDS Vancouver recently released a report on ethical review in community-based research. The report identifies some barriers facing community-based researchers and makes recommendations for facilitating this area of HIV/AIDS research in Canada. The following summary of the report was provided by its author.

British Columbia↗
PubMed1988

Monitoring methods, considerations, and statement of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) Ethical Review Committee.

The Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS) was terminated prematurely when an independent Ethical Review Committee concluded, on the basis of interim analyses, that continuation would not be advisable on either ethical or scientific grounds. Among 124 patients treated with enalapril and 120 randomized to placebo, 6-month mortality rates were 27 and 48%, respectively. The 2 groups were found to be well balanced with regard to baseline clinical characteristics, and a consistent treatment effect was evident among subgroups. Furthermore, the difference favoring enalapril was found to have been present since the beginning of the study and was consistent over time. Based on these findings, the study was halted on December 14, 1986.

Chronic Disease↗