Ethical review and ethical behaviour.
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Biomedical Research↗
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Ethics review in research: ethics committees are risk averse.
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Ethical Review↗
The task for ethics review: should research ethics boards address an approach or a paradigm?
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Behavioral Research↗
Ethics review in research: role of ethics committee review is interpreted widely.
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Decision Making↗
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.
Clinical Trials as Topic↗
Human ethics review and social sciences: several emerging ethical issues.
The extension of ethical review to research in the social sciences and humanities has raised a number of new issues for Institutional Ethics Committees. The emergent issues discussed here are: the relationship between subject and researcher, the use of data to which employment gives access, the impact of questionnaires, the impact of sampling techniques, the impact of observation, when the subject is an organisation, and conflicting rights to research. These issues underscore the importance of IECs maintaining a flexible and watchful oversight of research and the impossibility of a simple clutch of rules to guide ethical research in this domain.
Behavioral Research↗
[Time for professionalising the system of medical ethics review in the Netherlands].
In two recent papers, a radical change of the review system for medical ethics review committees was proposed. The current systems in Great Britain and Australia were described and it was suggested that the extended roles and responsibilities of the medical ethics review committees could not be fulfilled by the present committees. It was proposed that professional medical ethics committees be established with full time members who would receive an appropriate honorarium. The Netherlands has a decentralised system of medical ethics review, which is based on peer review. A radical change of the current system of medical ethics review is not warranted. There is however a need for further improvements to the current peer-review system. An important aspect of this improvement is an honorarium for the members as well as a budget for training and for the adequate scientific and administrative support of the committee by a secretariat. The fees levied for reviewing each protocol could in part finance the committee and its secretariat. However, these fees will probably not meet all of the costs. Therefore the centres involved in medical research should consider supporting their committees. It is in their interest to demonstrate their wish to protect those persons who consent to participate as research subjects. This will maintain the confidence of both the public and future participants in clinical trials. Furthermore, an efficient and adequate system of ethical review will support a balanced view towards medical research with human subjects and will also contribute to a positive image of the centre also as an attractive environment for medical professionals.
Ethics Committees↗
Centralized and non-centralized ethics review: a five nation study.
The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fully centralized, dual, and decentralized or multicommittee) in place; all are made up of two, interrelated components (the administrative and ethics review). We suggest that both components need to be considered in discussions about centralized review. Serious consideration of centralization of the administrative component may address many concerns. Centralization of the ethics review may provide a context that deals with other issues and may encourage reviews that more effectively focus on the ethical issues involved.
Australia↗
Ethical review of human experimentation in the consumer products industry.
BACKGROUND: Ethical review of human experimentation in the consumer products industry is important and provides instructive parallels and contrasts with clinical medical research. The procedures used in Unilever NV/plc are described. METHODS: A central body sets standards for and monitors compliance with ethical review of human studies throughout Unilever. Guidance has been produced on many topics including issues applying generally to human experimentation and more specifically to the consumer products sector. RESULTS: Deficiencies and inconsistencies in the procedures for ethical review and the care of subjects during the conduct of studies have been identified and corrected. Appropriate uniform standards have been achieved across all Unilever operations. CONCLUSION: All human experimentation in the industry needs adequate ethical review. Although the methods used by individual companies may differ, procedures must ensure uniform high standards across a global industry.
Consumer Product Safety↗
Ethical review of research involving human subjects: when and why is IRB review necessary?
Requirements for ethical review of research involving human subjects are based on widely accepted international standards that are implemented by various national regulations and institutional policies. In the United States, most human research is reviewed by institutional review boards (IRBs) applying federal standards. Researchers may not realize the variety of studies that should be submitted for review. Studies involving interventions must be reviewed regardless of whether these are standard interventions, nonmedical interventions, or retrospective studies. Quality improvement activities require IRB review if the results may be published. Research use of information from medical records or of biomedical specimens requires review unless no identifiers are recorded. Review must be sought at least annually and whenever the research changes. Even human research that is technically exempt from Federal regulations usually needs to have that exemption certified by someone other than the researcher.
Ethics Committees, Research↗
Ethical review of multi-centre research: a survey of local research ethics committees in the south Thames region.
OBJECTIVE: To generate baseline data about the standards of practice of local research ethics committees (LRECs) in order to describe accurately the situation of ethical review procedures prior to the establishment of multi-centre research ethics committees (MRECs). DESIGN: The LERECs in the South Thames NHS Region were asked to describe their current practices, and to send us a copy of their application forms and guidance notes for researchers. RESULTS: All of the 27 LRECs approached for the survey responded. The results indicate that there are generally high standards of practice, and that most LRECs work in accordance with published guidelines. CONCLUSION: The problems that researchers face in seeking to obtain ethical approval for multi-centre research (pages 242-5) do not seem to have been caused by substandard LRECs. Hence the new system needs to sustain the high standards of practice whilst confronting the difficulties.
Attitude↗
Reporting of ethical review of clinical research submitted to the Journal of the American Academy of Dermatology.
BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P <or= .001). Of the remaining authors who did not initially provide information on ethics review, 25% of US and 53% of international authors were able to provide documentation of ethics board review when asked. Of international authors asked for ethics information, 67% of European authors provided confirmation of ethical review, as compared with 48% of non-European authors. LIMITATIONS: It is not possible to know with certainty whether each study not citing ethics review actually did not undergo review by an ethics board. Additionally, other editors may have handled some studies requiring ethics review. CONCLUSIONS: One half of authors submitting papers on prospective clinical studies to the JAAD did not provide evidence of ethical review on initial submission. The reason for omission was likely oversight in half of the cases, but in others ethics review and approval were likely not obtained. International authors were more likely to omit mention of ethics review, but, although sample size was too small for statistical analysis, international authors were more often able to provide it when asked, suggesting oversight or misunderstanding as a reason for omission. Furthermore, ethics review may be more standard in the European Union, as European authors were more likely to be able to provide the information when asked, although small sample size precluded statistical analysis.
Dermatology↗
Ethical review of health promotion program evaluation proposals.
Some policies state that program evaluation falls within the domain of administrative research that does not require review by an ethics review board. We propose that some health promotion program evaluations include at least one element of research and can be distinguished from quality assurance. Although American and Canadian evaluation societies provide important guidelines and standards for evaluation practitioners, processes for accountability to the public are provided by research ethics boards. The field of health promotion is, by its nature, replete with challenges to existing research ethics boards. Given the dearth of published literature on the ethics of health promotion evaluation or practice, the field could benefit from the open debate that reviews of proposals would encourage.
Canada↗
Ethical review of multi-centre research: a survey of multi-centre researchers in the South Thames region.
OBJECTIVE: To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data. DESIGN: Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review. RESULTS: Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review. CONCLUSIONS: The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.
England↗
Making research ethics review work in Zimbabwe--the case for investment in local capacity.
OBJECTIVE: To describe the status of ethics review as pertaining to medical research in Zimbabwe, to compare this with international guidelines, and thus to identify potential improvements in the process. DESIGN: The description includes background about the national review body, the Medical Research Council of Zimbabwe (MRCZ), and the findings of an analysis of institutional ethics review performed by the MRCZ liaison office. RESULTS: Discrepancies with international guidelines include application of the concepts of independent and competent review, monitoring of ongoing studies, and ensuring appropriate membership of institutional ethics review committees (IRECs). CONCLUSION: A focus on research ethics education for researchers and IREC members, as well as ensuring appropriate respect for IREC review, are opportunities for improvement in the process.
Ethical Review↗
Independent ethical review of studies involving personal medical records. Report of a working group to the Royal College of Physicians Committee on Ethical Issues in Medicine.
There is a duty to use available information for the general good where this can be done without detriment. It is, in principle, ethically acceptable to use personal medical records without approaching or involving the patients concerned, provided that confidentiality and anonymity are preserved; such use does not require independent ethical approval provided that confidentiality is assured and subject to safeguards described below. Epidemiologists have a special interest in the use of personal medical records in their work (in this context the use of health-related registers and existing biological samples may be included), though access to such data involves professional staff in all medical specialties, not only those in epidemiology. The following guidance is based on a report of a working group (which included non-medical members) to the Royal College of Physicians Committee on Ethical Issues in Medicine. Activities such as medical audit, epidemiological surveillance, inquiries designed to establish indices of morbidity and mortality and outbreak investigations all constitute medical practice and as such do not require independent ethical review. Research involving access to medical records, health-related registers, or existing biological samples only, without direct patient involvement, requires neither explicit individual patient consent nor independent ethical review provided that: a) explicit consent to access a person's records is obtained either from official custodians of the records (who have a duty to satisfy themselves as to the bona fides and competence of the investigator) or from the patient's clinician: the decision to access personal medical information should not be left to the sole discretion of the investigator.(ABSTRACT TRUNCATED AT 250 WORDS)
Confidentiality↗
Evolving participation of aboriginal communities in health research ethics review: the impact of the Inuvik workshop.
The International Workshop "Ethical Issues in Health Research among Circumpolar Indigenous Peoples" was held in Inuvik on June 2-3, 1995 (1). Its purpose was to bring together researchers, representatives of aboriginal organizations and First Nations leaders to discuss problems in the current ethical review process and to develop new frameworks which would increase community participation in the research process. The paper summarizes some of the ethical and political issues involved in developing such frameworks. It describes developments which have occurred since the Inuvik workshop reflecting the changing process of ethical review and new relationships between researchers, participants and aboriginal communities.
American Indian or Alaska Native↗
Ethical review of regulatory toxicology guidelines involving experiments on animals: the example of endocrine disrupters.
The safety assessment of new chemicals (including medicines, pesticides, food additives, and industrial chemicals) relies on the results of animal experiments. Because the safety of those exposed to these products and the welfare of the experimental animals used are considered critically important, both testing requirements and the welfare of experimental animals are controlled by law. In the U.K., projects that propose to use animals for experimental purposes, including for the testing of chemicals, have been controlled by law for over a century, with the most recent legislation (Animals [Scientific Procedures] Act of 1986) requiring a cost/benefit assessment before it may proceed. New regulations introduced in 1998 will require an ethical review process for all projects from April 1999. Such ethical review will have to take account of the toxicity testing methods and schemes that are required by the legislation aimed at protecting human health. Neither national nor international proposals for toxicity testing methods and schemes are generally subjected to ethical review from the point of protecting animal welfare. The international nature of the chemical and pharmaceutical industry means that testing requirements from one of the major national regulatory agencies (USA, EU, or Japan) or the international organizations (Organization for Economic Co-operation and Development [OECD]or the International Conference on Harmonization [ICH]) have an impact on the testing carried out by industrial organizations in all countries. The recent proposals for screening and testing chemicals to identify endocrine disrupters (ED) from the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) of the U.S. Environmental Protection Agency (EPA) are used as an example of the interaction between regulatory proposals and animal welfare issues. The current proposals are the most extravagant in the use of animals. Between 0.6 and 1.2 million animals would be required for each 1000 chemicals tested. The EPA, before incorporating them into regulation, is subjecting the recommendations to further review. This will undoubtedly moderate the number of animals actually used from the worst-case calculation. The variables that have the greatest impact on the number of animals required for testing are the prevalence of ED chemicals in the chemicals to be tested, and the sensitivity and specificity of the testing methods. The modeling demonstrates, for example, that increasing the prevalence from 10 to 50% reduces the number of animals used to detect one ED from 10,000 to 2700. Knowledge of the prevalence of EDs in the chemicals to be tested would allow rational selection of tier one screening based on the sensitivity and specificity of the screening tests. The EDSTAC proposals are difficult to justify from an ethical perspective, as equally effective detection rates may be achieved with fewer animals. National and international regulatory testing proposals should be subjected to formal independent ethical review before they are finalized, with a view to improving animal welfare.
Animal Rights↗