European Ethical Review Committee: the experience of an international ethics committee reviewing protocols for drug trials.
نویسندگان
چکیده
منابع مشابه
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...
متن کاملThe European ethical review committee.
The European Ethical Review Committee, which concerns itself with the standards applicable to clinical trials with medicinal products, was established in 1977 and, as the name suggests, draws its membership from the countries of Europe. Its structure comprises a Board and panels of experts representing internal medicine, clinical pharmacology, general practice, nursing, legal and lay persons. B...
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INTRODUCTION AND OBJECTIVES Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessmen...
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Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively a...
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ژورنال
عنوان ژورنال: BMJ
سال: 1984
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.289.6451.1052