Local Research Ethics Committees can audit ethical standards in research.
نویسنده
چکیده
OBJECTIVES To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN Postal questionnaire. SETTING Clinical research by one doctor during one year. SUBJECTS Eleven patients entered in clinical trials. MAIN OUTCOME MEASURES Success in ethics committee obtaining data. Achievement of ethical standards in recruitment of subjects and in obtaining consent. RESULTS The audit was successfully carried out and standards were partly met. CONCLUSIONS Local Research Ethics Committees can carry out audits of the conduct of research projects which they have approved. Provision for possible audits can be made at the time of application to the committee. Our committee thought the ethical standards in the research which we audited were acceptable.
منابع مشابه
Ethics committee review of medical audit: a personal view from the United Kingdom.
Until now, medical practice in the United Kingdom has, unlike in medical research, largely resisted ethics committee scrutiny of clinical audit. I support this position. On what grounds do I do so? Are there suYcient diVerences between medical research and medical audit to reliably sustain this thesis? I shall argue that research ethics committees may be operating under philosophical constraint...
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ورودعنوان ژورنال:
- Journal of medical ethics
دوره 23 6 شماره
صفحات -
تاریخ انتشار 1997