Local Research Ethics Committees Can Audit Ethical Standards in Research
Journal of Medical Ethics. 1997 Dec; 23(6): 379-381.
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.
Clinical Trials; Comprehension; Clinical Research; Consent; Disclosure; Ethical Review; Ethics; Ethics Committees; Evaluation; Human Experimentation; Informed Consent; Patients; Questionnaires; Recall; Research; Research Ethics; Research Ethics Committees; Research Subjects; Review; Standards; Survey;
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Ethical Review of Multi-Centre Research: A Survey of Local Research Ethics Committees in the South Thames Region Holley, Sandra; Foster, Claire (1998-05)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 ...