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Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
Clinical investigators rarely describe the rationale for ethically controversial features of study design or procedures instituted to enhance the protection of patients taking part in research, or how they ensured informed consent. We recommend a policy of extensive reporting of pertinent ethical issues to promote public accountability for clinical research. Guidelines are presented, and possible objections to this recommended policy are addressed.
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