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Research on Humans Faces Scrutiny: New Policies Adopted

Paul T. Kefalides, MD
Ann Intern Med. 2000;132(6):513-516. doi:10.7326/0003-4819-132-6-200003210-00102
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Structural changes in the field of biomedical research have in turn changed the climate for research involving humans. Both Institutional Review Board (IRB) administrators and investigators are feeling new pressures. Although they are stirred by a steady increase in research projects, especially those sponsored by industry, they are challenged by new public advocacy for the protection of human participants and aggressive, punitive enforcement by government regulators. Several reforms are being drafted and may be put into place by the end of the year, intended to modernize the system of research oversight and regain the public's trust.





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