Paul T. Kefalides, MD
Kefalides P.; Research on Humans Faces Scrutiny: New Policies Adopted. Ann Intern Med. 2000;132:513-516. doi: 10.7326/0003-4819-132-6-200003210-00102
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Published: Ann Intern Med. 2000;132(6):513-516.
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.
Institutional review boards are charged with the responsibility of reviewing and approving all research projects that involve human participants. In addition to approving new projects, IRBs are responsible for continuing reviews, a form of oversight on ongoing research. Most research institutes divide IRB duties between a small administrative staff and a committee or committees that are composed primarily of faculty members, supplemented by ethicists, attorneys, and community representatives. Most institutional IRBs meet monthly or biweekly to discuss new applications.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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