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Special Article
August 13/27, 2007

Institutional Review Boards Should Require Clinical Trial Registration

Author Affiliations

Author Affiliations: Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison (Dr Levin); Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada (Dr Levin); and University of Chicago Law School, Chicago, Illinois (Ms Palmer).

Arch Intern Med. 2007;167(15):1576-1580. doi:10.1001/archinte.167.15.1576

Several stakeholders in human research have reached a general consensus in support of public registration of clinical research trials. Internationally, the World Health Organization,1 the American Medical Association,2 the Ottawa group,3,4 the biotechnology industry,5 and the pharmaceutical industry6 have issued statements supporting clinical trial registration. In the United States, Section 113 of the Food and Drug Administration (FDA) Modernization Act of 1997 mandates clinical trial registration on Clinicaltrials.gov for serious or life-threatening conditions. However, the Act includes no enforcement mechanism.7