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Institutional Review Boards Should Require Clinical Trial Registration
Leonard A. Levin, MD, PhD;
Julie Gage Palmer, JD
Arch Intern Med. 2007;167(15):1576-1580.
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INTRODUCTION
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
While the various stakeholders have not reached consensus on all of the details, they generally agree that a free, publicly accessible clinical trial registry is a goal worth pursuing, and for good reason. As stated by the World Health Organization, "Access to information about ongoing, completed and published clinical research is essential for appropriate decision-making. Researchers, research funders, policy-makers, medical practitioners, . . . [Full Text of this Article]
ETHICAL PRINCIPLES: CLINICAL RESEARCH RISK SHOULD BE BALANCED BY SOCIAL BENEFIT AND CONTINGENT ON INFORMED CONSENT
LEGAL PRINCIPLES: AN ARGUMENT FOR IRBs REQUIRING CLINICAL TRIAL REGISTRATION
REGISTRATION AND RISK-BENEFIT RATIO REGISTRATION AND INFORMED CONSENT IRBs AND CLINICAL TRIAL REGISTRATION
ARGUMENTS AGAINST IRBs REQUIRING TRIAL REGISTRATION
AUTHOR INFORMATION
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).
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