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Leonard A. Levin, MD, PhD; Julie Gage Palmer, JD

Arch Intern Med. 2007;167(15):1576-1580.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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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ABSTRACT | FULL TEXT