Disclosure of Financial Relationships to Participants in Clinical Research

doi:10.1056/NEJMsb0902598

Volume 361:916-921		August 27, 2009		Number 9

Disclosure of Financial Relationships to Participants in Clinical Research

Kevin P. Weinfurt, Ph.D., Mark A. Hall, J.D., Nancy M.P. King, J.D., Joëlle Y. Friedman, M.P.A., Kevin A. Schulman, M.D., and Jeremy Sugarman, M.D., M.P.H.

Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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PubMed Citation

In keeping with previous statements by a number of prominentgroups,¹^,²^,³^,⁴ the Institute of Medicine has recently stressedthe need for vigilance in managing conflicts of interest toensure the integrity of clinical research.⁵ The Institute ofMedicine adopts a position similar to that of the Associationof American Medical Colleges¹ — that is, it assumes thatthere is a rebuttable presumption of a conflict of interestif the investigator has a financial interest in the outcomeof research that involves human subjects. Although the institute'sreport emphasizes the need for disclosure of financial intereststo institutions and peer reviewers, . . . [Full Text of this Article]

Goals of Disclosure

Promoting Informed Decision Making

Respecting Participants' Perceived Right to Know

Establishing or Maintaining Trust

Minimizing Risk of Legal Liability

Deterring Troubling Financial Relationships

Protecting Research Participants' Welfare

Conclusions and Recommendations

Source Information

From the Center for Clinical and Genetic Economics, Duke Clinical Research Institute (K.P.W., J.Y.F., K.A.S.), and the Departments of Psychiatry and Behavioral Sciences (K.P.W.) and Medicine (K.A.S.), Duke University School of Medicine, Durham, NC; Wake Forest University Center for Bioethics, Health, and Society and the Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest University School of Medicine (M.A.H., N.M.P.K.) — both in Winston-Salem, NC; and the Berman Institute of Bioethics and the Department of Medicine, Johns Hopkins University, Baltimore (J.S.).

Address reprint requests to Dr. Sugarman at the Berman Institute of Bioethics, Johns Hopkins University, Hampton House 351, 624 N. Broadway, Baltimore, MD 21205, or to jsugarm1@jhmi.edu.