Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

Authors

  • Kevin P. Weinfurt Ph.D.,

    1. Associate Professor of Psychiatry and Behavioral Sciences in the Duke University School of Medicine and Deputy Director of the Center for Clinical and Genetic Economics in the Duke Clinical Research Institute. He holds a doctoral degree in psychology from Georgetown University
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  • Joëlle Y. Friedman M.P.A.,

    1. Project leader in the Center for Clinical and Genetic Economics. She holds a master's degree in public administration from Columbia University
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  • Michaela A. Dinan B.S.,

    1. Research assistant in the Center for Clinical and Genetic Economics. Ms. Dinan holds a B.A. in Biology from the University of Virginia
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  • Jennifer S. Allsbrook B.S.P.H.,

    1. Project planner in the Center for Clinical and Genetic Economics. Ms. Allsbrook hold B.A. in public health from the University of North Carolina at Chapel Hill
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  • Mark A. Hall J.D.,

    1. Fred D. and Elizabeth L. Turnage Professor of Law in the Wake Forest University School of Law. He holds a law degree from the University of Chicago
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  • Jatinder K. Dhillon B.S.P.H.,

    1. Research assistant in the Center for Clinical and Genetic Economics. Ms. Dillon holds a B.A. in public health from the University of North Carolina at Chapel Hill
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  • Jeremy Sugarman M.D., M.P.H., M.A.

    1. Harvey M. Meyerhoff Professor of Bioethics and Medicine in The Phoebe R. Berman Institute of Ethics, The Johns Hopkins University. He holds a medical degree from Duke University, an M.A. in Public Health from The Johns Hopkins University, and M.A. in Philosophy from Georgetown University.
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Abstract

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.

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