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Return of results: Ethical and legal distinctions between research and clinical care

Authors

  • Wylie Burke,

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    • Dr. Burke is Professor and former Chair of the Department of Bioethics and Humanities and is an internist and medical geneticist. Her research interests include the ethical and policy implications of genomics.
  • Barbara J Evans,

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    • Dr. Evans is Director of the Center for Biotechnology and Law and holds the George Butler Research Professorship in Law. Her research interests include privacy and data access in large health information systems and regulatory issues affecting genetic and other biomedical technologies.
  • Gail P Jarvik

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    • Dr. Jarvik is Head of Medical Genetics and holds the Arno G. Motulsky Endowed Chair of Medicine. Her research interests include the genetic basis of complexly inherited genetic disease, the clinical application of genomic technology and the bioethical implications of genomics.

  • Conflict of interest: none.
  • * Correspondence to: Wylie Burke, M.D., Ph.D., University of Washington, Box 357120, 1959 NE Pacific, Rm A204 Seattle, WA 98195. E-mail: wburke@u.washington.edu

Abstract

The return of individual results to research participants has been vigorously debated. Consensus statements indicate that researchers and bioethicists consider the return of research results most appropriate when the findings are clinically relevant. Even when clinical utility is the motivator, however, the return of individual research results is not equivalent to clinical care. There are important differences in the domains of research and medical care, both from a legal standpoint and in terms of the ethical responsibilities of clinicians and researchers. As a corollary, researchers risk promoting a therapeutic misconception if they create quasi-clinical settings for return of clinically relevant research results. Rather, efforts should be focused on clarity in the provision of research results, appropriate caveats and, most important, appropriate referrals when the results may be helpful to consider in medical care. © 2014 Wiley Periodicals, Inc.

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