An unexplored ethical issue in clinical research: Disclosure of individual findings in the Creando Posibilidades [creating possibilities] study

Authors

  • Karen Farchaus Stein,

    1. School of Nursing, University of Rochester, Box SON, Helen Wood Hall, 601 Elmwood Avenue, Rochester, NY 14642
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    • Brody Endowed Professor.

  • Colleen Keller,

    Corresponding author
    1. College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd St., Phoenix, AZ 85004
    • College of Nursing and Health Innovation, Arizona State University, 500 N. 3rd St., Phoenix, AZ 85004
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    • Regents' Professor, Foundation Professor in Women's Health, Director Center for Healthy Outcomes in Aging.

  • Astrid Fishstrom

    1. University of Michigan School of Nursing, 400 N. Ingalls Building, Ann Arbor, MI 48109
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    • Project Manager.


  • This study was supported by National Institutes of Health/National Institute of Nursing Research Grant 1R01NR009691-01A2 Creando Posibilidades for College Students of Mexican Origin (Stein, PI).

Abstract

Individual disclosure refers to the presumptive ethical responsibility of an investigator to communicate to a study participant information that was collected as a part of a research study protocol and is specific to the individual. Currently, there are no federal regulatory guidelines specifying the conditions and management of disclosure of health-related individual-specific information. In this report, the authors discuss the challenges associated with individual disclosure in the context of a longitudinal descriptive study. Arguments favoring disclosure and those challenging disclosure as a general ethical duty are presented. Finally, strategies for addressing individual disclosure are discussed using a research exemplar in which risk behaviors related to health outcomes were measured. © 2013 Wiley Periodicals, Inc. Res Nurs Health 36:311–319, 2013

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