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Returning Individual Research Results to “Vulnerable” Individuals

  • Author Footnotes
    ∗ All authors contributed equally to this work
    Christi L. Kolarcik
    Footnotes
    ∗ All authors contributed equally to this work
    Affiliations
    Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA
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  • Author Footnotes
    ∗ All authors contributed equally to this work
    Marianna J. Bledsoe
    Footnotes
    ∗ All authors contributed equally to this work
    Affiliations
    Independent Consultant, Colorado Springs CO
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  • Author Footnotes
    ∗ All authors contributed equally to this work
    Timothy J. O’Leary
    Correspondence
    Corresponding Author: Timothy J. O’Leary, Office of Research and Development, Veterans Health Administration, 810 Vermont Avenue NW, Washington, DC. 20420, Phone: 2404600271
    Footnotes
    ∗ All authors contributed equally to this work
    Affiliations
    Office of Research and Development, Veterans Health Administration, Washington DC

    Department of Pathology, University of Maryland School of Medicine, Baltimore MD
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  • Author Footnotes
    ∗ All authors contributed equally to this work

      Abstract

      Although issues associated with returning individual research results to study participants have been well explored, these issues have been less thoroughly investigated in “vulnerable” individuals and populations. Considerations regarding return of research results to these individuals and populations, including how best to ensure “truly informed consent”, how to minimize the risks and benefits of the return of research results, and how best to ensure justice, may differ from those of the population at large. In this paper, we discuss the issues and challenges associated with the return of individual research results (such as genomic, proteomic, or other biomarker data) to potentially vulnerable individuals and populations including those who may be vulnerable for cognitive, communicative, institutional, social, deferential, medical, economic or social reasons. We explore factors that should be considered in the design, conduct and oversight of ethically responsible research involving the return of research results to vulnerable individuals and populations and discuss recommendations for those engaged in this work.
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