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    Return of Individual Research Results: A Guide for Biomedical Researchers Utilizing Human Biospecimens

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    Author
    Sobel, M.E.
    Dreyfus, J.C.
    O'Leary, T.J.
    Date
    2020
    Journal
    American Journal of Pathology
    Publisher
    Elsevier Inc.
    Type
    Article
    
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    Show full item record
    See at
    https://doi.org/10.1016/j.ajpath.2020.01.014
    Abstract
    The recent movement toward returning individual research results to study subjects/participants generates ethical and legal challenges for laboratories performing research on human biospecimens. The concept of an individual's interest in knowing the results of testing on their tissue is pitted against individual and systemic risks and an established legal framework regulating the performance of laboratory testing for medical care purposes. This article discusses the rationale for returning individual research results to subjects, the potential risks associated with returning these results, and the legal framework in the United States that governs testing of identifiable human biospecimens. On the basis of these considerations, this article provides recommendations for investigators to consider when planning and executing human biospecimen research, with the objective of appropriately balancing the interests of research subjects, the need for ensuring integrity of the research process, and compliance with US laws and regulations. Copyright 2020 American Society for Investigative Pathology
    Keyword
    returning individual research results to subjects
    United States law
    identifiable human biospecimens
    Risk
    Ethics
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85084069449&doi=10.1016%2fj.ajpath.2020.01.014&partnerID=40&md5=ed7183ba5e459419e42b7f6b4912236b; http://hdl.handle.net/10713/12777
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ajpath.2020.01.014
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