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  1.  11
    Comparative Approaches to Biobanks and Privacy.Mark A. Rothstein, Bartha Maria Knoppers & Heather L. Harrell - 2016 - Journal of Law, Medicine and Ethics 44 (1):161-172.
    Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow (...)
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  2.  25
    Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box.Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp & Aaron J. Goldenberg - 2017 - American Journal of Bioethics 17 (7):1-3.
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  3.  8
    Biobanking Research and Privacy Laws in the United States.Heather L. Harrell & Mark A. Rothstein - 2016 - Journal of Law, Medicine and Ethics 44 (1):106-127.
    Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other (...)
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    Broad Consent for Future Research: International Perspectives.Mark A. Rothstein, Heather L. Harrell, Katie M. Saulnier, Edward S. Dove, Chien Te Fan, Tzu-Hsun Hung, Obiajulu Nnamuchi, Alexandra Obadia, Gil Siegal & Bartha Maria Knoppers - 2018 - IRB: Ethics & Human Research 40 (6):7-12.
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