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  1. Return of Results in Participant-Driven Research: Learning from Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (S1):159-166.
    Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.
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  • Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.Susan M. Wolf, Pilar N. Ossorio, Susan A. Berry, Henry T. Greely, Amy L. McGuire, Michelle A. Penny & Sharon F. Terry - 2020 - Journal of Law, Medicine and Ethics 48 (1):69-86.
    Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
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  • Introduction: The Crucial Role of Law in Supporting Successful Translation of Genomics into Clinical Care.Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):7-10.
  • The Streetlight Effect: Regulating Genomics Where the Light Is.Barbara J. Evans - 2020 - Journal of Law, Medicine and Ethics 48 (1):105-118.
    Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.
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