I’m intrigued, on multiple levels, by the ethical, regulatory, and operational challenges of The Precision Medicine Initiative® (PMI) Cohort Program,…
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Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and…
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Just before entering the Arena to participate in Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent…
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On December 13, 2016, President Obama signed into law the 21st Century Cures Act. Passed as the Cures Act, the…
Read MoreUpdate: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18. There has been…
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