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HHS OCR Issues New Research Guidance

As part of its ongoing implementation of the 21st Century Cures Act (Public Law 114-255), the Department of Health and Human Services last month released a number of new HIPAA guidance tools, including additional information about research uses and disclosures.  The research guidance contains helpful tips for covered entities regarding authorizations, revocations, and “reviews preparatory … Continue Reading

National Institutes of Health Extends Effective Date of sIRB Policy

Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading
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