Regulatory Guidance on Optional Data and Biospecimen Use
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The NIH and HIPAA have guidance and regulations regarding mandatory future use of biospecimens and/or data collected in research that offers treatment/intervention to participants. NIH guidance focuses on ethical considerations, voluntariness, undue influence, and coercion of mandatory contribution of data/biospecimens for future use. HIPAA regulation defines access to and use of PHI in “conditional” […]
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