FDA and the Office for Human Research Protections (OHRP) issued a 16-page draft guidance, entitled “Key Information and Facilitating Understanding…
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By James M. DuBois, DSc, PhD There is currently nothing to prevent qualitative researchers from dumping data that are sensitive…
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The FDA issued guidance in August 2023 to provide more clarity to IRBs, clinical investigators, and sponsors in complying with FDA’s informed…
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By Elena Ghanaim and Jonathan Lawson The NIH Data Management and Sharing (DMS) Policy is a watershed moment for the…
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By Emily E. Anderson, Stephanie Solomon Cargill, and Ryan Spellecy Engaging communities in research beyond mere enrollment is not new…
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