By Erin D. Solomon, PhD The 2018 updates to the Common Rule emphasize the importance of participants understanding the information…
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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 Lindsay McNair, MD, MPH, MSB Several important ethical topics are currently relevant to the scientific and drug development communities.…
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On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…
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