Posts by: Academic and Clinical Research Group

Decision Charts to Help You Navigate the Common Rule NPRM’s Proposed Landscape of Covered Research, Exclusions, and Exemptions

In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep. 8, 2015)), we have been working, along with many of our clients, to map out the “big picture” in terms of the proposed regulations’ broader scope of covered research, the expanded definition of what constitutes a human subject, the new category of excluded activities, and the modified exemptions and implications of being exempt. (more…)

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At Long Last, the Notice of Proposed Rulemaking for the Common Rule is Here

For those of us who work in the clinical research field, the last two days have been quite exciting. At long last, the Notice of Proposed Rulemaking for the Common Rule is here, and the field is alive with talk of the proposed changes and the various ways in which the changes would impact the conduct of research in the U.S. (more…)

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