How the New Common Rule Will Impact Research in 2018 and Beyond
After years of public comment and revisions, the Common Rule has been updated to accommodate new research concerns. Some revisions proposed in the Notice of Proposed Rulemaking (NPRM) were retained, while others weren’t.
In this whitepaper, Kinetiq regulatory consultants review the impact of the final rule in eight key areas, from single IRB (sIRB) review to biospecimen research.
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Tags: biospecimen, clinical research, clinical trials, Common Rule, Common Rule 2018, continuing review, excluded research, FDA, HHS, informed consent, Kinetiq, NIH, regulatory consulting, single IRB, sIRB, waiver of consent