Common Rule changes will impact informed consent, IRBs, and more

On January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common...

Pearl IRB’s co -chair, Dr. Gretchen Parker published in Cureus

Gretchen Parker, PhD, RAC, CIP, and Pearl IRB Co-Chair, has completed another article published by Cureus.  The title of the article is “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”.  The article provides...

IRB Written Procedures Draft Guidance released

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the...

Streamlining IRB review process for multi-site research

On 6/21/16, the National Institutes of Health (NIH) issued a final policy to streamline IRB review. Expectations are that a single IRB (sIRB) will be used for all non-exempt multi-site research at U.S. sites for research funded by NIH.  There may be exceptions only if...

NPRM released outlines changes to Common Rule

A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...
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