PRIM&R’s 2018 IRB Administrator Boot Camp presented a good opportunity to be immersed in learning at a face-to-face event that was well-attended, but small enough to make personal connections. Read more
14Dec2018
TAG ARCHIVES FOR Common Rule
19Nov2018
The IRB Administrator 201 portion of PRIM&R’s IRB Administrator Boot Camp was very insightful and provides a good opportunity to apply critical thinking skills to real life scenarios faced by other IRBs. The presentations on implementation of the revised Common Rule and single IRB review considerations are particularly relevant with regard to the anticipated changes. A great deal of templates and samples were provided as examples of how other institutions are attempting to navigate the Common Rule changes and this is certainly an area in which IRBs can learn from each other. Read more
24Jul2018
From the Director: OHRP releases three draft guidance documents related to the revised Common Rule
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24 Jul
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On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
15May2018
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general compliance date for the revised Common Rule an addition six months, to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period. Comments on the NPRM are due May 21, and as you consider developing and submitting your comments, I wanted to share the letter PRIM&R has submitted. Read more
19Apr2018
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or “Common Rule,” six more months to January 21, 2019. On June 18, HHS released a final rule confirming this delay, while allowing three "burden-reducing provisions" during the delay period. Read more