TAG ARCHIVES FOR revised common rule

8
Nov2018

I had the pleasure of attending PRIM&R’s IRB Administrator Boot Camp (including IRB 101 and 201) in Chicago and it was a great experience! All of us are facing new challenges and uncertainties with the Common Rule update and it is difficult to anticipate how changes will be implemented in the future. It was reassuring to hear that other institutions are optimistic about future transitions, especially concerning the not-so-distant single IRB mandate. Read more

24
Jul2018

On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of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

15
May2018

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

7
May2018

At the 2017 AER conference, I caught the plenary session, “New Frontiers: The Changing Landscape of Research Regulations.” One of the presenters, John R. Baumann, PhD, the Associate Vice President for Research Compliance at Indiana University, shared with us how his institution was approaching the upcoming changes to the Common Rule, including the elimination of continuing review. Read more