TAG ARCHIVES FOR revised common rule


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


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


Like many others, I attended the 2017 Advancing Ethical Research Conference eager to hear presentations from the experts, but also looking forward to hearing from other attendees about their interpretations of the revisions to the Common Rule. I went in with a list of questions a mile long. Read more


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


With much anticipation, the Office of Human Research Protections (OHRP) released the final version of the 2018 Common Rule on January 19, 2017.  However, with the issuance of an Interim Final Rule on January 22, 2018, the changes are not to be implemented until July 19, 2018. The HRPP at Wake Forest University Health Sciences has developed a short survey to assess the time and effort put into preparing for the 2018 Common Rule before this announcement of the Interim Final Rule. The results of the survey may be useful as IRBs prepare to allocate resources for the future effective date. Complete the survey to share your feedback on the amount of time spent preparing for the 2018 Common Rule, strategies that your institution plans to employ, and what additional guidance would be most helpful. Read more

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