TAG ARCHIVES FOR revised common rule


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


One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more


Just before I left for San Antonio, I held an educational session with my IRB members, focusing on the revisions to the Common Rule that were likely to have the greatest impact on our processes. As an institution focused primarily on social, behavioral, and educational research (SBER), it seems likely that a large number of our currently expedited review projects will become exempt projects, especially under .104(d)(2) and .104(d)(3). Read more