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
TAG ARCHIVES FOR exemptions
In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule.
The effective and compliance date for the revised rule is January 19, 2018, and with this date on the horizon, webinar attendees had many questions for the presenters about the new rule and what implementation might look like in their own human [...] Read more