On April 14, 2020, PRIM&R hosted a webinar, Meaningful Metrics: How HRPPs Can Use Their Data Effectively. This webinar discussed how to effectively use data to assess HRPP performance. After the webinar, speaker Kim Serpico, MEd, CIP, EdD Candidate responded to attendee questions time didn't permit us to address live. We're pleased to share those responses with the readers of Ampersand. Read more
On October 23, 2019, PRIM&R hosted a webinar, Real-World Approaches to Informed Consent under the Revised Common Rule. This webinar served as a check-in on how the human subjects research oversight community is adapting to the new requirements, particularly the revised Common Rule's implications for informed consent. Presenters Karen Blackwell, MS, CIP; Patrick Herbison, MEd, CIP, and Ann Johnson, PhD, MPH, covered challenges and successes pertaining to informed consent requirements in the revised Common Rule and helped attendees identify strategies to benefit their organizations in adapting to the regulatory changes. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
Meet Ivy Tillman, MS, CCRC, CIP, who'll be covering the 2019 Advancing Ethical Research Conference (AER19) as a member of the Blog Squad. Members of PRIM&R's Conference Blog Squad provide an insider's view of the conferences by sharing their experience before, during, and after the meeting. Read more
In August, the RAND Corporation, a policy research organization, released the first comprehensive profile of IRB demographics and function in 20 years: a “Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule.” The report investigates questions about IRB practices, efficiency, and effectiveness on the cusp of implementation of the revised federal regulations, including single IRB review. (In December of 2017, PRIM&R helped get the word out to potential survey respondents.) Read more
Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” [46.116(a)(5)(i)]—the “key information requirement,” for short. I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. Read more
