TAG ARCHIVES FOR revised common rule

21
Apr2020

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

2
Oct2019

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

3
Sep2019

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

12
Aug2019

Attending the 2018 Advancing Ethical Research (AER) Conference was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. This year's AER Conference takes place November 18-20, 2019 in Boston, MA Read more