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

18
Sep2019

The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key drug developing countries, recently released their  revised “E8(R1) General Considerations for Clinical Studies” document. On September 16, PRIM&R submitted comments approving of ICH’s work to modernize their guidelines and suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those designing and conducting research to learn more about these fundamental ethical principles and related best practices. If you are based in the United States, we encourage you to consider submitting your own comments on the newly revised E8 document before the September 30 deadline. You are welcome to cite or quote PRIM&R’s comments. Read more

10
Sep2019

On June 20, PRIM&R hosted a webinar, Advanced Noncompliance Scenarios for IACUCs: Laboratory Animals and Wildlife, which presented interactive scenarios to assist IACUCs in navigating the challenges associated with identifying, investigating, reporting, and correcting noncompliance at their institution. In this blog post, Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, DACAW, assistant vice president for conflict of interest and the IACUC at the University of Texas Southwestern Medical Center, offers input on a protocol review process called veterinary verification and consultation (VVC), and explores a scenario from the webinar in which this method may be employed by the IACUC to prevent noncompliance as well as to reduce regulatory burden. 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