Health care partner Mark Barnes (Boston) and associate David Peloquin (Boston) co-authored an article in Bloomberg BNA’s Medical Research Law & Policy Report on Nov. 4 discussing the proposed U.S. Department of Health and Human Services mandate that all domestic research sites in a multi-site study rely upon a single institutional review board (IRB) as the IRB of record. The proposed rule would revise the Federal Policy for the Protection of Human Subjects, which governs the conduct of clinical research involving human subjects.
The article, titled “Single IRB Review: Legal and Policy Perspectives,” describes the current regulatory landscape for single IRB review, the perceived advantages and disadvantages of joint review, and responses to the recent shift toward mandating a central IRB for domestic multi-site research.
Attorneys
Stay Up To Date with Ropes & Gray
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Stay in the loop with all things Ropes & Gray, and find out more about our people, culture, initiatives and everything that’s happening.
We regularly notify our clients and contacts of significant legal developments, news, webinars and teleconferences that affect their industries.