But how can IRBs engage communities while operating within the boundaries of their current regulatory role? Do IRBs have an ethical obligation to be proactive in ensuring diversity in clinical trials? Indeed, IRBs are uniquely positioned to influence research practices toward an equitable and more inclusive research world. Perhaps, the FDA and HHS should consider revisiting the scope of responsibilities of IRBs to provide broader latitude for making a greater impact on public health. The questions in this blog are the types of engaging thoughts I plan to discuss during the 2022 PRIM&R Annual Conference. I am most grateful that PRIM&R is providing a forum to discuss these important thoughts and expect more ideas will be generated as we continue the journey of straightening the path towards health equity for all. Read more


IRB and other research regulatory professionals in the United States may not be familiar with Tecovirimat (TPOXX). This explainer is intended to acquaint them with basic facts about TPOXX and the efforts currently underway to 1) use it to treat patients with monkeypox and 2) collect efficacy and safety information concerning such use. This explainer deals with both the US Centers for Disease Control and Prevention (CDC)-run Expanded Access program for TPOXX and the only trial of Tecovirimat as a treatment for monkeypox currently underway in the United States, the Study of Tecovirimat for Human Monkeypox Virus  (STOMP). This explainer is up-to-date as of October 25, 2022. Read more


National Hispanic Heritage Month takes place from September 15 to October 15. We would like to honor this month by featuring some resources (from PRIM&R and from other organizations) that highlight the importance of the inclusion of the Latinx community in clinical research. Read more