Joint OHRP and FDA guidance on meeting minutes
The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while the regs are similar in some areas, there are discrepancies between the two. So we welcome any effort to provide us with a joint update on both agencies’ “current thinking” on a topic. Second, such guidance is a good refresher about all the things the IRB needs to address during its meetings, and how they should be documented. The Public Responsibility in Medicine and Research group (PRIM&R), also released comments about the new guidance. We encourage all of our IRB staff and members to click on the above links. Research teams may also be interested in getting a little insight into the inner workings of the IRB.