While we prepare for the looming implementation of the Revised Common Rule (RCR), keep in mind that some research the UAMS IRB oversees is also subject to Food and Drug Administration (FDA) oversight. While the FDA promises to work on harmonizing its regulations to the extent possible with the RCR, we’re not holding our breath on that. (The FDA is the same agency that spent more than 30 years finalizing regulations for sunscreen labeling, remember. Just sayin’.) So, in the interim, here are some reminders about how FDA-regulated studies will be affected by the RCR implementation next week.
While the RCR is generally good news for non-FDA-regulated research, as the oversight burden is generally reduced for those studies, it’s a little more complicated for FDA-regulated projects. In a nutshell, investigators initiating FDA-regulated studies will still have to comply with FDA regulations, even when they differ from RCR requirements. The FDA has issued guidance about some of the specifics.
Notable differences between the two sets of regulations relate to:
Continuing review — The RCR allows most minimal risk studies to forgo annual review, and even greater-than-minimal-risk studies will no longer need continuing review once they’ve reached the data analysis or long term follow up-only phase. EXCEPT if they’re FDA regulated, that is, as FDA regulations will continue to require continuing review.
Informed Consent — The RCR has some new requirements for consent process and form content and presentation. While the FDA’s consent requirements remain unchanged, the FDA specifically notes the RCR requirements are “not inconsistent” with FDA requirements. That means consent processes and forms can meet the new RCR requirements while still staying on the correct side of FDA requirements. The UAMS IRB strongly encourages FDA-regulated submissions to be approved after Jan. 21, 2019, to include consent materials that meet the RCR requirements, e.g. beginning with a “concise and focused summary” of key elements integral to the decision whether or not to join a study. We have a “key elements” template available on our website for studies for investigator-initiated studies, and we encourage PIs on industry-sponsored trials to encourage sponsors to include the RCR requirements in their consent forms.