We’ve been getting a close look lately from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a.k.a. our accrediting agency, as part of a reaccreditation application. One bit of feedback AAHRPP has provided is that we need to pay closer attention to the way our CLARA forms are filled out to ensure the forms are accurate and complete. The forms are important, because they are part of the documentation showing the IRB considered all the regulatory requirements pertinent to an individual study.
So that means you might see more contingencies from us regarding how new submission and modification forms are completed. We will double-check that things like the vulnerable populations that may be included are appropriately identified, and that if you’re asking for a waiver of consent, or a waiver of documentation of consent, those questions are answered correctly. If we include specific directions in our contingencies about how to respond to certain form queries, please be sure to follow those directions. We put those there to save you time and to keep us from having to go around and around to get things completed correctly.