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Remember — Human subject protection-related decisions are the purview of the UAMS IRB

Word has reached us, through the grapevine, of investigators being told things like, “You’ll have to rerecord that recruitment video” and “Unless you get a reconsent, you won’t be able to use that subject’s data because you didn’t follow your approved consent process” by people who are NOT the IRB. We’ve also heard that some people are citing that antique known as the Investigator’s Handbook as a basis for their policy recommendations. Yes, the handbook still turns up when you search for it at uams.edu — the 2004 version, on a web page for an office that no longer exists.

While we know the grapevine is a place of questionable reliability, we’d like to take this opportunity to remind everyone that ultimately, determinations related to human subject protections are the IRB’s responsibility, and also that the IRB’s operations are governed by current applicable regulations, policies, and accreditation standards, and not by a handbook that was replaced years ago.

All of which is to say that if well-meaning auditors, monitors, advisers, colleagues, etc. give you a directive related to human subject protections and/or issues that are under the IRB’s purview, please remember that the IRB needs to weigh in first on things like whether a particular consent process was appropriate, whether data are usable (although the IRB has shied away from that determination recently, preferring instead to determine whether the data in question were collected under the scope of your IRB approval), and similar issues. For the complete list of items under the IRB’s oversight, please see UAMS IRB Policy 7.1, Criteria for IRB Approval of Research.