Sometimes when reviewing an agenda item, you’ll notice that some of the documents linked to the form you’re reviewing will have bolded titles in CLARA, while others won’t. Please don’t take the bolding as a sign that only those documents with a bolded title need reviewing. The bolding could result from several things, none of […]

It’s not unusual for sponsors of multisite studies to draft long, periodic reports summarizing overall study progress. We recently saw one in the IRB that was more than 160 pages long submitted with a continuing review (CR). Please note that if you see one of these in a CR you are reviewing, you are NOT […]

When reviewing new submissions for an agenda, please keep in mind that you can discuss any questions or issues with the other assigned reviewer or the IRB chair before the meeting. You also have the option of getting in touch with the study staff directly. However, in case you want to maintain the anonymity of […]

Occasionally you’ll notice an item on a meeting agenda that includes a “budget modification” tag. These items should be reviewed in the normal way. The “budget modification” language indicates that the item in question has resulted in a change in the study’s budget, which is handled in another office and not by the IRB. So […]

The American Association of Public Opinion Research (AAPOR) has some publications and resources available online that will be of interest to IRB members. AAPOR recently announced the release of what it calls “updated and expanded resources for researchers who conduct surveys subject to institutional review board (IRB) review.” Although the announcement focused on researchers, the […]

IRB votes don’t have to be unanimous, or even close to unanimous. Reasonable people can have differing valid viewpoints, and there’s no need to wait until it looks as though everybody agrees on whatever’s being discussed to make a motion. If you are getting the sense during the meeting that further discussion would do nothing […]

When reviewing audits, please remember that the IRB must also vote on a noncompliance determination after its audit review. The noncompliance options are minor noncompliance, serious noncompliance, and continuing noncompliance. Definitions for each are listed in UAMS IRB Policy 12.6. The IRB may also, at its discretion, decide that a particular audit is so clean […]

Keeping contingencies as clear and to-the-point as possible will simplify discussion of them in the meetings and the PI’s ability to respond to them. Please limit contingencies to a single concept or requirement whenever possible. Embedding multiple requirements or requests for information into a single contingency can lead to the PI overlooking one of the […]

It can be difficult to remember, when you’re deep into the review of a complicated new submission, that there are only eight regulatory criteria for the approval of human subject research. These criteria are listed in more detail in UAMS IRB Policy 7.1 and at 45 CFR 46.111. A summary follows: Risks to subjects are […]

FALSE. You may have heard that consent forms should be written at a reading level that’s no higher than what an 8th-grader could understand. However, this bit of conventional wisdom is just that – conventional wisdom, and not a regulatory requirement. Instead, regulations at 21 CFR 50.20 and 45 CFR 46.116 require information given to […]