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 […]

If you are unable to review your agenda items for any reason, please let the office know well in advance of the IRB meeting so your studies can be reassigned. For example, if you have a conflict, or are out of pocket and won’t have computer access before the meeting, please let us know. Also […]

You may have heard the word “quorum” used during IRB meetings. The dictionary definition of quorum is “the minimum number of members required to be present at an assembly or meeting before it can validly proceed to transact business.” While federal regulations describe the minimum requirements for IRB membership, they do not specifically define “quorum.” […]

Imagine a research proposal involving deliberate manipulation of participants’ emotions. The investigator proposes to subtly influence the environment to see if these changes make people feel happier or sadder, and to see if participants alter their behavior as a result. Both the environment and behavior are arguably public, and when the participants initially entered this […]

Please remember to respond to the email you receive asking whether you’ll be at your next scheduled IRB meeting. You’ll get an email from the office staff about 2 weeks before the meeting asking if you’ll be able to attend. A quick response to that first email is appreciated – that helps us plan assignments […]

New submissions may be reviewed by several other offices before they ever reach the IRB. One of these reviews is done by legal staff, who negotiate with industry sponsors about, among other items, who will cover which costs associated with the study. Part of this negotiation includes nailing down the injury and cost statements in […]