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 […]

When reviewing studies, please remember to take a look at the notes and draft contingencies already entered into CLARA by the office staff. We use these CLARA functions to indicate areas that we think need may need additional input by the IRB, and to note draft contingencies the IRB may want to consider. Please note […]

Here’s a quick recap of the options available to reviewers to note comments and contingencies when they’re reviewing CLARA submissions. The “contingencies” option is for items that require a response from the study team. The “note” option can be used when you want to make a suggestion to the study team, or to bring something […]

Please take a quick look at all the items on your meeting agenda – even the ones assigned to other reviewers. You may have some expertise in a particular area that would be helpful to the IRB as it reviews a particular study that you’re not assigned to. Your contributions on *all* agenda items are […]

When reviewing a proposed modification, remember that reviewers can (and should!) ask for summaries of complicated submissions and/or a description of what the modification means for the study. These items are sometimes within the revised document itself, e.g. a revised Investigator’s Brochure (IB) will have a list of revisions in the first few pages of […]