Do you remember getting one of these books when you joined the IRB? (Older editions had a different cover – but those still count as the real item.) Haven’t seen your copy around lately? If so, please let Edith Paal in the IRB office know via email at paalediths@uams.edu. We like to keep enough of […]

Here in the office we’ve noticed the occasional “Required Change” created by an IRB reviewer creeping back into our reviews. Please note that the “Required Change” option is used by offices other than IRB. When writing contingencies or comments, please use the “contingency” option for information that you expect to be sent back to the PI for a […]

The IRB, when approving research, is required to ensure that informed consent will be sought from each subject, or subject representative, as required by federal regulations (that’s the fourth criterion for approval), and that consent will be appropriately documented to the extent required by the regulations (the fifth criterion). We’ve said it before, and we’ll […]

The next installment in our review of the criteria for IRB approval of research … The third approval criterion reads, “Seletion of subjects is equitable.” This criterion is rooted in the Belmont Report’s principle of justice. Who ought to receive the benefits of research, and who should bear its burdens? In considering this criterion, IRB […]

As we work our way through a review of the criteria for approval, please keep in mind that these criteria should guide our study reviews and the drafting of contingencies sent back to study teams. The second criterion for approval is “Risks to subjects are reasonable in relation to anticipated benefits, if any, and the […]

When participating in those lively, and sometimes lengthy, discussions at IRB meetings, it can be easy to forget that IRB approval is based on on just a handful of criteria. Upcoming IRB Members Blog items will provide a refresher of these criteria. These criteria should underpin all the contingencies the IRB sends back to investigators. […]

When you’re drafting contingencies during your study reviews, you’ll notice an “attach to letter” box at the bottom of the contingency box. When drafting contingencies before a meeting, please do not check “attach to letter.” Checking this box makes the draft contingency visible to the study team, even before a contingency letter is sent out. […]

When you’re reviewing a study, you’ll sometimes notice that a submission is missing a document. Your first temptation may be to email the study team to ask them to upload the missing item. However, please keep in mind that once a study has been assigned to an agenda, PIs cannot make any more changes to […]

When it’s your week to serve on an IRB committee, please try to have all of your assigned reviews done and any comments or draft contingencies entered into CLARA no later than Monday, the day before the meeting. The chair aims to have assignments completed and the agenda made available to members by Wednesday the […]

PIs have an opportunity to appeal IRB decisions, such as not approving a proposed modification, or a finding of serious or continuing noncompliance. To do so, they draft a written appeal request and send it, along with any supporting documentation, to the IRB office, where staff then assign it to an agenda using the “office […]