IRB Chair Allen Sherman reminds reviewers that it would be hugely helpful to have contingencies and notes for a Tuesday meeting entered into CLARA by noon on the Monday right before the meeting. Allen does at least a brief review of all agenda items, and sometimes needs time before the meeting to follow up on […]

Here’s a recap of the difference between a note and a contingency in CLARA: A contingency is an item that must be responded to before a submission can be approved. A note, on the other hand, is appropriate for anything you’d like to relay to the study team but  does not require a response before […]

No recap of the history of human research protections is complete without a mention of the Tuskegee study, which studied the course of untreated syphilis in black men who were not given access to available effective treatment for the disease. While the study, which began in 1932, went on under the radar of most observers for […]

The seventh criterion for approval [45 CFR 46.111(a)(7)] requires the IRB to determine that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data. Subject privacy can be a concern at several different points in the research process. Does the research under review require a […]

Sometimes when you’re reviewing a study modification or continuing review (CR), you’ll want to look up previous study documents or CRs or other forms. Finding previously submitted items is easy in CLARA. For a study that migrated into CLARA from ARIA, if you want to look up something that was migrated over from ARIA, first […]

The sixth criterion for approval of research reads, “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects” [45 CFR 46.111(a)(6)]. This criterion is particularly applicable to studies looking at new treatments or other interventions that may have an impact on subjects’ health, safety, or well-being. […]

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 assure 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 […]