Ideally, human research protection programs (HRPPs) stay out of the “above the fold” position in newspapers, because “above the fold” is where stories about big failures tend to wind up (or did, back when printed newspapers were still really a thing*; “on the homepage” may be a better way to put it now). The University […]

The UAMS Institutional Review Board has been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2005. In fact, we were one of the first two dozen or so institutions to earn that accreditation when it became available. Our next reaccreditation application is due in the fall of 2015, […]

Check one of your Certified Research Specialist requirements off your to-do list by attending an upcoming live class – and earn some SOCRA credit to boot. Dr. Thomas Cunningham of the Medical Humanities department is scheduled to present a class on Research Misconduct Friday, May 29, from 11 am to 1 pm. The class will take place in […]

Additional copies of the IRB Member Handbook have arrived. Please send an email to paalediths@uams.edu if you need a copy. We are also bringing them to each week’s meeting to distribute as needed. Please note you do NOT need to replace an older edition of this book that you may already have. The changes in […]

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. […]