The Journal of Clinical Research Best Practices (“Happy Trials to You” is its motto) recently published a list of items to be aware of when reviewing research. The authors, Dennis J. Mazur and Norman M. Goldfarb, call them “red flags” that should be addressed before an IRB begins its in-depth review of the project.  The […]

We’ve been seeing device studies off and on for years, but we still don’t fell like we’ve mastered all the regulatory ins and outs of studies that involve investigational devices. In trolling around the FDA’s website not long ago, we found a guidance that has a lot of good information about device studies and what […]

In the past, CLARA users could access study documents via live links at the bottom of a particular form (new submission form, modification form, etc.). We’ve made some changes in CLARA related to document access, so those links will no longer be live. To see documents in CLARA, you’ll now go to the “documents” tab. When […]

When they’re reviewing a study, some reviewers (and some of the IRB office staff too!) like to open a separate document in Word or some other program to draft contingencies as they work through a study. Then, they copy and paste those contingencies into CLARA when they wrap up their review. There’s nothing inherently wrong […]

An email with an attached self-evaluation was sent to all IRB reviewers Wednesday, Aug. 12. We know that completing self-evaluations might rank somewhere between “cleaning the gutters” and “going to the dentist” on the fun scale. However, we do ask that you take the time to complete the evaluations and return them to us. We will […]

The free marketplace of ideas can be an interesting place. In a recent Boston Globe opinion piece, psychologist and Harvard faculty member Steven Pinker has a recommendation for bioethicists who weigh in on the merits of biomedical research: Get out of the way. “A truly ethical bioethics should not bog down research in red tape, […]

In an attempt to streamline the overall approval process of industry-sponsored studies,  IRB office prereviews of those studies will be handled a little differently In the future. When our only prereview contingencies involve changes to the consent or HIPAA authorization forms, we will send those studies to the full board for review with those contingencies […]

The potential for actual or perceived conflicts of interest is always a concern in carrying out, reporting, and reviewing research. As reviewers, we have to be careful not to get involved in study reviews when a conflict exists. UAMS IRB Policy 3.3 spells out the various kinds of conflicts that need to be managed in […]

The AAHRPP reaccredition process has us all thinking about the regulations, policies, and guidances that govern human subject research. And there are an awful lot of regulations, policies and guidances. Do we expect you to remember them all, and what they all say? Of course not. Even those of us who work in IRB-land full […]

The University of Minnesota (UM) recently found itself in the news because of concerns related to human subject protections in its research program. (See the recent IRB Members Blog item on this issue for a refresher.)  As a result, UM has undertaken a reorganization of its human research protection program. The workplan guiding the reorganization is […]