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 […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
So many regulations and policies!
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 […]
Human Subject Protections — The University of Minnesota Reorganization
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 […]
Remember to look at all contingencies, notes, and comments on your assignments
When reviewing a study you’ve been assigned for a meeting, please remember to take a look at all of the previously entered contingencies, notes, and comments. You can find these under both the “Other Committees” and “My Committee” tab. (You don’t need to look at “required changes;” those are entered by budget reviewers and others […]
Another example of why the IRB’s work is important
We know the regulations governing human subject research can seem cumbersome. But when we read about the things that happened before such research was regulated, we can understand their intent better. A recent National Public Radio story about raced-based testing of chemical agents during WWII highlights the types of activities that seem to be have […]
An alphabet soup of IRB acronyms
We’ve had several requests to put together a list of commonly used IRB acronyms. Below is what we could come up with right off the top of our heads. Please let Edith Paal in the IRB office know if there are others you’re curious about – we can track them down for you. AARHPP – […]
Yikes! How closely should I review this gigantic case report form?
The short answer: You may not need to review it at all. Please check with the IRB office (Edith Paal prereviews almost all of the new submissions before you see them, so she’d be a good place to start) to see if you need to do anything with the CRF in the file. The less […]
Questions about audits? Feel free to ask ORC staff or study teams
If you’ve been assigned an audit to review for an upcoming meeting, and have some questions about the audit report, please keep in mind that you are welcome to contact Office of Research Compliance (ORC) staff before the meeting for more information. The auditors involved in each audit are listed on the front page of […]
Should people have access to their own genomes?
Not all that long ago, researchers and IRBs didn’t have to wrestle with the larger implications of genetics research. Scientific advances in this area mean we now have to consider the implications of the use and study of genetic information. An upcoming lecture will address one aspect of this issue, and we encourage reviewers to […]
Human Subject Protections — The U. of Minnesota Experience
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 […]