All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality […]
Blog
Stack audit responses just like you stack any other document in CLARA
Sometimes, for whatever reason, a study you’re working on will be audited more than once by the Office of Research Compliance. That means that you’ll be submitting more than one audit response to the IRB during the study. When that happens, the IRB asks that you “stack” new audit responses atop any previous audit responses […]
Conflicts of Interest and IRB Reviewers
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 […]
Where’s the human subject research determination form?
If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more […]
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 […]
Choose staff roles and responsibilities carefully in CLARA
When adding staff to a new or current study in CLARA, you will be asked to assign roles and responsibilities to each person included on the study. Please be careful to select only roles and responsibilities that are actually applicable. For example, we see a lot of submissions come through indicating a staffer will be […]
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 mention “research” in recruitment materials
When you’re developing recruitment materials for your study, please ensure that the final product makes it clear that this project is research. We know this can be tricky in tweets or other social media blurbs that don’t give you a lot of characters to work with. However, it’s important to emphasize to prospective participants that […]
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 […]
Tracked-changes documents need to show ALL changes — including deletions
When submitting revised documents to the IRB, either in response to contingencies or with modification forms, the IRB asks that you include clean and tracked-changes copies of all of the items being changed (particularly protocols, consents, and HIPAA authorizations). When creating tracked changes documents, please make sure all of your changes are tracked, including deletions. We have […]