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 […]
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 […]
Get help with the results modules of clinicaltrials.gov
ClinicalTrials.gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process. As part of the process, a member of the ClinicalTrials.gov results team would be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]
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. […]
Read the Blog. Pass a Test (it’s open book). Earn CRS credit!
You can now earn credit toward earning or maintaining your Certified Research Specialist (CRS) credential at your convenience, just by reading the IRB’s Research News Blog! Online quizzes based on blog entries are now available! So – Read the blog, pass the (open-book) test, and earn 0.5 credit hours! At your convenience! We plan to […]