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  4. Studies stemming from previous registry protocols require separate IRB submissions

Studies stemming from previous registry protocols require separate IRB submissions

So, someone in your department (maybe even you!) has set up a repository of human data and/or specimens, and now you’re ready to use that repository for research. Since the repository had IRB approval, and the subjects signed a consent for future use of the data/specimens, you’re good to go, right?

Actually, no, you’re not. New research projects using previously collected repository data/specimens can, depending on the specifics, meet the definition of research involving human subjects, and should not proceed until you’ve gotten clearance from the IRB to start.

At a minimum, please submit a human subject research determination form through CLARA to find out whether you need IRB review. If it turns out your project is not human subject research, you’ll have *official* documentation showing the IRB looked at your project and found IRB review is not required. Or you may learn that it is human subject research, in which case a full CLARA submission will be your next step.

Note that human subject research done without prior IRB approval not only violates UAMS policy and federal regulations, but it generally will not be accepted for publication or dissemination in journals and other venues.

Posted by Edith Paal on December 11, 2018

Filed Under: Institutional Review Board Members

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