If you’re working on a study that’s primarily being carried out at a different site, you may wonder whether your participation requires IRB review. The best way to find that out is by submitting a human subject research determination form in CLARA.
For that kind of submission, it would be up to the IRB to determine whether your involvement constitutes engagement in human subject research. Click on the link above to see the federal regulatory definition of engagement.
To do so, your HSR determination form should be very clear on exactly what your role in the research will be. If you will be traveling to the other site to interact with subjects and collect data, that’s one thing (and it would require IRB review). If your role is limited to drafting the protocol, or analyzing data or samples sent to you without any identifying information, that’s something else. In that case, you’re probably not engaged in the research and your participation wouldn’t need IRB review.
So, when completing your HSR determination form in CLARA, be sure to spell out what your role in the project will be. That information will be more helpful to us in determining whether you need IRB review than a detailed description of the overall study would be.