Human subjects researchers: You got the grant! What do you do now?

Congratulations! You got the grant. But you can’t actually get the grant until you determine  if you need Future Human Subjects or “Just-in-time” approval? Don’t panic—OHSU’s Research Integrity Office is here to help and can get you that “Just-in-time” approval quickly.

“Just-in-time” approval

The NIH (and other funding agencies) require full Institutional Review Board (IRB) approval for the research proposed in the grant. The IRB must review the IRB research protocol for that project under the same requirements as any other human subjects research project, but will do this as rapidly as possible because of the short notice given by the NIH for providing evidence of IRB approval. Please be sure to communicate with your IRB analyst when you submit your IRB protocol that this is in response to a “just-in-time” request.  The IRB must also review the full grant application to ensure that the IRB protocol covers the activities described in the grant application, so please remember to upload not only the research protocol but also the FULL grant application.

Note: If it will take significant time to write the IRB protocol and starting the project quickly is absolutely critical, we encourage the investigator to start writing that protocol and get it submitted before the NIH even makes its “just-in-time” request (e.g., as soon as the investigators know that they have a “fundable score” on the grant).

Future Human Subjects

Sometimes the activities in the grant won’t involve human subjects research until later years in the grant, and it is currently impossible to write a detailed IRB research protocol. Examples of this include studies when survey materials, assays, initial animal studies, etc. need to be developed in the early years of the grants for use with human subjects in the later years. (Note: This is not used when the investigator just needs to hire research support staff to prepare the IRB research protocol.)

To request this type of approval, the investigator should submit a “Future Human Subjects” application to the IRB with just the grant application (no IRB protocol). When doing this, please select via the Future Human Subjects application process in the eIRB. The IRB will review the grant and issue a memo confirming that the project qualifies for Future Human Subjects designation and assuring compliance with human subjects protections for the future human research activities, prior to the initiation of the work. Of course, before any human subjects are involved in the research, the investigator will have to submit a full IRB protocol for full review and approval.

Please contact Ames Elliot if you have any questions.