When, and why, does the IRB need grant applications, and what is the IRB supposed to do with them?

If you look closely at UAMS IRB Policy 10.3, you’ll notice that it lists “grant application” as a required element of a submission. (Item IV.A.6, in case you’re wondering.) When and why does the IRB need these, and what is the board supposed to do with them?

First, we only need these if a study is federally funded by the Department of Health and Human Services (HHS)(i.e. the National Institutes of Health) , and UAMS or ACH is the primary grant awardee.

Federal regulations require the IRB to review the actual application for HHS support to ensure that the research described in the proposal matches that described in the human subject research protocol submitted to the IRB.

And what should the IRB do with the submission? Per the guidance referenced above, “A designated IRB member (must) document that the proposed research is consistent with any relevant protocol(s) submitted to, or previously approved by, the IRB. A copy of the HHS application or proposal should be retained among IRB records and made available to any IRB member who may wish to review it.”

An important note for research team members: The IRB will still NOT accept a grant application in lieu of a protocol document. A separate, project-specific protocol document must still accompany a new submission, even if you are including a grant application. Grant applications can include a lot of material not relevant to the research project under review, and they also often don’t include some of the protocol elements the IRB needs to meet the determinations it is required to make.

IRB members, please be sure to read the OPRR guidance linked to here and also above. Researchers, you too are strongly encouraged to read the link. (OPRR was the Office for Protection from Research Risks, which is what the Office for Human Research Protections used to be called, back in the day.)