This happens quite often: a researcher would like to apply to a funding agency for a grant to perform a human subjects research study before they can finalize the study methods. But, the agency needs proof of IRB approval as part of the grant application. Can a principal investigator (PI) obtain IRB approval for a study protocol lacking in detail that is not yet in its final form?

The short answer is “Yes”, and Pearl IRB can help.

These reviews can go by many different names: concept approvals, just-in-time reviews, interim approval, and/or approval-in-principle studies. But the idea behind all these names is the same: the IRB provides a “we are likely to approve something like this” letter and the investigator promises to resubmit a separate IRB application, after funding is obtained, for approval of finalized documents before any study-specific activities occur.

45 CFR 46.118 specifically addresses this subject, stating “Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 46.101(i) or exempted under § 46.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.”

What does an investigator need to submit for an approval under 45 CFR 46.118? The IRB will want to see a draft proposal/protocol, concept note, and/or abstract describing the probable study procedures and methods in as much detail as possible at this stage.

• The document must include a statement confirming that the PI will seek IRB approval of finalized study documents prior to beginning any proposed study activities. Remember, researchers may not begin any recruitment, consenting, or data collection activities until they have obtained formal IRB approval of final study documents (45 CFR 46.103(d)).
• The IRB application will also need to supply an anticipated start date.

After the PI receives the interim approval notice, they may submit their application to the appropriate funding agency.  The PI may also need to submit the Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption (Formerly Optional Form 310) with their grant application.

Once funding is secured, the PI must work on finalizing study documents and once the documents are ready, the investigator may then apply for full IRB approval of the study. Don’t forget to include a copy of the funding notice in the IRB application.