What are the eligibility criteria?

Applies to: Agreement V3.0

Your institution can join SMART IRB if it meets three criteria. Version 3.0 broadened the first one (any federal Assurance, not only an FWA) and narrowed it (oversight of non-exempt research only).

1. An Assurance and oversight of non-exempt research (§1.1). Unless it is an independent IRB organization, your institution must hold an assurance of compliance with the Common Rule from at least one federal department or agency — most often an OHRP-approved Federalwide Assurance (FWA), but under Version 3.0 an assurance from any federal Common Rule agency (for example, the Department of Defense) also qualifies — even if it does no federally funded research. It must also require IRB review and provide institutional oversight of its non-exempt human subjects research regardless of funding source. The Agreement does not require you to extend your Assurance to non-federally funded research; internal policies that require IRB review of it are enough.

2. A recent HRPP quality assessment, if you have an IRB (§1.2). If your institution operates an IRB or is an independent IRB organization, it must have completed or begun an assessment of the quality of its human research protection program within the five years before joining the Agreement — or before it first joined an earlier version, if its participation has been continuous since then. SMART IRB does not prescribe the method — see Does my institution need AAHRPP accreditation? for what qualifies.

3. A Point of Contact (§1.3). Your institution must name at least one person as its SMART IRB Point of Contact — the person responsible for communicating about the Agreement, including decisions about ceding review of particular studies. Most institutions also name an Alternate POC.

What Version 3.0 no longer requires. Earlier versions required institutional oversight of exempt research as well. Version 3.0 limits the criterion to non-exempt research. SMART IRB still encourages institutions to keep policies for exempt research, but they are not a condition of joining.

How SMART IRB checks. In the Joinder Agreement your institution represents and warrants that it meets these criteria. SMART IRB confirms that the Joinder is complete and valid but does not substantively audit how you met them (for example, which assessment method you used). Other Participating Institutions may ask you how you satisfied the HRPP assessment requirement before agreeing to a ceded review with you.

See also - Does my institution need an IRB to join? - Affiliates, FWAs, and who has to join - Join SMART IRB (step by step)