Exempt research, limited IRB review, and the Common Rule

Applies to: Agreement V3.0

Yes, the Agreement complies with the 2018 Common Rule, including the cooperative research (single IRB) provision at 45 CFR 46.114(b), and yes, it can be used for exemption determinations.

Exemptions under Version 3.0 - A Reviewing IRB or Reviewing IRB Institution may make exemption determinations for a Relying Institution. Exemption determinations are a Covered Activity alongside Ceded Review (§2.1.2). - Determinations, including any limited IRB review (45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), or (d)(8)), are made in accordance with the Common Rule (§5.4.2.1). - After an exemption is granted, the Relying Institution tells the Reviewing IRB about proposed changes so it can decide whether the research is still exempt or needs a new limited IRB review (§§5.4.2.3, 6.3). Several study-oversight provisions (continuing review, COI, injury coverage, and others) do not apply to exempt research (§2.1.2).

Exempt research is no longer an eligibility issue. Versions 1.0 and 2.0 required institutions to provide institutional oversight of exempt research as a condition of joining. Version 3.0 removed that requirement. SMART IRB encourages institutions to keep policies covering exempt research, but the Common Rule does not require IRB review of it and neither does the Agreement.

If you are still operating a legacy (V1.0/V2.0) arrangement, the older oversight expectation applies to that arrangement: institutional oversight, which may include limited IRB review, for exempt categories that require it.

Broad consent. The Agreement does not restrict which parts of a consent document may be customized, so it accommodates broad consent where a Reviewing IRB and Relying Institution choose to use it.

See also - What research can be reviewed under the Agreement? - What are the eligibility criteria?