What's new in Version 3.0

Applies to: Agreement V3.0

The SMART IRB Reliance Agreement Version 3.0 took effect on March 17, 2025. It is a significant amendment of Version 2.0, developed with the Harmonization Steering Committee, NCATS and other federal agencies, and two rounds of public comment (November 2023–February 2024, with 250 comments from 54 institutions; and November–December 2024). Its aims were to respond to community feedback, fully reflect the 2018 Common Rule, allow more federal agencies to participate, and offer an optional Indemnification Addendum.

Here is what changed, by topic. Section numbers refer to the Version 3.0 Agreement.

Eligibility (Article 1) - Any assurance of Common Rule compliance with a federal department or agency now qualifies — an HHS FWA is no longer the only accepted Assurance (§1.1). - The oversight criterion is limited to non-exempt research; institutional oversight of exempt research is no longer required (§1.1). - The five-year HRPP quality assessment is measured from when an institution first joined if its participation has been continuous (§1.2). - A Joinder covers one legal entity; a legally separate affiliate must sign its own Joinder even if it shares the parent's Assurance (§1.4.4).

Scope and exemptions (Articles 2 and 5) - The Agreement continues to cover exemption determinations; they must be made in accordance with the Common Rule, and Reviewing IRBs are expressly expected to perform limited IRB review where the Common Rule requires it. "Covered Activities" now means Ceded Review plus Exemption Determinations. - A Reviewing IRB may withdraw from review and oversight of a study for significant cause (for example, a Relying Institution's ongoing failure to meet its obligations after notice and a reasonable time to correct) with 60 business days' written notice explaining the cause (§2.5.2.2). Such a withdrawal is not itself a suspension or termination of IRB approval.

Which policies govern the relationship (Article 3) - Where a federal regulation or funding policy prescribes processes for initiating reliance or choosing the Reviewing IRB (Mandated Processes), those govern instead of the Agreement's default process (§3.1). Where a federal department or agency prescribes policies for conducting the relationship (Mandated Policies), those govern over any conflicting Agreement term (§3.4.1). - Otherwise institutions may agree on Other Policies, but where an Other Policy conflicts with the Agreement, the Agreement governs (§3.4.2). Institutions must document among themselves which policies apply; if nothing is documented, the SMART IRB SOPs apply (§3.4.3).

All Participating Institutions (Article 4) - Every institution, not only Relying Institutions, must ensure its Personnel are adequately trained, qualified, and resourced. - Institutions must diligently correct noncompliance with applicable law and work together in good faith to resolve concerns about a breach of the Agreement. - Institutions must notify partners in a reliance relationship of any for-cause federal compliance investigation that relates to the research or affects research conduct or integrity (§4.6.1). - Insurance (§4.9): self-funded liability coverage is acceptable, and government (public) institutions are exempt from the insurance requirement. - Indemnification (§4.10): a new optional Indemnification Addendum (Exhibit C) with a separate joinder. Joining or declining it does not affect eligibility; federal agencies will not indemnify other institutions. - HIPAA (§4.4): the Relying Institution that is a Covered Entity performs all tasks required for its own HIPAA compliance. It may use its own authorization form and obtain its own waiver or alteration of authorization; only if it does not does the Reviewing IRB provide an authorization form or review a waiver request. The Relying Institution must flag Local or Other Considerations that require a separate authorization or that would prevent a waiver. Reviewing IRBs that do not provide these services (for example, some federal or non-Covered-Entity IRBs) say so, and the Relying Institution handles them itself.

Reviewing IRBs (Article 5) - For research not subject to the Common Rule, FDA regulations, or other human subjects protection requirements, the Reviewing IRB applies Common Rule standards unless the parties agree otherwise (no external reporting is required for such research). - The Reviewing IRB must consider a Relying Institution's requested consent-form modifications needed for legal, regulatory, or federal department-specific requirements. - Clarified reporting: by default the Reviewing IRB drafts and sends Reports to OHRP and FDA with at least five business days for the Relying Institution to comment (§5.13.1); joint or Relying-Institution-made Reports may be agreed (§5.13.2); every other report — to funding-agency program staff, sponsors, state or local authorities — is the Relying Institution's sole responsibility (§5.13.3). - Each side must promptly tell the other about its communications with federal human subjects regulators (and, for Relying Institutions, funding agencies) concerning the study (§§5.14, 6.17). - Grant congruence review (§5.15) applies only when law, regulation, a funding agency, or a sponsor requires it, and federal-agency Reviewing IRBs do not perform it.

Relying Institutions (Article 6) - Local Considerations that the Relying Institution must identify, interpret, and communicate now expressly include requirements beyond the Common Rule and FDA regulations; a new defined term, Other Considerations, covers federal requirements not readily apparent from the IRB submission (§6.6). - Any reports other than those to OHRP and FDA — to funding agencies, sponsors, state bodies — are the Relying Institution's sole responsibility.

Termination (Article 7) - An institution with ongoing Covered Activities must give 60 business days' written notice to the institutions it works with before ending its participation (§7.2.1.2). - Loss of an Assurance or IRB registration no longer terminates participation immediately: participation ends 60 business days later (extendable by 30 by agreement) unless the Assurance or registration is reinstated; no new Covered Activities in the meantime (§7.2.1.3). - New provisions govern termination of, and withdrawal from, the Indemnification Addendum (§7.2.2).

Miscellaneous (Article 8) - Joinder Agreements and Indemnification Addendum Joinders are electronic and e-signed (§8.1). - Amendments are issued by the SMART IRB Executive Coordinating Committee after written comment; institutions continue under an amended Agreement without further action unless the change is significant enough to require new Joinders (§8.6). - No Participating Institution may modify the Agreement or the Addendum (§8.7); where the Addendum or any separate financial or indemnification agreement conflicts with the Agreement, the Agreement prevails (§8.12). - No Violation of Law (added in Version 2.0 as §8.10) is retained as §8.11. - The Agreement itself contains no governing-law or venue clause; the Indemnification Addendum does (Exhibit C, §7).

What did not change. Participation is voluntary, study by study, and non-exclusive (§§2.2, 2.3); the Agreement creates no financial commitment (§2.4); its language cannot be modified (§8.7); flexible implementation is still available; the Agreement still works for consortia; audit provisions (§§5.12, 6.15) are unchanged.

The full text and the related-documents package, which includes the summary of key changes, are on the Agreement page.

See also - Key dates and the transition from V1.0/V2.0 - How HIPAA works under Version 3.0 - The optional Indemnification Addendum - The SMART IRB SOPs: what they are and when they apply