Ending a reliance arrangement for a study

Applies to: Agreement V3.0 · SMART IRB SOPs

Once review is ceded, the expectation is that the study stays with the Reviewing IRB for as long as IRB oversight is required. Either side can nevertheless end the arrangement for a study.

A Relying Institution taking back oversight (§2.5.2.1). A Relying Institution may withdraw its research from ceded review at any time. Its Point of Contact notifies the Reviewing IRB and contacts the Overall PI, asking that the institution be removed as a relying site. The Overall PI submits an amendment removing the site under the SOP on protocol amendments. The Overall PI and Site Investigator arrange alternative review and approval — the site's own IRB or another external IRB — before local activities continue.

A Reviewing IRB withdrawing for significant cause (§2.5.2.2, new in Version 3.0). A Reviewing IRB may withdraw from review and oversight of a study with respect to a Relying Institution for significant cause — for example, the Relying Institution's ongoing failure to meet its obligations under the Agreement after being put on notice and given a reasonable time to correct it. It gives the Relying Institution 60 business days' written notice explaining the cause. The withdrawal is not itself a suspension or termination of IRB approval. Where the Relying Institution will continue the research, the two work together to transfer oversight to another IRB with as little disruption as possible (§2.5.3).

Withdrawal without an approval decision (§2.5.2.3). In two situations the Agreement itself withdraws a study from ceded review for a particular institution without an approval or disapproval: when a Reviewing IRB cannot implement a Relying Institution's COI management plan (or cannot rely on a federal agency's COI assurance) and the two cannot agree (§§5.7, 6.8), and when a Participating Institution cannot comply with a provision without violating law and no alternative can be found (§8.11).

See also - Section 8.11: No Violation of Law - COI for non-federal Relying Institutions - Terminating your institution's participation