What survives termination

Applies to: Agreement V3.0 (§8.14)

When an institution's participation ends — voluntarily or automatically — a substantial set of obligations continues to bind it for the research it took part in. Section 8.14 lists them; the ones that matter most in practice are:

• notification and compliance duties — informing Personnel of Agreement obligations (§4.3), cooperating with legal requests and claims (§4.5), notifying partners of Assurance, registration, or investigation changes (§4.6),
• confidentiality (§4.7) and use of name (§4.8),
• insurance (§4.9),
• recordkeeping by the Reviewing IRB and the Relying Institution (§§5.5, 6.5),
• notifications and external reporting of IRB decisions, unanticipated problems, complaints, noncompliance, suspensions, and communications with federal agencies (§§5.8–5.14, 6.12–6.17), and
• audits, investigations, and corrective actions (§§5.12, 6.15),

along with Articles 7 and 8, the Glossary, and anything else that by its nature is meant to survive.

Ongoing studies. The Agreement does not dictate an outcome. The institutions involved work together to determine the effect of the termination on each ceded review, with the goals of continued protection of participants and minimal disruption; where possible and appropriate, the Reviewing IRB continues oversight for the reasonable time needed to transfer the research to another IRB or reliance agreement (§7.2.1.4).

Indemnification Addendum. For Covered Activities within its scope, all obligations under the Addendum survive its termination, whether the Addendum ends entirely or a single institution withdraws.

See also - Terminating your institution's participation - Access to IRB minutes and records