Making sure Personnel follow the rules

Applies to: Agreement V3.0

The Agreement requires every Participating Institution to make sure its Personnel (and, for a Reviewing IRB, its IRB leadership and staff) know about and comply with the institution's obligations under the Agreement — coordination, communication, compliance, and reporting — and the policies governing the reliance relationship, and to work diligently to correct any noncompliance (§4.3). A Relying Institution must also require its Personnel to accept and comply with the Reviewing IRB's determinations and requirements (§6.2). Version 3.0 extends to every Participating Institution the duty to ensure its Personnel are adequately educated, trained, qualified, and resourced (§4.1).

How you do it is up to you. The Agreement does not prescribe a mechanism. Institutions commonly:

• adopt an institutional policy on relying on external IRBs;
• send investigators written notice of their responsibilities when a study is ceded;
• require an investigator acknowledgment or agreement at submission; and
• use SMART IRB's Relying Site Investigator Guidance and Checklist, which lists the responsibilities in plain language.

The Harmonization Steering Committee's Responsibilities Associated with Review of Study Personnel covers how institutions and IRBs divide personnel review.

See also - Relying Site Investigator checklist - Amendments and personnel changes