COI for non-federal Relying Institutions

Applies to: Agreement V3.0 · SMART IRB SOPs

Whose policy applies? Personnel at a Relying Institution follow their own institution's conflict-of-interest policies for disclosure and management; the Relying Institution must maintain such policies and share them with the Reviewing IRB on request (§6.8). The Reviewing IRB works from the Relying Institution's determinations and may add requirements of its own; it may not change a management plan or required disclosure without the Relying Institution's agreement (§5.7).

What the Relying Institution does. Unless the institutions agree on a different plan for a study, the Relying Institution analyzes its Personnel's potential conflicts under its policies and gives the Reviewing IRB the results: any COI determinations, required prohibitions, and management plans (including any required consent disclosures).

What the Reviewing IRB does. It considers that information in its review, incorporates the Relying Institution's prohibitions and management plans without change (unless the Relying Institution agrees to a change), and may impose additional, more stringent requirements if needed to approve the study. In the rare case where the Reviewing IRB concludes it cannot approve the study with a particular plan in place — say, a required consent disclosure it finds misleading — and the Relying Institution does not accept the proposed change, the Reviewing IRB informs the institution and the study is withdrawn from ceded review for that institution, without an approval or disapproval.

How disclosures travel (SMART IRB SOPs). Study team members disclose potential conflicts and management plans first to their institution's Point of Contact, who checks whether the conflict affects the decision to cede. The team (or POC) then passes the information to the Lead Study Team, which informs the Reviewing IRB. Whether a team must also disclose to its local IRB depends on the institution's own policy.

After approval. New or changed conflicts identified during the study follow the same path: POC first, then Lead Study Team, then Reviewing IRB. Changes in COI are among the amendments a Relying Institution's POC must authorize before submission.

Institutional conflicts (conflicts of the Relying Institution itself) are outside the Agreement; institutions address them locally before considering ceded review.

The Harmonization Steering Committee's Conflict of Interest Review Processes guidance describes workable models.

See also - COI when a federal agency is a Relying Institution - Amendments and personnel changes