Noncompliance, investigations, and audits

Applies to: Agreement V3.0

Who investigates? (§§5.12, 6.15) Both the Reviewing IRB and the Relying Institution have authority to investigate or audit any allegation or matter relating to a ceded study, separately or jointly, and the Reviewing IRB may ask the Relying Institution to investigate. Whoever investigates, the other party must cooperate reasonably — records, meetings, help implementing corrective actions — and the investigating party must report its findings of fact to the other within a reasonable time. Neither side has to contravene its legal responsibilities or waive legal privileges. The Relying Institution must comply with any corrective actions the Reviewing IRB requires and may add its own more stringent ones. Issues that turn out to be something other than human subjects protection matters — a potential research misconduct allegation, say — are referred by the Reviewing IRB to the Relying Institution (§5.11).

Compliance monitoring (§6.11). A Relying Institution must maintain or have access to a compliance monitoring function able to conduct for-cause and not-for-cause audits of its research — or an alternative means of reviewing conduct — unless the Reviewing IRB agrees to waive that requirement at the Relying Institution's request.

Audits. A study may be audited by the Reviewing IRB Institution, the Relying Institution, or both (§§5.12, 6.15 — unchanged in Version 3.0). A Reviewing IRB that audits (itself or through a designee) promptly notifies the Relying Institution and reports its findings within a reasonable time. Relying Institutions cooperate with Reviewing IRB audits and share their own audit findings. The Harmonization Steering Committee's Post-Approval Auditing in sIRB Review guidance describes common approaches.

Who is told about a finding? When the Reviewing IRB finds serious or continuing noncompliance (or apparent noncompliance) with human subjects regulations or with its own requirements, or suspends or terminates approval, it promptly notifies the Overall PI, the Site Investigators, and the Relying Institutions concerned — including institutions whose participants could be affected by a finding at another site — along with the steps it requires for remediation. Under the SOPs, notice goes to the Overall PI, Lead Study Team, and the affected institutions' Points of Contact and Site Investigators; study-wide actions go to all sites.

Who reports it externally? The Reviewing IRB reports to OHRP and FDA as required (considering funding, each Relying Institution's Assurance, and FDA jurisdiction). All other reports are the Relying Institution's; see Who reports to OHRP, FDA, sponsors, and funders.

See also - Who reports to OHRP, FDA, sponsors, and funders - Notifying other institutions of federal for-cause investigations - Access to IRB minutes and records