Subject complaints and injuries

Who handles a subject's complaint? The Relying Institution. Ceding IRB review does not transfer the duty to receive and address complaints from participants at your site; each Relying Institution must maintain a local mechanism through which participants or others can complain to a local contact (§6.10). Significant complaints must also be reported to the Reviewing IRB, which — in consultation with the institution where the complaint arose — assesses the impact on the study and decides whether further action is needed to protect participants.

What counts as "significant"? The Agreement's touchstone is a complaint that could affect the conduct of the research (§§5.9, 6.12); the SOPs make that concrete as a complaint the study team cannot resolve that (a) suggests an increased or unexpected risk or harm, or (b) changes the risk–benefit balance of the research. Examples: a participant was not given time to read the consent form; a blood draw happened before consent. Not usually significant: a missing parking voucher or an incorrect payment amount. The Reviewing IRB makes the final call in the context of the study, and its policies may require that all complaints be reported; if so, relying sites must comply.

When the complaint arose elsewhere. The Reviewing IRB must notify Relying Institutions of its findings and actions on significant complaints at other sites when they could affect the rights and welfare of participants at your site.

Why report injuries that are not unanticipated problems? Because in a reliance relationship the Reviewing IRB does not know your investigators or your institution's norms, the Agreement takes the judgment about whether a research-related injury rises to the level of an unanticipated problem away from the investigator alone and gives it to the IRB. Site Investigators report research-related injuries to the Reviewing IRB (through the Lead Study Team, under the SOPs); the Reviewing IRB decides whether further reporting is required. Only injuries related to the research need to be reported.

See also - Who reports to OHRP, FDA, sponsors, and funders - Consent documents: templates and site-specific language (injury language) - Reportable events guidance (Harmonization)