Institutional Review Boards
Under federal law, research involving human participants or their identifiable health information is subject to oversight by a qualified Institutional Review Board (IRB).
The role of the Kaiser Permanente Northern California IRB is to provide the ethical, regulatory, and scientific oversight critical to protecting the rights, safety, welfare, and privacy of human research participants in compliance with federal and state regulations and Kaiser Permanente policies.
Kaiser Permanente Northern California operates two IRBs:
- The Biomedical IRB primarily reviews research involving investigational drugs, devices, biologics, and experimental clinical procedures.
- The Health Services IRB primarily reviews epidemiologic, behavioral, and health services research.
These two IRBs review, approve, and monitor all research that involves Kaiser Foundation Health Plan members and patients, their medical records, and biologic specimens. Each Kaiser Permanente Northern California IRB includes medical, scientific, nonscientific, and community members.
Researchers must obtain IRB approval for all research proposals, protocols, informed consent processes, and study materials, including but not limited to consent forms, telephone scripts, patient contact letters and recruitment materials, and questionnaires. The IRB also reviews applications for continuing review of ongoing studies, requests for study modification, and reports of adverse events and protocol violations.