DOR IRB Overview:

Since its inception in 1961, Division of Research (DOR) has placed a strong emphasis on the conduct of responsible research. DOR investigators maintain the highest standards of research integrity. The Manager for Research Compliance (Diana Holt) is responsible for assisting investigators and staff with all aspects of research compliance, including the protection of human subjects involved in research. The Manager meets with new investigators and staff to provide consultation and an overview of compliance issues that pertain to specific job responsibilities and projects.

Institutional Review Boards (IRBs) within and outside —Kaiser Permanente establish their own unique practices. Investigators who conduct research studies that involve multiple IRBs are advised to consult the specific policies of each and every IRB that may have jurisdiction over the research.

The role of the IRB is to assure protection of the rights, safety, privacy, and dignity of all human research subjects. Federal regulations require an IRB to review and monitor all research that involves Kaiser Foundation Health Plan members and patients, their medical records and biologic specimens. The Kaiser Permanente, Northern California, IRB, which has jurisdiction over all DOR projects, operates under a Federalwide Assurance Agreement #A00002344.

IRB approval must be obtained for all research proposals and protocols, including but not limited to, consent forms, telephone scripts, patient contact letters and recruitment materials, questionnaires, and mail surveys. The IRB reviews such materials for appropriateness, clarity, and accuracy.

The IRB is divided into two panels, each of which meets one day per month. The Health Services Panel primarily reviews epidemiologic, behavioral, and health services research. The Biomedical Panel primarily reviews research studies involving investigational drugs, devices, biologics, and experimental clinical procedures.

The DOR Manager for Research Compliance oversees and coordinates all aspects of the DOR IRB submission process. The Manager is responsible for reviewing all applications for completeness, appropriateness, and for overall quality control. This includes obtaining the approval signatures of a DOR Local Research Committee representative and the DOR Director. The deadline for submitting IRB materials to the DOR Manager for Research Compliance is 12 noon on the last working day of the month in order to be included on the following month's IRB agenda. To avoid unnecessary work or common errors, contact the Manager prior to commencing work on any new IRB application.

^{Questions concerning IRB, contact the Compliance Liaison}