Kaiser Permanente Northern California (KPNC) IRB
The role of the Kaiser Permanente Northern California IRB is to assure that the rights, safety, privacy, and dignity of all human research subjects are protected. Federal regulations require an IRB to review and monitor all research which involves Kaiser Foundation Health Plan members and patients, their medical records, or biologic specimens. 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 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 reviews research studies involving investigational drugs, devices, biologics and experimental clinical procedures. Investigators may contact the Research Compliance Liaison to confirm IRB meeting dates for any given month.
For Division of Research projects, the DOR Compliance Liaison oversees and coordinates all aspects of the DOR IRB submission process. The deadline for submitting materials to the DOR Compliance Liaison is 12:00 p.m. two days prior to the actual IRB Submission Deadline (2007 Biomedical Panel Deadlines; 2007 Health Services Panel Deadlines). Early submissions are strongly encouraged to permit sufficient time for DOR internal review and correction of identified problems.
The KPNC IRB staff will make every effort to include a project on the agenda for a desired month. It should be noted, however, that some projects require additional review steps prior to the IRB review that may necessitate delay. In that circumstance, investigators receive email notification from KPNC IRB staff.
KFRI and IRB policy stipulates that there must be a Kaiser Permanente Principal Investigator (KP PI) for any study that is being conducted, in whole or in part, at KP. This responsibility includes monitoring the overall conduct of the study, including the efforts of collaborating colleagues both within and outside of the DOR. The KP PI is responsible for communicating with the Institutional Review Board (IRB) and submitting reports and documents, including continuing review requests, modification requests, adverse event reports, final reports, and all other communications as appropriate.
The KP PI also is responsible for ensuring that all members of the research team (including those at collaborating institutions) are certified in Human Subjects Protection training. Non-KP Investigators should contact their local IRB for information on training options. It is the policy of KFRI that IRB forms be completed by Kaiser Permanente investigators and staff. Collaborators should review a copy of the most recent KPNC IRB Application and submit input to the KP PI for completion of the application.
For additional information, please see Guidance for Researchers.
