Why is there an Institutional Review Board (IRB), and what does it do?
The purpose of the IRB is to ensure that the rights and welfare of human research study participants are protected.
Federal regulations and KP policy prohibit the involvement of human subjects in research until the IRB has reviewed and approved the research, including the protocol and informed consent process. The IRB must
- approve all research and research documents prior to use in a study, and
- review and monitor the progress of the research, with special emphasis on the experience of human participants, until the project is complete and a final report has been received and accepted by the IRB.
The IRB has the responsibility and authority to verify whether projects qualify as human subjects research or are exempt from IRB review.
What is the Research Subjects Protection Office (RSPO), and what does it do?
The RSPO, based at the Center for Health Research, is a department that is responsible for administering KPNW’s program for ensuring protection of human research participants. The RSPO provides guidance for investigators and research staff on interpretation of the various federal and state regulations and regional policies regarding research with humans. The RSPO is also responsible for ensuring IRB review, monitoring, and documenting of all regional research; administering federally required investigator and staff training programs; and ensuring compliance with all federal, state, and local regulatory requirements.
What is a Federalwide Assurance?
A Federalwide Assurance (FWA) is an agreement between a research institution and the Office for Human Research Protections (OHRP). An FWA stipulates terms by which the institution will protect the safety, welfare, and rights of research participants in accordance with federal regulation (45 CFR 46).
Kaiser Foundation Research Institute (KFRI) is the entity within the Kaiser Permanente Medical Care Program (KP) that holds and maintains the KP FWA. KFRI registers all KP IRBs with OHRP as IRBs that review research funded by the U.S. Department of Health and Human Services.