Research Determination Review
To conduct research in Kaiser Permanente Hawaii (KPHI), you need a written determination letter from the KPSC-HI IRB stating that the study or project doesn’t need to be reviewed by the Institutional Review Board (IRB). The KPSC-HI IRB reviews research projects that are not federally regulated and issues this written determination when IRB review is not necessary. Activities that typically are not regulated research include:
- Quality improvement projects
- Case studies involving a very small number of patients (1-3)
- Public health surveillance
Request a copy of the RDO form by emailing KPSC.IRB@kp.org and submit the completed form to the same address.
The Institutional Review Board is responsible for reviewing activities that are federally regulated to ensure the activities meet ethical and professional standards and are compliant with regulatory requirements. Regulated activities include:
- Research involving humans
- Research involving data or information about humans
- Research using biospecimens
- Research using FDA regulated test articles (drugs, devices or biologics)
- Clinical use of certain FDA regulated products
The KPSC-HI IRB only reviews protocols submitted by KPHI employees and physicians. A person external to KPHI may only submit a protocol if a KPHI employee or physician is a co-investigator. The KPSC-HI IRB does not serve as a “single IRB” for multi-site studies. However, KPHI is willing to enter into a “reliance agreement” with an external IRB to achieve single IRB review. Studies that rely upon an external IRB must still receive an approval letter from KPSC-HI before starting research in the region. The approval letters are sent from the KPSC-HI IRB office. Contact the KPSC-HI IRB office as early as possible because it takes time to negotiate the reliance agreements.
The KPSC-HI IRB office provides guidance and assistance on the following:
- To researchers submitting a research protocol to the KPHI IRB
- To researchers negotiating IRB reliance agreements and seeking approval to rely upon an external IRB
- To physicians requesting clinical use of FDA regulated products
Helpful KPHI IRB Links:
For questions, email the KPSC-HI IRB office directly at KPSC.IRB@kp.org.