Research Determination Review
In order to conduct research in Kaiser Permanente Hawaii (KPHI), you need either
- A written determination from the Research Determination Officials (RDO) committee that the study or project doesn’t need to be reviewed by the Institutional Review Board (IRB), or
- An approval memo issued by the KPHI IRB Office.
The RDO committee reviews research projects that are not federally regulated and provides a written determination that the study does not need to be reviewed by the IRB. 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
Contact the RDO committee for additional information or instructions at email@example.com
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 KPHI 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 KPHI 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 in order to achieve single IRB review. Studies that rely upon an external IRB must still receive an approval letter from KPHI before starting research in the region. The approval letters are sent from the KPHI IRB office. Contact the KPHI IRB office as early as possible because it takes time to negotiate the reliance agreements.
The KPHI 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 KPHI IRB office directly at KPHI-IRB@kp.org.