OHSU

Investigator Requirements at Kaiser Permanente & OHSU

This page details the policies that affect collaborations between OHSU and Kaiser Permanente when an investigator wants to conduct research at the partner institution without a scientific collaborator from that institution.

 

Kaiser Permanente Kaiser Permanente Logo

Policy on Investigator Eligibility


Research conducted in Kaiser Permanente Northwest (KPNW) by investigators not employed by KPNW, Northwest Permanente (NWP) or Permanente Dental Associates (PDA) is usually required to have an experienced KPNW co-investigator.

Non-KPNW investigators who meet OHSU Principal Investigator Eligibility Requirements (i.e., paid OHSU faculty members) are not always required to have an experienced KPNW co-investigator.  With the endorsement of the OCTRI directors (Drs. Eric Orwoll and Mary Durham), the KPNW IRB will consider the advisability of allowing the non-KPNW investigator to conduct the research independently, considering the particular investigator’s suitability – for example, the investigator’s experience conducting research generally, experience conducting research within KPNW, and the scope of research activities that will take place at KPNW.

In all instances where a non-KPNW OCTRI investigator submits an application that does not include a KPNW co-investigator, the OCTRI directors must each document in writing their assurance to the KPNW IRB of their role in ensuring that the investigator will abide by KPNW IRB policies and procedures and all terms of the Kaiser Permanente Federalwide Assurance (FWA).    

Non-KPNW OCTRI investigators who plan to submit their research to KPNW's IRB without a KPNW co-investigator must submit a request for Drs. Orwoll and Durham to sign an attestation form well in advance of the KPNW IRB deadline.  Such requests will be evaluated by Drs. Orwoll and Durham on a study-by-study basis.

The non-KPNW OCTRI investigator must acknowledge KPNW’s collaboration on the research in related publications, presentations, etc.


Oregon Health & Science UniversityOregon Health & Science University (OHSU) Logo

Policy on Investigator Eligibility

 

To be eligible as a principal investigator on an OHSU protocol, a researcher must be a paid faculty member.  OCTRI investigators without an OHSU paid faculty collaborator who wish to serve as Principal Investigator for a research protocol may be approved on a case-by-case basis by:

  • Pursuing a formal adjunct appointment in OCTRI
  • Documenting in a letter assurance of the OCTRI Director, Dr. Eric Orwoll, for assuming responsibility for administrative issues including all financial matters, and 
  • Permission of the IRB chair.  

The OCTRI Director does not need to be listed as a Co-Investigator on the protocol.  All investigators must be authorized on a project-by-project basis to conduct sponsored projects at OHSU by acquiring the requisite signatures on the Proposed Project Questionnaire (PPQ).  All PIs are obligated to adhere to the responsibility of a PI as outlined in OHSU’s Roles and responsibilities in the Proper Conduct of Research and Administration of Sponsored Projects and all applicable IRB policies and procedures. 


Additional Information


Contact

For more information, contact Kathryn Schuff, M.D., Director Regulatory Support Services at OCTRI.

Kathryn Schuff, M.D.
schuffk@ohsu.edu
(503) 494-1685


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