Research Involving OHSU Personnel, Sites, and Funding

 

Policy:

The Oregon State University (OSU) IRB will review all OSU College of Pharmacy applications for human subjects research, with the exception of applications:

• that use only Oregon Health and Science University (OHSU) personnel or patients; or
• for which the external funding is held by OHSU.

This applies to all levels of review.

The appropriate OHSU IRB will review the projects following the procedures outlined in the OHSU IRB Policy/Procedure Manual 2002. The OHSU IRB will issue the approval letter and be the point of contact for all questions, complaints, adverse events, continuing reviews, and modification requests. However, the OSU IRB may have access to and obtain copies of all related materials to the IRB project file, as requested.

It is the OSU Principal Investigator's responsibility to forward a copy of the approved application, approval letter and any subsequent approved application materials or reports filed with the OHSU IRB to the OSU IRB. It is not the intention of this policy to duplicate the detailed files maintained by the OHSU IRB, but rather to keep the OSU IRB informed of the project details and any approved significant changes to the project. The OSU IRB will keep a copy of approved application materials on file.

Procedures:

OSU College of Pharmacy faculty conducting human subjects research that uses only OHSU personnel or patients, or for studies for which the external funding is held by OHSU, will be required to submit IRB applications to the OHSU IRB for review and approval. When the project has received OHSU IRB approval, it is the OSU Principal Investigator's responsibility to forward the approved application and approval letter to the OSU IRB Human Protections Administrator. The OSU Principal Investigator is also responsible for forwarding a copy of any subsequent approvals issued by the OHSU IRB (e.g., significant modifications to the approved project, renewal requests, outcomes from reported adverse events, etc.). The OSU IRB will file and maintain these applications in the same manner as other approved applications.

Approved 06-12-03