New Human Researchers

Institutional Review Board (IRB)

OHSU Members should visit the Institutional Review Board (IRB) page on O2.

The OHSU Institutional Review Board (IRB) reviews research that involves human subjects. In general, a human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.  IRB review ensures that the project is in compliance with the Common Rule, FDA regulations, HIPAA requirements and pertinent Oregon rules.

Trainings for human researchers

All OHSU employees, and those affiliated with OHSU or participating in human research under review by the OHSU IRB (such as OHSU students or volunteers), are required to complete OHSU research training and complete an annual CoI disclosure form.  See the New Researcher Training website for details on how to find the trainings required for your project.

The IRB offers a variety of educational sessions on preparing IRB applications and working with the IRB.  See the IRB Education and Resources website for details about course offerings and information on how to register.

Getting started on an IRB application

The IRB Frequently Asked Questions website  provides information on when IRB oversight is needed, how to get started on your IRB application in eIRB, where to find protocol and consent templates, fees for IRB review (just charged to industry-sponsored research) and a variety of other topics.  The IRB Policies and Forms website contains the most commonly used forms and templates as well as numerous Help Sheets and Quick Guides.  All of the Human Research Protection Program policies, SOPs and review Checklists and Worksheets can be found on this page. 

Waiving oversight to other IRBs

The OHSU IRB allows the use of a single or central IRB. This meets the requirements under the National Institutes of Health (NIH) policy on the use of a single IRB (sIRB) for multi-site research and the Cooperative Research (§45 CFR Part 46.114(b)) requirements of the revised Common Rule (effective January 20th, 2020).  This is described in more detail on our Working with Other IRBs website.

Research that involves both the Veterans Affairs Portland Health Care System and OHSU can undergo a single IRB review by the OHSU IRB.  Visit the VAPORHCS IRB website for details on preparing a submission.

Communicating with the IRB

Please contact us if you have questions about your human subjects project at any stage – while you are designing your study, preparing your IRB application or if questions arise while your project is ongoing.  We are here to help you!

If your study is in the review process or is already approved, contact the IRB Coordinator listed on your eIRB project via the ‘Add Comment’ action in eIRB and check the box for "IRB Coordinator" to a receive a notification of your comment.  For general questions or before your study is submitted, contact us at irb@ohsu.edu.  To speak to someone urgently, call the Research Integrity office at 503-494-7887, option 2.