What does the OHSU IRB do?
Institutional Review Boards (IRBs) are formally designated groups constituted according to federal regulations that are charged with performing the regulatory and ethical review of research involving human subjects. The federal regulations for the protection of human subjects, known as the Common Rule, define Research and Human Subject as follows:
- Research is "a systematic investigation designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]
- 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." [45 CFR 46.102(f)(1-2)]
Human research protocols and related study documents are reviewed by IRB committee members. IRBs have the authority to approve, require modifications in order to secure approval, or disapprove human research. The role of the IRB is to ensure:
- Institutional compliance with federal, state, and local regulations and laws
- Compliance with applicable OHSU institutional policies and requirements
- The protection of the rights, welfare, and safety of human research subjects
The OHSU IRB also provides information and guidance to researchers about applicable OHSU policies and requirements, as well as regulatory and ethical issues and concerns that may arise in human research.
Statement of compliance
The OHSU IRB (FWA00000161; IRB00000471) complies with 45 CFR Part 46, 21 CFR Parts 50 and 56, and other federal and Oregon laws and regulations, as applicable. The OHSU IRB also complies with ICH-GCP (E6) codes 3.1-3.4, which outline responsibilities, composition, functions, and operations, procedures, and records of the IRB.
OHSU IRB and FWA registration
OHSU IRB00000471 divides its IRB review activities among four "panels", titled Panel 1, Panel 2, etc., for administrative and scheduling purposes. All four of these groups are comprised of primary members and alternates from the single membership roster for IRB00000471 registered with OHRP. Dana Director, PhD, Vice President, Research Operations & Student Affairs is the Institutional Official. The current OHSU IRB membership roster and all past rosters are available on the IRB Committee Member Rosters page.
|Registration Number||Name||Expiration Date|
|FWA00000161||Oregon Hlth & Sci U||08/21/2024|
|IRB00000471||Oregon Hlth & Sci U||03/25/2022|
OHSU IRB fees
The OHSU IRB charges an IRB use fee for the review of industry-sponsored or industry-funded clinical trials. This includes applicable studies under OHSU IRB oversight as well as studies that are waived to a central or external IRB. For more information about IRB fees, see the IRB Fee Policy page. Please contact David Holmgren and Lily Bartlett with any questions regarding IRB Fees.
IRB volume and turn around time
Below are the OHSU IRB submission volume and turn around time (TAT) reports. The reports provide detail based on review category.
- IRB volume turn around time (TAT) - initial reviews - 2016-2019 (view 6 pages)
- IRB volume turn around time (TAT) - initial reviews - 2018 Q3 - 2019 Q2 (view 6 pages)
- IRB volume turn around time (TAT) - initial reviews - 2018 Q4 - 2019 Q3 (view 6 pages)
- IRB volume turn around time (TAT) - initial reviews - 2019 Q1 - 2019 Q4 (view 6 pages)
- IRB volume turn around time (TAT) - initial reviews - 2019 Q2 - 2020 Q1 (view 6 pages)