About IRB Review
IRB Fees (see the IRB Fee Policy).
- The OHSU IRB charges an IRB use fee for review of industry sponsored clinical trials. The fees are for real expenses incurred and paid by the IRB in the process of reviewing protocols. IRB fees are considered as part of overhead costs or a budget line item.
- Please note that our policy will conform to the OHSU/Central Financial Services (CFS) policy where erroneous charges must be reported to the IRB within the same fiscal year or within 90 days of posting to an account ledger.
- For questions concerning IRB fees or comments regarding the IRB Fee Policy, please contact David Holmgren at firstname.lastname@example.org.
Three Types of IRB Review
Certain categories of research involving human subjects qualify for exemption from the federal regulations for the protection of human subjects. Oregon Health and Sciences University (OHSU) is authorized by the federal government to determine whether studies qualify for this exemption.
Expedited reviews may be carried out by the IRB Chair, an IRB Co-Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB. Consultants may assist the IRB in the review of issues which require expertise beyond, or in addition to, that available on the IRB.
In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.
Full Board Review
Research that does not qualify as Exempt status or Expedited Review must be submitted for a full review by a quorum of IRB members at a convened meeting. The application process remains the same as for the other levels of review, but investigators should note that a Full Review can take up to two months from the time of submission. Investigators should also be aware that the initial Full Review process frequently does not result in an outright approval of the research; minor or major revisions and written clarifications are often requested.