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 email@example.com
IRB Volume & Turn Around Time (TAT) Report
Three Types of IRB Review
Certain types of research involving human subjects qualify for limited IRB review under one or more of the six "Exempt" categories designated by the federal regulations. If you are conducting exempt research, you must submit your study to the IRB for a determination that it is exempt.
When a study is exempt, that means it is exempt from the regulations at 45 CFR 46 ( the Common Rule). It does not mean it is exempt from state laws, HIPAA, or certain other regulations and it does not mean that the research need not conform to the principles of sound research ethics. The IRB will review your project to ensure that the research is not contrary to the ethical principles of the Belmont Report and that it complies with any other applicable laws and regulations. The IRB usually grants exempt studies a three-year approval period before a continuing review is due.
Under the federal regulations, some categories of research are eligible for "Expedited" review if they pose no greater than minimal risk to subjects. Expedited review includes consideration of all determinations required for approval as defined in applicable federal, state and local regulations. The standard requirements for informed consent (or its waiver or alteration) apply. However, rather than needing review at a convened meeting of the IRB, expedited reviews may be carried out by the IRB Chair, an IRB Vice-Chair, or by one or more experienced reviewers designated by the Chair from among members of the IRB ("Designated Reviewers"). In reviewing the research, the Designated Reviewer may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The IRB will determine the approval period, which will not exceed one year, at which point a continuing review must be submitted to maintain approval.
Full Board Review
Research that does not qualify for Exempt or Expedited Review must receive a full review by a quorum of IRB members at a convened meeting. The regulatory criteria for approval of Full Board research are the same as for Expedited research. However, because Full Board studies are usually more complex and pose greater than minimal risk to subjects, investigators should be aware that the initial Full Board review process frequently does not result in an outright approval of the research. Minor or major revisions and written clarifications are often requested. Upon approval, the IRB will determine the approval period, which will not exceed one year, at which point a continuing review must be submitted to maintain approval.