OHSU

About IRB Review

IRB Fees

 

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 holmgred@ohsu.edu

APPROVAL TIMEFRAMES-SERVICE LEVEL UNDERSTANDING

ORIO is committed to service. Effective October 1, 2006, ORIO agreed to a Service Level Understanding PDF Icon , which helps meet OHSU's research needs as timely and efficiently as possible.

SERVICE LEVEL UNDERSTANDING REPORTS

Past SLU Reports

Three Types of IRB Review

 

Exempt 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.  

A determination of eligibility for exemption under 45 CFR 46.101(b)(1-6) or exemption from the requirements of 21 CFR 56 must always be made by the OHSU IRB or its designee.
When a study is exempt, the OHSU IRB will ensure that the approved research is not contrary to the ethical principals of the Belmont Report.  Exempt does not mean that the research activity is exempt from state laws, and it does not mean that the research need not conform to the principles of sound research ethics.  Research with human subjects is exempt from the requirements of 45 CFR 46, including informed consent, when it is determined that the involvement of human subjects is limited to one or more of the six "exempt" categories listed, in the exempt review policy

Expedited Review

Expedited review of research includes consideration of all determinations required for approval as defined in applicable federal, state and local regulations per 45 CFR 46.111 . The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review.

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.