Health Sciences Institutional Review Boards

IRB Review Fee Schedule

With the exceptions noted below, the proposed fees, which include F&As, will be applied to new Initial Review Applications submitted to the Health Sciences IRBs Office for review at the March 17th or March 24th IRB meetings. The fees are billed upon formal submission to the Health Sciences IRBs Office and apply regardless of whether the research is reviewed by the University of Wisconsin-Madison IRB or Western IRB.

*The Western IRB charges a reduced initial review fee when it has approved a research study and an investigator at a new site submits the same protocol for review. This initial review fee is $1848. In the rare instance this occurs at the University of Wisconsin-Madison, the same reduced fee will be assessed for IRB review.

**Trainee projects are defined as those conducted to fulfill educational or training requirements of fellows, residents, graduate students, or undergraduates. These projects will only be reviewed by a UW-Madison IRB.

The fees will not be applied to the following:

• Human subjects research that is solely or primarily federally funded

• Medical records research that is not industry-sponsored

• Human subjects research that is determined to qualify for exemption from IRB review

• Applications submitted to the IRB that are determined to not:

  1. constitute research (e.g., quality assurance or quality improvement activities) or
  2. involve human subjects

• Reporting of noncompliance, potential unanticipated problems, or adverse events

• Applications involving a non-research use of a Humanitarian Use Device

• Application for emergency or one-time use of an investigational drug or device

• Study personnel changes, except changes in Principal or Co-Principal Investigators

• Provision of supplemental approvals (e.g., VA Research & Development Committee approval, approval of certificates of confidentiality)

• Study closures

The Senior Associate Dean for Clinical and Translational Research in the School of Medicine & Public Health retains the right to reduce the fee when justified. Any approved fee waiver does not establish a precedent for other actions unless the policy is amended.

All research studies reviewed or received prior to March 7, 2008 will be billed according to the prior IRB fee structure: $2500 for the initial review of industry-sponsored research and $750 for the annual review of the study.

If a contract has been negotiated and signed for a study before the notice of the fee change, the prior IRB fee structure will be applied to the studies. To alert the Health Sciences IRBs Office of this situation, attach a copy of the signature page of the contract to your IRB submission so that the correct fees are applied.

The fees are assessments of costs associated with application review by the IRB and its office. Payment of fees are due in full even if the IRB does not approve the study, subjects are never enrolled, a research contract is never executed, expenditures exceed revenue, or the study is terminated before objectives are reached. The fees will be reviewed annually and are subject to change.