MSU HRPP Manual Section 5-8

5-8, IRB Fees

An IRB fee will be charged for all clinical trial industry sponsored research applications. Government funded research, internally funded research, and non-funded research are not subject to an IRB fee. All investigators submitting clinical trial industry-sponsored research studies to the IRB are required to include a separate line item in the study budget for initial and continuing IRB review. Indirect costs should not be applied to these fees.

If the clinical trial industry sponsored research application meets the criteria for submission to a commercial IRB, an IRB fee will be charged to offset administrative costs associated with the review process and interactions with the commercial IRB.

Payment of IRB fees is regarded as a contractual responsibility of the sponsor. The fees are assessments of costs associated with study review by the IRB and are charged for services rendered.  Because the IRB office commits its full resources to each review, the fees are due in full from the sponsor, even if the IRB does not approve the study, subjects are never enrolled, the study is terminated before objectives are reached, or the commercial IRB does not approve the study.

The fees charged to sponsors of research are listed in the Human Research Protection Program (HRPP) Manual Appendix 14-26. Fees are subject to change upon approval of the MSU Institutional Official (IO). The IO shall have the flexibility to alter or waive the fees for particular studies based on extenuating circumstances.

ORA staff will notify the individual(s) listed on the research application upon receipt of an initial IRB application subject to the IRB fee and subsequent renewal applications and generate an internal bill. The research study team will invoice the sponsor and approve the internal bill as appropriate.

Collected fees will be used to support IRB operations and educational programs and opportunities for the IRB staff, IRB members, and researchers.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President for Research and Graduate Studies, 2-1-2006. Revision 1 approved by VP Research & Graduate Studies on 7-21-2011. Revision 2 approved by VP Research & Graduate Studies on 1-13-2014.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 5-8, IRB Fees.