Author: Chandan Gupte, VP of Clinical Excellence and Research
Background
McLaren Health Care charges fees for IRB review of research studies supported by pharmaceutical, medical device, and other for-profit entities. The current IRB review fees were last increased in April 2024. Following a comprehensive review of fee structures, resource utilization, and a fair market value analysis, McLaren Health Care will implement new fees for the review and oversight of human subject research studies supported by industry and other for-profit entities, effective February 1, 2026.
New Fee Schedule Implementation
- Effective Date: All industry/for-profit sponsored protocols submitted on or after February 1, 2026, will be subject to the new rates.
- Updated Fee Schedule: SHOULD BE a HYPER link to the IRB Fees (Effective 2/1/2026) that you updated in step 1
- Notification Requirement: Please notify all parties responsible for managing IRB payments.
- Payment Policy:
- The IRB commits its full resources to each review.
- Fees are due in full even if the IRB does not approve the study, participants are never enrolled, a research contract is not executed, or the study is terminated before objectives are reached.
- All IRB fees are non-refundable.
Contact
For questions, please contact the IRB Office at 248-282-4950.
IRB Fee Policy Statement
The McLaren Health Care Institutional Review Board (MHC IRB) charges for the review and oversight of human subject research studies supported by pharmaceutical, medical device, and other for-profit entities. Investigators submitting industry-sponsored research protocols are required to include in the study budget the cost of initial protocol review, continuing review, and sponsor-initiated full-board amendments requiring IRB review. IRB operations are specialized and rigorously regulated, and fees are based on the assessment of costs associated with protocol review. All IRB fees are mandatory, non-refundable, and billed directly to the sponsor. These charges apply regardless of whether the study is ultimately approved, whether participants are enrolled, or whether the study is terminated before completion. Fee payments are expected to be paid in full within 30 days of invoice. The IRB does not assess review fees for federally funded research, graduate medical education projects, or student-initiated studies, as these activities are exempt from IRB billing in order to comply with federal cost principles and to support the educational mission of the Institution.