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The University of North Carolina at Chapel Hill IRB Review Fee Policy November 1, 2004
Background The number and complexity of human research protocols at the University of North Carolina at Chapel Hill (UNC-Chapel Hill) have increased substantially in recent years. Each of these studies requires review and ongoing oversight by the Institutional Review Boards (IRBs), a process that is vital to the university’s ability to conduct such research. In the year 2000, the Schools of Medicine and Dentistry implemented an IRB review fee of $1500 for new industry-sponsored protocols, as most peer institutions around the country had already done. Prior to this, the cost of overseeing industry-sponsored research was effectively being subsidized by the F&A funds (“indirects”) for federally funded grants, or by state funds. Even still, the IRB review fee offsets only a small portion of the costs related to this activity. The fee structure for industry funded research is now being updated to help meet current needs.
IRB Review Fee Effective November 1, 2004, the charge for initial IRB review of a single protocol will be $2,000. As before, this will be a onetime upfront fee, with no additional charge for the continuing (annual) review of a protocol, or for the processing of protocol amendments.
Applicability This fee applies to all industry-funded human subjects research conducted in any School at UNC-Chapel Hill, including sponsor-initiated and investigator-initiated studies. Excluded from the IRB review fee are human research protocols funded by federal or state agencies, non-profit foundations, or by departments/divisions/centers within UNC-Chapel Hill. The fee will be added to the budgets of contracts that are entered directly with for-profit companies, as well as subcontracts issued to UNC-Chapel Hill from another institution.
Human Subjects Research Budgets The IRB review fee is to be included in budgets that are submitted with the Internal Processing Form (IPF) for University approval and signature. The IRB review fee is exempt from the calculation of indirect costs (F&A) on these projects, and therefore should be listed as a separate invoiced item that is included in the total budget amount. Clinical trial budgets submissions are reviewed by the Office of Clinical Trials (OCT), whose staff is available to investigators for assistance in budget preparation.
IRB Review Fee Invoice and Collections Process The IRB review fee is a line item in the sponsor budget, is included in the agreement, and is therefore an obligation of the external industry sponsor. The IRB review fees are assessments for a portion of the real costs associated with protocol review by the IRB. Invoices for the IRB review fee are generated and submitted to sponsors once a protocol has been submitted to the IRB for review. The actual costs of the review process are still incurred if subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or a contract is never finalized. The invoice is therefore due and payable upon receipt. The investigator and/or department will be responsible for all costs not covered by the sponsor, specifically including the IRB review fee. Contacts For questions regarding:
This Policy is maintained by the Office of the University Counsel |