IRB Review Fee

9/28/2005

Dear Colleagues,

As you are aware, universities are now charging a fee to commercial /industry sponsors of clinical research for IRB-related expenses.  This is either a single flat fee, or a fee for initial review and continuing review.   The funds generated by this fee are used to support the IRB and related expenses (e.g. accreditation fees, educational initiatives, or costs incurred by the IRBs).  Attached is a survey of institutions that do levy such a charge.  The industry sponsors are accustomed to this as an expected fee for clinical research projects.     

Therefore, effective immediately, budgets for commercially funded clinical projects should include a one-time fee of $2,000, listed as "IRB Review Fee".  ORI will send a separate invoice to the company for this fee and the income will be deposited in an account other than the grant account.

I realize that you may have some projects where the budget has been under development for some time.  If your budget has been under development, you may request (Debbie Davis) that your budget be grandfathered in without the IRB Review Fee.  However, by December 1, 2005, our expectations would be that there would be no need to grandfather in exceptions to this fee.

This fee is separate from any start-up costs that your department may apply or any costs incurred through the UKCRO.

Please share this memorandum with others who may be involved in developing industrially sponsored clinical trials.   There is an attached list that includes the PIs and co-PIs of industry sponsored studies which might help you identify people in your college who should receive this memo.   If you have any questions about this, please email me at baldwin@uky.edu

As we seek to accelerate UK's clinical research activities it is important that we have strong, well-supported systems for the protection of the individuals who participate in that research.  We are deep into the accreditation process and by applying this fee we will help support these vital activities and place UK in the mainstream of how such systems function and are supported.

Wendy Baldwin
Executive Vice President for Research