Clinical Trials and IRBs

Clinical Trials & IRBs

University of Washington Correspondence

INTERDEPARTMENTAL
OFFICE OF RESEARCH
OFFICE OF SPONSORED PROGRAMS, Box 354945
May 25, 1999
Subject: Clinical Trials and IRBs

Provost Huntsman has approved the addition of another Institutional Review Board (IRB). This new IRB will be the third biomedical committee at the UW and the fourth IRB overall. The other IRB is the behavioral committee. This action was taken on the recommendation of the Clinical Trials Committee, chaired by Dr. Walter Stamm, and with the endorsement of the School of Medicine. Our goal is to ensure the quality of our reviews and to improve the timeliness of the human subjects reviews, particularly in response to the rapidly increasing number of industry sponsored clinical trials.

In order to help defray the cost of additional staff required to support the new IRB, the University will begin direct charging an IRB fee of $1,000 for all new industry sponsored clinical trials. This practice is consistent with that at a number of other universities with extensive clinical trials sponsored by industry.

We are beginning the recruitment process to staff the new committee and will be appointing new committee members soon. Arrangements for implementing the fee are in process with a planned implementation date of July 1, 1999. Don Allen will send detailed instructions regarding the fee as soon as the procedures can be worked out.

Let me thank you for your suggestions and advice as we formulated this policy. We hope it will improve service for all those who require human subject reviews.

Sincerely,

Alvin L. Kwiram
Vice Provost for Research

IRB Review Fee For Industry Sponsored Clinical Trials

University of Washington Correspondence

INTERDEPARTMENTAL
OFFICE OF RESEARCH
OFFICE OF SPONSORED PROGRAMS, Box 354945
June 11, 1999

Subject: IRB Review Fee for Industry Sponsored Clinical Trials

Vice Provost Alvin Kwiram announced the approval of another Institutional Review Board (IRB) in his memo of May 25. The new IRB will be the third biomedical committee at the UW and the fourth overall, including the existing behavioral committee. The goal is to ensure the quality of human subjects reviews and to improve the timeliness of the reviews, particularly in response to the rapidly increasing number of industry sponsored clinical trials.

The announcement also noted that, consistent with the practice at a number of other universities with extensive clinical trials sponsored by industry, the University will begin charging an IRB fee to all new industry sponsored clinical trials in order to help defray the cost of additional staff required to support the new IRB. The memo noted that I would send detailed instructions regarding fee implementation.

The fee will be a direct charge of $1,000 for all new industry sponsored clinical trial agreements (fixed price agreements either directly from industry or from a non-industry sponsor provided the pass through or prime funding is from industry). Indirect costs at the rate of 25% will apply to the fee (the same rate charged to all other direct costs on industry sponsored clinical trials). The implementation date will be July 1, 1999.

When new clinical trial agreements are being negotiated with industry, the $1,000 fee should be included as a separate line item "IRB Review Fee $1,000." The fee ($1,000) and the indirect costs on the fee ($250) will be nonrefundable and included as part of the first payment from the sponsor. When the budget number is established, a direct charge of $1,000 will be made by the Grant and Contract Accounting Office resulting in a corresponding indirect charge of $250 per instructions to be provided on the Notice to Establish Account (NEA) by Office of Sponsored Programs. Please note that this IRB Review Fee as a separate line item is different from the "IRB Preparation Fee" which is sometimes included in clinical trial budgets and used for direct costs incurred in academic departments.

The "IRB Review Fee" will be charged once on all new clinical trials sponsored by industry regardless of the total amount of the clinical trial agreement. There will not be an additional fee for amendments or supplements to the initial agreement.

I would appreciate your help in disseminating this memo to those affected in your respective areas. In order to make the process easier, I will forward this memo by e-mail as well.

Sincerely,

Donald W. Allen, Director
Office of Sponsored Programs