To: Deans, Division Heads, Chairs

From: Gail Habicht, Vice President for Research and Norman Edelman, Vice President for Health Sciences

Subject: Industry-sponsored Research Involving Human Subjects

Date: April 6, 2001

Memorandum

As you know, the protection of human subjects participating in research activities has always been one of our most important priorities at this Institution. It is clear that in order to be maximally effective in this regard, our Institutional Review Board program must be running at optimal efficiency.

To better accomplish this goal, in the next few months we will be creating a second IRB, and increasing administrative and clerical staff support to the University IRBs. IRB member workload will be re-distributed to allow for a more comprehensive review of clinical research for compliance with ethical and regulatory requirements, while the increase in IRB personnel will allow staff to be able to better assist, and meet the needs of, clinical investigators. The resulting increased frequency of IRB meetings will reduce delays in project review.

Adequate funding for our IRB program is critical. To this end, effective May 1, 2001, please be advised that what are commonly referred to as ‘IRB fees’ will be secured as follows from all industry-sponsored grants and contracts that fund activities involving human subjects:

It is important to note that the IRB fee is a per-study charge, covering the initial protocol review, as well as review of subsequent amendments, adverse event reports, and continuing review submissions for the study. An additional IRB fee will be charged at the mandatory complete review required at 5 years.

Applications Requiring Full Committee Review

(including 5 year renewal of Full Committee Applications)

For grants/contracts with direct costs (DC) up to $14,999:

*IRB fee will be 10% of the DC

For grants/contacts with direct costs (DC) of $15,000 and up:

*IRB fee will be $1500.00.

Applications Requiring Expedited Review

*IRB fee will be $200, regardless of award amount

*Note: For submissions made between May 1, 2001, and April 30, 2002, the rates charged will be 70% of those posted above.

The inclusion of the fee will be required on all applications for industry-sponsored projects involving human subjects and will be extracted from awards in accordance with the above schedule. Questions may be directed to the Office of Sponsored Programs or the Office of Research Informatics and Compliance.

Cc:

CORIHS-approved investigators
Ms. Judy Matuk
Mr. Ivar Strand
Mr. Aaron Rosenblatt