Donald P. Schmigel, Director
Office of Sponsored Programs
Children's Research Institute
Children's National Medical Center
111 Michigan Avenue, N.W.
Washington, D.C. 20010-2970
Phone: (202) 884-4021
FAX: (202) 884-6510 (FAX)
Email: xxxxxx@cnmc.org
>>> xxxxxx@UAMS.EDU 03/14/01 08:27AM >>>
Let's do this survey again...
How much is your current IRB fee for industry sponsored clinical trials? $2000.
What office at your institution is responsible for actually collecting the
fee? Office of Sponsored Programs (interacting with Clinical Trial Unit).
Do you charge a fee for continuing review? No, but we do have additional charges for IRB review due to protocol modifications by the sponsor and for processing adverse event reports received from the sponsor (primarily on multi-center trials) to the IRB. How much? $1,000 for modifications and $500 for AERs.
Your Opinion: Is it best to collect the up-front fee and the continuing
review fee together or try to go back and get the continuing review fee
later on? (I'll tell you my view..."It hasn't been easy to get that
continuing review fee out of the company later on..Heck, sometimes it's hard
for us to get the up-front fee.) Suggest a method. Initial review fees are collected normally with the initial payment (as a pass through, outside the per subject fees, upon our submitting an invoice. Modification and Adverse Event Reporting fees are collected by invoice as they occur. Suggest you include the fees and payment schedule in your Clinical Trial Budget Agreement.
Respond privately if you want. I'll gladly distribute results.
(With all due respect...hit me with your best shot, Mr. Chermside.)
Thanks,
Tim
Timothy N. Atkinson
Director, Office of Research Administration
University of Arkansas for Medical Sciences
Little Rock, AR 72205
Phone: 501-686-8845
Fax: 501-686-8359
Fax2: 202-318-7225
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