Alan A. Schreier writes:

>At our academic medical center, we have recently received two contracts
>for clinical trials that include a line item for 'IRB Fees'. These fees
>were not solicited in our negotiations with the sponsors and just
>appeared in the final contracts. Our local institutional review board
>has not charged fees in the past. Has anyone in this discussion group
>had experience with 'IRB fees'? We are particularly interested in
>answers to these questions: 1) How are IRB fees set and at what levels?
>2) What type of documentation do sponsors require to pay IRB fees? Is a
>simple invoice from the IRB Office sufficient? 3) Can IRB fees be used
>to offset preparation costs of IRB submission materials before they are
>sent to the IRB? Any information about this new budget item would be
>appreciated.

The recent trend to move clinical trials away from universities (which all
have appropriately constituted IRBs) to smaller private clinical research
operations (which cannot, by virtue of their size, support an IRB) has
resulted in the formation/creation of a number of "for hire" IRBs, which
will conduct a review for a fee.  The example I am most familiar with in CT
is the "Nutmeg IRB", which services a number of private physicians and
clinical research operations.  The pharmaceutical industry has embraced such
interactions, thinking that it is cheaper (and faster) to do this, than to
have clinical trials reviewed by IRBs at university medical centers, where
IRB reviews are more thorough and where IDC are charged to the trials.
I assume that because such "for hire" IRBs are becoming more prevalent
throughout the nation, the pharmaceutical industry has simply begun to include
IRB review fees in its standard pricing protocols for clinical trials.

We have not yet, to the best of my knowledge, seen anything like this at UCONN,
but nothing would surprise me.

As to Alan's specific question, my guess is that you can establish an
institutional policy of charging IRB fees for clinical trials (perhaps to
offset a reduced IDC recovery on such contracts), but you'd better have some
consistently applied policy.

I'd be real interested in learning which companies have included such fees in
their clinical trial budgets.

Len

--------------------------------------------------------------------
Leonard P. Paplauskas    Assistant Vice President for Research     |
203-679-3173             University of Connecticut Health Center   |
FAX 679-2670             Farmington, CT   06030-5355               |
 |
xxxxxx@sun.uchc.edu                                            |
xxxxxx@neuron.uchc.edu                                           |
--------------------------------------------------------------------