We do the following:

1.  Require a letter from the company which states that Boston Medical
Center and Investigator X have met all contractual obligations and that
nothing further is due to the company from either party.  We
deliberately do not state what categories or specifics of obligations to
which we are referring.  Thus far we have not been refused in this
request.

2.  The investigator is instructed to send to me a letter requesting
that any income in excess of expenses remaining in the study fund be
transferred to a new "discretionary" fund, the purpose of which is YYY.
The mission statement for the fund must clearly be for research or
education or the funds will not be made available.  Our non-profit
status is carefully guarded.  In addition to the mission statement, the
letter must contain a statement that the funds are to be budgeted in the
following way.... or a statement that the use will be on an ad hoc
basis, with the justification of relevance to the mission provided at
the time of each request for expenditure.  We also require a list of
authorized signators on the fund, as well as the signature/approval of
the Chief of the appropriate department.  (Each department chief has
discretion for use of any commercial study "balances", and s/he may
choose to put all of part of the funds into an account under his/her
control.

3.  Our office then administers the fund, sending out monthly reports,
etc.  Since we insist on doing commercial research to support our
hospital's mission of patient care, teaching and research, it is
important that any "residual" funds from such activities are clearly in
support of that tripartite mission.

Thus far, this process has been running smoothly (which means I probably
should be worried!)

Diane C. Gilbert, CRA
Director, Research and Service Grants Administration
Boston Medical Center
xxxxxx@bmc.org

Doug Wilkerson wrote:
>
> I would be interested in knowing how those of you involved in the management of industry-sponsored clinical trials handle any funds remaining AFTER all of the work is completed, i.e., after the company has accepted all deliverables required in the contract, and all of the bills are paid.   Do you leave the residual funds in the same account that was established to support the work of the clinical trial, or move them to another account?  Do you place restrictions on the use of the residual funds?  At the end of the trial, do you consider any residual funds to be completely dissociated from the original contract and thus available for expenditure for any research-related activity, assuming that no contract clauses survive the contract which might obviate this option?  What if your investigator wanted to utilize residual funds to finance a collaborative research agreement with another entity for basic research, would you be comfortable with it?
>
> Doug Wilkerson, Ph.D.              Phone:   (419) 383-4252
> Assoc. V.P. For Research          Fax:   (419) 383-4252
> Professor of Pharmacology         E-mail:   xxxxxx@mco.edu
> Research & Grants Admin.          Web: www.mco.edu/research
> Block Health Sci. Bldg., Rm. 148
> 3035 Arlington Ave.
> Toledo, OH 43614-5804
>
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