Do you actually mean that the investigator (or his non-institution company)
sponsors the clinical trial?  I am presuming a clinical trial of a product
or near-product, i.e., obviously a trial for regulatory  product approval.

If so, I personally believe that the institution should avoid the
trial.  If the PI has an intellectual property interest in what is being
tested, that seems pretty close to a COI.  If the institution does, it is
clearly an institutional COI.

If the trial is early in the process leading to a product, animal toxicity
studies, or pharmacological result studies (sometimes called a clinical
trial!), there is much less COI problem, and could be done if there is no
institutional COI.

Chuck

At 03:51 PM 11/19/2004, you wrote:
>Hello Everyone,
>
>I am interested in getting information on how other institutions manage
>investigator sponsored clinical trials.  It would be helpful to know what
>types of things institutions require from the investigators in order to
>initiate these trials.  Does the institutions accept the responsibility
>for monitoring the trials or do they require the investigator to come up
>with a management plan?  What about liability issues?  My questions are
>endless!  Any help will be greatly appreciated.
>
>Anita
>
>
>
>Anita Mills MA, CRA
>Manager,  Sponsored Programs
>Albert Einstein Healthcare Center
>Office of Research and Technology Development
>5501 Old York Road
>Korman Research Bldg, Rm 100
>Philadelphia, PA 19141
>Phone: (215) 456-7214
>Fax (215) 456-8122
>
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Herbert "Chuck" Chermside, CRA
Director Emeritus, VCU
Executive Director, Research Administrators Certification Council
1915 Robindale Rd.
Richmond, VA 23235-3931
804-320-5502
xxxxxx@verizon.net

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