Subj:   Issues in Negotiating Clinical Trial Agreements

Several weeks ago I posted a request for information about institutional
priorities in negotiating issues on clinical trial agreements.  I have rec'd
8 responses to this request for information, and have summarized those
responses below.  Thanks to all who have responded, your information is most
important for us at UCHC, and I assume most interesting to the participants
of this list.  If anyone else wants to share their institutional priorities,
I'll do an update of this survey at the end of July.

"L"
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Summary of Clinical Trials Issues Survey Responses

CODES FOR COMPLETING SURVEY:

1 = Imperative, must preserve right in all cases.
2 = Very Important, but may negotiate away right under compelling circumstances.
3 = Important, but will usually negotiate away right for something else.
4 = Not Very Important, but would be nice to have in the agreement.
5 = Prefer not to have issue addressed in agreement.

INSTITUTION NAME (Optional):  I am withholding the names of the responding
 institutions to protect the "innocent".

TYPE OF INSTITUTION (Check one):

Private Institution?    4 Respondents
Public Institution?     4 Respondents

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Issue                                *    Institutional         *
 *    Preference/Policy     *
 *    (enter 1 - 5)         *
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Fiscal Reporting To Sponsor          *   1/8 said 3
 *   7/8 said 5
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Indemnification of Institution       *   7/8 said 1
 *   1/8 said 1-2
*****************************************************************
Indemnification of Research Subject  *   3/8 said 1
 *   1/8 said 2
 3/8 said 4
 1/8 said 5
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Intellectual Property Rights To      *   5/8 said 1
New Discoveries                      *   2/8 said 3
 1/8 said "Usually expect rights to
 be property of sponsor, and
 accept that."
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Publication Restriction - Prohibition*   6/8 said 1
 *   1/8 said 2
 1/8 said "Usually expect to be able to
 publish upon prior submission
 to company (45 days)."
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Confidentiality Provisions           *   3/8 said 1
 *   1/8 said 2 "Only term (?) of info being
 kept confidential."
 2/8 said 5
 1/8 said "Usually expect this provision
 with opportunity to disclose
 upon written consent by
 company."
 1/8 said nothing (did not respond on
 this issue)
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Governing Law Preference             *   2/8 said 2
 *   3/8 said 3
 1/8 said 4
 2/8 said 5
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Institutional/PI Ownership of Data   *   3/8 said 1
 *   2/8 said 2
 1/8 said 3
 1/8 said 4
 1/8 said "Usually assume company has
 ownership of data as clinical
 agreements usually stipulate
 that PI is consultant.
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Leonard P. Paplauskas    Assistant Vice President for Research     |
203-679-3173             University of Connecticut Health Center   |
FAX 679-2670             Farmington, CT   06030-5355               |
                                                                   |
xxxxxx@neuron.uchc.edu                                           |
xxxxxx@sun.uchc.edu                                            |
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