UCONN Health Center, at this time, will not accept such terms in
research agreements.  I say "at this time" because there is significant
pressure from clinicians conducting clinical trials to change this
policy.  This pressure is being generated by the pharmaceutical
industry, i.e., the clinical investigators are being threatened with
diversion of the funds to organizations which accept the terms
unconditionally.  I would not be surprised to see a formal review of
this policy at UCONN in the near future.

I believe this to be a major issue of concern to the academic community,
especially those institutions which conduct clinical trials.  Some of
the recent horror stories about disputes with industrial sponsors about
the publication of results which were considered adverse to the
sponsors' interests, illustrate the need for a uniform response from the
research community.  This matter gets to the heart of academic freedom,
and objective analysis and reporting of research results.

If the pharmaceutical industry muscles its way into getting institutions
to accept funding that carries publication restrictions, then I believe
we will have lost a major battle in the war to provide the public with
unbiased information about the results of such studies.  It is a
fundamental conflict of interest for academic institutions to accept
funding for research which carries such restrictions.

What surprises me is that the feds have not looked into this, i.e., it
seems to me that the feds would be concerned that publication
restriction on research which leads to products ultimately regulated by
federal agencies is a flawed check on the credibility of the entire
clinical research industry.

There is some concern on the part of the IRS related to whether
contracts containing such language can be construed as "commercial"
activities, as opposed to research, and thus affect the tax exempt
status of bonds used to finance the facilities conducting those
activities.  However, the IRS does not flat out prohibit such
activities, just expects institutions to manage them.

I don't know what the DFARS language you are referring to states, it
undoubtedly has some bearing on this issue, but many universities have
successfully resisted the feds' attempts at restricting publication.

This is not a trivial issue!  I'd love to see a comprehensive analysis
of this matter in some forum.

Leonard P. Paplauskas
Assistant Vice Chancellor for Research
University of Connecticut Health Center
Farmington, CT  06030-5355
860-679-3173 (voice)
860-679-2670 (fax)
xxxxxx@adp.uchc.edu

> -----Original Message-----
> From: NORMAN HEBERT [SMTP:xxxxxx@BROWN.EDU]
> Sent: Wednesday, November 25, 1998 9:02 AM
> To:   xxxxxx@hrinet.org
> Subject:      Publication 'approval'
>
> I have been asked by our dean's office to gather information about
> whether
> other colleges or universities will accept agreements from industry
> which
> allow industry/government the right of approval on publications.  One
> example of this is a subcontract from industry containing the federal
> DFARS
> clause at 252.204-7000 Disclosure of information.
>
> I would appreciate as many responses as possible - please email, fax
> or call.
>
> Thanks!
> -Norm
> ****************************************
> Norman J. Hebert, Associate Director
> Office of Research Administration
> Brown University
> 164 Angell St., Box 1929
> Providence, RI   02912
> email:  xxxxxx@brown.edu
> phone: (401) 863-3141
> fax: (401) 863-7292
>
>
> ======================================================================
> =======

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