Hi Scott,

Most of the NIH sponsored clinical trails we have are contracts or
cooperative agreements, not grants, which may or may not incorporate the
standard NIH publication language.  The standard NIH
publication/copyright language is addressed in the Grants Policy
Statement
http://grants2.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm.  The
specific language is below, but check the specific award terms and
conditions before acting on the information from the GPS.

Rights in Data (Publication and Copyrighting)

In general, grantees own the data generated by or resulting from a
grant-supported project. Special terms and conditions of the award may
specify alternative rights, e.g., under a cooperative agreement or if
there are shared rights to data. Except as otherwise provided in the
terms and conditions of the award, the grantee is free to copyright
without NIH approval when publications, data[18], or other copyrightable
works are developed under, or in the course of, work under an NIH grant.
Copyrighted or copyrightable works also include materials developed by
students, fellows, or trainees under awards whose primary purpose is to
further the education or training of such individuals. Whenever any work
subject to this copyright policy is developed by a consortium
participant or a contractor (or subcontractor) under a grant, the
written agreement/contract must require the consortium
participant/contractor (subcontractor) to comply with these requirements
and can in no way diminish NIH's rights in that work. NIH must be
provided a royalty-free, nonexclusive, and irrevocable license for the
Government to reproduce, publish, or otherwise use the material and to
authorize others to do so for Federal purposes.

Grantees may arrange for publication of initial reports of original
research, supported in whole or in part by NIH grant funds, in primary
scientific journals and for copyright by the journal unless the
journal's copyright policy would preclude individuals from making or
having made, by any means available to them without regard to the
copyright of the journal and without royalty, a single copy of any such
article for their own use (see 45 CFR 74.36 and 92.34). The disposition
of royalties and other income earned from a copyrighted work is
addressed in "Administrative Requirements-Management Systems and
Procedures-Program Income." Grantees are encouraged to assert copyright
in scientific and technical articles based on data produced under the
grant where this is necessary to effect publication in academic,
technical, or professional journals, symposia, proceedings, or similar
works.

Grantees are required to place an acknowledgment of NIH grant support
and a disclaimer, as appropriate, on any publication written or
published with such support and, if feasible, on any publication
reporting the results of, or describing, a grant-supported activity. An
acknowledgment shall be to the effect that:

"This publication was made possible by Grant Number ________ from
_________" or "The project described was supported by Grant Number
________ from ________" and "Its contents are solely the responsibility
of the authors and do not necessarily represent the official views of
the (name of awarding office or NIH)."

In the event that the recipient wishes to join with NIH in a
simultaneous news release announcing the results of a project, the
action should be coordinated with the awarding office.

One copy of each publication resulting from work performed under an NIH
grant-supported project must accompany the annual progress report
submitted to the NIH awarding office (see "Administrative
Requirements-Noncompeting Continuation Awards").

Hope this is what you were looking for.

Kris

_____________________________________________
Kris Rhodes, Associate Director
Office of Sponsored Projects Administration
University of Kentucky
214 Kinkead Hall, Lexington KY 40506-0057
Phone:  859-257-4826   Fax:  859-323-1060

-----Original Message-----
From: Davis, Scott (HSC) [mailto:xxxxxx@OUHSC.EDU]
Sent: Monday, July 07, 2003 2:51 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] NIH Publication Guidelines for Clinical Trials

Good Afternoon Group,

I am trying to find the following or similar language on the NIH website
regarding publications for NIH sponsored clinical trials.  If anyone can
provide me with a link it would be greatly appreciated.

Prior to submission for publication of any manuscript, poster,
presentation, abstract or other written or oral material describing the
results of the Study, the Institution and/or the Principal Investigator
shall provide NIH 45 days to review a manuscript. . .  In the event
there is no multi-center publication within 12 months after the Study
has been completed or terminated at all Study sites, data has been
received and analyzed by NIH, and all queries have been resolved,
Institution shall have the right to publish its results from the Study.
. .

Thanks

scott

Scott Davis, CRA
Sponsored Programs Administrator
University of Oklahoma Health Sciences Center

Tel  405.271.2090
Fax 405.271.8651
xxxxxx@ouhsc.edu

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