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 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
