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ORA

Publication Restrictions & Registration of Sponsored Clinical Trials

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. To that end, Tulane University School of Medicine cannot accept any fundamental limitation on the freedom to publish and therefore cannot accept publication restrictions which convey veto or censorship authority to extramural sponsors of University projects. Publication delays not exceeding sixty (60) days are acceptable so that a sponsor may review publications and (1) offer comments or suggestions and/or (2) determine that its proprietary data are not inadvertently disclosed. In either case, the final decision on content must rest with the author. Delays not exceeding ninety (90) days also are permitted so that the University and/or the sponsor may screen proposed publications for possibly patentable ideas. If both sixty- and ninety-day delays are applicable, the total period of delay should not exceed ninety (90) days.

The School of Medicine will consider waivers for multi-center clinical trials that prohibit publication by any one participating site, so long as that restriction applies to all participating sites, and if there is a reasonable time-limit on the restriction (i.e., publication of the study as a whole, or, in the absence of acceptance of the full publication, within 2 years from the specified endpoints or earlier termination of the study). After that time, the investigator must be free to publish his/her independent findings.

The School of Medicine will not accept sponsored clinical trial agreements where the clinical trial is not registered in a Clinical Trials Registry. Registration should be accomplished either in clinicaltrials.gov or in another public, non-profit, international registry and should include all elements required by that registry.

Exceptional cases will be considered by the Dean of the School of Medicine, but must be made in writing by the Investigator with supporting documentation.

 


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