Publication Restrictions & Registration of Sponsored Clinical Trials

Tulane University School of Medicine policy on publication restrictions and 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. When the University will perform as a subrecipient on a clinical research project, the School of Medicine will accept a total period of delay not to exceed 120 days to permit the prime awardee sufficient time to meet its obligations to the sponsor for the publication screening process.

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 or in another public, non-profit, international registry and should include all elements required by that registry.

Exceptions to this policy may be made in writing by the Investigator and coordinated by Sponsored Projects Administration for consideration and approval by the Senate Committee on Research.