Per NIH guidance, any NIH or PHS grant application involving Human Subjects and Clinical Trials must include a Dissemination Plan. This plan must contain the following assurances:
- the applicant will ensure that clinical trial(s) under the award are registered and results information is submitted to ClinicalTrials.gov as outlined in the NIH policy on the dissemination of NIH-funded clinical trial information and according to the specific timelines stated in the policy;
- informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov; and
- the recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.
To assist researchers in submitting assurances consistent with UF policy, the UF Office of Clinical Research has drafted the following template language to be used/inserted into the required Dissemination Plans:
UF Template Language
[Beginning of UF template language – copy and paste all of the following sections and clauses into your Dissemination Plan document]
Under University of Florida institutional policy, all results of research projects must be publishable and university investigators engaged in research must be permitted to present at symposia, national, or regional professional meetings, and publish in journals of their own choosing. Sponsors of research conducted at the university grant the institution the right to use study data and results for their research, educational, noncommercial, and publication purposes in accordance with terms and conditions of applicable research agreements.
- [Insert Name of PI], Principal Investigator, is responsible for conducting the trial, has access to and control over the data from the trial, has the right to publish the results of the trial, and has the ability to meet all the requirements of submitting and updating clinical trial information.
- Registration of the project into ClinicalTrials.gov will occur no later than 21 calendar days after the first participant enrollment.
- Protocols and associated Informed Consent Forms are reviewed by the UF ClinicalTrials.gov program prior to Institutional Review Board (IRB) approval.
- Required ClinicalTrials.gov template language is confirmed within the Informed Consent Forms.
- Study teams are informed prior to IRB approval when ClinicalTrials.gov registration and results reporting are required.
- ClinicalTrials.gov record creation is initiated once the NIH Clinical Trial Definition determination has been made.
- The UF ClinicalTrials.gov program works collaboratively with the IRB and study team to ensure data elements requiring rapid updates are addressed within timelines.
- University of Florida, as “sponsor” within the ClinicalTrials.gov PRS platform, oversees quality and compliance to ensure timely updates accurately reflect the most current state of the project as approved by the IRB, and has systems in place to facilitate timely results submission.
- For details, see 42 CFR §§ 11.4(c)(2), 11.44, and 11.64; also see NIH: NOT-OD-16-149.
[End of UF template language]
If you have questions regarding this template language, please contact the UF ClincialTrials.gov program via UFCTfirstname.lastname@example.org.