Provision Language
6. Clinical Studies
[…]
6.6 Registration of Clinical Trials. Awardee shall publish details of any clinical trial in a publicly accessible clinical trial register, where patient privacy is upheld, as required under law and, as applicable, prior to the commencement of patient recruitment for such clinical trial.
9. Dissemination of Project Results; Publication
9.1 Dissemination of Project Data. Awardee shall disseminate pre–clinical and clinical trial data (including any negative results, animal model deaths and any toxicology study issues) produced under the Project (collectively, “Project Data”), as described in the iPDP and this Agreement or as otherwise agreed by the JMAG.
9.2 Dissemination of Project Materials. Awardee shall disseminate biological samples, Project Vaccines, and other tangible materials produced under the Project (collectively, “Project Materials”) as described in the iPDP and this Agreement or as otherwise agreed by the JMAG. If Awardee develops animal models under the Project, they shall also be considered Project Materials and disseminated as described in the iPDP and this Agreement or as otherwise agreed by the JMAG.
9.3 Dissemination of Project Results to the Broader Outbreak Community. As described in the iPDP and elsewhere in this Agreement, or as otherwise agreed by the JMAG, and subject to the payment by CEPI of actual costs and reasonable protection for Awardee’s rights under this Agreement, Awardee shall disseminate Project Results (excluding any chemistry, manufacturing and controls (“CMC”) data, or any information that would violate relevant privacy laws, or any information that Awardee can reasonably demonstrate to CEPI is sensitive and should not be so disseminated) with the broader Outbreak research community, such as disease–specific assays and standards, animal models, correlates of protection or risk, or diagnostics and epidemic preparedness mechanisms.
9.4 Dissemination of Project Data to Countries Hosting Clinical Studies. Subject to reasonable protection for Awardee’s rights under this Agreement, Awardee shall, to the extent it has the legal right to do so, make all Project Data (excluding any chemistry, manufacturing and controls (CMC) data), such as results of disease–specific assays, animal models, correlates of protection or risk, or diagnostics and epidemic preparedness mechanisms arising from such clinical trial available to that country’s Ministry of Health or equivalent.
9.5 Publication of Project Data for the Outbreak Research Community. Project Data shall be shared rapidly with the broader community, consistent with Awardee’s requirements as a public company, in accordance with (i) WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks; (ii) WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens; (iii) and Wellcome Trust’s Statement on Sharing Research Data and Findings Relevant to the Coronavirus (COVID–19) Outbreak to which CEPI is a signatory.
9.6 Clinical Trial Data. CEPI’s Clinical Trials Policy requires that clinical data and results (including negative results) must be disclosed publicly in as close to real time as possible. Accordingly, such data must be shared through an easily discoverable existing public route (website or system) that includes a metadata description, where patient privacy is upheld, and the system follows a request–for–information approach (where requests are fulfilled subject to an independent review and approval step). Clinical trial data shall be submitted for publication within twelve (12) months after each final study report or report submitted to CEPI. During the same time period, Awardee shall make the results available to the relevant country’s Ministry of Health or equivalent. The clinical trial ID or registry identifier code/number shall be included in all publications of clinical trials.
9.7 Open Access. CEPI requires “Open Access” for Project Data. This means that a copy of the final manuscript of all research publications, journal articles, scholarly monologues and book chapters published under this Clause 9 must be deposited into PubMed Central (or Europe PubMed Central) or otherwise made freely available upon acceptance for publication or immediately after the publisher’s official date of final publication. Moreover, all peer–reviewed published research that is funded, in whole or in part, by CEPI shall be published in accordance with the principles of Plan S (“Accelerating the transition to full and immediate Open Access to scientific publications”), a UK and European data sharing initiative for research funded by public grants.
9.8 Statement of Support in Publications. All such publications shall include a statement that the work was “supported, in whole or in part, by funding from CEPI” (or words to the same effect) and shall credit, where appropriate, the country in which any clinical trials were performed.