Following approval, access is provided after the relevant study sponsor or sponsors receive a signed Data Sharing Agreement. This agreement includes requirements for the research team to:
- Only use the data for the agreed research purpose and not download or transfer
the data for future use.
- Protect the privacy and confidentiality of research participants; the researchers
must not attempt to establish the individual identities of research participants.
- Obtain any regulatory or ethics approvals necessary to conduct the analysis.
- Inform the relevant sponsor(s) and regulatory authorities of any safety concerns
as soon as they are identified.
- Post a summary of the analysis plan prior to conducting the Analysis. Post summary results on a public register or website within one (1) year of completing the analysis and seek publication of the research in a peer reviewed journal.
- Include in the publication a description of the strengths and weaknesses of
the analysis and a citation or a register identification number to the original
- Provide the relevant sponsor(s) with a copy of any public disclosure of the results, including a copy of the manuscript. (Some sponsors include a provision for prior review of the manuscript and other sponsors require the manuscript after submission; refer to the terms specified in your actual Data Sharing Agreement.) Also provide the relevant sponsor(s) with the citation after publication.
- Provide other researchers with additional details of the analysis on request.
- Allow the relevant sponsor(s) to use any invention coming out of the research
that impacts the ability of the sponsor to develop or commercialise their products.
Such use will be free of charge and throughout the world. If the sponsor requests
additional rights, you agree to negotiate in good faith with the sponsor.
- Confirm that you do not have, and do not plan to have, any other agreements
which would prevent you from complying with “i” above.
- Meet any additional requirements identified by the Independent Review Panel.
Note this is a legal document and so may require legal review within your organisation prior to your signing.
The Data Sharing Agreement template is provided here. Your
actual Data Sharing Agreement may have minor modifications. Please note that the
sponsors do not anticipate negotiation on the provisions in this template.