- Collaborators: All parties that are members of the POLARIS consortium.
- Contributor: Principle investigator of a research group providing data from the RCT for the POLARIS database, and who acts as consortium member.
- Recipient: A person that uses the data from the POLARIS database for proposed analyses.
- Third parties: All parties (e.g., researchers) that are not members of the POLARIS consortium.
Data ownership and data confidentiality
- The data made available for the POLARIS database are and remain the property of the Contributor.
- All data that are included in the POLARIS database will be stored securely at the EMGO Institute for Health and Care Research and are treated as confidential.
- All data in the POLARIS database are anonymous; all confidential and privacy sensitive information is removed, and the data is not traceable to patients.
- Contributors may decline participation on a paper-by-paper basis, without giving any reason.
- Contributors have to sign the Data Sharing Agreement (Appendix D) before transferring their data to the POLARIS database.
- Contributors have to confirm that they are authorized to provide the data to the POLARIS database (Appendix D)
Data access and use
- Data from the POLARIS database can be used by Contributors and third parties under the rules provided in his document.
- To access the POLARIS data, a paper proposal should be submitted in writing to the Steering Committee (see paper proposal and publication rules ).
- After receiving a paper proposal, the Steering Committee will contact each Contributor to ask permission for the use of their data for the proposed study.
- Each Contributor will be given three weeks to decide whether he/she approves that the proposed analyses are conducted on the data they provided to the POLARIS database. A reminder will be send after two weeks. In case of no reply, automatic approval of the proposed analyses is given after three weeks.
- If the Contributor decides not to participate, his/her data will not be included in the proposed analyses.
- The data in the POLARIS database can only be used for the proposed analyses, and is not allowed to be used for other studies nor should it be provided to third parties without written permission from each Contributor.
- The data can only be used according to the proposed analyses. In case other research questions are considered based on the same data base, approval for this new research question should be obtained.
- Access to the POLARIS data for consortium members is free of charge.
- POLARIS data is only available for non-commercial scientific research.
Recipients will have to sign the Data Sharing Agreement (Appendix E) before they receive the data for analyses.
Paper proposals and publication rules
- Paper proposals should include information on authors, working title, the research question(s) to be addressed, the variables to be included, the analysis plan, the timetable and targeted journal(s) (see Appendix B1, example in Appendix B2).
- The Steering Committee will check potential overlap with other proposals or competing interests (i.e. ongoing studies using the POLARIS database). In case of conflicts of interest that cannot be resolved by the individuals involved, the issues at hand will be presented in writing to the Steering Committee, which will make the final decision, blind to the involved authors.
- In case the proposed research activities exceed the proposed timeline by six months or more, the topic will be made available to other researchers. Before exceeding the time line, the leading author may ask permission in writing of the Steering Committee to extend the proposed timeline.
- A leading (first) author can submit a maximum of two paper proposals at the same time. After the paper has been submitted to a journal, the author is allowed to submit the next research proposal. Paper proposals for PhD students, i.e. proposals for papers to be part of the PhD thesis, are an exception. For a PhD thesis, a PhD proposal (Appendix C1, example in Appendix C2) can be submitted including a maximum of 5 papers answering several research questions.
- The results of each study will be submitted for publication in scientific peer‐reviewed journals. The submitted version will be sent to all Collaborators.
- Before submission, the paper will be sent to the Steering Committee for information and approval to be submitted as a POLARIS paper. The Steering Committee has 2 weeks to check whether the paper is in correspondence with the paper proposal and that the acknowledgments (see acknowledgments) are used in a correct manner.
- The lead author (or corresponding author) is responsible for the quality of the paper.
- At the time of acceptance, the complete paper should be sent to the Steering Committee.
- When the manuscript has been accepted for publication, the PDF of this paper will be e-mailed to each member of the POLARIS Consortium or a link to the open access journal will be published on the POLARIS website.
- For (co-)authorship, the POLARIS Consortium complies with the Vancouver Protocol, i.e. authorship credit should be based on (1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published.
- In all publications, the POLARIS Consortium will be mentioned as a co-author, i.e. ‘(on behalf of) the POLARIS Consortium’.
- The participating studies and investigators of the POLARIS Consortium will be listed at the end of each publication, with a maximum of 2 investigators per study (PI and co-PI).
- Names of lead authors conducting the analysis and writing the paper will be listed separately in addition to the POLARIS Consortium.