Data sharing

Aim

To make proper arrangements with third parties (all parties that are not directly part of the project) about the use of your research data.

 

Requirements

  • A data transfer agreement with the third parties should be made in writing and must be signed by both parties;
  • The data must be de-identified prior to making it available to the third party, unless there is written informed consent from the participants to share their data with this particular third party;
  • The scientific purpose of the third party requesting data should be within the scope of your project/informed consent given by the participants whose data is to be shared.

 

Documentation

Copy of the signed agreement (example in Dutch and English). The agreement should contain statements about the terms and conditions under which data are made available:
  • What the third party may and may not do with the data. The data made available should only be used to answer the scientific questions described in the third parties’ data analysis proposal (example in Dutch and English);
  • The data made available are and remain the property of the research group;
  • The data may not be used for other studies and should not be provided by the third party to other third parties without written permission from the research group;
  • Agreement how to provide access to the data if a publisher or sponsor demands open access;
  • Results described in articles already written by the research group, but which have not yet been accepted for publication (add a list to the agreement), may not be mentioned in articles or reports by the third parties before these articles have been accepted for publication;
  • An agreement about co-authorships (who and order). At least one member of the research group should be involved as a co-author per scientific article or report;
  • All third parties’ articles or reports should include the grant body of the research group in the Acknowledgements section of their articles or reports;
  • Time period in which the third party may use the data, what the third party should do if an extension is needed, and what third party should do with the data after the termination date;
  • Minimal security measures the third party should take;
  • The third party should treat the data confidentially and may not (try to) trace back the identity of the subjects whose data is provided;
  • Financial agreement, e.g. if and what fee is charged for the time to generate the dataset and advise;
  • Agreement on the acknowledgment statement in publications (scientific papers, presentations, etc);
  • Agreement on intellectual property rights, if applicable.

 

Responsibilities

Executing researcher: To organise and archive the agreement with the third party.
Project leaders:
  • To make written arrangements with the third party about the data sharing. The agreement should be signed by both parties by an mandated person (who is authorised by the board to sign agreements for the organisation);
  • To verify that the purpose of the third party is compatible with the Original study/informed consent provided by the participants whose data is to be shared.
Research assistant: N.a.

 

How To

For the financial agreement, we employ certain rules of thumb drawing from experience within large cohort studies about sharing data with third parties. These rules apply to all EMGO+ projects, based on the aim that the third party has with the requested data:
  1. If the third party’s research is intended for scientific publication, then the data may be used, provided that someone from the project group is a co-author;
  2. If the third party’s research is not intended for scientific publication, but there is a public interest (e.g. RIVM reports), then datasets will be made available. The time required to generate the dataset and provide advice will be subject to a charge;
  3. If there is no public interest, then a charge applies for each variable (e.g. gender, education).

 

In addition, it is very important that the data are anonymous:
  1. De-identifie your data set eg remove all confidential, privacy sensitive information; Genetic datasets are considered to be identifiable. Transfer of gentitic should be covered in the informed consent of the participant.
  2. Have the third party produce a proposal for the data analysis (see an example in the Appendix);
  3. Contact legal assistance at the IXA for a suitable data transfer agreement

 

In 2017, the project ‘Zorg voor Delen’ published a checklist for data sharing. Click for more information, and the checklist (both in Dutch).

 

Appendices/references/links

  • Example of a data analysis proposal in Dutch (original) and English (translated)
  • Example of a data sharing agreement in Dutch (original) and English (translated)

 

Audit questions

1) Is there a written agreement with the third party?
2) Does this include the point mentioned under 3?
3) Are all the data anonymous?

 

V2.1: 6 sept 2018: removed EMGO+
V2.0: 12 May 2015: Revision format
V1.1: 1 Jan 2010: English translation
V1.0: 31 Jan 2008: Extension with rules of thumb for various objectives