Access to Constances

Requests for access to data or to participants are evaluated by the International Scientific Committee of Constances, and must have taken the regulatory steps required to access the data [the synopsis form]. Please read the information contained in the Constances Charter which frames access to the Infrastructure. It describes the rights and responsibilities of research teams whose projects have been accepted.

• Contact Prof. Marie Zins, Constances PI, for an initial discussion by e-mail or by completing the synopsis form. At this stage, you should provide some information about your proposed project: scientific team, objectives, main types of data required, and whether the project is funded in whole or in part by commercial entities. If the proposed project seems to fit the general characteristics of a Constances project and if it seems to be feasible, Pr Zins will guide you to the project submission process.
• Submit your application in our dedicated application. The application must contain:

1. A protocol specifying, among other things, the scientific objectives, the methods, the nature of the statistical analyses, the data requested (which participants; which variables) with some justification for their inclusion, and, if applicable, a description and justification for any additional data collection envisaged.
2. A description of the scientific team in charge of the project and the sources of funding, both for the implementation of the project and for the costs of access to Constances.
3. The declaration of acceptance of the operating rules described in the Constances Charter by the project’s PI.

• Your request for access will then be evaluated by the Constances International Scientific Committee, leading to the formalization of a favorable (with or without reservations) or unfavorable opinion. The Constances Steering Committee, informed of projects that have received a favorable opinion, may oppose the use of certain data due to conflicts of interest. Finally, the INSERM Ethics Committee may be called upon to verify compliance with medical research regulations. Access requests are evaluated as they are submitted.
• If your request for access is accepted, and before the data is made available, your organization must:
  • In close collaboration with the Constances team, take the appropriate legal and regulatory steps with regard to the use of personal data and, if necessary, with regard to ethics.
  • Contract with INSERM, the Constances data controller. A Data Transfer Agreement (DTA) and if applicable a Material Transfer Agreement (MTA) have to be established.
  • If you need to access data from the national administrative health database (SNDS) or any other sensitive data, you will need to take the necessary steps to open a secure CASD (Secure Data Access Center) workspace. The rates applied can be consulted on the CASD website (https://www.casd.eu/en/).
• The results obtained from Constances data must be made public, in the form of scientific publications, reports, theses or dissertations, etc. These scientific productions must involve the Constances team. Wherever possible, publications should be open access.
• At the end of your project, you must send a destruction report for the data transmitted to the Constances team (any further use of the data made available is forbidden, unless a subsequent formal proposal is made).