The data collected in Epipage 2 is used anonymously and for research purposes only. Only researchers whose research projects have been validated by the scientific committee can access the data that parents agreed to transmit to professionals.
Each data collect is performed only after getting the authorization of different regulatory committees CEREES (Expert Committee for Research, Studies and Evaluations in the Field of Health) which advises on the scientific relevance of health projects. The CNIL (Commission nationale de l'informatique et des libertés) issues a data processing authorisation and monitors the procedures in order to guarantee the protection of personal data. In addition, the CPP (Committee for the Protection of Persons) is also referred for research involving a biomedical dimension.
The cohort was initially qualified as a routine care study. This qualification was applied at the initial cohort implementation and up to 3-year follow-up, for which only data collection from medical records or from families took place. The initial stage of the cohort was approved by CPP-IDF 3 (No. SC-2873 of 22/02/2011) and approved by the CNIL (No. 911009 of 24/03/2011). The 1- and 2-year follow-up stages received a favourable opinion from the CCTIRS (n°12.109, 09/02/2012 and 13/12/2012) and a CNIL authorisation (n°912175, 28/05/2012 and n°913020 on 18/07/2013).
The 5.5-year follow-up was qualified as a prospective, multicentre, open, non-randomized interventional study. The following authorizations were obtained: ANSM (French National Agency for Health and Medicines) (n°160275B-2, of 07/03/2016), CPP (n°2016-A00333-48, of 10/05/2016 then Am7223-1-3377, of 24/11/2016 and Am7220-2-3377 of 23/02/2017), CCTIRS (n°16.263 of 23/03/2016) and CNIL (n°916 212 of 28/06/2016).
At different stages of the cohort follow-up, we collect two types of data:
- "Nominative" or directly identifying data (first and last names, postal and electronic addresses and telephone numbers), which we use solely to contact you, and
- Study-specific data, collected by questionnaires, including medical data but also more detailed information about your family (housing conditions, family composition, etc.), which are used for the analyses. As you know, these data are not nominative, that is, they do not contain any first or last names, dates of birth, or addresses that would allow the identification of you, your child, or your family. They are instead associated with a so-called "anonymity number".
All of these data are stored on a secure server accessible only to members of the team that manages the Epipage 2 study. The nominative data on this server are stored on a separate file that cannot be linked to other data, except by the coordination team and are never used for any reason except to contact families.
The non-nominative data, on the other hand, are intended to be used by researchers associated with the Epipage 2 team.
All of the data and/or samples collected may also be reused for other research projects related to preterm birth. In particular, they are accessible to the scientific community through data platforms: the RECONAI platform (pooling French birth cohorts) and the RECAP Preterm platform (grouping together European cohorts). These data can be transmitted securely by the Epipage 2 study management team, which does so only when:
- the project proposed by the requesting team has a scientific interest, and
- the requesting team makes a commitment to comply with existing regulations that protect the use of health data.
Data enabling the direct identification of the children or the families cannot be transmitted.
All of the work performed that has led to scientific publications can be consulted here.
Rights of participants
In accordance with the General Data Protection Regulation (EU Regulation 2016/679) and the Data Protection Act (Law n° 78-17), persons included in the study have:
- the right to request access, rectification or limitation of your data collected as part of this study. You can also access directly or through a physician of your choice, all your medical data in application of the provisions of article L. 1111-7 of the Public Health Code;
- the right to object to the collection and transmission of your data covered by medical secrecy;
- the right to object to secondary reuse of your personal data and biological samples for the purpose of conducting health-related research, studies and assessments that are of public interest under the scientific themes of the Epipage 2 study;
- The right to withdraw your consent to the collection of your data at any time. However, please be aware that the relevant data collected prior to the exercise of your right of objection or withdrawal may continue to be treated confidentially in order to not compromise the achievement of the research objectives.
Stakeholders and Entities
Data protection officer
Autorité de contrôle
Who is responsible for the research?
Where to exercise your rights
In case of difficulties in exercising your rights
To file a claim
Institut national de la santé et de la recherche médicale (Inserm)
Pr Pierre-Yves Ancel
101 rue de Tolbiac,
Equipe Epipage 2, Bâtiment Recherche Hôpital Tenon,
101 rue de Tolbiac,
3 Place de Fontenoy,
In the Epipage 2 study, the data are analysed in such a way as to ensure confidentiality.
If you accept the principle, your data may be communicated to other national or international private or public research teams according to appropriate and adapted safeguards ensuring their confidentiality and provided for in an agreement/contract between Inserm and the recipient(s) the data.
Once accepted, you will find a list of research projects here.
Some may be detailed in the newsletters we send you.