“Patient facing governance of cohorts” research project
The Ethics and Law Working Group, led by MLCF and the HEAP project, has developed an on-line questionnaire to find out how cohorts are addressing consent and participant facing governance in practice, against the background of the GDPR and national regulations, and how interactions are being managed between participants and research groups.
We are reaching out to all data cohort owners participating in European Human Exposome Network (EHEN) projects, as well as cohorts linked to EHEN partner institutions, inviting them to participate
The research project and questionnaire focuses on two main areas:
- Participant facing governance , and how to ensure that any follow-on studies using cohort data or tissue follow data protection, ethics, and FAIR data principles.
- How cohorts strike a balance between efficiently conducting biomedical research using cohort data, while safeguarding the interests of participants and wider society
There is considerable debate about these topics, but little empirical material on how cohorts currently approach them in practice. The research project aims to provide that empirical material, and the results will be made available on this webpage.
The results from the questionnaire will guide our thinking, and reflect our recommendations on good research governance as an alternative to granular consent.
Our ELSI research will result in two papers, one presenting the results of the questionnaire, and the second providing reflections and recommendations on how cohort governance and data processing could be designed to meet both regulatory and social challenges, and fulfil their research mission.
We believe that the focus of this research is unique. Our aim is to find out whether there are good governance mechanisms in cohorts, and if these can compensate for lack of control over which new (sub)studies will be performed by individual participants.