Abstract
The CHRIS dynamic consent enables us to combine the broad aim of research with the specific oversight and governance mechanisms, coupled with ongoing communication with participants. Through dynamic consent, CHRIS participants can change their choices on participation over time, and regularly receive information on the research that is being conducted with their data and samples. To achieve this, information technology and a coherent communication strategy are essential elements of the CHRIS dynamic consent model.
Through the online interface MyCHRIS, CHRIS participants can access and review their informed consent and obtain the information on the research that they are participating in. Communication between researchers and participants is therefore an integral part of the dynamic consent process. Transparent communication aims to ensure that participants are in the position to make autonomous decisions on their participation throughout their involvement in research and not just at the point of initial consent. Key in this communication is the acknowledgment that values and life circumstances, and, accordingly, decisions may change during the years. A multi-media (digital and traditional), multi-level (from the individual participant to the community and the stakeholders), and culturally-sensitive (attention to language) communication strategy, developed through time, aims to guarantee the accessibility to the study and to the information, and to promote scientific and health literacy.
The CHRIS dynamic consent model not only enables participants to update their consent preferences but has also enabled the involvement of participants in the co-production of policy. Empirical studies conducted with the CHRIS participants aims to collect views on the return of results and on the recall-by-genotype research approach have allowed to incorporate participant perspective in the CHRIS policy-making process.
This paper will reflect on how this participant-centric approach provided for the building of a transparent relationship between participants and the CHRIS study. In particular, it will focus on the role that dynamic consent has played in the governance of the CHRIS study, enabling us to meet scientific utility and the legal and ethical requirements for research.