Genomic and biobank research requires the large collection and storage of samples and data. The data and samples can be used in future research and shared with other researchers across the world. While the data and samples are a valuable resource, the use and re-use of the samples and data poses considerable legal and ethical challenges. One issue is that the future uses of the samples and data and the potential researchers and jurisdictions to where the samples and data may be shared are unlikely to be known at the time of collection. Other forms of consent, such as broad consent and tiered consent, have been promoted as providing more flexibility to researchers while also (provided future re-use is subject to appropriate independent governance) protecting participants. Dynamic consent is a less discussed and adopted consent model that uses information technology to provide for interactive consent.
The Cooperative Health Research in South Tyrol (CHRIS) study is a population-based study that explores the genetic and molecular foundation of cardiovascular, metabolic, neurological, and oncologic diseases in the general population of the middle and upper Vinschgau/Val Venosta in South Tyrol, Italy. Since its commencement in 2011, it has adopted a patient-centric approach that requires an assessment of patient preferences at all stages of the research. A key factor in enabling this patient-centric approach is dynamic consent, the consent model used as part of the CHRIS study. Over the past 10 years, the dynamic consent model of the CHRIS study integrates broad research aims with specific oversight and governance mechanisms, continuous communication with participants, and allows for nuanced choices to be changed over time.
In this panel we reflect on dynamic consent, its operation as part of the CHRIS study to enable the exercise of personal autonomy, but also its part in the governance of the CHRIS study itself. The panel will also reflect on the future role of dynamic consent as the CHRIS study enters its second decade and looks to make its samples and data available.
Designing a participant centric approach to research
Dr. Roberta Biasiotto | Eurac Research | Italy
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Dr. Roberta Biasiotto | Eurac Research | Italy
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.
Legal and ethical complexities in making data available for research
Dr. Andrea Parziale
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Dr. Andrea Parziale
Data and sample sharing for research poses critical legal complexities to biobanks. It requires the consideration of participant preferences, the governance of the secondary re-use of samples and data, and the development of access policies for samples and data. As part of the next phase of the CHRIS study, the CHRIS 2D project is developing a data portal to enable the sharing of samples and data with external researchers. The access policies and data portal must be designed in such a way that it continues to respect participant preferences as expressed through dynamic consent, even after the data and sample has been shared. As part of the CHRIS 2D project, dynamic consent will enable participant preferences to be ascertained. A necessary first step in this process is the identification of the permitted legal rules on data and sample access.
The GDPR sets out the minimum standards that must be met in the processing of personal data, including access to personal data. In this respect, a first legal complexity concerns the allocation of the respective GDPR compliance responsibilities between the biobank and external researchers seeking access to their data and samples. These data protection responsibilities also need to be aligned with the responsibility of the CHRIS study to ensure that participant preferences are respected. This required the unpacking of the meaning of the data controller and data processor and how these definitions apply in making CHRIS samples and data available. Due to the access-controlled system and dynamic consent model, it was determined that the CHRIS biobank makes data and samples available on a joint-controller basis.
A particular early issue facing the CHRIS 2D portal is the making of data and samples available to third countries outside of the EEA. While there is an ethical obligation to develop process to provide for equity of access to researchers around the globe, the data protection obligations make this in practices challenging.
This paper will discuss these issues and how the CHRIS 2D project responded to these challenges.
Reflections on 10 years of dynamic consent as part of CHRIS
Dr Deborah Mascalzoni
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Dr Deborah Mascalzoni
The CHRIS dynamic consent model has proven to be very powerful in building a strong trusted environment for the CHRIS study. Furthermore, its intrinsic flexibility has also supported changes in regulations. Supported by very high numbers of participation rates and participant positive feedback collected through different qualitative and quantitative studies, dynamic consent has proven to be a useful tool for supporting research and participants. Through established communication channels, re-calls and new collections of data have proven to be easier, demonstrated through the recent COVID sub studies where the CHRIS cohort were quickly mobilized with high response rates.
As the CHRIS study moves into the second decade of dynamic consent, this paper will reflect on challenges it has faced and recommendations for those considering the adoption of dynamic consent.
First, dynamic Consent for CHRIS only works within a participant centric approach where the aim is to protect participants rights, make the study available, understandable, and transparent, and also provided for changes in participant preferences over time of the study. Building this participant centric approach required the designing of communication strategies and tools for building an understandable and trusted environment for the CHRIS participants.
Second, IT technologies play a critical role as it is only with the help of IT technologies can participants perform informed and nuanced choices.
Third, trust is critical in any dynamic consent model. The importance of participant trust is well discussed, but we quickly discovered the need to win over another populations’ trust: the trust from the scientists. Scientists, both within the CHRIS study and in many international discussions, were (and still often are) skeptical if not openly against the use of dynamic consent. There were concerns about the capacity of participants to make choices and also concerns that changes in preferences would disrupt datasets or precious collections. Over the past 10 years, researchers as part of the CHRIS study see its value and importance in research.
The dynamic consent model has served the CHRIS study and its participants well. From the design to the implementation and the continuous adaptation to new technologies (pads and Smartphones), dynamic consent approaches need further studies as they can be optimized and aligned with participants needs and potentially with the new needs of science.