GHGA launches patient involvement efforts
The increase in the collection and storage of, as well as access to human genomic data has intensified ethical and social concerns about the risks of these efforts. As part of this debate, governance of genetic research databases (GRD) such as GHGA has come under increasing scrutiny. For a long time, the role of patients in GRDs has been limited to that of donors. This is changing, with patients being increasingly seen as collaborators in the development and operations of GRDs. There is no one-size-fits-all framework for patient involvement, it has to be context-specific: tailored to the GRD’s size, data groups and types, goals and resources. In many cases, the reasons for patient involvement have been framed in a functionalist or descriptive way (i.e. focusing on improving recruitment and retention in studies). There is, however, a need to explore normative grounds for patient involvement.
A qualitative study exploring german cancer and rare disease Patients‘ perspectives on Governance of an Omics Database (Study number: S- 061/2022) PaGODa-Study is our first step within GHGA to establishing sustainable, impactful patient involvement that will build and maintain trust in our relationship with patients and the public and empower them through active participation and education. This is a participatory study (meaning patient representatives are involved as co-researchers in the design and implementation of the study) that will use deliberative democratic forums to (a) explore patients‘ perspectives and preferences as pertains to governance of GHGA and (b) explore which concrete roles patients see themselves taking and whether or how these can be operationalized. To this end, aside from publications, a key output of the study will be a white paper in 2023, documenting these findings and offering suggestions concerning the governance structure and how it can be implemented.
The study also has methodological and theoretical objectives: Literature on the use of the deliberative method in medical and health research is lacking. This study will give useful insights into the method, and inform efforts to involve actively patients as co-researchers in projects in this context. Moreover, the study will give us an empirical basis for further theoretical exploration of the reasons to carry out and support patient involvement in all its forms.
Our efforts within the PaGODa-Study have already produced tangible results: the study protocol has been approved by the ethics commission and will be submitted for peer review and publication in coming weeks. A detailed text in plain language explaining databank operations and showing various perspectives of the ethical challenges has been prepared for use by study participants. After internal review, we will also make it accessible to patients and the public on the GHGA website. We have ongoing collaborations with international players (notably the European Clinical Research Infrastructure Network) through our participations in events in which we have advocated for patient involvement in big data governance in the health sector.
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