Establishing Adaptive Governance in NFDI Consortia:

Lessons Learned from Deliberative Forums with Patients on their Role in the Governance of the German Human Genome-Phenome Archive (GHGA)

Abstract

There is widespread support for patient and public involvement (PPI) as an ethical requirement in biomedical research and policy development [1, 2], including research using personal health data, such as genomic data [3]. Sharing genomic and other personal health data is important for progress in health research [4], but poses ethical, legal and societal challenges for the governance of research and the institutions that conduct and support it. These challenges arise in part from the varied interests of the stakeholders involved, including patients, researchers, and funders [5]. In recent years, there has been a rise in collaborations between research institutions that conduct joint research programs. In these research consortia, the objectives and stakeholders in research are multiplied and more varied, making governance even more complex  [6].  There has been debate about strengths and weaknesses of different forms of governance of research, with proponents of adaptive governance highlighting its responsiveness and flexibility to evolving goals and needs of stakeholders [5, 7]. However, there are no set standards for involving patients in the governance of health research. Moreover, as it is a highly context-specific process, cultural, legal and social contexts of the individual institutions or consortia must be considered.

Within the German National Research Data Infrastructure (NFDI), there are consortia supporting research with personal health data, one of which is the German Human Genome-Phenome Archive (GHGA) [8]. We describe GHGA’s PaGODA Project (Patient Involvement in the Governance of an Omics Data Archive), whose goals are to gather patients’ views for their involvement in the governance of GHGA by conducting deliberative forums, and to implement these views. We focus here on the process of translating the findings from the forums into the GHGA governance policy, and identify procedural factors that were important for the process.