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)
Keywords:Governance, Consortia, Deliberative forums, translation, policy, personal health data, research
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 . Sharing genomic and other personal health data is important for progress in health research , 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 . 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 . 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) . 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.
Kaye J, Terry SF, Juengst E, Coy S, Harris JR, Chalmers D, et al. Including all voices in international data-sharing governance. Human Genomics. 2018;12(1):13. doi: 10.1186/s40246-018-0143-9
McCoy MS, Warsh J, Rand L, Parker M, Sheehan M. Patient and public involvement: Two sides of the same coin or different coins altogether? Bioethics. 2019;33(6):708-15. doi: 10.1111/bioe.12584
Jasanoff S, Hurlbut JB, Saha K. Democratic Governance of Human Germline Ge-nome Editing. Crispr j. 2019;2(5):266-71. doi: 10.1089/crispr.2019.0047
Global Alliance for Genomics and Health (GA4GH). Enabling responsible genomic da-ta sharing for the benefit of human health 2023 [Available from: wwww.ga4gh.org. 10 Apr 2023
Juengst ET, Meslin EM. Sharing with Strangers: Governance Models for Borderless Genomic Research in a Territorial World. Kennedy Institute of Ethics Journal. 2019;29:67 - 95. doi:
Pratt B, Hyder AA. Governance of Transnational Global Health Research Consortia and Health Equity. Am J Bioeth. 2016;16(10):29-45. doi: 10.1080/15265161.2016.1214304
Brunner RD, Steelman TA. Towards Adaptive Governance. In: Brunner RD, Steelman TA, Coe-Juell L, Cromley CM, Edwards CM, Tucker DW, editors. Adaptive Govern-ance: Integrating science, policy and decision making. New York: Columbia University Press; 2005.
National Research Data Infrastructure (NFDI) e.V. The German National Research Data Infrastructure (NFDI) Karlsruhe: NFDI; 2023 [Available from: https://www.nfdi.de/association/?lang=en. 10 Apr 2023
Goodin RE. Innovating democracy: Democratic theory and practice after the delibera-tive turn. Oxford, UK: Oxford University Press; 2008.
Pope C, Ziebland S, Mays N. Analysing Qualitative Data. BMJ. 2000;320:114-6. doi: 10.1136/bmj.320.7227.114
Nicol D, Critchley C, McWhirter R, Whitton T. Understanding public reactions to commercialization of biobanks and use of biobank resources. Soc Sci Med. 2016;162:79-87. doi: 10.1016/j.socscimed.2016.06.028
O'Doherty K, Hawkins A. Structuring Public Engagement for Effective Input in Policy Development on Human Tissue Biobanking. Public health genomics. 2010;13:197-206. doi: 10.1159/000279621
Street J, Duszynski K, Krawczyk S, Braunack-Mayer A. The use of citizens' juries in health policy decision-making: A systematic review. Social Science & Medicine. 2014;109:1-9. doi: 10.1016/j.socscimed.2014.03.005
Conference Proceedings Volume
Copyright (c) 2023 Eric Apondo, Andrea Züger, Andreas Bruns, Katja Mehlis, Christoph Schickhardt, Eva Winkler
This work is licensed under a Creative Commons Attribution 4.0 International License.
Grant numbers 441914366