The Nordic Alliance for Clinical Genomics (NACG) Nordic Consent project is an inclusive, multi-disciplinary co-development process to develop a clinical consent framework for genetic testing. The validated framework has the potential to both allow patients more control over their choices and enable better data access and sharing for healthcare institutions across the Nordic countries.
Consent for the new generation of genetic testing is particularly challenging with multiple needs currently unmet, such as that to share patients’ data in order to provide them with best quality of care. Cross-border data sharing in the new era of heightened privacy awareness also leaves healthcare practitioners uncertain of the legal boundaries of what can be shared. Similarities across the Nordic countries on societal values, healthcare systems and legal systems provide an opportunity for the development of cross-border approaches to overcoming these challenges.
“Encouraging countries to standardise how they approach consent for research and sharing may not be easy, but this project aims to address exactly this challenge.”
Elsebet Ostergaard, MD
Department of Clinical Genetics
Rigshospitalet, Copenhagen, Denmark
A pan-Nordic consent framework
The value of a pan-Nordic harmonized consent framework was first conceived of and discussed at a consent workshop of the NACG (Nordic Alliance for Clinical Genomics), of which DNV is a founding partner. The project was initiated in January of 2020, shortly after which the project partnership with Nordic PerMed Law was established. Both organizations are voluntary, non-governmental and Nordic in identity, with an interest in the clinical and legal aspects of precision medicine respectively.
The co-development process of a Nordic harmonized framework was iterative in nature, consisting of a series of interviews, multi-disciplinary workshops and consultation and feedback rounds, in addition to mapping of relevant legislative and regulatory documents, guidelines and policies that influence regional and national clinical consent processes in the Nordic countries for genetic and genomic testing.
Stakeholders included legal and clinical genomics professionals from healthcare institutions from each of the Nordic countries, governmental organizations such as the Danish National Genome center, and representatives from industry such as DNV who are involved due to the interest in developing roles to enable the safe and secure implementation of consent.
The benefits and learnings
The resulting pan-Nordic harmonized consent framework for genetic testing developed through this process and validated by the legal partners in the project comprises three parts: an information package for adults explaining risks, benefits and limitations, an adult consent form for genetic testing and guidance to the process of delivering consent for the use of genetic testing in a clinical setting within the Nordic countries.
While such a framework has the potential to both allow patients more control over their choices and enable better data access and sharing for different healthcare institutions, this project also flagged topics addressing full harmonization, and as such guided customized options were developed. These findings illustrate the different regulatory stages and levels of maturity the Nordic countries are at for personalized medicine. However the framework has successfully acted as a vehicle to guide and concretize discussions around needs and accelerated harmonization efforts, while validating the need for legally compliant technical solutions for digital dynamic consent.
The consent framework drafts are currently under revision, but available on the NACG website, and will be published January 2021 for download, translation and implementation through engagement with interested and relevant partners.
