NACG Pan-Nordic Consent project

An inclusive, multi-disciplinary co-development process to develop a clinical consent framework for genetic testing.

Welcome to the NACG Nordic Consent Framework.

Included in this framework you will find the following documents to aid in the delivery of informed consent in combination with a healthcare provider to patients in the clinical context for genetic testing; to be used with a non-vulnerable, adult population.

1. Guidance document to the below documents
2. Genetic testing information sheet
3. Genetic testing consent form

Please refer to the following guidance regarding the genetic testing information sheet and consent form prior to adoption in your healthcare institution. The documents may require multiple adjustments to tailor it to your healthcare institution before use with patients. The genetic testing information sheet and consent form do not represent professional or legal advice of any kind. Obtaining informed consent from patients participating in genetic and genomic testing in the clinical context requires legal and ethical review prior to administration to patients. As a result, healthcare institutions should seek appropriate legal guidance when developing their consent processes.

The genetic testing information sheet and consent form were developed by the Nordic Alliance for Clinical Genomics (NACG), the BIGMED legal network and, following their establishment in May 2020, the Nordic PermedLaw legal network. The work was led by DNV GL, Precision Medicine research program who are NACG members. 

As of today (22 Dec 2020), in the Nordic countries, there is no single, standardized approach to administering informed consent to patients undergoing genetic testing. Starting January 2020, NACG conducted a Nordic multi-disciplinary focused approach to developing a harmonized approach to clinical consent framework and toolkit development with the following motivation:

1. As the leading precision medicine initiative in the Nordics, NACG is well-positioned to initiate and co-ordinate discussions around consent practices across the Nordic countries in genetic testing.
2. Development of a harmonized consent framework can serve as a vehicle to harmonize and identify categories for discussion in consent in genetic testing and data sharing across the Nordic countries.
3. Development of a harmonized consent framework can enable partnerships across disciplines and borders in consent in clinical genetic testing

In brief, the development process included multiple stages that started with a comprehensive mapping of Danish, Islandic, Finnish, Norwegian, Swedish and European legislation, best practices, and policy on the topic of informed consent and genetic testing in the clinical context.  A multi-disciplinary network consisting of those working in healthcare institutions in genetic testing (such as genetic counselors, laboratory personnel, clinicians and healthcare leaders), legal advisors specifically from the Nordic Permed Law network, patient groups and industry partners working in quality assurance and genetic testing all provided input to on-going reiterations to the consent documents over the course of a year.  The input was gathered through the following channels:

1. Two major workshops in May 2020 and Nov 2020, consisting of approx. 50-60 participants in total.
2. Three review sessions followed by reiterations by NACG and Nordic Permedlaw legal network members for input via google document for edits and comments.
3. Interviews and surveys to stakeholder groups such as clinicians, patient advocacy groups, laboratory and healthcare leaders in genetic testing.