With the increased utilization of genomic sequencing in the clinical context in Norway, practical and ethical issues in the development of the content and process of informed consent (IC) are emerging. Challenges exist in bridging the gap between Norwegian law and regulations and clinical practice for establishing an adequate IC process for genetic testing in the clinical context.

In the scope of this activity, DNV GL performed a literature review, a series of interviews with experts as well as a workshop with Oslo University Hospital (OUS), Department for Medical Genetics (AMG). These activities focused laboratory,clinical, and legal representatives on the legal, ethical, and practical issues related to IC for clinical genetic testing. The emphasis of these activities was on understanding the current and future needs related to:

  • the delivery of clear and concise information to support patients and / or guardians in deciding to undergo genetic testing; and
  • increasing the further sharing of knowledge generated through clinical pathways for the benefit of current and future patients.

The project findings detail the issues and nuanced considerations associated with various consent challenges around genetic testing in the clinical context. Towards developing a practical strategy for managing these challenges, a set of considerations were developed to serve as a starting point for laboratories and clinics for the development of the content and process of IC in the clinical genomic setting.

See the attached file for the report on this subject.