Genome sequencing in research requires a new approach to consent



    A one-off paper-based consent form is not necessarily the best solution when it comes to obtaining consent from research participants for genome sequencing.

    A dynamic consent process that allows continuous interaction between researchers and research participants is preferable, particularly in scenarios where it may be appropriate to inform participants about the results of genetic testing.

    Genome sequencing technologies make it possible to map the entire genetic make-up (DNA sequence) of a human being. Such technologies are used increasingly in medical research, including to study cancer (1). There is debate over the extent to which research participants should be informed about individual results from genetic research (2, 3). In projects where such feedback might be appropriate, modernisation of the consent process may be required.

    National solution

    National solution

    Use of dynamic consent is being tested in several research projects (11, 13, 14), also in Norway (15). There is a need to determine which models of dynamic consent may be appropriate for Norwegian health research, and also to identify the ethical, legal and economic implications of adopting dynamic consent, preferably in dialogue with the research ethics committees. For example, it is unclear whether electronic consent is legally sufficient in cases where the law stipulates that written consent is required (7). It is also important to consider under what conditions dynamic consent solutions can satisfy the informational requirements for valid consent. Furthermore, we must work out how to ensure that dynamic consent is used as intended, and not misused to render the consent process a mere formality.

    One possible strategy for the future may be to create a national IT-based system for dynamic consent that offers a basic structure that conforms to legal requirements and that includes practical solutions for withdrawing consent. It should also include essential links, such as to the Regional Committees for Medical and Health Research Ethics (REK) and to registers by which patients can express preferences regarding the use of their biological material in research («Biologisk forskningsreservasjon» in Norway). Such a national system could provide a single portal for the research participant and simultaneously be tailored to the needs of each and every project, in line with their aims, participant group and plans regarding feedback of genetic findings.

    In the Norwegian Cancer Genomics Consortium (16), work is underway to identify appropriate models for dynamic consent. There is little doubt that the time is ripe for innovation regarding consent procedures in medical research, especially when new technologies such as genome sequencing are used. Dynamic consent can lead to greater participant engagement, better oversight for all parties, and a new form of long-term partnership between researchers and research participants.

    We wish to thank Professor Dag Wiese Schartum (Dr.juris), Norwegian Research Centre for Computers and Law, Faculty of Law, University of Oslo, for his comments.


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