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BIOTEK2021-Bioteknologi for verdiskaping

LegRegPCM - Legal Regulation of Information Processing relating to Personalized Cancer Medicine (PCM)

Alternative title: LovRegPKM - lovregulering av genetisk informasjonsbehandling i Persontilpasset Kreft-Medisin (PKM)

Awarded: NOK 4.0 mill.

The development in genomics and technology in recent years has opened up new possibilities in the fields of medical diagnosis, treatment, and prevention, in particular in the field of cancer medicine. Instead of a one-size-fits-all approach, the hope is that in a not too distant future it might become possible to develop genomic diagnostics and treatment strategies targeting mutations present in subpopulations of different disease groups. This research strategy is often referred to as Personalized Medicine (PM). The LegRegPCM project was linked to the ELSA Work Package (WP5) of the Norwegian project, A national research and innovation platform for personalized cancer medicine (PCM), and aims at addressing legal questions pertaining to the development and implementation of genomic diagnostics and treatment strategies in personalized cancer medicine (PCM). The project, which was coordinated by Professor Jan Helge Solbakk, Centre for Medical Ethics (CME), Faculty of Medicine, University of Oslo, was a collaboration between CME and The Norwegian Research Center for Computers and Law (NRCCL) at the Faculty of Law, University of Oslo, and involved as well collaboration with legal scholars from the Norwegian University of Science and Technology, the University of Bergen, the University of Copenhagen, the University of Oxford, the University of Boston and Bond University. Heidi Beate Bentzen was a Doctoral Research Fellow on the project writing a thesis on the legal regulation of personalized medicine. A legal, ethical, health economics and medical anthropological study regarding the processing of genetic data in cancer research was also part of the project. Main research questions in the project pertained to the legal regulation of personalized medicine in the EU/EEA. This included the regulation of genetic testing, and the processing of human biological samples and DNA data, including reuse and data sharing both within and outside the EU/EEA. Several scientific articles were published as part of the project, amongst others on legal challenges related to the increased availability of genetic data, legal challenges related to biobank research, dynamic consent, return of results to research participants, jurisdictional issues for transnational genomic clouds, use of health databases for unintended future purposes, GDPR's balancing of data protection and free movement of personal data, and deposit of genetic data in research repositories. Additional publications are underway.

Prosjektet benyttet en rekke vitenskapelige metoder for å undersøke hvordan persontilpasset medisin reguleres rettslig i EØS, og hvordan det bør reguleres. Utstrakt internasjonalt samarbeid sikret harmonisert tilnærming mellom land, og Bentzen var en av lederne for arbeidsgruppen for jus og etikk i en COST Action om genomikk, samt deltaker i en COST Action fokusert på implementering. Nær interaksjon med medisinere, informatikere og andre relevante faggrupper sikret praktisk tilnærming. Videre ble forskningsdeltakere, forskere og helsepersonell intervjuet. Resultatene fra forskningen ble publisert i topprangerte tidsskrifter og forlag, og ble også formidlet populærvitenskapelig. Prosjektet hadde policy-virkning. Bentzen ble invitert med som medlem av FNs spesialrapportør for personvern sin helsedata-task force, og var med på å utarbeide den globale Recommendation on the protection and use of health-related data. Hun ble også oppnevnt som medlem av Helsedirektoratets Bioreferansegruppe.

The sequencing of the human genome has opened up new possibilities in the fields of medical diagnosis, treatment, and prevention, in particular in the field of cancer medicine. Instead of a one-size-fits-all approach, the hope is that in a not too distant future it might become possible to develop genomic diagnostics and treatment strategies targeting mutations present in subpopulations of different disease groups. This differential approach to specific subsets of tumor mutations is important in determini ng cancer progression and response to therapies. This research strategy is often referred to as Personalized Medicine (PM). This topic has been declared the single national focus within cancer Research in Norway, and a national research collaboration has been established through a Norwegian Cancer Genomics Consortium (NCGC). The present proposal is linked to the ELSA Work Package (WP5) of their project, A national research and innovation platform for personalized cancer medicine, and aims at addressing le gal questions pertaining to the development and implementation of genomic diagnostics and treatment strategies in personalized cancer medicine (PCM). It is believed that addressing these questions in cooperation with ethicists, genomic researchers, and cl inical oncologists creates a fruitful research environment and a potential for synergy effects. Main research questions: What is the applicable legal framework for PCM in Norway? What are the legal implications of the distinction between human biological samples and personal data? To what extent is the current legal framework harmonized with the information process suggested in the project, A national research and innovation platform for personalized cancer medicine? Furthermore: How should the testing be arranged? How should the storage of biological samples and genetic data be arranged? How can the biological samples and the personal data be shared and reused?

Publications from Cristin

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BIOTEK2021-Bioteknologi for verdiskaping