Norway, governance and research databanks Reidar K. Lie, MD, PhD University of Bergen, Norway

Examples CONOR – Cohort of Norway – Mother and Child Cohort study – pregnancies, fathers NOWAC - NORWEGIAN WOMEN AND CANCER STUDY – women

History Large databases were established in the 1970s without the written consent of the donors. Specifically no specification what research they would be done in the future Introduction of research ethics review and specific informed consent requirements in the 1980s. What to do about previously collected data?

Debate around year 2000 NOU 2001: 19 On Biobanks (Report to the Norwegian Government) – Majority opinion allowed for both general and passive consent (with REC consent and minimal risk) General consent: No specification of purpose of project Passive consent: Announcement of project, and possibility to refuse participation – Minority opinion required specific consent

Biobank law 2003 Scope: Diagnostic and treatment biobanks Requirement of specific consent and new consent for new use Status of research biobanks?

Research ethics law Mainly about organization of research ethics review

Law on biomedical research Scope: Research on human beings, human tissue and health data. NOT establishment of health registries General requirement for informed consent to a specific research project Exception: Can give consent to use of human tissue or data for broadly defined research projects, with REC approval and possible conditions Duty to give regular updates to those who have given broad consent

Biomedical research law Changes in project – new consent required – But REC can make exceptions, if consent is difficult, project has important benefit for society, and participant interests are proteced Consent can be withdrawn. Involves destruction of samples and deletion of data – But not if sample is used in another product, or data have been used in research analysis – REC can also make exceptions

MIDIA study 2007 Environmental causes of type I diabetes – Started in Purpose to follow infants with a specific genotype with high risk of diabetes to study environmental triggers of diabetes. – children were tested. About 900 recruited – Stopped in 2007 (goal was testing of children). Continued follow up of recruited children

Reason for discontinuation Parents had given consent to receive information about genetic risk. But some parents said had not been informed that testing would be done on a disease with no possibility of prevention. Biotechnology law in Norway – Prohibits predictive genetic testing of children where there is no possibility of prevention