Hens, Kristien3; Van El, Carla E3; Borry, Pascal3; Cambon-Thomsen, Anne3; Cornel, Martina C3; Forzano, Francesca3; Lucassen, Anneke3; Patch, Christine3; Tranebjaerg, Lisbeth5; Vermeulen, Eric3; Salvaterra, Elena3; Tibben, Aad3; Dierickx, Kris3
1 Section of Neurology, Psychiatry and Sensory Sciences, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet2 Section IV. Building 22.4/24.4, Department of Cellular and Molecular Medicine, Faculty of Health and Medical Sciences, Københavns Universitet3 unknown4 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet5 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
principles for good practice
The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions.European Journal of Human Genetics advance online publication, 20 June 2012; doi:10.1038/ejhg.2012.99.
European Journal of Human Genetics, 2013, Vol 21, Issue 1, p. 2-7