Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing.
The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as 'young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of 'minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle.
Centre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, Quebec, Canada.
Karine
K
Sénécal
Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Kristof
K
Thys
Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Danya F
DF
Vears
Research Group on Personality Rights and Property Rights, Faculty of Law, University of Antwerp, Antwerp, Belgium.
Kristof
K
Van Assche
Centre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, Quebec, Canada.
Bartha M
BM
Knoppers
Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Pascal
P
Borry
D000293:Adolescent; D000328:Adult; D002170:Canada; D002648:Child; D000066491:Clinical Decision-Making; D003657:Decision Making; D005062:European Union; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence*; D059014:High-Throughput Nucleotide Sequencing / Q000941:ethics*; D006801:Humans; D057828:Informed Consent By Minors / Q000331:legislation & jurisprudence* / Q000592:standards; D017422:Sequence Analysis, DNA / Q000941:ethics*