title: Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion.
abstract: The National Institutes of Health and other federal agencies are considering initiating a cohort study of 500,000 people, including 120,000 children, to measure genetic and environmental influences on common diseases. A community engagement pilot study was conducted to identify public attitudes and concerns about the proposed cohort study, including the ethics of involving children. The pilot included 15 focus groups where the inclusion of children in the proposed cohort study was discussed. Focus groups, conducted in six cities, included 141 adults of different ages, incomes, genders, ethnicities, and races. Many of the concerns expressed by participants mirrored those addressed in pediatric research guidelines. These concerns included minimizing children's fear, pain, and burdens; whether to include young children; and how to obtain children's assent. There was little agreement about which children can assent. Some voiced concern about children's privacy, but most expected that parents would have access to children's study results. Some believed children would not benefit from participating, while others identified personal and societal benefits that might accrue. A few people believed that children's participation would not advance the study's goals. To successfully include children, proposed cohort study would need to address children's changing capabilities and rights as they grow and reach the age of consent.
authors.affiliation: Genetics and Public Policy Center, Johns Hopkins University, Washington DC, USA. dkaufma2@jhu.edu
authors.forename: David
authors.initials: D
authors.lastname: Kaufman
authors.forename: Gail
authors.initials: G
authors.lastname: Geller
authors.forename: Lisa
authors.initials: L
authors.lastname: Leroy
authors.forename: Juli
authors.initials: J
authors.lastname: Murphy
authors.forename: Joan
authors.initials: J
authors.lastname: Scott
authors.forename: Kathy
authors.initials: K
authors.lastname: Hudson
mesh_terms: D018070:Biological Specimen Banks; D002648:Child; D015331:Cohort Studies; D000013:Congenital Abnormalities / Q000235:genetics*; D016021:Epidemiologic Studies; D036281:Genetic Research / Q000941:ethics*; D006801:Humans; D011639:Public Opinion; D036301:Qualitative Research; D012307:Risk Factors