Beth Baldwin Tigges1. 1. College of Nursing, MSC09 5350, 1 University of New Mexico, Albuquerque, NM 87131-0001, USA. btigges@salud.unm.edu
Abstract
PURPOSE: To identify methodological issues related to the use of active or passive parental consent in school-based research on adolescent risk behavior research and to propose recommendations consistent with current legal and ethical standards in the United States. METHODS: Review and synthesis of the professional literature related to adolescents and parental consent, federal regulations and guidelines in the United States, and the author's experience presenting these arguments and issues to institutional review boards and funding agencies for over 10 years. FINDINGS: The procedures used for parental consent affect a study's participation rates, costs, and selection bias. When active parental consent is required, parental permission is typically obtained for only 30%-60% of students, compared to 93%-100% when passive consent is used. Extensive follow-up may result in 55%-100% of parents giving permission, but at significant cost (typically $20-$25 per student). Active consent results in the exclusion of minorities, students having problems in school, and students already engaged in or at risk for problem behaviors. Strong methodological reasons were identified for using passive parental consent procedures when possible. Current federal regulations include four areas for possible waiver or alterations in parental consent procedures, including the use of passive parental consent. CONCLUSIONS: Health researchers must understand the methodological, legal, and ethical issues related to parental consent to produce high-quality, valid research about adolescents and to provide evidence for laws, policies, and regulations.
PURPOSE: To identify methodological issues related to the use of active or passive parental consent in school-based research on adolescent risk behavior research and to propose recommendations consistent with current legal and ethical standards in the United States. METHODS: Review and synthesis of the professional literature related to adolescents and parental consent, federal regulations and guidelines in the United States, and the author's experience presenting these arguments and issues to institutional review boards and funding agencies for over 10 years. FINDINGS: The procedures used for parental consent affect a study's participation rates, costs, and selection bias. When active parental consent is required, parental permission is typically obtained for only 30%-60% of students, compared to 93%-100% when passive consent is used. Extensive follow-up may result in 55%-100% of parents giving permission, but at significant cost (typically $20-$25 per student). Active consent results in the exclusion of minorities, students having problems in school, and students already engaged in or at risk for problem behaviors. Strong methodological reasons were identified for using passive parental consent procedures when possible. Current federal regulations include four areas for possible waiver or alterations in parental consent procedures, including the use of passive parental consent. CONCLUSIONS: Health researchers must understand the methodological, legal, and ethical issues related to parental consent to produce high-quality, valid research about adolescents and to provide evidence for laws, policies, and regulations.
Keywords:
Biomedical and Behavioral Research; Empirical Approach; Legal Approach
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