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Item The Influence of Age, Health Literacy, and Affluence on Adolescents’ Capacity to Consent to Research(Springer, 2016-04) Nelson, Lance R.; Stupiansky, Nathan W.; Ott, Mary A.; Department of Pediatrics, IU School of MedicineWhile adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents’ capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents’ capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents’ capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.Item The Neurobiology of Decision-Making in High Risk Youth & the Law of Consent to Sex(2014-01) Drobac, Jennifer Ann; Hulvershorn, Leslie A.; Robert H. McKinney School of LawUnder certain circumstances, the law treats juvenile consent the same as it treats adult decisions, even though a growing body of scientific research demonstrates that children make decisions using less developed cognitive processes. This Article highlights the gaps and deficiencies of legal treatment of juvenile decisions in the context of sex with an adult, as well as integrates new scientific information regarding the decision-making of minors in risky situations. Part I examines recent pediatric brain imaging findings during a risky decision-making task. Specifically, a new study demonstrates that brain scan results differed between juveniles at high risk for potentially harmful or criminal conduct and healthy children. These differences within juvenile populations support the notion that particular biological and environmental traits in children may further distinguish juvenile decision-making from adult decision-making. Part II explores the potential impact of these novel neurobiological findings on the legal treatment of juvenile “consent” to sexual activity. A discussion and summary of the juvenile sex crime statutes of all fifty states demonstrates how the law attributes legal capacity and ability to make legally binding decisions to even very young teenagers. Part II also highlights where state civil and criminal law treat juvenile “consent” inconsistently. Criminal and civil laws’ treatment of juvenile capacity, in the context of sexual activity with an adult, is not congruent with recent neurobiological discoveries regarding juvenile risk-taking and decision-making. Therefore, society should reconsider designations regarding legal capacity in light of novel neurobiological findings regarding decision-making in juveniles.Item Understanding Ethical Issues of Research Participation from the Perspective of Participating Children and Adolescents: A Systematic Review(Wiley, 2017-06) Crane, Stacey; Broome, Marion E.; School of NursingBackground The past twenty years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children’s and adolescents’ experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population. Aims The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives. Methods This systematic review was conducted per the Long et al. framework by means of an iterative searching process. Using the key words ‘research ethics’ and ‘child or pediatric or adolescent’, PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the original searches were: English language, year of publication between 2003–2014, humans, abstract available, and age birth–18 years. Findings Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals. Discussion Even young children demonstrated the ability to understand essential elements of research, although there is variability in children’s level of understanding. Trust was a significant contributing factor to children’s and adolescents’ participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed. Linking Evidence to Action This systematic review highlights the importance of including the perspectives of children and adolescents and provides researchers and nurse clinicians with best practices for involving children in research.Item Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?(Massachusetts Medical Society, 2019-07) Silverman, Ross D.; Opel, Douglas J.; Omer, Saad B.; Health Policy and Management, School of Public Health