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Genomics, Big Data, and Broad Consent: A New Frontier for Developmental

Fri, March 22, 7:45 to 9:15am, Baltimore Convention Center, Floor: Level 1, Exhibit Hall B

Integrative Statement

The growing field of genomic technologies has enriched the contributions of developmental science for understanding the unique and interacting roles of genetic and environmental factors on the development of behavioral risk and individual responsivity to prevention and intervention programs in areas including academic achievement, behavioral disorders, substance use and other health compromising behaviors (e.g. Beach, Lei, Brody, & Philibert, 2018; Glenn et al., 2018; Haworth & Plomin, 2012; Musci & Schlomer, 2018; Russell et al., 2017). The collection and analysis of biospecimens has also benefited from the growth of Big Data tools that allow linking genomic data to health, educational, child welfare, juvenile justice, and other personal information stored in large integrated datasets (Caspi et al., 2017; Gilmore, 2016; Perlman & Fantuzzo, 2013; Wertz et al., 2018). These advances have created a new frontier of ethical challenges for developmental scientists as they collect, store or engage in secondary use of potentially identifiable information and biospecimens collected from children and adolescents (De Vries et al, 2016; Fisher, 2017; Fisher & McCarthy, 2013; Grady et al, 2015). To address challenges arising from technological advances and the expanding contexts in which potentially identifiable information and biospecimens are collected and stored, the Office of Human Research Protections has issued new federal regulations for the protection of human subjects (OHRP, 2017), scheduled to go into effect in 2019. The regulations create new format, content, and transparency requirements relevant to guardian permission and child assent including a new mechanism known as broad consent. Broad consent offers participants and their guardians a range of choices regarding consent for the storage and future use of their personally identifiable data. Scientists seeking broad consent are mandated to disclose the type of data stored, time period for storage and use, types of future use, and with whom data may be shared. Specifying the terms of broad consent carries unique implications for developmental scientists. For example, investigators collecting identifiable data from minors and seeking to store data for future use for extended periods of time must consider whether they will notify child participants about their biological materials and offer a right to re-consent or withdraw permission for further use when they become legal adults (Fisher et al., 2013). It also raises issues regarding the extent to which the aims of secondary data analysis are aligned with participant expectations for future use, especially for socially sensitive research involving biospecimens collected from social minority populations. In addition, the new regulations require a concise consent/assent summary tailored to the “reasonable person” raising challenges for defining the “reasonable” child or adolescent. Finally, a broader regulatory definition of “clinical trials” has raised concerns that some developmental non-intervention research may be inappropriately labelled and subject to public posting of consent documents (SRCD, 2018). This poster will describe challenges and present recommendations for responding to regulatory changes affecting traditional informed consent formats, requirements for obtaining broad consent, and calls for public transparency in ways that enhance the scientific and ethical dimensions of developmental science.


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