Ethics & Human Research
Volume 43, Issue 4 Pages: 1-44 July–August 2021
Participants communicating online • Community perspectives in Malawi
Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children’s Identities
Erin Turbitt, Ainsley J. Newson, Barbara B. Biesecker, Benjamin S. Wilfond
First Published: 01 July 2021
Knowledge of genetic mechanisms contributing to neurodevelopmental conditions is advancing. This is informing development of new drugs to treat or ameliorate these conditions, through targeting underlying genetic pathways. Drugs are tested in clinical trials, necessitating parents to engage with decisions about whether to enroll their child. In this article, we consider important ethical issues to anticipate as clinical research opportunities in genetic neurodevelopmental conditions arise. For example, genetic pathways targeted by the drugs may interact with valued character and personality traits. It is essential that recruitment and consent processes are optimized for families who will grapple with whether these novel drug treatments interact with their child’s personality and authentic identity. We call for focused social science research and further normative analysis so that parents are better supported to make informed choices. Additionally, clinical research regulators should have a sound understanding of the contextual experiences regarding how this population of parents engages with decisions.