Returning raw genomic data to research participants in a pediatric cancer precision medicine trial

Abstract

In pediatric cancer precision medicine clinical trials settings, parents proactively seeking treatment and answers to causation may request return of their child's raw data and/or biospecimen. To satisfy such requests, the ZERO Childhood Cancer Program required a guidance document. Literature review led to Version(V)1; Delphi consultation with 21/54 invited experts (V2-4) and parent consultations (V5-6). A final V7 was approved for implementation: Policy (purpose; background; ethical considerations), Process (nine steps), and consent form. Issues addressed included: child's best interests, clinical utility, non-maleficence, reciprocity between researchers and participants/parents; responsibility to genetic relatives; acknowledging potential value of subsequent analysis/interpretation but no obligation on treating clinicians to act on therapeutic recommendations arising; practical barriers to return; and supporting parental empowerment by facilitating meeting with a study genetic counselor, separate from their treating clinician, if preferred, to manage their request. This guide may be a model for other research groups and inform ethical guidelines.