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.