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 n

SUBMITTER: Barlow-Stewart K 

PROVIDER: S-EPMC11832931 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature