Policy and process for returning raw genomic data to parents and young adult participants in a pediatric cancer precision medicine trial.

Abstract

Sharing raw genomic data with research participants is not universally mandated. Yet, in padiatric 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 with ethical, timely and appropriate responses, the ZERO Childhood Cancer Program required development of a Policy and Process document. Development occurred iteratively: V1 from the literature; V2-4 following a modified Delphi expert consultation over three Rounds; V5-6 following two rounds of consumer consultation; and a final ethically approved V7: Policy (purpose; background; ethical considerations), Process (nine steps), leaflet for those making a request and consent form. Twenty-one Delphi experts (71% pediatric oncologists/hematologists, clinical geneticists/genetic counsellors – most likely involved with requests) achieved consensus (> 80%) by Round 3. Issues addressed included broadening ethical considerations (autonomy/child’s best interests, beneficence/clinical utility, non-maleficence, reciprocity, responsibility to genetic relatives); no obligation on treating clinicians to act on therapeutic recommendations arising; limiting practical barriers to return by streamlining the process. Consumer consultations highlighted need for expected turnaround times, given no reportable or actionable findings may trigger requests; acknowledging potential great value of subsequent analysis/interpretation; and supporting parental empowerment by facilitating meeting with a study genetic counselor (or equivalent), separate from their treating clinician, if preferred, to manage their request. Informed by expert consensus and consumer views, this guide to fulfilling data sharing requests, in a spirit of reciprocity between researchers and participants/parents/guardians, may be a model for other research groups and inform ethical guidelines.