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Returning raw genomic data to research participants in a pediatric cancer precision medicine trial
Kristine Barlow-Stewart1,2,3,4, Eliza Courtney5,6,7, Mark Cowley5,6
1Children's Cancer Institute, Lowy Cancer Research Centre, UNSW, Kensington, NSW, Australia. kristine.barlowstewart@sydney.edu.au.
Insights
Parents in pediatric cancer trials can now get their child's raw data and biospecimens back. A new guide helps researchers manage these requests ethically, ensuring child welfare and parental empowerment.
Area of Science:
- Pediatric Oncology
- Genomics
- Bioethics
Background:
- Parents in pediatric cancer precision medicine trials often request their child's raw data or biospecimens.
- Existing guidelines were insufficient to address these complex requests.
Purpose of the Study:
- To develop a comprehensive guidance document for handling parental requests for return of pediatric patient data and biospecimens.
- To ensure ethical considerations, child welfare, and parental empowerment are central to the process.
Main Methods:
- Literature review to establish initial guidelines (Version 1).
- Iterative Delphi consultations with 21 experts (Versions 2-4).
- Parent consultations to refine the document (Versions 5-6), resulting in an approved Version 7.
Main Results:
- A final guidance document (Version 7) was approved, encompassing policy, a nine-step process, and a consent form.
- Key ethical issues addressed include child's best interests, clinical utility, non-maleficence, reciprocity, and responsibilities to genetic relatives.
- The guide incorporates practical barriers and supports parental empowerment through optional genetic counseling.
Conclusions:
- The developed guide provides a framework for managing data and biospecimen return requests in pediatric cancer research.
- This model can inform other research groups and contribute to evolving ethical guidelines in precision medicine.
- The guidance prioritizes ethical conduct, participant rights, and the unique needs of families in pediatric cancer clinical trials.
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.
