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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年2月17日

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  • Kristine Barlow-Stewart,
  • Eliza Courtney,
  • Mark Cowley,
  • Camron Ebzery,
  • Noemi Fuentes Bolanos,
  • Andrew J. Gifford,
  • Hazel Harden,
  • Sarah Josephi-Taylor,
  • Rishi S. Kotecha,
  • Marion K. Mateos,
  • Mitali Manzur,
  • Chelsea Mayoh,
  • Di Milnes,
  • Jane Nielsen,
  • Matthew O’Connor,
  • Bhavna Padhye,
  • Catherine Pitman,
  • Elizabeth Pitman,
  • Mark Pinese,
  • Catherine Speechly,
  • Ashleigh Sullivan,
  • Toby Trahair,
  • Katherine Tucker,
  • Vanessa Tyrrell,
  • Meera Warby,
  • Andrew Wood,
  • David S. Ziegler,
  • Carolyn Johnston

摘要

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.