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Ethics in Genetic and Genomic Research

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Ethical Issues in Pediatric Hematology/Oncology

Abstract

The introduction of next-generation sequencing, including genome and exome sequencing (GS/ES), has moved us closer to the practice of precision medicine in oncology. It is estimated that by 2025 oncology will dominate the global next-generation sequencing market, with nearly US$13.6 billion spent on companion diagnostics [95]. These advances in clinical oncology, however, must be built on a solid foundation of research to better understand the molecular profile of different cancers and how they respond to available therapeutics. Several large-scale genomic research studies are ongoing in pediatric oncology. These studies not only generate new insights to improve patient care but they also raise ethical considerations that must be studied and responsibly managed. In this chapter, we will highlight some of the large-scale genomic research studies in pediatric oncology and discuss several ethical issues that they raise: informed consent, return of results, data sharing, privacy and genetic discrimination.

We would like to acknowledge Rebecca Hsu and Jill Robinson for their help in editing this chapter.

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Notes

  1. 1.

    Note that under the revised Common Rule, secondary research with a study plan that includes return of individual research results to participants is excluded from an exemption for secondary research using identifiable information or biospecimens, even if the research falls within the scope of a broad consent to future research use and satisfies other criteria [22].

  2. 2.

    Whether healthcare providers have a duty to recontact patients in the event a VUS is reclassified is unclear in the clinical context [18]. Some have argued that caution should be exercised about imposing expansive legal duties to return results or follow up on findings in the research setting [19], and that any ethical duties in the research setting should terminate with study completion [86], although this has been identified as an area of continuing debate [54].

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Authors and Affiliations

  1. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA

    Amy L. McGuire, Stacey Pereira, Amanda M. Gutierrez & Mary A. Majumder

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  1. Amy L. McGuire
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  2. Stacey Pereira
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  3. Amanda M. Gutierrez
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  4. Mary A. Majumder
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Correspondence to Amy L. McGuire .

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  1. Texas Children’s Cancer and Hematology Centers, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX, USA

    Kate A. Mazur

  2. Texas Children’s Cancer and Hematology Centers, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX, USA

    Stacey L. Berg

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McGuire, A.L., Pereira, S., Gutierrez, A.M., Majumder, M.A. (2020). Ethics in Genetic and Genomic Research. In: Mazur, K., Berg, S. (eds) Ethical Issues in Pediatric Hematology/Oncology . Springer, Cham. https://doi.org/10.1007/978-3-030-22684-8_6

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