Returning raw genomic data: rights of research participants and obligations of health care professionals

Nielsen, Jane; Johnston, Carolyn; O’Brien, Tracey; Tyrrell, Vanessa

doi:10.5694/mja2.51546

Cited by 2 publications

(4 citation statements)

References 11 publications

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“…This position is in the context of an Australian setting where the Australian Federal Privacy Act 1988 (Cth) [30] and State and Territory laws provide a right to access, upon request, personal data that identi es or reasonably identi es an individual. There may however be some uncertainty about whether raw genomic data falls into this category [3,31]. Adding to the lack of clarity, the NHMRC guidelines provide that researchers are not expected to return raw genomic data to participants.…”

Section: Discussionmentioning

confidence: 99%

“…Sharing genomic data between research groups and other agencies is often mandated by funding bodies and promoted in ethical guidelines, as it is critical to the advancement of precision medicine [1,2]. Increasingly, attention is shifting to sharing data, on request, with parents/guardians of child research participants or adult participants (hereafter referred to collectively as parents/participants) [3,4,5].…”

Section: Introductionmentioning

confidence: 99%

“…These include utility of the data, potential for harm arising from third party interpretation, and the possibility of unnecessary interventions [5,12]. Given this complexity, recommendations guiding ethical access to raw genomic data were developed in the USA, Europe, and Australia [3,9,13].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Barlow-Stewart,

Courtney

et al. 2024

Preprint

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Barlow-Stewart,

Courtney

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“…It has recently been argued that patients and research participants have a moral-and sometimes a legal-right to genomic data generated from their cells in a research setting. 30 On the one hand, this right is based on the right to privacy, which encompasses the right to control personal information that relates to oneself. This can be reasonably interpreted to infer that we should enjoy privacy over our genomic information.…”

Section: The Right To Access One's Genomic Datamentioning

confidence: 99%

Storing paediatric genomic data for sequential interrogation across the lifespan

et al. 2023

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Genomic sequencing (GS) is increasingly used in paediatric medicine to aid in screening, research and treatment. Some health systems are trialling GS as a first-line test in newborn screening programmes. Questions about what to do with genomic data after it has been generated are becoming more pertinent. While other research has outlined the ethical reasons for storing deidentified genomic data to be used in research, the ethical case for storing data for future clinical use has not been explicated. In this paper, we examine the ethical case for storing genomic data with the intention of using it as a lifetime health resource. In this model, genomic data would be stored with the intention of reanalysis at certain points through one’s life. We argue this could benefit individuals and create an important public resource. However, several ethical challenges must first be met to achieve these benefits. We explore issues related to privacy, consent, justice and equality. We conclude by arguing that health systems should be moving towards futures that allow for the sequential interrogation of genomic data throughout the lifespan.

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Returning raw genomic data: rights of research participants and obligations of health care professionals

Cited by 2 publications

References 11 publications

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

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

Storing paediatric genomic data for sequential interrogation across the lifespan

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