Broad consent for children’s genomic data works only with safeguards, Australian professionals say

Broad consent is widely used in paediatric genomics to allow children’s genomic data to be stored, shared, re-analysed and drawn into future studies. But a new qualitative study from Australia suggests that the clinicians, researchers and data-governance professionals who actually seek, explain and oversee this consent do not regard it as sufficient on its own. Instead, they describe a practice that works only when it is wrapped in continuing communication, meaningful choices and ongoing institutional oversight — safeguards that, in their accounts, are inconsistently understood, unevenly implemented or still largely aspirational.

The study, published in BMC Medical Ethics, drew on semi-structured interviews with 20 Australian professionals involved in seeking, explaining, operationalising or governing consent for the research use of paediatric genomic data. The interviews were conducted between February and August 2025 and analysed thematically. Because the research is qualitative and focused on a single professional community in Australia, its findings describe how these practitioners understand and experience broad consent rather than measuring how often particular practices occur across the wider system.

Broad consent occupies an uneasy position in paediatric genomics. It is designed to facilitate future research by permitting data collected now to be used in studies not yet conceived, but it raises ethical questions about whether consent given in those terms can truly be informed, whether it is appropriate, and whether it offers sufficient protection for the autonomy of the children and families involved. The interviewed professionals generally described broad consent as workable only when accompanied by clear explanation, proportionate disclosure, voluntary choice, governance oversight and options concerning future contact.

Their accounts also identified conditions that could undermine meaningful engagement with the consent process. Diagnostic urgency — the pressure of families seeking answers about a child’s condition — emotional pressure, compressed consultations and reliance on professional or institutional trust all emerged as factors that could erode the quality of consent decisions. In other words, even when a broad consent form is technically completed, the circumstances under which families encounter it may leave little room for genuine deliberation.

Participants varied considerably in how they interpreted the boundaries of broad-consent clauses, and in when they believed recontact, reaffirmation or re-consent would be required. This variation matters, because the practical meaning of a broad consent agreement depends on how the professionals applying it understand its limits. The study also found that participants described the progressive involvement of children and young people in consent decisions as desirable, but reported that this was not consistently implemented in practice — a gap between principle and operation that the authors highlight as central to how broad consent functions in real settings.

The study’s conclusion is measured: it captures professionals’ accounts of how broad consent is understood and operationalised for the future research use of paediatric genomic data, and finds that participants commonly did not regard broad consent as sufficient in itself. Its appropriate operation, in their view, depends on continuing communication, meaningful choices, opportunities to revisit earlier decisions, the progressive involvement of children and young people, and ongoing ethical and institutional oversight. How far those conditions are met, the study suggests, currently varies across Australian practice.

Subject of Research: How Australian clinical, research and data-governance professionals understand and operationalise broad consent for the future research use of paediatric genomic data

Article Title: Australian professionals’ understandings and experiences of broad consent for the future research use of paediatric genomic data

Article References: Luo, Y., Keogh, L., Richards, B., Ferrie, M., & Nielsen, J. (2026). Australian professionals’ understandings and experiences of broad consent for the future research use of paediatric genomic data. BMC Medical Ethics. https://doi.org/10.1186/s12910-026-01633-x

Image Credits: AI Generated

DOI: 10.1186/s12910-026-01633-x

Keywords: broad consent, paediatric genomics, genomic data, research ethics, informed consent, qualitative interviews, data governance, children's autonomy, re-consent, BMC Medical Ethics, Australia, genomic research