Rethinking broad consent in the age of genomic AI: the Hungarian case

Nogel, Mónika (2026) Rethinking broad consent in the age of genomic AI: the Hungarian case. FRONTIERS IN MEDICINE, 13. No. -1936581. ISSN 2296-858X

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Abstract

Broad consent is an ethical framework that enables patients to authorize the use of their biosamples and health data for multiple, unspecified future medical studies. This approach underpins modern precision medicine, which relies on large and diverse datasets to tailor disease treatments, diagnostics, and prevention strategies to individual genetic profiles and lifestyles. This issue is particularly significant in genomic research, where a sample may subsequently be sequenced, linked with longitudinal health records, utilized in algorithm development, and reanalyzed as scientific knowledge and computational methods advance. Such subsequent uses may yield clinically relevant information that could not have been anticipated at the time consent was obtained, including new evidence regarding disease risk, variant significance, or treatment response. Hungary's 2025 reform highlights this challenge by permitting broad consent for current and future medical research deemed "national strategic significance." However, this framework does not provide a mechanism for returning individual research findings or re-identifying coded material for the benefit of participants. This combination grants research institutions considerable future flexibility while fixing the participant's informational position at the time of consent. The present article refers to the distance between the material initially contributed and the inferences subsequently derived from it as the sample-data-inference gap. It proposes a model of bounded, reciprocal broad consent, supported by ongoing transparency, review triggered by material changes, and a limited pathway for independently validated, clinically actionable findings.

Item Type:	Article
Uncontrolled Keywords:	artificial intelligence, biobanks, broad consent, precision medicine, research ethics
Subjects:	K Law / jog > K Law (General) / jogtudomány általában R Medicine / orvostudomány > R1 Medicine (General) / orvostudomány általában
Depositing User:	Dr Mónika Nogel
Date Deposited:	07 Oct 2026 14:27
Last Modified:	07 Oct 2026 14:27
URI:	https://real.mtak.hu/id/eprint/248282

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• Rethinking broad consent in the age of genomic AI: the Hungarian case. (deposited 27 Sep 2026 09:23)
  • Rethinking broad consent in the age of genomic AI: the Hungarian case. (deposited 07 Oct 2026 14:27) [Currently Displayed]

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