ArticleEuropean journal of human genetics : EJHG2013
A tiered-layered-staged model for informed consent in personal genome testing.
Article in European journal of human genetics : EJHG, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
59 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- International policies guiding the selection, analysis, and clinical management of secondary findings from genomic sequencing: A systematic review.American journal of human genetics · 2024Pooled it
- Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review.Science and engineering ethics · 2022Pooled it
- Measuring informed choice in population-based reproductive genetic screening: a systematic review.European journal of human genetics : EJHG · 2015Pooled it
- Australian parents' perspectives on extended genomic screening: what information to return and when?European journal of human genetics : EJHG · 2026Article
- Clinician perspectives on patient consent for metagenomic next-generation sequencing of blood samples for the diagnosis of infection in clinical practice.Journal of medical microbiology · 2026Article
- Research integrity and data ethics in AI-driven integrated healthcare: a critical appraisal.Frontiers in public health · 2026Review
- Legal protection of personal health information in medical AI applications in China: challenges and regulatory responses.Frontiers in public health · 2026Article
- Critical consideration towards broad consent by patient experts: results of a semi-structured interview study on the secondary use of medical data.BMC medical ethics · 2025Article
- Consent for genomic sequencing: a conversation, not just a form.European journal of human genetics : EJHG · 2025Article
- Lessons for a learning health system: Effectively communicating to patients about research with their health information and biospecimens.Learning health systems · 2025Article
- Ethical and Legal Issues Surrounding Genetic Testing in the NICU.NeoReviews · 2024Article
- Australian Public Perspectives on Genomic Newborn Screening: Risks, Benefits, and Preferences for Implementation.International journal of neonatal screening · 2024Article
- Future-proofing genomic data and consent management: a comprehensive review of technology innovations.GigaScience · 2024Review
- 'It's a nightmare': informed consent in paediatric genome-wide sequencing. A qualitative expert interview study from Germany and Switzerland.European journal of human genetics : EJHG · 2023Article
- Uncertain futures and unsolicited findings in pediatric genomic sequencing: guidelines for return of results in cases of developmental delay.BMC medical ethics · 2023Article
- How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity.Public health ethics · 2023Article
- Evaluating models of consent in changing health research environments.Medicine, health care, and philosophy · 2022Article
- The fetus in the age of the genome.Human genetics · 2022Article
- Ethical implications of epigenetics in the era of personalized medicine.Clinical epigenetics · 2022Review
- Informed consent practices for exome sequencing: An interview study with clinical geneticists in the Netherlands.Molecular genetics & genomic medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.