ArticleEuropean journal of human genetics : EJHG2013
Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process.
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. It is linked to trial NCT01927770 (Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies), which is not on this map. Cited by 59 papers, 2 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.
Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies
Who cites it
59 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Parents' understanding of genome and exome sequencing for pediatric health conditions: a systematic review.European journal of human genetics : EJHG · 2022Pooled it
- Is there a duty to recontact in light of new genetic technologies? A systematic review of the literature.Genetics in medicine : official journal of the American College of Medical Genetics · 2015Pooled it
- A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study.European journal of human genetics : EJHG · 2018Trial
- Assessment of the current status of real-world pharmacogenomic testing: informed consent, patient education, and related practices.Frontiers in pharmacology · 2024Article
- '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
- What can the citations of systematic reviews of ethical literature tell us about their use?-an explorative empirical analysis of 31 reviews.Systematic reviews · 2023Article
- WGS Data Collections: How Do Genomic Databases Transform Medicine?International journal of molecular sciences · 2023Review
- Moving from 'fully' to 'appropriately' informed consent in genomics: The PROMICE framework.Bioethics · 2022Article
- Informed consent practices for exome sequencing: An interview study with clinical geneticists in the Netherlands.Molecular genetics & genomic medicine · 2022Article
- Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe.Journal of personalized medicine · 2022Article
- Views on genomic research result delivery methods and informed consent: a review.Personalized medicine · 2021Review
- Information, communication, and cancer patients' trust in the physician: what challenges do we have to face in an era of precision cancer medicine?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Article
- Experiences and lessons learned by genetic counselors in returning secondary genetic findings to patients.Journal of genetic counseling · 2020Article
- Navigating the Intersection between Genomic Research and Clinical Practice.Cancer prevention research (Philadelphia, Pa.) · 2020Review
- Revised Common Rule Changes to the Consent Process and Consent Form.Ochsner journal · 2020Review
- Challenges to informed consent for exome sequencing: A best-worst scaling experiment.Journal of genetic counseling · 2019Article
- Informed Consent in the Newly Established Biobank.International journal of environmental research and public health · 2019Article
- Researchers' Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study.Journal of empirical research on human research ethics : JERHRE · 2019Article
- Article
- Recontacting patients in clinical genetics services: recommendations of the European Society of Human Genetics.European journal of human genetics : EJHG · 2019Article
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4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of new massive sequencing techniques has now made it possible to significantly reduce the time and costs of whole-genome sequencing (WGS). Although WGS will soon become a routine testing tool, new ethical issues have surfaced. In light of these concerns, a systematic review of papers published by expert authors on IC or specific ethical issues related to IC for WGS analysis in the clinical setting has been conducted using the Pubmed, Embase and Cochrane Library databases. Additionally, a search was conducted for international ethical guidelines for genetic studies published by scientific societies and ethical boards. Based on these documents, a minimum set of information to be provided to patients in the IC form was determined. Fourteen and seven documents from the database search and from scientific societies, respectively, were selected. A very high level of consistency between them was found regarding the recommended IC form content. Pre-test counselling and general information common to all genetic tests should be included in the IC form for WGS for diagnostic purposes, but additional information addressing specific issues on WGS are proposed, such as a plan for the ethical, clinically oriented return of incidental findings. Moreover, storage of additional information for future use should also be agreed upon with the patient in advance. Recommendations for WGS studies in the clinical setting concerning both the elements of information and the process of obtaining the IC as well as how to handle the results obtained are proposed.
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