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Related Experiment Video

Updated: Nov 11, 2025

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease

Published on: April 4, 2018

Mainstreaming informed consent for genomic sequencing: A call for action.

Eline M Bunnik¹, Wybo J Dondorp², Annelien L Bredenoord³

¹Erasmus MC, Department of Medical Ethics, Philosophy and History of Medicine, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.

European Journal of Cancer (Oxford, England : 1990)

|March 30, 2021

Summary

Genomic sequencing in cancer care can reveal unexpected results. Patients need clear informed consent processes to understand and decide on receiving this genetic information, preparing them for potential psychosocial impacts.

Keywords:

Ethics Genetic counselling Genomics Incidental findings Informed consent Mainstreaming Precision medicine

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Last Updated: Nov 11, 2025

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease

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Published on: April 4, 2018

Detecting Somatic Genetic Alterations in Tumor Specimens by Exon Capture and Massively Parallel Sequencing

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Published on: October 18, 2013

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Published on: June 21, 2018

Area of Science:

Genomic Medicine
Bioethics
Oncology

Background:

Genomic sequencing, including gene panels, is increasingly used in cancer care for personalized medicine.
While primarily for therapy, genomic tests can yield unexpected results like suspected germline mutations, variants of uncertain significance (VUS), and unrelated findings.

Purpose of the Study:

To adapt ethical informed consent practices from clinical genetics for mainstream oncology.
To ensure patients are prepared for and can consent to unsolicited genomic findings.

Main Methods:

Review of ethical traditions in informed consent for genomic sequencing.
Proposal for a layered informed consent approach integrated into information systems for non-geneticists.

Main Results:

Mainstream informed consent should prepare patients for three types of unsolicited genomic outcomes.
Opt-out consent may be acceptable when the likelihood of unsolicited findings is very low.
A layered approach can make informed consent feasible for non-geneticist clinicians.

Conclusions:

Informed consent practices must evolve with the mainstreaming of genomic sequencing in cancer care.
Development of national and international guidelines for informed consent in genomic sequencing is crucial.