Disclosure of individual genetic data to research participants: the debate reconsidered

Bredenoord, Annelien L.; Kroes, Hester Y.; Cuppen, Edwin; Parker, Michael; Delden, Johannes J. M. van

doi:10.1016/j.tig.2010.11.004

Cited by 198 publications

(213 citation statements)

References 70 publications

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“…10 The rise of data-intensive science stemming from the use of high-throughput technology has led to a debate on the pertinence of returning IRRs and IFs in genomic biobanks. [11][12][13] Although most of these debates are jurisdictionspecific, how is the issue of the return of IRRs and IFs reflected in international norms? What trends, if any, are discernable?…”

mentioning

confidence: 99%

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

Zawati

Knoppers

2012

Genetics in Medicine

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Managers of genomic biobanks constantly face ethical and legal challenges ranging from issues associated with the informed consent process to procedural concerns related to access by researchers. Yet, with the availability of next-generation sequencing technologies, one topic is emerging as the focus of ongoing debate: the return of individual research results and incidental findings to participants. This article examines this topic from an international perspective, where policies and guidelines discussing the matter in the context of genomic biobanks and genomic research are analyzed and commented. This approach aims to highlight the shortcomings of these international norms, mainly the danger arising from both the therapeutic misconception and the conflation of research results with incidental findings. This article suggests some elements to consider in order to complement available guidance at the international level. 2012:14(4):484-489 Genet Med

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confidence: 99%

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

Zawati

Knoppers

2012

Genetics in Medicine

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“…[12][13][14][15][16] Options suggested range from full disclosure of all results to disclosing only those with known clinical significance, and/or which have an intervention that can prevent, treat, or mitigate disease. What our examples highlight is that it may be extremely difficult to withhold details of IFs, even if a conclusion is that they are not clinically significant, because further investigations of the patient, and their relatives, may be required to come to this conclusion.…”

Section: Disclosure Of Resultsmentioning

confidence: 99%

“…Research governance usually requires clear up front policies about such matters, and many studies have decided not to report IFs back to participants. 15,17 Such clear policies are more difficult in clinical practice since the relationship between researcher and participant is different to that between clinician and patient. The researcher, bound by rules derived from the Declaration of Helsinki, undertakes researches for which the participant has given clear consent 18 ; the clinician must also include considerations of patient welfare in such decisions.…”

Section: Lessons From Researchmentioning

confidence: 99%

Genetic medicine and incidental findings: it is more complicated than deciding whether to disclose or not

Crawford

Foulds

Fenwick

et al. 2013

Genetics in Medicine

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“…Consensus now emerges that genetic risk information should be returned to patients 9 but disagreement exists what results should be communicated, how and by whom and to who. With the rapidly expanding use of NGS procedures generating large amounts of genetic data, informed consent procedures become increasingly important, but at the same time very challenging.…”

Section: Discussion Of Current Recommendations In the Literaturementioning

confidence: 99%

Unsolicited findings of next-generation sequencing for tumor analysis within a Dutch consortium: clinical daily practice reconsidered

et al. 2016

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Cancer patients participating in studies involving experimental or diagnostic next-generation sequencing (NGS) procedures are confronted with the possibility of unsolicited findings. The Center for Personalized Cancer Treatment (CPCT), a Dutch consortium of cancer centers, is offering centralized large-scale NGS for the discovery of somatic tumor mutations with their germline DNA as reference. The CPCT aims to give all cancer patients with advanced disease stages access to tumor DNA analysis in order to improve selection for experimental therapy. In this article, our experiences at the CPCT will serve as an example to discuss the ethical and practical aspects regarding the management of unsolicited findings in personalized cancer research and treatment. Generic issues, relevant for all researchers in this field are discussed and illustrated by description of three patients faced with an unsolicited DNA finding, while they intended to be candidate for future anticancer treatment by participating in a trial that included NGS of both somatic and germline DNA. As options for DNA analysis expand and costs decrease rapidly, more and more patients are offered large-scale NGS testing. After reviewing current recommendations in literature, we conclude that classical informed consent procedures need to be adapted to become more explicit in asking patients if they want to be informed about unsolicited findings and if so, what level of detail of genetic risk information exactly they want to be returned after the analysis.

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Disclosure of individual genetic data to research participants: the debate reconsidered

Cited by 198 publications

References 70 publications

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

International normative perspectives on the return of individual research results and incidental findings in genomic biobanks

Genetic medicine and incidental findings: it is more complicated than deciding whether to disclose or not

Unsolicited findings of next-generation sequencing for tumor analysis within a Dutch consortium: clinical daily practice reconsidered

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