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Managing incidental genomic findings: legal obligations of clinicians.
Clayton EW, Haga S, Kuszler P, Bane E, Shutske K, Burke W. Clayton EW, et al. Genet Med. 2013 Aug;15(8):624-9. doi: 10.1038/gim.2013.7. Epub 2013 Feb 28. Genet Med. 2013. PMID: 23448723 Free PMC article.
PURPOSE: Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians' obligations to identify and disclose such findings are a matter of debate. ...These cases suggest that clini …
PURPOSE: Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but c …
Societal preferences for the return of incidental findings from clinical genomic sequencing: a discrete-choice experiment.
Regier DA, Peacock SJ, Pataky R, van der Hoek K, Jarvik GP, Hoch J, Veenstra D. Regier DA, et al. CMAJ. 2015 Apr 7;187(6):E190-E197. doi: 10.1503/cmaj.140697. Epub 2015 Mar 9. CMAJ. 2015. PMID: 25754703 Free PMC article.
BACKGROUND: An important challenge with the application of next-generation sequencing technology is the possibility of uncovering incidental genomic findings. A paucity of evidence on personal utility for incidental findings has hindered clinica …
BACKGROUND: An important challenge with the application of next-generation sequencing technology is the possibility of uncovering inciden …
Differences in Conceptual Understanding of the "Actionability" of Incidental Findings and the Resultant Difference in Ethical Responsibility: An Empirical Study in Japan.
Ibuki T, Yamamoto K, Matsui K. Ibuki T, et al. AJOB Empir Bioeth. 2020 Jul-Sep;11(3):187-194. doi: 10.1080/23294515.2020.1784308. Epub 2020 Jul 2. AJOB Empir Bioeth. 2020. PMID: 32615058
In what situations should researchers and clinicians disclose incidental findings to study participants or patients? ...And this difference in "actionability" would lead to variations in management of incidental findings....
In what situations should researchers and clinicians disclose incidental findings to study participants or patients? .. …
The fiduciary relationship model for managing clinical genomic "incidental" findings.
Lázaro-Muñoz G. Lázaro-Muñoz G. J Law Med Ethics. 2014 Winter;42(4):576-89. doi: 10.1111/jlme.12177. J Law Med Ethics. 2014. PMID: 25565622 Free PMC article.
This paper examines how the application of legal fiduciary principles (e.g., physicians' duty of loyalty and care, duty to inform, and duty act within the scope of authority), can serve as a framework to promote management of clinical genomic "incidental …
This paper examines how the application of legal fiduciary principles (e.g., physicians' duty of loyalty and care, duty to inform, an …
Normative and conceptual ELSI research: what it is, and why it's important.
Parker LS, Sankar PL, Boyer J, Jean McEwen JD, Kaufman D. Parker LS, et al. Genet Med. 2019 Feb;21(2):505-509. doi: 10.1038/s41436-018-0065-x. Epub 2018 Jul 4. Genet Med. 2019. PMID: 29970926 Free article.
The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute sponsors research examining ethical, legal, and social issues arising in the context of genetics/genomics. ...To illustrate the distinct …
The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute sponsors r …
Mainstreaming informed consent for genomic sequencing: A call for action.
Bunnik EM, Dondorp WJ, Bredenoord AL, de Wert G, Cornel MC. Bunnik EM, et al. Eur J Cancer. 2021 May;148:405-410. doi: 10.1016/j.ejca.2021.02.029. Epub 2021 Mar 27. Eur J Cancer. 2021. PMID: 33784533 Free article.
The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring of clinical management to the genetic characteristics of tumours. While the primary aim of mainstream genomic sequencing of can …
The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring o …
Managing unsolicited findings in genomics: A qualitative interview study with cancer patients.
Bijlsma RM, Wouters RHP, Wessels H, May AM, Ausems MGEM, Voest EE, Bredenoord AL. Bijlsma RM, et al. Psychooncology. 2018 Apr;27(4):1327-1333. doi: 10.1002/pon.4676. Epub 2018 Mar 24. Psychooncology. 2018. PMID: 29471587
CONCLUSIONS: The results of our study contribute to a better understanding of what cancer patients consider important and what may motivate and influence them when making decisions on the disclosure of unsolicited findings following NGS. We show how Joel Feinberg's …
CONCLUSIONS: The results of our study contribute to a better understanding of what cancer patients consider important and what may motivate …
Grappling with genomic incidental findings in the clinical realm.
Hull SC, Berkman BE. Hull SC, et al. Chest. 2014 Feb;145(2):226-230. doi: 10.1378/chest.13-1976. Chest. 2014. PMID: 24493507 Free PMC article.
In particular, there has been significant debate about the appropriate management of genomic incidental findings (GIFs), which we define as pathogenic or likely pathogenic test results that are not apparently relevant to the diagnostic indications for …
In particular, there has been significant debate about the appropriate management of genomic incidental findings …
How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.
Dheensa S, Crawford G, Salter C, Parker M, Fenwick A, Lucassen A. Dheensa S, et al. Fam Cancer. 2018 Jan;17(1):155-166. doi: 10.1007/s10689-017-9994-9. Fam Cancer. 2018. PMID: 28405783 Free PMC article.
Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for in …
Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic i …
Points to consider in the clinical use of NGS panels for mitochondrial disease: an analysis of gene inclusion and consent forms.
Platt J, Cox R, Enns GM. Platt J, et al. J Genet Couns. 2014 Aug;23(4):594-603. doi: 10.1007/s10897-013-9683-2. Epub 2014 Jan 8. J Genet Couns. 2014. PMID: 24399097
Five of the panels included genes that are not listed in OMIM to be associated with a disease phenotype (5 %-49 % of panel contents). None of the consent documents reviewed had options for patient preference regarding receipt of incidental findings. ...We hop …
Five of the panels included genes that are not listed in OMIM to be associated with a disease phenotype (5 %-49 % of panel contents). …
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