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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. We sought legal cases that co …
PURPOSE: Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but c
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 …
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
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
We show how Joel Feinberg's classification of autonomy may help clinicians to better understand cancer patients' desire for autonomous decision making while also acknowledging the emotional and cognitive difficulties regarding the disclosure of unsolicited findin
We show how Joel Feinberg's classification of autonomy may help clinicians to better understand cancer patients' desire for au …
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
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
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 …
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.
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 incidental findings, in consent (forms) for genetic testing. …
Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about ho …
Genome sequencing and carrier testing: decisions on categorization and whether to disclose results of carrier testing.
Himes P, Kauffman TL, Muessig KR, Amendola LM, Berg JS, Dorschner MO, Gilmore M, Nickerson DA, Reiss JA, Richards CS, Rope AF, Simpson DK, Wilfond BS, Jarvik GP, Goddard KAB. Himes P, et al. Genet Med. 2017 Jul;19(7):803-808. doi: 10.1038/gim.2016.198. Epub 2017 Jan 12. Genet Med. 2017. PMID: 28079899 Free PMC article.
PURPOSE: We investigated the use of genome sequencing for preconception carrier testing. Genome sequencing could identify one or more of thousands of X-linked or autosomal recessive conditions that could be disclosed during preconception or prenatal counseling. Ther …
PURPOSE: We investigated the use of genome sequencing for preconception carrier testing. Genome sequencing could identify one …
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
None of the consent documents reviewed had options for patient preference regarding receipt of incidental findings. These findings raise points of discussion applicable to mitochondrial diagnostics, but also to the larger arenas of exome and genome seq …
None of the consent documents reviewed had options for patient preference regarding receipt of incidental findings. These f
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