Managing incidental genomic findings: legal obligations of clinicians

被引:45
|
作者
Clayton, Ellen Wright [1 ,2 ]
Haga, Susanne [3 ]
Kuszler, Patricia [4 ,5 ]
Bane, Emily [5 ]
Shutske, Krysta [5 ]
Burke, Wylie [5 ,6 ]
机构
[1] Vanderbilt Univ, Ctr Biomed Eth & Soc, Nashville, TN 37235 USA
[2] Vanderbilt Univ, Sch Law, Nashville, TN 37240 USA
[3] Duke Univ, Inst Genome Sci & Policy, Durham, NC USA
[4] Univ Washington, Sch Law, Seattle, WA 98195 USA
[5] Univ Washington, Inst Publ Hlth Genet, Seattle, WA 98195 USA
[6] Univ Washington, Dept Bioeth & Humanities, Seattle, WA 98195 USA
基金
美国国家卫生研究院;
关键词
genomics; incidental findings; medical malpractice; radiology; INFORMATION; MEDICINE; RETURN; DUTY;
D O I
10.1038/gim.2013.7
中图分类号
Q3 [遗传学];
学科分类号
071007 ; 090102 ;
摘要
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 could offer insights into clinicians' legal liability. Methods: We searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance. Results: We found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise. Conclusions: Clinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import.
引用
收藏
页码:624 / 629
页数:6
相关论文
共 50 条
  • [21] Informed consent for return of incidental findings in genomic research
    Appelbaum, Paul S.
    Waldman, Cameron R.
    Fyer, Abby
    Klitzman, Robert
    Parens, Erik
    Martinez, Josue
    Price, W. Nicholson, II
    Chung, Wendy K.
    GENETICS IN MEDICINE, 2014, 16 (05) : 367 - 373
  • [22] Education about the possibility of "incidental findings" in genomic medicine
    Schmidtke, Joerg
    GYNAKOLOGIE, 2023, 56 (05): : 296 - 297
  • [23] Management and return of incidental genomic findings in clinical trials
    Ayuso, C.
    Millan, J. M.
    Dal-Re, R.
    PHARMACOGENOMICS JOURNAL, 2015, 15 (01): : 1 - 5
  • [24] MODELS OF CONSENT TO RETURN OF INCIDENTAL FINDINGS IN GENOMIC RESEARCH
    Appelbaum, Paul S.
    Parens, Erik
    Waldman, Cameron R.
    Klitzman, Robert
    Fyer, Abby
    Martinez, Josue
    Price, W. Nicholson, II
    Chung, Wendy K.
    HASTINGS CENTER REPORT, 2014, 44 (04) : 22 - 32
  • [25] Management and return of incidental genomic findings in clinical trials
    C Ayuso
    J M Millan
    R Dal-Re
    The Pharmacogenomics Journal, 2015, 15 : 1 - 5
  • [26] Dialogues, dilemmas, and disclosures: genomic research and incidental findings
    Bush, Lynn W.
    Rothenberg, Karen H.
    GENETICS IN MEDICINE, 2012, 14 (03) : 293 - 295
  • [27] LEGAL OBLIGATIONS
    DEVLIN, DH
    JOURNAL OF THE AMERICAN DENTAL ASSOCIATION, 1993, 124 (11): : 16 - 16
  • [28] Managing incidental findings in human subjects research: Analysis and recommendations
    Wolf, Susan M.
    Lawrenz, Frances P.
    Nelson, Charles A.
    Kahn, Jeffrey P.
    Cho, Mildred K.
    Clayton, Ellen Wright
    Fletcher, Joel G.
    Georgieff, Michael K.
    Hammerschmidt, Dale
    Hudson, Kathy
    Illes, Judy
    Kapur, Vivek
    Keane, Moira A.
    Koenig, Barbara A.
    LeRoy, Bonnie S.
    McFarland, Elizabeth G.
    Paradise, Jordan
    Parker, Lisa S.
    Terry, Sharon F.
    Van Ness, Brian
    Wilfond, Benjamin S.
    JOURNAL OF LAW MEDICINE & ETHICS, 2008, 36 (02): : 219 - 248
  • [29] Managing "incidental findings" in biobank research: Recommendations of the Taiwan biobank
    Lin, Jui-Chu
    Hsiao, Wesley Wei-Wen
    Fan, Chien-Te
    COMPUTATIONAL AND STRUCTURAL BIOTECHNOLOGY JOURNAL, 2019, 17 : 1135 - 1142
  • [30] Legal Implications of an Ethical Duty to Search for Genetic Incidental Findings
    Price, W. Nicholson, II
    AMERICAN JOURNAL OF BIOETHICS, 2013, 13 (02): : 48 - 49