TY - JOUR
T1 - Beyond the Helix
T2 - Ethical, Legal, and Social Implications in Genomics
AU - Hammer, Marilyn J.
N1 - Funding Information:
This case study highlights the challenges in genomics research and clinical care application. Addressing these challenges, investigators awarded Clinical Sequencing Exploratory Research studies funded by the NIH NHGRI and National Cancer Institute 25,39,40 were encouraged to include in their consent forms that the science of genomics is still under development and that there may be secondary, incomplete, and possibly inaccurate findings.41 The current ACMG guidelines41 contain recommendations for what to include in the informed consent (see Table 2). Even with guidelines, a study recently revealed that informed consents from nine NIH-funded studies that included genomic analyses had a great deal of heterogeneity between consent forms.40 These findings are reflective of a science that is still unfolding with many challenges and unanswered questions about the implementation of informed consent in research and practice.
Funding Information:
This case study highlights the challenges in genomics research and clinical care application. Addressing these challenges, investigators awarded Clinical Sequencing Exploratory Research studies funded by the NIH NHGRI and National Cancer Institute25,39,40 were encouraged to include in their consent forms that the science of genomics is still under development and that there may be secondary, incomplete, and possibly inaccurate findings.41 The current ACMG guidelines41 contain recommendations for what to include in the informed consent (see Table 2 ). Even with guidelines, a study recently revealed that informed consents from nine NIH-funded studies that included genomic analyses had a great deal of heterogeneity between consent forms.40 These findings are reflective of a science that is still unfolding with many challenges and unanswered questions about the implementation of informed consent in research and practice.
Publisher Copyright:
© 2019 Elsevier Inc.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/2
Y1 - 2019/2
N2 - Objective: To review ethical, legal, and social implications of genomics, a ground-breaking science that when applied improves cancer care outcomes. Data Sources: PubMed, Cumulative Index to Nursing and Allied Health (CINAHL), Cochrane Library, consensus statements, and professional guidelines. Conclusion: Ethical, legal, and social domains of genomics are not fully delineated. Areas needing further discussion and policies include return of findings, informed consent, electronic health records, and data resources and sharing. Implications for Nursing Practice: All nurses need a basic understanding of the ethical, legal, and social implications of genomics.
AB - Objective: To review ethical, legal, and social implications of genomics, a ground-breaking science that when applied improves cancer care outcomes. Data Sources: PubMed, Cumulative Index to Nursing and Allied Health (CINAHL), Cochrane Library, consensus statements, and professional guidelines. Conclusion: Ethical, legal, and social domains of genomics are not fully delineated. Areas needing further discussion and policies include return of findings, informed consent, electronic health records, and data resources and sharing. Implications for Nursing Practice: All nurses need a basic understanding of the ethical, legal, and social implications of genomics.
KW - data resources and sharing
KW - electronic health records
KW - ethical, legal, social implications
KW - genomics
KW - informed consent
KW - regulatory
UR - http://www.scopus.com/inward/record.url?scp=85060226038&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85060226038&partnerID=8YFLogxK
U2 - 10.1016/j.soncn.2018.12.007
DO - 10.1016/j.soncn.2018.12.007
M3 - Review article
C2 - 30683550
AN - SCOPUS:85060226038
VL - 35
SP - 93
EP - 106
JO - Seminars in Oncology Nursing
JF - Seminars in Oncology Nursing
SN - 0749-2081
IS - 1
ER -