The Fiduciary Relationship Model for Managing Clinical Genomic "Incidental" Findings

Journal of Law, Medicine and Ethics

Volumn 42, Issue 4, 2014, Pages 576-589

  Lázaro Muñoz, Gabriel ^a  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOCTOR PATIENT RELATION; ETHICS; GENOMICS; HUMAN; HUMAN GENOME; INCIDENTAL FINDING; INTERPERSONAL COMMUNICATION; PATIENT RIGHT; SEQUENCE ANALYSIS;

DISCLOSURE; GENOME, HUMAN; GENOMICS; HUMANS; INCIDENTAL FINDINGS; PATIENT RIGHTS; PHYSICIAN-PATIENT RELATIONS; SEQUENCE ANALYSIS;

EID: 84921649795     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/jlme.12177     Document Type: Article

References (53)

1. R. C. Green et al., "ACMG Recommendations for Reporting Incidental Findings in Clinical Exome and Genome Sequencing, "Genetics in Medicine 15, no. 7 (2013): 565-574
2. V. Anastasova et al., "Genomic Incidental Findings: Reducing the Burden to Be Fair, "American Journal of Bioethics 13 (2013): 52-54
3. P. Su, "Direct-to-Consumer Genetic Testing: A Comprehensive View, "Yale Journal of Biology and Medicine 86, no. 3 (2013): 359-365
4. M. R. Schweiger et al., "Genomics and Epigenomics: New Promises of Personalized Medicine for Cancer Patients, "Briefings in Functional Genomics 12, no. 5 (2013): 411-421.
5. T. M. Scuffham and J. C. Macmillan, "Huntington Disease: Who Seeks Presymptomatic Genetic Testing, Why and What Are the Outcomes?" Journal of Genetic Counseling 23, no. 5 (2014): 754-761
6. S. C. Warby, "Huntington Disease," GeneReviews, available at (last visited November 25, 2014)
7. N. Petrucelli, "BRCA1 and BRCA2 Hereditary Breast and Ovarian Cancer," GeneReviews, available at (last visited November 25, 2014)
8. W. Kohlmann and S. B. Gruber, "Lynch Syndrome," GeneReviews, available at (last visited November 25, 2014)
9. K. W. Jasperson and R. W. Burt, "APC-Associated Polyposis Conditions," GeneReviews, available at (last visited November 25, 2014)
10. A. L. Cirino and C. Ho, "Hypertrophic Cardiomyopathy Overview," GeneReviews, available at (last visited November 25, 2014)
11. R. E. Hershberger and A. Morales, "Dilated Cardiomyopathy Overview," GeneReviews, available at (last visited November 25, 2014).
12. E. D. Green and M. S. Guyer, "Charting a Course for Genomic Medicine from Base Pairs to Bedside, "Nature 470, no. 7333 (2011): 204-213
13. T. Walsh et al., "Detection of Inherited Mutations for Breast and Ovarian Cancer Using Genomic Capture and Massively Parallel Sequencing," Proceedings of the National Academy of Sciences of the United States of America 107, no. 28 (2010): 12629-12633.
14. J. Shendure and E. L. Aiden, "The Expanding Scope of DNA Sequencing, "Nature Biotechnology 30, no. 11 (2012): 1084-1094.
15. J. P. Evans et al., "We Screen Newborns, Don't We?: Realizing the Promise of Public Health Genomics, "Genetics in Medicine 15, no. 5 (2013): 332-334.
16. A. R. Harper and E. J. Topol, "Pharmacogenomics in Clinical Practice and Drug Development, "Nature Biotechnology 30, no. 11 (2012): 1117-1124.
17. A. M. Cressman and M. Piquette-Miller, "Epigenetics: A New Link toward Understanding Human Disease and Drug Response, "Clinical Pharmacology & Therapeutics 92, no. 6 (2012): 669-673
18. C. S. Ku, et al. "Studying the Epigenome Using Next Generation Sequencing," Journal of Medical Genetics 48, no. 11 (2011): 721-730.
19. L. G. Biesecker and R. C. Green, "Diagnostic Clinical Genome and Exome Sequencing, "New England Journal of Medicine 371, no. 12 (2014): 2418-2425.
20. V. A. Moyer, "United States Preventive Services Task Force. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement, "Annals of Internal Medicine 160, no. 4 (2014): 271-281
21. R. Klitzman, "Exclusion of Genetic Information From the Medical Record, "JAMA 304, no. 10 (2010): 1120-1121
22. T. L. Beauchamp and J. F. Childress, Principles of Biomedical Ethics, 7th ed. (New York: Oxford University Press, 2012): at 106-110
23. M. Alders and M. M. A. M. Mannens, "RomanoWard Syndrome, "GeneReviews, available at (last visited November 25, 2014).
24. D. F. Maron, "Patients Can Now Choose Not to Know Their Own DNA Secrets, "Scientific American, April 1, 2014, available at (last visited November 25, 2014)
25. T. Frankel, "Fiduciary Law, "California Law Review 71, no. 3 (1983): 795-836
26. Restatement (Third) of Trusts § 2 (2003)
27. T. L. Hafemeister and S. P. Bryan, "Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing, "University of Kansas Law Review 57, no. 3 (2009): 491-537
28. E. S. Scott and R. E. Scott, "Parents as Fiduciaries, "Virginia Law Review 81, no. 8 (1995): 2401-2476
29. D. B. Matthew, "Implementing American Health Care Reform: The Fiduciary Imperative, "Buffalo Law Review 59, no. 3 (2011): 715-807
30. A. B. Laby, "Resolving Conflicts of Duty in Fiduciary Relationships, "American University Law Review 54, no. 1 (2004): 75-149
31. M. J. Duncan, "Legal Malpractice by Any Other Name: Why a Breach of Fiduciary Duty Claim Does Not Smell as Sweet, "Wake Forest Law Review 34, no. 4 (1999): 1137-1177
32. M. A. Rothstein and G. Siegal, "Health Information Technology and Physicians' Duty to Notify Patients of New Medical Developments, "Houston Journal of Health Law & Policy 12, no. 2 (2012): 93-136
33. M. A. Rodwin, "Strains in the Fiduciary Metaphor: Divided Physician Loyalties and Obligations in a Changing Health Care System, "American Journal of Law & Medicine 21, nos. 2-3 (1995): 241-257
34. D. A. DeMott, "Breach of Fiduciary Duty: On Justifiable Expectations of Loyalty and Their Consequences, "Arizona Law Review 48, no. 4 (2006): 925-956
35. D. G. Smith, "The Critical Resource Theory of Fiduciary Duty," Vanderbilt Law Review 55, no. 5 (2002): 1399-1497
36. T. L. Hafemeister and S. Spinos, "Lean on Me: A Physician's Fiduciary Duty to Disclose an Emergent Medical Risk to the Patient, "Washington University Law Review 86, no. 5 (2009): 1167-1210
37. M. A. Hall et al., Medical Liability and Treatment Relationships, 2nd ed., V. Been et al., eds. (New York: Wolters Kluwer Law and Business, 2008): at 173.
38. American College of Medical Genetics and Genomics, "ACMG Policy Statement: Points to Consider for Informed Consent for Genome/Exome Sequencing, "Genetics in Medicine 15, no. 9 (2013): 748-749
39. E. J. Topol, "Individualized Medicine from Prewomb to Tomb, "Cell 157, no. 1 (2014): 241-253
40. A. R. Brooks-Wilson, "Genetics of Healthy Aging and Longevity, "Human Genetics 132, no. 12 (2013): 1323-1338
41. R. Harris et al., "Reconsidering the Criteria for Evaluating Proposed Screening Programs: Reflections from 4 Current and Former Members of the U.S. Preventive Services Task Force, "Epidemiologic Reviews 33 (2011): 20-35
42. R. C. Green et al., "Reporting Genomics Sequencing Results to Ordering Clinicians: Incidental, but Not Exceptional, "JAMA 310, no. 4 (2013): 365-366
43. A. L. McGuire et al., "Ethics and Genomic Incidental Findings," Science 340, no. 6136 (2013): 1047-1048.
44. T. T. Lineweaver et al., "Effect of Knowledge of APOE Genotype on Subjective and Objective Memory Performance in Health Older Adults, "American Journal of Psychiatry 171, no. 2 (2014): 201-208
45. S. Timmermans and M. Buchbinder, "Patients-in-Waiting: Living between Sickness and Health in the Genomics Era, "Journal of Health and Social Behavior 51, no. 4 (2010): 408-423.
46. National Human Genome Research Institute, "Table of State Statutes Related to Genomics, "available at (last visited November 25, 2014)
47. M. A. Rothstein, "GINA's Beauty Is Only Skin Deep, "Gene-Watch 22, no. 2 (2009): 9-12.
48. M. A. Rothstein, "Access to Sensitive Information in Segmented Electronic Health Records, "Journal of Law, Medicine & Ethics 40, no. 2 (2012): 394-400.
49. B. Katz Rothman, "Genetic Counselling: Placing the Room in Context, "in C. Rehmann-Sutter and H. Müller, Eds., Disclosure Dilemmas (2009): at 19, 22-23.
50. B. J. Evans, "Minimizing Liability Risks under the ACMG Recommendations for Reporting Incidental Findings in Clinical Exome and Genome Sequencing, "Genetics in Medicine 15, no. 12 (2013): 915-920
51. E. W. Clayton, "Managing Incidental Genomic Findings: Legal Obligations of Clinicians," Genetics in Medicine 15, no. 8 (2013): 624-629
52. A. R. Derse, "What Part of "No" Don't You Understand? Patient Refusal of Recommended Treatment in the Emergency Department, "Mount Sinai Journal of Medicine 72, no. 4 (2005): 221-227, at 223 (internal quotation marks omitted).
53. B. S. Wilfond and K. Nolan, "National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Lessons from Cystic Fibrosis, "JAMA 270, no. 24 (1993): 2948-2954.