The Fiduciary Relationship Model for Managing Clinical Genomic “Incidental” Findings

Green R. C. , “ACMG Recommendations for Reporting Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7(2013): 565–574, at 568 [hereinafter ACMG Report].

Presidential Commission for the Study of Bioethical Issues, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, 64 (2013) [hereinafter PCSBI Report].

A number of commentators and a recent report by the PCSBI argue that possible abnormal genomic findings that are not the primary target of the test, but are actively sought by a practitioner, should be called “secondary findings.” Id. (PCSBI Report, at 28).

Similarly, others argue that “actively looked for incidental findings constitute a new category of data” and prefer the term “nonincidental secondary findings.” Anastasova V. , “Genomic Incidental Findings: Reducing the Burden to Be Fair,” American Journal of Bioethics 13 (2013): 52–54, at 52, n.2. The present article refers to actively sought, but non-primary target genomic findings, as “secondary targets”.

Su P. , “Direct-to-Consumer Genetic Testing: A Comprehensive View,” Yale Journal of Biology and Medicine 86, no. 3(2013): 359–365.

Food and Drug Administration, Warning Letter to 23andMe, Inc., Document Number: GEN1300666 (Nov. 22, 2013), available at <http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm>(last visited November 25, 2014).

Schweiger M. R. , “Genomics and Epigenomics: New Promises of Personalized Medicine for Cancer Patients,” Briefings in Functional Genomics 12, no. 5(2013): 411–421.

Bird T. D. , “Alzheimer Disease,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1161/>(last visited November 25, 2014).

Scuffham T. M. Macmillan J. C. , “Huntington Disease: Who Seeks Presymptomatic Genetic Testing, Why and What Are the Outcomes?” Journal of Genetic Counseling 23, no. 5(2014): 754–761.

Warby S. C. , “Huntington Disease,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1305/>(last visited November 25, 2014).

Petrucelli N. , “BRCA1 and BRCA2 Hereditary Breast and Ovarian Cancer,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1247/>(last visited November 25, 2014).

Kohlmann W. Gruber S. B. , “Lynch Syndrome,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1211/>(last visited November 25, 2014).

Jasperson K. W. Burt R. W. , “APC-Associated Polyposis Conditions,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1345/>(last visited November 25, 2014).

Cirino A. L. Ho C. , “Hypertrophic Cardiomyopathy Overview,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1768/>(last visited November 25, 2014).

Hershberger R. E. Morales A. , “Dilated Cardiomyopathy Overview,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1309/>(last visited November 25, 2014).

National Human Genome Research Institute, “DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program (GSP),” available at <http://www.genome.gov/sequencingcosts/>(last visited November 25, 2014).

Green E. D. Guyer M. S. , “Charting a Course for Genomic Medicine from Base Pairs to Bedside,” Nature 470, no. 7333(2011): 204–213.

Walsh T. , “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.

Shendure J. Aiden E. L. , “The Expanding Scope of DNA Sequencing,” Nature Biotechnology 30, no. 11(2012): 1084–1094.

Evans J. P. , “We Screen Newborns, Don't We?: Realizing the Promise of Public Health Genomics,” Genetics in Medicine 15, no. 5(2013): 332–334.

Harper A. R. Topol E. J. , “Pharmacogenomics in Clinical Practice and Drug Development,” Nature Biotechnology 30, no. 11(2012): 1117–1124.

Cressman A. M. Piquette-Miller M. , “Epigenetics: A New Link toward Understanding Human Disease and Drug Response,” Clinical Pharmacology & Therapeutics 92, no. 6(2012): 669–673.

Ku C. S. , “Studying the Epigenome Using Next Generation Sequencing,” Journal of Medical Genetics 48, no. 11(2011): 721–730.

Biesecker L. G. Green R. C. , “Diagnostic Clinical Genome and Exome Sequencing,” New England Journal of Medicine 371, no. 12(2014): 2418–2425.

Moyer V. A. , “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.

see also, Whitlock E. P. , “Screening for Hereditary Hemochromatosis: A Systematic Review for the U.S. Preventive Services Task Force,” Annals of Internal Medicine 145, no. 3(2006): 209–223.

Id.;

Kohane I. S. , “The Incidentalome: A Threat to Genomic Medicine,” JAMA 296, no. 2(2006): 212–15.

Burke W. , “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11(2013): 854–859, at 856.

Klitzman R. , “Return of Secondary Genomic Findings vs Patient Autonomy,” JAMA 310, no. 4(2013): 369–370, 369.

Ross L. F. , “Mandatory Extended Searches in All Genome Sequencing: ‘Incidental Findings,’ Patient Autonomy, and Shared Decision Making,” JAMA 310, no. 4(2013): 367–368, at 367.

Genetic Information Nondiscrimination Act of 2008, Pub. L. No. 110–233, 122 Stat. 881;

Rothstein M. A. , “Putting the Genetic Information Nondiscrimination Act in Context,” Genetics in Medicine 10, no. 9(2008): 655–656, at 655.

Klitzman R. , “Exclusion of Genetic Information From the Medical Record,” JAMA 304, no. 10(2010): 1120–1121;

National Human Genome Research Institute, “Genetic Discrimination,” available at <http://www.genome.gov/10002077>(last visited November 25, 2014).

Beauchamp T. L. Childress J. F. , Principles of Biomedical Ethics, 7th ed. (New York: Oxford University Press, 2012): At 106–110.

U.N. Educational, Scientific and Cultural Organization, Universal Declaration of Human Genome and Human Rights: Article 5(c), Resolution 16 adopted by the General Conference at its 29th Session, Records of the General Conference Vol. 1, at 43 (1997) [hereinafter Universal Declaration Article 5].

Task Force on Genetic Testing, Joint National Institutes of Health-Department of Energy Ethical, Legal and Social Implications Working Group of the Human Genome Project, Promoting Safe and Effective Genetic Testing in the United States, Chapter 1 (1997) available at <http://www.genome.gov/10002405>(last visited November 25, 2014) [hereinafter U.S. Task Force on Genetic Testing].

Wolf S. M. , “Patient Autonomy and Incidental Findings in Clinical Genomics,” Science 340, no. 6136(2013): 1049–1050, at 1049.

Allyse M. Michie M. , “Not-So-Incidental Findings: The ACMG Recommendations on the Reporting of Incidental Findings in Clinical Whole Genome and Whole Exome Sequencing,” Trends in Biotechnology 31, no. 8(2013): 439–441, at 439.

see Burke , supra note 13, at 855.

Klitzman , supra note 13.

Ross , supra note 13, at 368.

See ACMG Report supra note 1, at 568.

American College of Medical Genetics and Genomics, “ACMG Practice Guidelines: Incidental Findings in Clinical Genomics: A Clarification,” Genetics in Medicine 15, no. 8(2013): 664–666, 664 [hereinafter ACMG Clarification].

See ACMG Report supra note 1, at 570–571.

Cirino Ho , supra note 5.

Alders M. Mannens M. M. A. M. , “Romano-Ward Syndrome,” GeneReviews, available at <http://www.ncbi.nlm.nih.gov/books/NBK1129/>(last visited November 25, 2014).

See ACMG Report, supra note 1, at 569.

See Ross , supra note 13.

Klitzman , supra note 13.

Burke , supra note 13.

Wolf , supra note 15.

Allyse Michie , supra note 15.

See ACMG Report, supra note 1, at 568.

Id. (emphasis added).

American College of Medical Genetics and Genomics, “ACMG Updates Recommendation on “Opt Out” for Genome Sequencing Return of Results,” available at <https://www.acmg.net/docs/Release_ACMGUpdatesRecommendations_final.pdf>(last visited November 25, 2014).

See Maron D. F. , “Patients Can Now Choose Not to Know Their Own DNA Secrets,” Scientific American, April 1, 2014, available at <http://www.scientificamerican.com/article/patients-can-now-choose-not-to-know-their-own-dna-secrets/>(last visited November 25, 2014) (quoting ACMG President Gail Herman: “At this point we are not recommending selective opting out,”…. “Of course the physician and the patient can decide what is in the patient's best interest, but we are not [recommending] that at this level at this point”.

See PCSBI Report, supra note 1, at 64 (emphasis added).

Frankel T. , “Fiduciary Law,” California Law Review 71, no. 3(1983): 795–836, at 795; The present article offers a perspective of the physician as a fiduciary grounded in trust, agency, and health law. Still, others describe the physician as a “moral fiduciary of the patient ” and state that the moral foundations of the physician as a fiduciary are the virtues of: Self-effacement, self-sacrifice, compassion, and integrity. This view has different implications for the physician-patient relationship and results in the physician playing a more protective role for the patient.

Chervenak F. A. McCullough L. B. , “The Moral Foundation of Medical Leadership: The Professional Virtues of the Physician as Fiduciary of the Patient,” American Journal of Obstetrics and Gynecology 184, no. 5(2001): 875–880, at 876.

Restatement (Third) of Trusts § 2 (2003).

Restatement (Third) of Trusts § 3 (2003).

See Frankel , supra note 25, at 809–816.

Restatement (Third) of Trusts § 70 (2007) (Comment on Clause (b)).

Restatement (Third) of Trusts §§ 76, 78, 82 (2007).

Hafemeister T. L. Bryan S. P. , “Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing,” University of Kansas Law Review 57, no. 3(2009): 491–537, at 519–520.

Scott E. S. Scott R. E. , “Parents as Fiduciaries,” Virginia Law Review 81, no. 8(1995): 2401–2476, at 2401–2403.

Matthew D. B. , “Implementing American Health Care Reform: The Fiduciary Imperative,” Buffalo Law Review 59, no. 3(2011): 715–807, at 746.

Laby A. B. , “Resolving Conflicts of Duty in Fiduciary Relationships,” American University Law Review 54, no. 1(2004): 75–149, at 149.

Duncan M. J. , “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.

Rothstein M. A. Siegal G. , “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, 113–114.

but see Rodwin M. A. , “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, at 247–248.

DeMott D. A. , “Breach of Fiduciary Duty: On Justifiable Expectations of Loyalty and Their Consequences,” Arizona Law Review 48, no. 4(2006): 925–956, at 934–935.

Smith D. G. , “The Critical Resource Theory of Fiduciary Duty,” Vanderbilt Law Review 55, no. 5(2002): 1399–1497, at 1497.

See Matthew , supra note 29, at 745–747.

Restatement (Third) Of Agency § 1.01 (2006).

See Matthew , supra note 29, at 753–754.

See DeMott , supra note 30.

Smith supra note 30.

See Frankel , supra note 25, at 809.

Lockett v. Goodill, 430 P.2d 589, 591 (Wash.1967);

Hafemeister T. L. Spinos S. , “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, at 1187–1188.

Hall M. A. , Medical Liability and Treatment Relationships, 2nd ed., Been V. , eds. (New York: Wolters Kluwer Law and Business, 2008): At 173.

Lockett, 430 P.2d at 591.

Emmett v. E. Dispensary & Cas. Hosp., 396 F.2d 931, 935 (D.C. Cir. 1967).

Canterbury v. Spence, 464 F.2d 772, 782 (D.C. Cir. 1972).

Cobbs v. Grant, 502 P.2d 1, 11–12 (Cal. 1972).

Miller v. Kennedy, 522 P.2d 852, 860 (Wash. 1974).

Truman v. Thomas, 611 P.2d 902, 906 (Cal. 1980).

MacDonald v. Clinger, 446 N.Y.S.2d 801, 805 (1982).

Tighe v. Ginsberg, 540 N.Y.S.2d 99, 100 (1989).

Moore v. Regents of Univ. of California, 793 P.2d 479, 483 (Cal. 1990).

San Roman v. Children's Heart Ctr., Ltd., 954 N.E.2d 217, 223 (2010).

Walk v. Ring 44 P.3d 990, 999 (Ariz. 2002).

Lockett, 430 P.2d at 591.

Canterbury, 464 F.2d at 782.

See Rothstein Siegal , supra note 29, at 113–114.

Rodwin , supra note 29, at 247–248.

Canterbury, 464 F.2d at 782.

Parris v. Limes, 2012 OK 18, 277 P.3d 1259, 1265.

Cobbs, 502 P.2d at 12.

Miller, 522 P.2d at 860.

Truman, 611 P.2d at 906 (quotation marks omitted).

MacDonald, 446 N.Y.S.2d at 802, 805.

San Roman, 954 N.E.2d at 223.

Tighe v. Ginsberg, 540 N.Y.S.2d 99, 99 (1989).

see also American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics, Principles of Medical Ethics IV, available at <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/principles-medical-ethics.page?>(last visited November 25, 2014).

Moore v. Regents of Univ. of California, 793 P.2d 479, 483 (Cal. 1990).

but see Rodwin , supra note 29, at 247–248.

Pegram v. Herdrich, 530 U.S. 211 (2000).

American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics: Opinion 10.015: The Patient-Physician Relationship [hereinafter AMA Ethics Opinion 10.015], available at <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion10015.page?>(last visited November 25, 2014).

See ACMG Report, supra note 1, at 569, 572.

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, at 748.

See ACMG Report, supra note 1, at 568.

Restatement (Third) of Trusts § 82 (2007) (section c).

Restatement (Third) Of Agency § 8.11 (2006).

See ACMG Report, supra note 1, at 570–571.

Id., at 568.

Topol E. J. , “Individualized Medicine from Prewomb to Tomb,” Cell 157, no. 1(2014): 241–253.

Brooks-Wilson A. R. , “Genetics of Healthy Aging and Longevity,” Human Genetics 132, no. 12(2013): 1323–1338, at 1330.

Harris R. , “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.

Klitzman , supra note 13.

Ross , supra note 13.

Moyer , supra note 12.

Jonas D. E. , “Chapter 11: Challenges in and Principles for Conducting Systematic Reviews of Genetic Tests used as Predictive Indicators,” Journal of General Internal Medicine 27, Supp. 1 (2012): S83–S93, at S85.

See Moyer , supra note 12, at 278.

Klitzman , supra note 13.

Ross , supra note 13.

Burke , supra note 13, at 856.

but see ACMG Clarification, supra note 16, at 665.

Green R. C. , “Reporting Genomics Sequencing Results to Ordering Clinicians: Incidental, but Not Exceptional,” JAMA 310, no. 4(2013): 365–366.

McGuire A. L. , “Ethics and Genomic Incidental Findings,” Science 340, no. 6136(2013): 1047–1048.

See Lineweaver T. T. , “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.

but see Green R. C. , “Reveal Study Group: Disclosure of APOE Genotype for Risk of Alzheimer's Disease,” New England Journal of Medicine 361, no. 3(2009): 245–254.

See ACMG Report, supra note 1, at 570–571.

Alders Mannens , supra note 17.

Cirino Ho , supra note 5.

Timmermans S. Buchbinder M. , “Patients-in-Waiting: Living between Sickness and Health in the Genomics Era,” Journal of Health and Social Behavior 51, no. 4(2010): 408–423.

See Klitzman , supra note 13.

McGuire , supra note 55, at 1048.

Id.

See supra note 14.

See National Human Genome Research Institute, “Table of State Statutes Related to Genomics,” available at <http://www.genome.gov/27552194>(last visited November 25, 2014).

National Conference of State Legislatures, “Genetics and Life, Disability and Long-Term Care Insurance,” available at <http://www.ncsl.org/research/health/genetic-nondiscrimination-laws-in-life-disability.aspx>(last visited November 25, 2014).

See Klitzman , supra note 14, at 1121.

Rothstein M. A. , “GINA's Beauty Is Only Skin Deep,” Gene-Watch 22, no. 2(2009): 9–12.

In addition, with the advent of electronic health records many questions remain about what information should be included and how genetic information may be protected. The potential inclusion of genetic information in electronic medical records makes information about secondary targets even more material to patient interests given the added risk of privacy breaches for digitally stored information. Hazin R. , “Ethical, Legal, and Social Implications of Incorporating Genomic Information into Electronic Health Records,” Genetics in Medicine 15, no. 10(2013): 810–816, at 813.

Rothstein M. A. , “Access to Sensitive Information in Segmented Electronic Health Records,” Journal of Law, Medicine & Ethics 40, no. 2(2012): 394–400.

Restatement (Third) of Trusts § 82 (2007) (section c).

Restatement (Third) Of Agency § 8.11 (2006).

Canterbury, 464 F.2d at 787.

Id., at 788.

Cobbs, 502 P.2d at 12.

see also Beauchamp Childress , supra note 15, at 110, 137.

See Wolf , supra note 15, at 1049.

See PCSBI Report, supra note 1, at 66–68.

See Frankel , supra note 25, at 809–816.

Id., at 809.

See supra notes 36, 73.

See ACMG Report, supra note 1, at 568.

Restatement (Third) Of Agency § 8.05 (2006).

Restatement (Third) of Trusts § 78 (2007).

See Bouvia v. Superior Court of Los Angeles County, 225 Cal. Rptr. 297, 306 (1986).

see also Cruzan v. Mo. Dep't of Health 497 U.S. 261 (1990).

Id. (Bouvia), at 306.

Restatement (Third) Of Agency § 8.09 (2006).

Restatement (Third) of Trusts § 76 (2007).

See supra notes 41–42.

Schloendorff v. Society of New York Hosp., 105 N.E. 92, 93 (N.Y. 1914).

Cruzan, at 270 (1990).

Bouvia, at 306.

See Laby , supra note 29, at 113–114.

AMA Ethics Opinion 10.015, supra note 45.

See ACMG Report, supra note 1, at 568.

Restatement (Third) of Trusts § 74 (2007).

see also Restatement (Third) of Trusts § 78 (2007) (Commentaries c(3)).

Restatement (Third) of Trusts § 63 (2003).

Restatement (Third) Of Agency § 8.01 (2006).

Restatement (Third) Of Agency § 8.06 (2006).

See Truman, 611 P.2d, at 906.

See supra notes 36, 45, 77.

Restatement (Third) of Trusts § 78 (2007).

Restatement (Third) of Trusts § 76 (2007).

Restatement (Third) Of Agency § 8.01 (2006).

Restatement (Third) Of Agency § 8.10 (2006).

Restatement (Third) Of Agency § 8.05 (2006).

Restatement (Third) of Trusts § 78 (2007).

See AMA Ethics Opinion 10.015, supra note 45.

American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics: Opinion 10.01: Fundamental Elements of the Patient-Physician Relationship, available at <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion1001.page?>(last visited December 8, 2014).

See ACMG Report, supra note 1, at 568.

Green , supra note 55.

McGuire , supra note 55.

See Wolf , supra note 15, at 1049.

Allyse Michie , supra note 15, at 440.

See ACMG Report, supra note 1, at 567.

Universal Declaration Article 5, supra note 15.

U.S. Task Force on Genetic Testing, supra note 15.

PCSBI Report, supra note 1, at 64.

Wolf , supra note 15, at 1049.

Austl. Law Reform Comm'n, Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC Report 96) 360 (2003), available at <http://www.alrc.gov.au.libproxy.lib.unc.edu/sites/default/files/pdfs/publications/ALRC96_vol1.pdf>(last visited November 25, 2014).

Andorno R. , “The Right Not to Know: An Autonomy-Based Approach,” Journal of Medical Ethics 30, no. 5(2004): 435–439.

See Universal Declaration Article 5, supra note 15.

Katz Rothman B. , “Genetic Counselling: Placing the Room in Context,” in Rehmann-Sutter C. Müller H. , eds., Disclosure Dilemmas (2009): At 19, 22–23.

See PCSBI Report, supra note 1, at 64 (emphasis added).

See McGuire , supra note 55, at 1048.

See Klitzman , supra note 13, at 369.

Evans B. J. , “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, at 916.

Clayton E. W. , “Managing Incidental Genomic Findings: Legal Obligations of Clinicians,” Genetics in Medicine 15, no. 8(2013): 624–629.

Rothstein Siegal , supra note 29, at 94, 113–114.

See Evans , supra note 105, at 917.

Wolf , supra note 15, at 1049.

Pate v. Threlkel, 661 So.2d 278 (Fla. 1995).

Derse A. R. , “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).

See Safer v. Estate of Pack, 677 A.2d 1188, 1192 (N.J. Super. Ct. App. Div. 1996).

Tarasoff v. Regents of the University of California, 551 P.2d. 334 (Cal. 1976).

Offit K. , “The ‘Duty to Warn’ a Patient's Family Members about Hereditary Disease Risks,” JAMA 292, no. 12(2004): 1469–1473.

Clayton E. W. , “Ethical, Legal, and Social Implications of Genomic Medicine,” New England Journal of Medicine 349, no. 6(2003): 562–569, at 566.

Wilfond B. S. Nolan K. , “National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Lessons from Cystic Fibrosis,” JAMA 270, no. 24(1993): 2948–2954.

See Part IV, Section 1.

See Part IV, Sections 2–4.