Finding fault? Exploring legal duties to return incidental findings in genomic research

Georgetown Law Journal

Volumn 102, Issue 3, 2014, Pages 795-843

  Pike, Elizabeth R ^a,b   Rothenberg, Karen H ^c   Berkman, Benjamin E ^c  

^a Law and Health Care Program   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84899839573     PISSN: 00168092     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (83)

1. See, e.g., Francis S. Collins, Michael Morgan & Aristides Patrinos, The Human Genome Project: Lessons from Large-Scale Biology, 300 SCI. 286, 287 (2003).
2. See International Consortium Completes Human Genome Project, NAT'L HUMAN GENOME RES. INST. (Apr. 14, 2003), http://www.genome.gov/11006929.
3. See, e.g., Greer Donley, Sara Chandros Hull & Benjamin E. Berkman, Prenatal Whole Genome Sequencing: Just Because We Can, Should We?, HASTINGS CENTER REP., July-Aug. 2012, at 28, 28, 31.
4. See, e.g., Francis S. Collins, Eric D. Green, Alan E. Guttmacher & Mark S. Guyer, A Vision for the Future of Genomics Research, 422 NATURE 835, 836 (2003)
5. Olena Morozova & Marco A. Marra, Applications of Next-Generation Sequencing Technologies in Functional Genomics, 92 GENOMICS 255, 257-58 (2008)
6. Ben Tran et al., Cancer Genomics: Technology, Discovery, and Translation, 30 J. CLINICAL ONCOLOGY 647, 647 (2012).
7. See Susan M. Wolf et al., The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties, 36 J.L. MED. & ETHICS 361, 363 (2008) (defining IFs as "a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study").
8. See, e.g., Mildred K. Cho, Understanding Incidental Findings in the Context of Genetics and Genomics, 36 J.L. MED. & ETHICS 280, 280 (2008) (noting the "common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, 'incidental' or otherwise"); Wolf et al., supra note 6, at 362 ("Despite the potential to generate IFs during the course of research, researchers, Institutional Review Boards (IRBs), and universities have been conducting research with no agreement that they have any responsibility to address and report IFs.").
9. See, e.g., Susan M. Wolf, The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science, 13 MINN. J.L. SCI. & TECH. 435, 439 (2012) (calling work on the legal implications of IFs "surely needed")
10. Ellen Wright Clayton & Amy L. McGuire, The Legal Risks of Returning Results of Genomics Research, 14 GENETICS MED. 473, 475 (2012) (noting that "the possibility of exposing researchers to legal liability for negligence if results are not offered and returned deserves careful analysis").
11. See, e.g., Richard L. Furman, Jr., Genetic Test Results and the Duty to Disclose: Can Medical Researchers Control Liability?, 23 SEATTLE U. L. REV. 391, 404 (1999) ("No court has yet been faced with deciding whether a nonphysician medical researcher has an affirmative duty to disclose genetic test results to a research subject or other third party."); Wolf, supra note 12, at 436 ("There is no law directly on point.... To date, no reported legal case has been discovered that addresses return of results or incidental findings in the domain of research.").
12. See, e.g., PRESIDENTIAL COMM'N FOR THE STUDY OF BIOETHICAL ISSUES, PRIVACY AND PROGRESS IN WHOLE GENOME SEQUENCING 17, 106, 116-17 (2012) [hereinafter PRESIDENTIAL COMM'N]; Collins et al., supra note 4, at 836; Morozova & Marra, supra note 4, at 840.
13. See, e.g., Nicholas M. Orme et al., Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden, 170 ARCHIVES INTERNAL MED. 1525, 1528 (2010) (finding that approximately forty percent of imaging examinations had at least one IF).
14. Some have even argued that IFs could be in the thousands. For example, applying a set of criteria developed in 2010 by the National Heart, Lung, and Blood Institute (NHLBI), researchers analyzed whole-genome-sequence data from asymptomatic individuals and concluded that each had approximately 2,000 of the most serious category of variants; any or all of these variants could show up as IFs in research. See Christopher A. Cassa et al., Disclosing Pathogenic Genetic Variants to Research Participants: Quantifying an Emerging Ethical Responsibility, 22 GENOME RES. 421, 423 (2012)
15. see also Catherine Gliwa & Benjamin E. Berkman, Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?, AM. J. BIOETHICS, Feb. 2013, at 32, 37 ("Before any filtering, each exome typically has around 80,000 variants; each genome, 3 to 4 million.... Thus, the first step in identifying significant mutations is filtering the results to leave only those variants most likely to cause disease... This reduces the number of relevant exome variants to around 10,000-15,000.") (internal citations omitted).
16. See, e.g., Matthew P. Gordon, A Legal Duty to Disclose Individual Research Findings to Research Subjects?, 64 FOOD & DRUG L.J. 225, 228 (2009) (noting that "data will vary regarding predictive value, with a range from highly predictive of health outcomes to negligibly so"); Wolf et al., supra note 6, at 363 (noting that IFs range from "those that have clear clinical significance and reveal conditions that can be treated... to those whose clinical meaning is unknown").
17. See, e.g., Brodersen N. Henning et al., Anticipated Reactions to Genetic Testing for Hereditary Non-Polyposis Colorectal Cancer Susceptibility, 66 CLINICAL GENETICS 437, 437-38 (2004).
18. See, e.g., NAT'L INST. ON AGING, U.S. DEP'T OF HEALTH & HUMAN SERVS., ALZHEIMER'S DISEASE GENETICS FACT SHEET 4 (2011), available at http://www.nia.nih.gov/alzheimers/publication/alzheimers-disease-genetics-fact- sheet.
19. Vardit Ravitsky & Benjamin S. Wilfond, Disclosing Individual Genetic Results to Research Participants, AM. J. BIOETHICS, Nov./Dec. 2006, at 8, 8.
20. See, e.g., Lisa S. Parker, The Future of Incidental Findings: Should They be Viewed as Benefits?, 36 J.L. MED. & ETHICS 341, 344 (2008) ("Nevertheless, one must guard against assessing benefit solely in medical terms. Health risk information has enabled people to engage in reproductive and other life planning and has afforded many individuals psychological benefit, even when nothing could be done medically.").
21. See, e.g., Laura M. Beskow & Wylie Burke, Offering Individual Genetic Research Results: Context Matters, SCI. TRANSLATIONAL MED., June 30, 2010, at 1, 1 ("Genetic research typically involves informational risk, including the potential for psychosocial harm and for the loss of privacy or confidentiality.")
22. Annelien L. Bredenoord et al., Disclosure of Individual Genetic Data to Research Participants: The Debate Reconsidered, 27 TRENDS IN GENETICS 41, 43-44 (2011) (noting that "[t]he information disclosed to research participants could be harmful in several ways," including "adverse social and financial consequences, such as affecting someone's opportunity to obtain or maintain health insurance[,] and could potentially be stigmatizing")
23. Franklin G. Miller, Michelle M. Mello & Steven Joffe, Incidental Findings In Human Subjects Research: What Do Investigators Owe Research Participants?, 36 J.L. MED. & ETHICS 271, 277 (2008) ("Disclosing incidental findings carries the risk of distress in the subject, the risk of a false-positive finding, and the risk of physical harm from procedures to diagnose and (in some cases) treat the putative problem.").
24. David Kaufman et al., Subjects Matter: A Survey of Public Opinions About a Large Genetic Cohort Study, 10 GENETICS MED. 831, 837 (2008).
25. See, e.g., Susan M. Wolf et al., Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 36 J.L. MED. & ETHICS 219, 222 (2008)
26. See, e.g., Bredenoord et al., supra note 29, at 43 ("[I]f results are obtained in a research laboratory, feedback could also imply re-testing of the genetic data in an accredited clinical laboratory...."); Clayton & McGuire, supra note 12, at 474 ("Research testing typically does not meet the laboratory requirements of the clinic. There are reasons why tests whose results may be used to alter clinical care must be obtained in clinically approved laboratories... and interpreted by appropriately qualified clinicians."). There is some disagreement about whether this confirmation is, in fact, necessary. See, e.g., Richard R. Fabsitz et al., Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group, 10 CIRCULATION: CARDIOVASCULAR GENETICS 574, 576 (2010) ("Working Group members disagreed on the interpretation of what constitutes compliance with the CLIA regulations for the return of research results in genetics studies.").
27. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 44 Fed. Reg. 23, 192, 23,194 (Apr. 18, 1979) (codified at 45 C.F.R. pt. 46 (2010)) [hereinafter Belmont Report].
28. Robert C. Green et al., ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing, 15 GENETICS MED. 565, 571 (2013) (selecting variants to return that maximize benefits and minimize harms); Ravitsky & Wilfond, supra note 24, at 9 ("Beneficence requires that investigators offer results that are clinically useful, which means results are expected to be valuable to participants' physical or psychological well being, to their reproductive decision making or to their life planning.").
29. See, e.g., Leah Belsky & Henry S. Richardson, Medical Researchers' Ancillary Clinical Care Responsibilities, 328 BRITISH MED. J. 1494, 1494 (2004) (arguing that "everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves"); Beskow & Burke, supra note 29, at 1 ("A duty to rescue is based on the premise that, when confronted with a clear and immediate need, an individual who is in a position to help must take action to try to prevent serious harm when the cost or risk to self is minimal."); Miller, Mello & Joffe, supra note 29, at 273 (noting that "presented with a situation in which you can prevent something very bad from happening, or alleviate someone's dire plight, by making only a slight (or even moderate) sacrifice, then it would be wrong not to do so").
30. See, e.g., Peter Singer, The Drowning Child and the Expanding Circle, NEW INTERNATIONALIST MAG. (Apr. 5, 1997), www.newint.org/features/1997/04/05/ drowning/.
31. See, e.g., Henry S. Richardson & Leah Belsky, The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking About the Clinical Care That Researchers Owe Their Subjects, HASTINGS CENTER REP., Jan.-Feb. 2004, at 25, 26 ("Ancillary care is that which goes beyond the requirements of scientific validity, safety, keeping promises, or rectifying injuries.").
32. See, e.g., Isaac S. Kohane & Patrick L. Taylor, Multidimensional Results Reporting to Participants in Genomic Studies: Getting It Right, SCI. TRANSLATIONAL MED., June 23, 2010, at 1, 1 ("Participants believe that researchers are obligated to provide useful personal results.").
33. see also Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 838 (Md. 2001) ("The experiment is driven by the investigator's dedication to the advancement of knowledge... ; it is also driven by society's interest in future benefits that will flow from medical discoveries.").
34. Pilar N. Ossorio, Letting the Gene Out of the Bottle: A Comment on Returning Individual Research Results to Participants, AM. J. BIOETHICS, Nov./Dec. 2006, at 24, 25 ("[T]he practicalities of returning results may impose untenable burdens on the existing research infrastructure.").
35. A commonly accepted definition of "analytic validity" is how accurately and reliably the test measures the genetic variant of interest. See, e.g., Genomic Testing: ACCE Model Process for Evaluating Genetic Tests, CENTERS FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/genomics/gtesting/ACCE/ (last updated Jan. 3, 2010).
36. Amy L. McGuire, Timothy Caulfield & Mildred K. Cho, Research Ethics and the Challenge of Whole-Genome Sequencing, 9 NATURE REV. GENETICS 152, 153 (2008) (focusing on "the type of study, the clinical significance and reliability of the information, and whether the study involves patients... or healthy volunteers")
37. Mark A. Rothstein, Tiered Disclosure Options Promote the Autonomy and Well-Being of Research Subjects, AM. J. BIOETHICS, Nov./Dec. 2006, at 20, 20 (focusing on the subjective interests of research participants).
38. see also NATL BIOETHICS ADVISORY COMMN, RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS: ETHICAL ISSUES AND POLICY GUIDANCE 72 (1999), available at http://bioethics.georgetown.edu/nbac/hbm.pdf (relying on these factors); Fabsitz et al., supra note 33 (same)
39. NHLBI Working Group on Reporting Genetic Results in Research Studies, Meeting Summary, NAT'L HEART, LUNG, & BLOOD INST. (July 12, 2004) [hereinafter NHLBI Working Group], http://www.nhlbi.nih.gov/meetings/workshops/ gene-results.htm (same).
40. See, e.g., Susan M. Wolf, George J. Annas & Sherman Elias, Patient Autonomy and Incidental Findings in Clinical Genomics, 340 SCI. 1049, 1049-50 (2013)
41. Wylie Burke et al., Recommendations for Returning Genomic Incidental Findings? We Need to Talk!, 15 GENETICS MED. 854 (Aug. 1, 2013), http://www.nature.com/gim/journal/vaop/ncurrent/pdf/gim2013113a.pdf.
42. See generally Carla G. van El et al., Whole-Genome Sequencing in Health Care, 21 EUR. J. HUM. GENETICS 580 (2013).
43. Robert Klitzman et al., Processes and Factors Involved in Decisions Regarding Return of Incidental Genomic Findings in Research, GENETICS MED. (Sept. 26, 2013), http://www.nature.com/gim/journal/vaop/ncurrent/full/ gim2013140a.html.
44. Although a more detailed analysis is beyond the scope of this Article, a participant who was not told of an IF and who subsequently suffered injury would have even less of a chance of succeeding in a lawsuit upon bringing a breach of contract or property claim. A research participant bringing a breach of contract claim against a researcher for failing to return IFs could only succeed if the informed consent document were treated as a contract and the informed consent document made clear that IFs would be returned. Courts and scholars are divided about whether an informed consent document should be treated as a contract. See, e.g., Dahl v. HEM Pharm. Corp., 7 F.3d 1399, 1404-05 (9th Cir. 1993) (interpreting participation in a medical trial as a contract)
45. Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 843-44 (Md. 2001) (finding that the consent form created a bilateral contract between parties); Gordon, supra note 21, at 255 ("Informed consent documents have previously been treated as binding contracts by courts....")
46. Michelle N. Meyer, The Subject-Researcher Relationship: In Defense of Contracting Around Default Rules, AM. J. BIOETHICS, Apr. 2011, at 27, 28 ("Courts have increasingly held... that the research consent form constitutes a contract....").
47. But see, e.g., Wash. Univ. v. Catalona, 490 F.3d 667, 674-77 (8th Cir. 2007) (holding that the signed consent forms demonstrated the donors' intent to make a gift)
48. Natalie Ram, Assigning Rights and Protecting Interests: Constructing Ethical and Efficient Legal Rights in Human Tissue Research, 23 HARV. J.L. & TECH. 119, 163 (2009) ("Despite their frequent similarity in form to contracts, however, informed consent documents, whether tiered or otherwise, are generally not considered to be contractual documents.")
49. Richard S. Saver, At the End of the Clinical Trial: Does Access to Investigational Technology End As Well?, 31 W. NEW ENG. L. REV. 411, 428 (2009) (observing that some courts have "treat[ed] the informed consent documents as merely notice of the subjects' consent rather than an enforceable contract")
50. Wolf et al., supra note 6, at 372 ("[C]ourts have generally been reluctant to find binding contractual obligations in the research setting."). Research participants who are unsuccessful in bringing claims either in tort or for breach of contract may try to bring claims alleging a property right in their genetic-research results. Individuals claiming that they have a property right to information about themselves uncovered during research would require courts to find that individuals retain ownership interests in the biological material that they have contributed to research and the results derived there from - claims that courts have been unwilling to recognize. See, e.g., Yael Bregman-Eschet, Genetic Databases and Biobanks: Who Controls Our Genetic Privacy?, 23 SANTA CLARA COMPUTER & HIGH TECH. L.J. 1, 22-26 (2006) (noting that, in a number of cases, courts have not recognized an individual's property rights in biological specimens donated to research)
51. Radhika Rao, Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?, 35 J.L. MED. & ETHICS 371, 372 (2007) ("There are three important cases in which individuals have claimed ownership of their own bodies in the context of biomedical research. In all three cases, the courts refused to accord property rights to those who supply body parts for medical research...."); Wolf et al., supra note 6, at 372 ("In Ande v. Rock, researchers conducted a cystic fibrosis study on samples from newborns and did not inform parents of a newborn who tested positive of the results. The parents claimed a property right to these test results and argued that if this information had been disclosed, they could have avoided harm in two ways: they would have been able to accept treatment for their child to lessen the severity and progression of her disease, and they would have chosen not to have a second child who was also diagnosed with cystic fibrosis. None of their claims to this information succeeded."). It is therefore extremely unlikely that a research participant can succeed in claiming that she has a property right in her genomic information that includes a derivative right to obtain IFs.
52. See, e.g., Elizabeth R. Pike, Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants, 38 AM. J.L. & MED. 7, 27-29 (2012) (articulating the many reasons that injured research participants will always have difficulty recovering in tort).
53. See, e.g., DAN B. DOBBS, PAUL T. HAYDEN & ELLEN M. BUBLICK, THE LAW O F TORTS § 124 (2d ed. 2011) (setting forth the elements of a tort law negligence claim); Ram, supra note 96, at 156-57 (same).
54. Diane E. Hoffmann & Karen H. Rothenberg, Whose Duty Is It Anyway?: The Kennedy Krieger Opinion and Its Implications for Public Health Research, 6 J. HEALTH CARE L. & POL'Y 109 (2002), 111-12 ("[T]he law provides that there is 'no duty to act affirmatively for the benefit of others in the absence of some special relationship.'").
55. See, e.g., Furman, supra note 13, at 400 ("Under common law, a person owes no duty to control the conduct of another or to warn others of anticipated conduct."). One such exception may occur in cases where an individual created the risk of physical or emotional harm. See, e.g., RESTATEMENT (THIRD) OF TORTS § 18 (2010)
56. See, e.g., Pehle v. Farm Bureau Life Ins. Co., Inc., 397 F.3d 897, 902 (10th Cir. 2005) ("A duty arises when 'a relation exists between the parties [such] that the community will impose a legal obligation upon one for the benefit of the other....'")
57. Stanley v. McCarver, 92 P.3d 849, 851 (Ariz. 2004) ("Duties may also arise from a special relationship between the parties....")
58. See, e.g., Leslie A. Meltzer, Undesirable Implications of Disclosing Individual Genetic Results to Research Participants, AM. J. BIOETHICS, Nov./Dec. 2006, at 28, 29 ("[P]hysicians are fiduciaries to their patients. This means that physicians have not only an ethical, but also a legal duty to act solely for the benefit of their patients.")
59. Thomas L. Hafemeister & Selina Spinos, Lean on Me: A Physician's Fiduciary Duty to Disclose an Emergent Medical Risk to the Patient, 86 WASH. U. L. REV. 1167, 1186-87 (2009).
60. See, e.g., Elizabeth R. Pike, Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants, 38 AM. J.L. & MED. 7, 12 (2012) ("In fact, many elements of research - placebo-controlled trials, random assignment to treatment arms, restricted flexibility in adjusting dosages, restrictions on using concomitant medications - are contrary to good medical care.").
61. See, e.g., Stanley v. McCarver, 92 P.3d 849, 853 (Ariz. 2004) ("[I]n placing oneself in the hands of a medical professional, even at the request of one's employer or insurer, one may have a reasonable expectation that the expert will warn of any incidental dangers of which he is cognizant due to his peculiar knowledge of his specialization.") (internal quotation marks omitted)
62. Reed v. Bojarski, 764 A.2d 433, 443 (N.J. 2001) ("[T]he patient is entitled to rely on the physician to tell him of a potential serious illness if it is discovered. Any reasonable person would expect that and the duty to communicate with a patient who is found to be ill is non-delegable.")
63. Meinze v. Holmes, 532 N.E.2d 170, 173-74 (Oh. Ct. App. 1987) (holding that third-party doctors had a duty to communicate a significant risk of danger to the plaintiff, even in the absence of a doctor-patient relationship).
64. See, e.g., Whitlock v. Duke Univ., 637 F. Supp. 1463, 1471 (M.D.N.C. 1986) (holding that the federal research regulations provided the standard of care), aff'd, 829 F.2d 1340 (4th Cir. 1987)
65. Daum v. SpineCare Med. Grp., 61 Cal. Rptr. 2d 260, 273 (Cal. Ct. App. 1997) (same)
66. Vodopest v. MacGregor, 913 P.2d 779, 787 (Wash. 1996) (same)
67. Roger L. Jansson, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 WASH. L. REV. 229, 247 (2003) ("[T]here appears to be an emerging trend among courts to use the federal regulations as the standard of care for informed consent in human subject research.").
68. At least one leading case, Grimes v. Kennedy Krieger Inst., Inc., has concluded that a researcher's obligations may extend significantly beyond the federal regulations. 782 A.2d 807 (Md. 2001). The Supreme Court of Maryland noted that research can, and normally will, give rise to special relationships that obligate researchers beyond the general tort law duty not to cause injury. Id. at 834-35. This special relationship arises, in part, because "investigators are in a better position to anticipate, discover, and understand the potential risks to the health of their subjects." Id. at 851. Several scholars have expressed concern about the implication of Grimes in the context of IFs - that Grimes indicates "that a legal trend may be emerging toward recognizing an obligation on the part of a researcher to provide a research participant with information acquired from a study, when that information has clinical implications for the participant." Wolf et al., supra note 6, at 365. To the extent Grimes is extended or followed in other courts, a court could conclude that researchers have a legal duty to return IFs in certain circumstances. See, e.g., Gordon, supra note 21, at 234. But courts that have considered similar fact patterns have generally refused to extend the holding of Grimes, and Grimes has been the subject of significant scholarly criticism. See, e.g., Hoffmann & Rothenberg, supra note 101, at 147.
69. See, e.g., Stanley v. McCarver, 92 P.3d 849, 854 n.6 (Ariz. 2004). ("While rules of professional conduct may provide evidence of how a professional would act, they do not create a duty or establish a standard of care as a matter of law.")
70. See, e.g., Stanley v. McCarver, 92 P.3d 849, 854 n.6 (Ariz. 2004) ("We continue to believe, however, that while such rules may illuminate the standard of care, they do not serve as a basis on which to impose a duty.")
71. See, e.g., Sawlani v. Mills, 830 N.E.2d 932, 938 (Ind. Ct. App. 2005) ("No matter how negligent the doctor's performance, it can never be the proximate cause of the patient's death. Since the evidence establishes that it is more likely than not that the medical problem will kill the patient, the disease or injury would always be the cause-in-fact."
72. (quoting Mayhue v. Sparkman, 653 N.E.2d 1384, 1387 (Ind. 1995)))
73. Joseph H. King, Jr., Causation, Valuation, and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 YALE L.J. 1353, 1358 (1981) ("The disease was obviously a cause of the harm. The doctor's negligence in allowing the disease to progress may also have caused harm.").
74. See, e.g., Matsuyama v. Birnbaum, 890 N.E.2d 819, 823 (Mass. 2008) ("[T]he loss of chance doctrine views a person's prospects for surviving a serious medical condition as something of value, even if the possibility of recovery was less than even prior to the physician's tortious conduct.")
75. David A. Fischer, Tort Recovery for Loss of a Chance, 36 WAKE FOREST L. REV. 605, 611 (2001) ("Loss of a chance is often justified in these cases because the physician breached a duty to protect the patient from the preexisting condition, and the patient would have placed high value on the chance of a cure even if it was less than 50 percent.").
76. Wolf et al., supra note 6, at 371-72 (noting that loss of a chance "can be applied more broadly" and that "[a] number of courts have used the doctrine to allow recovery for 'failure to protect a person from a pre-existing condition'" (quoting RESTATEMENT (THIRD) OF TORTS § 26 (2005)
77. See, e.g., Pipe v. Hamilton, 56 P.3d 823, 827 (Kan. 2002) ("The proportional damage approach ensures that a plaintiff recovers only the loss attributable to the loss of chance and not for an arbitrary amount awarded by the jury or for the total damages sustained.")
78. See Sawlani v. Mills, 830 N.E.2d 932, 947 (Ind. Ct. App. 2005). An interesting caveat in the research context is that had the participant never enrolled in research and never had his whole genome sequenced, he would be unlikely to have learned about his predisposition, potentially negating a claim that he lost a chance to prevent a harm.
79. This Article is not the first to suggest a clearer, more consistent standard. See, e.g., Richard R. Sharp & Morris W. Foster, Clinical Utility and Full Disclosure of Genetic Results to Research Participants, AM. J. BIOETHICS, Nov./Dec. 2006, at 42, 43 (proposing several approaches to standardize the return of IFs, including making "determinations on a case-by-case basis according to the researcher's assessment of the pertinent values at stake (the current default position)").
80. See, e.g., Stanley v. McCarver, 92 P.3d 849, 855 (Ariz. 2004) ("Finally, we note that doctors may deal with this issue as a matter of contract. They may, for example, require x-ray subjects to consent to having the results reported only to the employers.").
81. See, e.g., Beskow & Burke, supra note 29, at 2 (noting that some have suggested that "the failure to return clinically meaningful research results to individuals 'seems, at least in extreme situations, immoral, possibly illegal, and certainly unwise'" (quoting Henry T. Greely, The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks, 8 ANN. REV. GENOMICS & HUM. GENETICS 343, 359 (2007)))
82. Kayte Spector-Bagdady & Elizabeth R. Pike, Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information, 92 NEB. L. REV. (forthcoming Jan. 2014), available at http://papers.ssrn.com/sol3/papers.cfm? abstract-id=2343723 (discussing the emergence and significance of genomic interpretation services).
83. See, e.g., Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 838 (Md. 2001) ("The experiment is driven by the investigator's dedication to the advancement of knowledge... ; it is also driven by society's interest in future benefits that will flow from medical discoveries.")