This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the trade-offs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”
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References
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See, e.g., A.Banerjeeet al., “What Can Quality Improvement Learn From Evidence-Based Medicine?”Journal of the Royal Society of Medicine105, no. 2 (2012): 55-59; S. D. Pearson, “Cost, Coverage, and Comparative Effectiveness Research: The Critical Issues for Oncology,” Journal of Clinical Oncology 30, no. 34 (2012): 4275-4281 (discussing the development of comparative effectiveness research in oncology as driven in part by a desire to constrain costs, which some found to be controversial); see generally R. Avraham, D. A. Hyman, and C. M. Silver, Economics of Health Law (forthcoming 2016). When unexamined, medical treatments that do more harm than good may go unchallenged for years. See A. Ghossain, “History of Mastectomy Before and After Halsted,” Lebanese Medical Journal 57, no. 2 (2009): 65–71.
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See generally P. L.Young and L.Olsen, The Healthcare Imperative: Lowering Costs and Improving Outcomes(Washington, D.C.: National Academies Press, 2010).
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See, e.g., D.Wendleret al., “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries' Health Needs?”American Journal of Public Health94, no. 6 (2004) 923-928 (discussing the ethics of international “standard of care” trials).
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Id. These studies sometimes also have a control group, in addition to the two treatment arms. See id., at 924 (discussing the need for control groups in international “standard of care” trials). The value of the control group is that it “provid[es] rigorous evidence to guide what should be considered the standard of care.”B. T.Thompson and D.Schoenfeld, “Usual Care as the Control Group in Clinical Trials of Nonpharmacologic Interventions,”Proceedings of the American Thoracic Society Journal4, no. 7 (2007): 577-582, at 580; see also S. Tavernise, “Study of Babies Did Not Disclose Risks, U.S. Finds,” New York Times, April 10, 2013, available at <http://www.nytimes.com/2013/04/11/health/parents-of-preemies-werent-told-of-risks-in-study.html> (discussing the lack of a control group in SUPPORT) (last visited July 6, 2016).
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For a thoughtful treatment of the duties of medical personnel, especially medical researchers, see J.Menikoff and E. P.Richards, What the Doctor Didn't Say: The Hidden Truth About Medical Research (New York: Oxford University Press, 2006).
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D.Magnus and A. L.Caplan, “Risk, Consent, and SUPPORT,”New England Journal of Medicine368, no. 20 (2013): 1864-1865, at 1865; see also D. Magnus, “The SUPPORT Controversy and the Debate over Research within the Standard of Care,” American Journal of Bioethics 13, no. 12 (2013): 1-2 (introducing a special issue of the American Journal of Bioethics covering SUPPORT). For a recent controversy over a study authorized as “minimal risk” and waiving consent, see C. U. Niemann et al., “Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function,” New England Journal of Medicine 373, no. 5 (2015): 405-414; Letter from Public Citizen to Jerry Menikoff, Director, The Office for Human Research Protections, & to J. Thomas Puglisi, Chief Officer, The Office of Veterans' Affairs Office of Research Oversight, April 20, 2016, available at <http://www.citizen.org/documents/2315.pdf> (last visited July 6, 2016).
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See Transcript, supra note 8.
12.
Schloendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).
13.
See J. W.Berget al., Informed Consent: Legal Theory and Clinical Practice, 2nd ed. (New York: Oxford University Press, 2001): 2, 14; B. Lo, Resolving Ethical Dilemmas: A Guide For Clinicians, 2d ed. (New York: Wolters Kluwer, 2000): 3, 21.
14.
See, generally, Presidential Commission for the Study of Bio-ethical Issues, “‘Ethically Impossible’: STD Research in Guatemala from 1946 to 1948,” (2011): at 99-101, available at <http://bioethics.gov/node/654> (last visited July 6, 2016). U.S. Dept. of Health and Human Services (DHHS), The Common Rule, available at <http://www.hhs.gov/ohrp/humansubjects/commonrule/> (last visited July 6, 2016).
See Wilson, Promise of Informed Consent, supranote *, at 2 (citation omitted).
18.
General Requirements for Informed Consent, 45 C.F.R. § 46.116 (2015).
19.
Fifteen governmental departments have codified the Common Rule, requiring that the human research they fund adhere to it: Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce - National Institute of Standards and Technology, Consumer Product Safety Commission, Agency for International Development (USAID), Department of Housing and Urban Development, Department of Justice - National Institute of Justice, Department of Defense, Department of Education, Department of Veterans Affairs - Office of Research Oversight - Office of Research and Development, Environmental Protection Agency - Research and Development, Department of Health and Human Services, National Science Foundation, and the Department of Transportation. Three additional agencies follow the Common Rule via executive order: the Central Intelligence Agency, Department of Homeland Security, and Social Security Administration. U.S. Dep't of Health and Human Services, Federal Policy for the Protection of Human Subjects (‘Common Rule’), supra note 14.
20.
See DHHS, supra note 14.
21.
General Requirements for Informed Consent, 45 C.F.R. § 46.116.
22.
See Transcript, supra note 8, at 24 (statement of Lois Shepard).
23.
See Wilson, “Promise of Informed Consent,”supra note *, at 4.
24.
Id., at 3.
25.
71 Nev. 280 (1955).
26.
Id. at 282.
27.
Id.
28.
Id.
29.
Id., at 283.
30.
Id., at 281. Mrs. Corn also sued Dr. French for negligently removing her breast because he never performed the promised biopsy. Id.
31.
Id.
32.
Id., at 284.
33.
Id. Mrs. Corn also failed to adduce sufficient evidence of Dr. French's negligence to reach the jury, the trial court found. Her own expert admitted that he also would have removed Mrs. Corn's her breast without a biopsy, even though “ordinarily[,]… a biopsy would have been done” first. Id., at 287.
34.
Corn v. French, 74 Nev. 329, 330 (1958).
35.
Corn, 71 Nev. at 285. Mrs. Corn's negligent diagnosis claim also should have gone to the jury. Id., at 290-91, 296.
36.
Mrs. Corn asked for and received “[i]nstructions fixing defendant's liability if he operated without plaintiff's consent or after revocation of her consent.” The trial judge also instructed the jury that Dr. French would be liable if he did not follow “standard practice in the community;” in the end, the jury remained unconvinced. Id.
37.
317 P.2d 170 (Cal. App. 1957).
38.
Berg, et al., supranote 13, at 44.
39.
Salgo, 317 P.2d at 181.
40.
Id. (citations omitted).
41.
Id., at 172.
42.
Id., at 177–78.
43.
Id., at 180.
44.
Id., at 172.
45.
Id., at 181.
46.
See Wilson, Promise of Informed Consent, supranote *, at 6.
47.
Id.
48.
Culbertson v. Mernitz, 602 N.E.2d 98, 98–103 (Ind. 1992); id.
49.
Canterbury v. Spence, 464 F.2d 772, 778 (D.C. Cir. 1972); see also A.Meisel, “Canterbury v. Spence: The Landmark Case,” in S. H.Johnson, J. H.Krause, R. S.Saver, and R.Fretwell Wilson, eds., Health Law & Bioethics: Cases in Context(Aspen Publishers, 2009): at 9, 17, 18, 19.
50.
479 So. 2d 1150, 1152 (1985).
51.
Id., at 1151.
52.
Id.
53.
Id., at 1152.
54.
Id.
55.
Id., at 1156.
56.
519 P.2d 981 (Wash. 1974) (holding that custom was not determinative of the reasonableness inquiry in a medical negligence case).
57.
Id., at 983.
58.
Canterbury, 464 F.2d at 772.
59.
Id., at 776.
60.
Id., at 787 (citation omitted).
61.
See D. M.Studdertet al., “Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks,”Journal of Empirical Legal Studies4, no. 1 (2007): 103-124, at 105, 106.
62.
R.Gatter, “Informed Consent Law and the Forgotten Duty of Physician Inquiry,”Loyola University Chicago Law Journal31, no. 4 (2000): 557-597, at 559.
63.
See e.g., M. C.Rowbothamet al., “Interactive Informed Consent: Randomized Comparison with Paper Consents,”PLOS ONE8, no. 3 (2013): 1 (finding that consent obtained using interactive devices, such as iPads and videos, is more effective than paper forms at conveying risks and benefits of procedures).
64.
Id.; R. M.Hrobak and R.Fretwell Wilson, “Emergency Contraceptives or ‘Abortion-Inducing’ Drugs? Empowering Women to Make Informed Decisions,”Washington & Lee Law Review71, no. 2 (2014): 1386-1428, at 1426.
65.
R.Gatter, “Walking the Talk of Trust in Human Subjects Research: The Challenge of Regulating Financial Conflicts of Interest,”Emory Law Journal52, no. 1 (2003): 327-401, at 377.
66.
E. M.Tenenbaum, “Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation,”Oklahoma Law Review64, no. 5 (2012): 697-758, at 720.
67.
See Wilson, Promise of Informed Consent, supra note *, at 3.
68.
See Ethically Impossible, supra note 14, at 99.
69.
Id.
70.
Id. (citations omitted).
71.
Id.
72.
H. A.Washington, Medical Apartheid: The Dark History Of Experimentation From Colonial Times To The Present (New York: Broadway Books, 2006).
73.
Centers for Disease Control and Prevention, “The Tuskegee Timeline,”December10, 2013, available at <http://www.cdc.gov/tuskegee/timeline.htm> (last visited July 6, 2016).
74.
Id.
75.
F. D.Gray, The Tuskegee Syphilis StudyMontgomery: NewS-outh Books 1998): 74-79; see also Wilson, Promise of Informed Consent supra note *, at 12.
76.
This protection was enacted as part of the National Research Act of 1974 and codified with the Church Amendment. 42 U.S.C. § 300a-7(c) (2012); see also D.McLellan, “Ernest Hendon, 96; Tuskegee Syphilis Study's Last Survivor,”L.A. Times, January25, 2004, available at <http://articles.latimes.com/2004/jan/25/local/me-hendon25> (last visited July 6, 2016).
77.
General Requirements for Informed Consent, 45 C.F.R. § 46.116 (2015).
78.
The trial was sponsored by the University of Pennsylvania and the Children's Hospital of Philadelphia. See Wilson, Estate of Gelsinger, supra note *, at 230.
79.
Id., at 229.
80.
Id., at 237-238, 242 (citing Letter from Dennis E. Baker, Assoc. Comm'r for Regulatory Affairs, FDA. Ctr. for Biologics Evaluation & Research to James M. Wilson, Inst. for Human Gene Therapy, Univ. of Pa. Health Sys. (Feb. 8, 2002), available at <http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm144564.htm> (notice of opportunity for hearing)).
81.
R.Fretwell Wilson, “The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research,”American Journal of Law & Medicine36, nos. 2-3 (2010): 295-325, at 303-304 (reproducing the consent form at 7) [hereinafter Death of Gelsinger].
82.
See id., at 299; Wilson, Estate of Gelsinger, supra note *, at 233.
83.
Wilson, Estate of Gelsinger, supra note *, at 237 (reproducing the consent form for the study).
84.
Wilson, Death of Gelsinger, supra note 81, at 303 (quoting the consent form for the study).
85.
Id., at 304 (emphasis added).
86.
See P. S.Appelbaumet al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,”Hastings Center Report17, no. 2 (1987): 20–25.
87.
M. K.Cho and D.Magnus, “Therapeutic Misconception and Stem Cell Research,” Nature.com, September27, 2007, available at <http://www.nature.com/stem-cells/2007/0709/070927/full/stemcells.2007.88.html> (citing P. Appelbaum, C. Lidz, and T. Grisso, “Therapeutic Misconception in Clinical Research: Frequency and Risk Factors,” IRB: Ethics of Human Research 26, no. 2 (2004): 1-8) (last visited July 6, 2016).
88.
Wilson, Estate of Gelsinger, supra note *, at 251–253.
89.
Wilson, Death of Gelsinger, supra note 81, at 305; see also id., at 237-238 (summarizing University of Pennsylvania documents valuing Wilson's equity interest in a sponsor of the research as between $28.5 and 33 million).
90.
Wilson, Estate of Gelsinger, supra note *, at 248.
E. H.Morreim, “Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities,”Journal of Law, Medicine & Ethics32, no. 3 (2004): 474-484, at 476 (citing Spenceley v. M.D. Anderson Cancer Center, 938 F. Supp. 398, 398 (S.D. Tex. 1996)).
CLD describes long-term respiratory problems that sometimes result from premature birth. See, e.g., R. E.Behrman and A.Stith Butler, eds., Preterm Birth: Causes, Consequences, and Prevention (2007): 319–321.
102.
Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT Study), University of Alabama at Birmingham Protocol 2 (emphasis added), Updated March 28, 2005, available at <https://www.nih.gov/sites/default/files/institutes/foia/support-protocol.pdf> [hereinafter UAB Protocol].
103.
See Carlo, supra note 5, at 1960.
104.
The Protocol outlined the trade-offs from oxygen therapy: [O]xygen toxicity can result in increased risk for CLD, retinopathy of prematurity (ROP), and other disorders. Alternatively, oxygen restriction may impair neurodevelopment.… While prevention of hyperoxia [excess oxygen] may decrease the risk for ROP and CLD, efforts to maintain lower oxygenation levels may result in an increase in periods of hypoxemia [low oxygen] because of the marked variability in oxygen in ELBW infants.… Thus, it is necessary to determine if lower oxygenation levels that may prevent ROP and CLD are deleterious for brain development and result in impaired neurologic outcome. UAB Protocol, supra note 102, at 2-3 (emphasis added).
105.
Id.
106.
Id,. at 2.
107.
UAB Protocol, supra note 102, at 2 (“[T]here is no current agreement on the accepted SpO2 ranges for managing the ELBW infant from birth.”).
108.
C. H.Coleet. al., “Resolving Our Uncertainty about Oxygen Therapy,”Pediatrics112, no. 6 (2003): 1415-1419, at 1417.
109.
Id. (emphasis added). Similarly, a report published in 2011 based on references predating the February 2005 beginning of the SUPPORT Study, noted “two opposing concerns.” These were that “[l]ess inspired oxygen [under 90%] may increase patent ductus arteriosus, pulmonary vascular resistance and apnoea, and impair survival and neuro-development. More inspired oxygen [greater than 90%] may increase severe [retinopathy] and chronic lung disease.”L. M.Askieet al., “Neoprom: Neonatal Oxygenation Prospective Meta-Analysis Collaboration Study Protocol,”BMC Pediatrics11, no. 6 (2011): 1-9 at 3 (emphasis added). Similarly, commentaries published in October 2006, as SUPPORT was enrolling infants, expressed continuing concerns about these tradeoffs: Lowering oxygen saturation targets in preterm infants in the first few weeks of life has been shown to reduce the incidence of certain complications; however, prolonged periods of hypoxemia may result in poor growth, cardiopulmonary complications of chronic lung disease, neurodevelopmental disabilities, or increased mortalities. J. S. Greenspan and J.P. Goldsmith, “Oxygen Therapy In Preterm Infants: Hitting The Target,” Pediatrics 18, no. 4 (2006) 1740-1741, at 1740 (emphasis added). A 2009 review, before the end of SUPPORT, assessed whether oxygen levels affect “mortality, [ROP], lung function, [and] growth or development” and found that “the restriction of oxygen significantly reduced the incidence and severity of retinopathy of prematurity without unduly increasing death rates.” See L. M. Askie et. al., “Restricted Versus Liberal Oxygen Exposure for Preventing Morbidity and Mortality in Preterm or Low Birth Weight Infants,” Cochrane Database of Systematic Reviews (2009),available at <http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001077.pub2/pdf> (emphasis added). Although one study reviewed showed “increased rates of chronic lung disease and home oxygen use,” the review concluded that “the question of what is the optimal target range for maintaining blood oxygen levels in preterm/LBW infants was not answered by the data available for inclusion in this review.” Id. (emphasis added).
110.
See UAB Protocol, supra note 102, at 2.
111.
Id., at 17.
112.
R.Macklin and L.Shepherd, “Informed Consent and Standard of Care: What Must Be Disclosed,”American Journal of Bio-ethics13, no. 12 (2013): 9-13, at 11.
113.
Id. (“According to the available evidence, however, the likelihood that infants outside the study would have been intentionally maintained at the lower oxygen target range was very low.”) (citing C. G. Anderson, W. E. Benitz, and A. Madan, “Retinopathy of Prematurity and Pulse Oximetry: A National Survey of Recent Practices,” Journal of Perinatology 24, no. 3 (2004): 164-168, at 164-168) (surveying 120 NICUs).
114.
J. D.Lantos and C.Feudtner, “SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies,”Hastings Center Report45, no. 1 (2015): 30-40, at 37 (“Many neonatologists chose other [oxygen saturation] targets as their standard NICU protocols. Rather than imagining that the conventional treatment at the time was to target 85 to 95 percent, a more accurate statement would be that, in each NICU, there was a different target and that most of those targets were within the range of 85 to 95 percent. Some, as part of their standard practice, targeted the lower end of the range. Others targeted the higher end.”).
115.
UAB Protocol, supra note 102, at 17.
116.
Id. (“These interventions will be delivered using specially developed pulse oximeters whose displays (the actual readings seen by caretakers) will be adjusted so that the randomized range of SpO2 (either 85%–89%, or 91%–95%) will be indicated by a range of 88%–92%.”).
117.
Id.
118.
Id., at 17–18.
119.
Letter from the Office for Human Research Protections to the University of Alabama at Birmingham at 3, June 4, 2013, available at <http://www.hhs.gov/ohrp/detrm_letrs/YR13/jun13a.pdf> [hereinafter June 4, 2013 Letter] (last visited July 6, 2016).
120.
See Carlo, supra note 5, at 1960.
121.
BPD is a “form of chronic lung disease that affects newborns (mostly premature) and infants. It results from damage to the lungs caused by mechanical ventilation (respirator) and long-term use of oxygen.” Bronchopulmonary Dysplasia, American Lung Associationhttp://www.lung.org/lung-health-and-diseases/lung-disease-lookup/bronchopulmonary-dysplasia/ (Last visited May 5, 2016).
122.
See UAB Protocol, supra note 102, at 19.
123.
See Carlo, supra note 5, at 1960 (noting ROP also causes “other visual disabilities in preterm infants. The incidence of [ROP] was increased with exposure to unrestricted oxygen supplementation in preterm infants in randomized controlled trials performed in the 1950s”). Id.
124.
Id.
125.
See Letter from the Office of Human Research Protections to the University of Alabama at Birmingham at 5, March 7, 2013, available at <http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf> [hereinafter March 7, 2013 Letter] (last visited July 6, 2016).
Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT Study), University of Alabama at Birmingham Consent Form 2 (Oct. 1, 2004) (emphasis added)available at <http://www.citizen.org/documents/support-study-consent-form.pdf> [hereinafter UAB Consent Form] (last visited July 6, 2016).
128.
Id., at 2 (emphasis added).
129.
See Macklin and Shepherd, supra note 112, at 11.
130.
UAB Consent Form, supra note 128, at 4.
131.
Id. (emphasis added).
132.
Id.
133.
See UAB Protocol, supra note 102, at 17–18.
134.
Memorandum from Suzanne Murrin, Deputy Inspector General for Evaluations and Inspections, to Jerry Menikoff, Director, OHRP (Sept. 14, 2014), available at <http://oig.hhs.gov/oei/reports/oei-01-14-00560.pdf> (last visited July 6, 2016).
135.
March 7, 2013 Letter, supra note 126, at 2, 9. Amended to remove an institution not involved in SUPPORT and resent on March 7, 2013. Id.
136.
Id., at 10.
137.
Id., at 4 (citing UAB Protocol at 2, 3).
138.
June 4, 2013 Letter, supra note 119, at 2.
139.
Id., at 9.
140.
See March 7, 2013 Letter, supra note 126, at 12. While it is true that these other trials were shut down based in part on SUPPORT findings, depending on how early the trade-off between blindness and death emerged during the SUPPORT study, SUPPORT researchers may have had a duty to—as two international counterparts had done—“shut down [the study] early.” N. Feldman, “Courts Can't Mend a Parent's Broken Heart,” Bloomberg View, September 10, 2015, available at <http://www.bloombergview.com/articles/2015-09-10/courts-can-t-mend-a-parent-s-broken-heart> (making this observation about the international studies). Investigators should be cognizant of “negative adverse reactions or events that a trial participant experiences during the conduct of the trial[,] [and these] should be documented. The investigators monitor for adverse reactions or events to determine safety during a clinical trial.” J. P. E. Karlberg and M. A. Speers, eds., Reviewing Clinical Trials: A Guide for the Ethics Committee (2010): at 38, available at <https://www.pfizer.com/files/research/research_clinical_trials/ethics_committee_guide.pdf> (last visited July 6, 2016); see also D. A.Sica, “Premature Termination of Clinical Trials - Lessons Learned,”4(3) Journal of Clinical Hypertension (2002): 219-225, at 220 (discussing the “[s]everal factors [that] can influence the decision to terminate an ongoing clinical trial including ethical concerns, alterations in accepted clinical practice that make the continuation of a clinical trial unwise, and/or reaching a positive or negative statistical end point earlier than anticipated”) (emphasis added); see Niemann, supra note 10 (detailing a study that was terminated after a negative endpoint became evident).
141.
See, e.g., J. M.Drazenet al., “Informed Consent and SUPPORT,”New England Journal of Medicine368, no. 20 (2013): 1929-1931, at 1930; Carlo, supra note 5; see also K. Hudson, A. Guttmacher, and Francis Collins, “In Support of SUPPORT: A View from the NIH,” New England Journal of Medicine 368, (2013): 2349–2351.
See, e.g., Lantos and Feudtner, supra note 114, at 37.
145.
See UAB Protocol, supra note 102, at 3.
146.
See Drazen, supra note 142, at 1930.
147.
W. A.Carlo, et al., “Oxygen-Saturation Targets in Extremely Preterm Infants,”New England Journal of Medicine368, (2013): 1949-1950, at 1949-1950, available at <http://www.nejm.org/doi/full/10.1056/NEJMc1304827> (last visited July 6, 2016).
148.
See e.g., R.Macklinet al., “The OHRP and SUPPORT—Another View,”New England Journal of Medicine369, no. 3 (2013) available at <http://www.nejm.org/doi/full/10.1056/NEJMc1308015> (last visited July 6, 2016).
149.
Id. (emphasis added).
150.
See June 4, 2013, Letter, supra note 119, at 5.
151.
Id.
152.
Id., at 2.
153.
Id.
154.
Id., at 4.
155.
See June 4, 2013 Letter, supra note 119, at 5 n.8 (citing the BOOST Study Consent Form (emphasis modified)).
156.
Id.
157.
Id. (citing Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT Study) Tufts University Consent Form (Oct. 1, 2004)available at <http://www.citizen.org/documents/support-study-consent-form.pdf> (noting that “at that center, for clinical purposes, oxygen saturation was ‘kept between 88 and 94%,’” rather than the minimum 85% and maximum 95% used at UAB) (last visited July 6, 2016).
Black's Law Dictionary defines “Foreseeability” as “[t]he quality of being reasonably anticipatable.” See Black's Law Dictionary 10th ed., s.v., “Foreseeability,” (2014).
161.
See June 4, 2013 Letter, supra note 119, at 2 (emphasis added).
162.
See id., at 2 n.2, 5 n.8 (collecting studies that recognized these risks); Part II.A, supra.
163.
Id.
164.
See Transcript, supra note 8.
165.
Although the notice and comment period has closed, final guidance has yet to be issued. OHRP, HHS, “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care,” Federal Register 79, (Oct. 24, 2014): 63629-63634, at 63632.
166.
Id. (emphasis added).
167.
See June 4, 2013 Letter, supra note 119, at 4.
168.
79(206) Federal Register 63629, 63632.
169.
Fifth Amended Complaint at ¶ 50, Looney v. Moore, 2015 WL 4773747 (N.D. AL. 2015) (No. 2:13-cv-00733-UNAS-KOB).
170.
Id., at ¶ 54.
171.
See, e.g., Dr. Carlo's Motion for Summary Judgment at 1–8, Looney v. Moore, 2015 WL 4773747 (N.D. AL. 2015) (No. 2:13-cv-00733-UNAS-KOB).
172.
Looney v. Moore, 2015 WL 4773747 at *8 (N.D. AL. 2015).
173.
Looney v. Moore, 2015 WL 4773747 at *8 (N.D. AL. 2015) appealed sub. nom. Lewis v. Moore (11th Cir. 2015).
174.
See Part I.A. supra. See Menikoff and Richards, supra note 9 for an explanation of the treating physician's disclosure duty. See also G. J. Annas and C. L. Annas, “Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants,”Journal of Contemporary Health Law & Policy30, no. 1 (2014): 1-36, at 25-26 (briefly discussing the intersection between research and treatment disclosure duties).
175.
See UAB Protocol, supra note 102, at 17.
176.
Id., at 19 (forbidding the use of steroids within the first 21 days of an infant's life).
177.
Id., at 17.
178.
Transcript, supra note 8, at 120 (quoting parents of Dagen Pratt, an infant enrolled in SUPPORT, as testifying that “[w] e want to know as information comes in, why the risks and intent of the study were not clear. If it were clear, we wouldn't have taken part in the study.”).
179.
See UAB Protocol, supra note 102, at 17–18.
180.
See, e.g., Lantos and Feudtner, supra note 114, at 37.
181.
The T.J. Hooper, 60 F.2d 737, 740 (2d Cir. 1932); see, e.g., Helling v. Carey, 519 P.2d 981 (1974) (holding that custom was not determinative of the reasonableness inquiry in a medical negligence inquiry, and citing The T.J. Hooper).
182.
Looney v. Moore, 2015 WL 4773747 at *8 (N.D. AL. 2015).
183.
Schloendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).
