1 See, e.g., Susan Levine, Clinical Trial Was Near-Death Experience Worth His While, L.A. TIMES, Aug. 13, 2001, at S5.

2 Id.

3 One other research participant also survived after receiving an organ transplant. Id.

4 See, e.g., Edwin Chen, FDA Faults Drug Testers in Patient-Death Probe, L.A. TIMES, May 14, 1994, at A16.

5 INST. OF MED., REVIEW OF THE FIALURIDINE (FIAU) CLINICAL TRIALS 12, 152 (1995).

6 See Joe Stephens, Where Profits and Lives Hang in Balance, WASH. POST, Dec. 17, 2000, at A1.

7 See, e.g., Edwards, Jim, Claim: LeCarre's “The Constant Gardener” Was Based on Pfizer Trovan Case, CBS NEWS (Feb. 17, 2009Google Scholar, 9:39 PM), http://www.bnet.com/blog/drug-business/claimlecarre-8217s-8220the-constant-gardener-8221-was-based-on-pfizer-trovan-case/653.

8 See Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009), cert. denied, 130 S. Ct. 3541 (2010). The case is discussed in more detail in Part III.C.3.

9 See, e.g., EZEKIEL J. EMANUEL ET AL., ETHICAL AND REGULATORY ASPECTS OF CLINICAL RESEARCH: READINGS AND COMMENTARY 369 (2003).

10 See, e.g., Reverby, Susan M., “Normal Exposure” and Inoculation Syphilis: A PHS “Tuskegee” Doctor in Guatemala, 1946–1948, 23 J. Pol’Y Hist. 6 (2011).CrossRefGoogle Scholar

11 Class Action Complaint for Injunctive Relief and Damages, Garcia v. Sebelius, No. 1:11-cv-00527-RBW (D.D.C. Mar. 14, 2011).

12 See infra Part II.C.

13 See Glickman, Seth W. et al., Ethical and Scientific Implications of the Globalization of Clinical Research, 360 New Eng. J. Med. 816, 816-17 (2009).CrossRefGoogle ScholarPubMed

14 See, e.g., Ctrs. for Disease Control & Prevention, Impact of Vaccines Universally Recommended for Children—United States, 1990-1998, 48 Morbidity & Mortality Wkly. Rep. 243, 243-48 (1999).Google Scholar

15 See EMANUEL ET AL., supra note 9, at xv.

16 See, e.g., Litton, Paul & Miller, Franklin G., A Normative Justification for Distinguishing the Ethics of Clinical Research from the Ethics of Medical Care, 33 J.L. Med. & Ethics 566, 568 (2005).Google ScholarPubMed

17 See, e.g., Haavi Morreim, E., Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities, 32 J.L. Med. & Ethics 474, 475 (2004)Google Scholar (“[I]t is not the goal of any research protocol to benefit any specified individual. That happens by good fortune, not by design.”).

18 See infra Part II.C.

19 See infra Part II.C.

20 See Joffe, Steven & Miller, Franklin, Bench to Bedside: Mapping the Moral Terrain of Clinical Research, 38 Hastings Center Rep. 30, 32 (2008).CrossRefGoogle ScholarPubMed

21 Franklin G. Miller, Revisiting the Belmont Report : The Ethical Significance of the Distinction Between Clinical Research and Medical Care, APA NEWSLS.: NEWSL. ON PHIL. & MED., Spring 2006, at 10-11.

22 See, e.g., Morreim, supra note 17, at 475.

23 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.”).

24 See, e.g., Joffe & Miller, supra note 20, at 40; Morreim, supra note 17, at 475 (“The goal of research is fundamentally different. It does not aim to benefit any specific individual, but rather to advance generalizable knowledge and thereby to benefit broader populations.”).

25 See, e.g., Miller, supra note 21, at 10, 11.

26 See, e.g., id. at 11.

27 See, e.g., Haavi Morreim, E., Medical Research Litigation and Malpractice Tort Doctrines: Courts on a Learning Curve, 4 Hous. J. Health L. & Pol’Y 1, 42–43 (2003)Google Scholar (“[C]ourts have felt free to call the standard physician-patient relationship fiduciary or at least a relationship of trust and confidence. The physician has knowledge and skills for which the patient has significant need.”).

28 See id. at 64.

29 See, e.g., id. at 43-44 (“The result is a relationship bearing the classic loyalty duties fiduciaries owe their beneficiaries.”).

30 See id. at 47.

31 At times, the doctor and researcher roles are not as dichotomous as set forth above; for instance, a primary care physician can enroll patients as research participants and may help conduct the research.

32 See, e.g., Childress, James, Compensating Injured Research Subjects: I. The Moral Argument, 6 Hastings Center Rep. 21, 22 (1984)Google Scholar (noting that research participants have “taken certain risks for the benefit of society through the advancement of medical knowledge”).

33 See, e.g., Joffe & Miller, supra note 20, at 30.

34 See, e.g., Criteria for IRB Approval of Research, 45 C.F.R. § 690.111(a)(2) (2011) (“Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”); COUNCIL FOR INT’L ORGS. OF MED. SCIS. & THE WORLD HEALTH ORG., INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS, guideline 8 (2002) [hereinafter CIOMS (2002)] (“Risks of interventions that do not hold out the prospect of direct diagnostic, therapeutic or preventive benefit for the individual must be justified in relation to the expected benefits to society.”); WORLD MED. ASS’N, DECLARATION OF HELSINKI: ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS § B.18 (1964) (noting that risks of research must be compared with “foreseeable benefits to them and to other individuals or communities affected by the condition under investigation”).

35 See, e.g., Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 838 (Md. 2001) (“[T]he price of a bad outcome is exacted from the individual who suffers the untoward reaction, whereas the benefit of the breakthrough is available to society as a whole.”).

36 See sources cited infra note 110.

37 See, e.g., Litton & Miller, supra note 16, at 569.

38 See, e.g., id.; Ruth Macklin, The Belmont Principles of Justice: An Idea Whose Time Has Come, APA NEWSLS.: NEWSL. ON PHIL. & MED., Spring 2006, at 5. While some research participants fare better simply because of increased medical attention during the trial, see, e.g., Morreim, supra note 17, at 475, there is certainly no guarantee that treatment in research will be successful. Of all drugs tested for later FDA approval, approximately eighty percent fail. Even in the later phases of research, randomization can mean that research participants are assigned treatment that is less effective. See, e.g., id.

39 See, e.g., Christine Pace, Miller, Franklin G. & Danis, Marion, Enrolling the Uninsured in Clinical Trials: An Ethical Perspective, 31 Critical Care Med. S121, S122 (2003).Google Scholar

40 See, e.g., Glickman et al., supra note 13, at 818.

41 For a discussion of those who make a living by participating in research, and the troubling implications thereof, see Carl Elliott, Guinea-Pigging, THE NEW YORKER, Jan. 7, 2008, at 36. Empirical data suggest that Phase I participants are motivated to participate in research equally by a desire to help as by money. See Ferguson, Pamela R., Clinical Trials and Healthy Volunteers, 16 Med. L. Rev. 23, 32–34 (2008).CrossRefGoogle ScholarPubMed

42 For examples of non-consensual research, see cases cited infra note 146, and the Guatemala and Tuskegee studies discussed supra in the Introduction.

43 See, e.g., PRESIDENT's COMM’N FOR THE STUDY OF ETHICAL PROBLEMS IN MED. & BIOMEDICAL & BEHAVIORAL RESEARCH, COMPENSATING FOR RESEARCH INJURIES: THE ETHICAL AND LEGAL IMPLICATIONS OF PROGRAMS TO REDRESS INJURED SUBJECTS 89 (1982) [hereinafter PRESIDENT's COMM’N] (“The focus of traditional (negligence) tort doctrine on the immediate parties to an accident—the victim and the allegedly negligent defendant—fits the moral equation of research injuries only imperfectly. The immediate parties—subject and investigator—encompass only one aspect of the wider society's interest in biomedical and behavioral research.”).

44 Prisoners were thrown into freezing water to calculate how long humans could withstand cold; they were subjected to malaria, mustard gas, and poison; they were subjected to forced sterilization; and they were put into pressurized chambers that resulted in either death from the pressure or execution for brain vivisection. See, e.g., Telford Taylor, Opening Statement of the Prosecution, December 9, 1946, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION 67 passim (George J. Annas & Michael A. Grodin eds., 1995).

45 See, e.g., U.S. Public Health Service Syphilis Study at Tuskegee – The Tuskegee Timeline, CTRS. FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/tuskegee/timeline.htm (last updated June 15, 2011). Tests were conducted on 400 impoverished African-American males, and the research continued long after penicillin was known to be an effective cure. Elaborate ruses were put in place to keep the research participants uninformed about medical advances and their health status. The study was not shut down until 1972, when its existence was leaked to the press, forcing the researchers to stop in the face of public outcry. See, e.g., Baker, Shamim M., Brawley, Otis W. & Marks, Leonard S., Effects of Untreated Syphilis in the Negro Male, 1932 to 1972: A Closure Comes to the Tuskegee Study, 2004, 65 Urology 1259 passim (2005).CrossRefGoogle ScholarPubMed

46 These experiments included injecting radioactive substances into babies and pregnant women, feeding radioactive material to mentally disabled children, and releasing radioactive materials over U.S. cities to simulate the effects of radioactive fallout. See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, FINAL REPORT (1995), available at http://ia700402.us.archive.org/10/items/advisorycommitte00unit/advisorycommitte00unit.pdf.

47 See, e.g., Reverby, supra note 10. The U.S. government has since formally apologized for its role in some of these experiments. See, e.g., Remarks in Apology to African-Americans on the Tuskegee Experiment, 33 WEEKLY COMP. PRES. DOC. 718 (May 16, 1997), available at http://www.gpo.gov/fdsys/pkg/WCPD-1997-05-19/pdf/WCPD-1997-05-19-Pg718.pdf; Press Release, HHS Press Office, Joint Statement by Secretaries Clinton and Sebelius on a 1946-1948 Study (October 1, 2010), available at http://www.hhs.gov/news/press/2010pres/10/20101001a.html. But, many participants received neither compensation nor acknowledgment of what had been done to them. See, e.g., Lee, Matthew T. & Gailey, Jeannine A., Attributing Responsibility for Organizational Wrongdoing, in International Handbook Of White-Collar And Corporate Crime 50, 62 (Henry N. Pontell & Gilbert Geis eds., 2007).Google Scholar

48 See, e.g., McHale, J.V., Law and Clinical Research - From Rights to Regulation? An English Perspective, 32 J.L. Med. & Ethics 718, 718 (2004)CrossRefGoogle ScholarPubMed (“The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally.”).

49 The Nuremburg Code, in THE NAZI DOCTORS AND THE NUREMBERG CODE: HUMAN RIGHTS IN HUMAN EXPERIMENTATION, supra note 44, at 2.

50 Id. § 1.

51 Id. § 2.

52 Id. § 4.

53 Id. § 6.

54 Particularly, the seemingly absolute requirement of informed consent left little room for experiments involving children, the mentally ill, and individuals in emergency situations. See, e.g., Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 836 (Md. 2001) (“[P]hysician groups tended to find the Code too ‘legalistic’ and irrelevant to their therapeutic experiments, and set about to develop an alternative code to guide medical researchers.”) (quoting Annas, George J., Mengele's Birthmark: The Nuremberg Code in United States Courts, 7 J. Contemp. Health L. & Pol’Y 17, 19–21 (1991))Google ScholarPubMed (internal quotation marks omitted).

55 WORLD MED. ASS’N, supra note 34; WORLD MED. ASS’N, DECLARATION OF HELSINKI: ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (2008), available at http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footerright=[page]/[toPage].

56 See WORLD MED. ASS’N, supra note 34, § II.1.

57 See, e.g., Bosnjak, Snezana, The Declaration of Helsinki - The Cornerstone of Research Ethics, 9 Archive Oncology 179, 180 (2001).Google Scholar Though the Declaration of Helsinki has its detractors, it has also been considered the “most successful and influential” code. Grimes, 782 A.2d at 836.

58 See U.S. Public Health Service Syphilis Study at Tuskegee – Research Implications, CTRS. FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/tuskegee/after.htm (last updated June 15, 2011).

59 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, 23,193 (Apr. 18, 1979) (codified at 45 C.F.R. pt. 46 (2010)).

60 See Subpart A – Basic HHS Policy for Protection of Human Research Subjects, 45 C.F.R. pt. 46 (2010).

61 EMANUEL ET AL., supra note 9, at 27.

62 See, e.g., Tom L. Beauchamp, Assessing the Belmont Report, APA NEWSLS.: NEWSL. ON PHIL. & MED., Spring 2006, at 3 (noting that the Belmont Report “is one of the few documents that has influenced almost every sphere of activity in bioethics[,]” and its principles “became the backbone of federal law governing research involving human subjects”). Proposed modifications to the Common Rule have been proposed in an advanced notice of proposed rulemaking. See Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Fed. Reg. 44,512 (proposed July 26, 2011) (to be codified at 45 C.F.R. pt. 46). These modifications seek to streamline the regulation of multi-site research and do not address the issue of compensation for research-related injuries.

63 COUNCIL FOR INT’L ORGS. OF MED. SCIS. & THE WORLD HEALTH ORG., INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1993) [hereinafter CIOMS (1993)]. The guidelines were updated in 2002. CIOMS (2002), supra note 34.

64 One such requirement is that research must be “responsive to the health needs and the priorities of the community in which it is to be carried out.” See CIOMS (2002), supra note 34, at 51.

65 See International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline; Availability, 62 Fed. Reg. 25,692 (May 9, 1997).

66 See, e.g., Emanuel, Ezekiel J., Wendler, David & Grady, Christine, What Makes Clinical Research Ethical?, 283 JAMA 2701, 2701 (2000)CrossRefGoogle ScholarPubMed; Schott, Markus, Medical Research on Humans: Regulation in Switzerland, the European Union, and the United States, 60 Food & Drug L.J. 45, 69 (2005)Google ScholarPubMed (“One of the most striking features of the examined legal sources is the high degree of similarity among them.”).

67 Emanuel, Wendler & Grady, supra note 66, at 2704.

68 Id. at 2705.

69 Id. at 2706.

70 See Criteria for IRB Approval of Research, 45 C.F.R. § 46.111(a) (2010) (noting that IRBs ensure that risks to subjects are minimized, that risks to subjects are reasonable in relation to anticipated benefits, that selection of subjects is equitable, and that informed consent is sought and documented). In many institutions, research is subject to scientific review by a committee tasked with ensuring sufficient scientific merit. See, e.g., Scientific Review Committees, AM. HEALTH ASSISTANCE FOUND., http://www.ahaf.org/aboutahaf/structure/src.html (last updated Sept. 23, 2011). Trials are subject to continuing review of adverse events and interim findings. See IRB Review of Research, 45 C.F.R. § 46.109(e) (2010). Many trials are also reviewed by data monitoring committees that monitor incoming data and assess patient safety and efficacy of the intervention while the trial is ongoing.

71 See generally supra notes 49, 55, 59, 60, 65; CIOMS (1993), supra note 63.

72 See CIOMS (2002), supra note 34, at 78 (“Investigators should ensure that research subjects who suffer injury as a result of their participation are entitled to free medical treatment for such injury and to such financial or other assistance as would compensate them equitably for any resultant impairment, disability or handicap.”); INST. OF MED., RESPONSIBLE RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCH PARTICIPANTS 193 (2002) (“Organizations conducting research should compensate any research participant who is injured as a direct result of participating in research, without regard to fault.”).

73 See infra note 112.

74 See infra note 112.

75 In the 1940s, the Army debated, but ultimately rejected, suggestions to compensate prisoner volunteers injured during malaria and hepatitis experiments. ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46, at 827.

76 See PUB. HEALTH SERV., U.S. DEP't OF HEALTH, EDUC. & WELFARE, FINAL REPORT OF THE TUSKEGEE SYPHILIS STUDY AD HOC ADVISORY PANEL 123 (1973), available at http://www.research.usf.edu/cs/library/docs/finalreport-tuskegeestudyadvisorypanel.pdf.

77 SEC’Y's TASK FORCE ON THE COMP. OF INJURED RESEARCH SUBJECTS, U.S. DEPT. OF HEALTH, EDUC. & WELFARE, REPORT OF THE TASK FORCE (1977) [hereinafter SECRETARY's TASK FORCE].

78 Institutional Review Boards: Report and Recommendation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 43 Fed. Reg. 56,174 (Nov. 30, 1978).

79 PRESIDENT's COMM’N, supra note 43.

80 ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46.

81 NAT’L BIOETHICS ADVISORY COMM’N, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS 125 (2001).

82 PRESIDENTIAL COMM’N FOR THE STUDY OF BIOETHICAL ISSUES, MORAL SCIENCE: PROTECTING PARTICIPANTS IN HUMAN SUBJECTS RESEARCH (2011) [hereinafter PRESIDENTIAL COMM’N].

83 See, e.g., Opening Letter to PRESIDENT's COMM’N, supra note 43 (acknowledging “the ethical obligation toward subjects”); SECRETARY's TASK FORCE, supra note 77, at VI-6 (“[T]he [federal government’s] compensatory obligation extends at least to injured volunteers … sponsored by and for the benefit of society as a whole.”).

84 PRESIDENT's COMM’N, supra note 43, at 1.

85 NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 123.

86 Weisbard, Alan J., The Role of Philosophers in the Public Policy Process: A View from the President's Commission, 97 Ethics 776, 780 (1987).CrossRefGoogle ScholarPubMed

87 PRESIDENT's COMM’N, supra note 43, at 50.

88 See, e.g., SECRETARY's TASK FORCE, supra note 77, at VI.

89 See, e.g., id. (noting that the “principle of distributive justice” could justify compensating injured research participants: “[S]ince society is the beneficiary of biomedical and behavioral research, it ought to bear the burden of biomedical and behavioral research injuries as well”). See also PRESIDENTIAL COMM’N, supra note 82, at 63 (“Thus, treatment or compensation/restitution for the costs of treatment, is justified by distributive or corrective justice and by duties of beneficence.”). Scholars have also used the principle of distributive justice to justify compensating injured research participants. See, e.g., Resnik, David B., Compensation for Research-Related Injuries: Ethical and Legal Issues, 27 J. Legal Med. 263 (2006).CrossRefGoogle ScholarPubMed

90 See Resnik, supra note 89, at 282-83.

91 See id. at 282.

92 See, e.g., SECRETARY's TASK FORCE, supra note 77, at VI-3 (“[S]ociety, through its governmental agents, has intervened in the lives of the injured individuals, and therefore society may be said to have an obligation to repair (so far as is possible) injury done to individuals … .”). See also PRESIDENTIAL COMM’N, supra note 82, at 63 (“Thus, treatment or compensation/restitution for the costs of treatment, is justified by distributive or corrective justice and by duties of beneficence.”).

93 See, e.g., SECRETARY's TASK FORCE, supra note 77, at VI-4 (defining compensatory justice as the “form of justice which seeks to redress injury even when no fault or blame is associated with the injury”).

94 PUB. HEALTH SERV., supra note 76, at 41-42.

95 This is closely related to the economic concept of risk-spreading, that the person who can best and most efficiently afford the costs of injury should bear them. According to Wendy Mariner, economic theory favors shifting the costs of research-related injuries to research sponsors, who have greater resources than individual injured research participants and can recover financial losses through revenue-generating mechanisms. See Mariner, Wendy K., Compensation for Research Injuries, in 2 Women And Health Research: Ethical And Legal Issues Of Including Women In Clinical Studies 113, 114 (Inst. of Med. ed., 1994).Google Scholar

96 INST. OF MED., supra note 72, at 14-15. See also PRESIDENTIAL COMM’N, supra note 82, at 61 (“Potential human research subjects may be more likely to agree to serve if they know they will be taken care of in the event that they are harmed as a direct result of their participation. In an era in which the recruitment of adequate numbers of research subjects continues to be a major challenge, this could be significant.”). This is not an idle concern. The fallout from the Tuskegee research experiments left wide swaths of the population unwilling to participate in research and untrusting of the medical establishment in general. Thomas, Stephen B. & Quinn, Sandra Crouse, >The Tuskegee Syphilis Study, 1932 to 1972: Implications for HIV Education and AIDS Risk Education Programs in the Black Community, 81 Am. J. Pub. Health 1498, 1498 (1991).CrossRefGoogle ScholarPubMed

97 This counterargument is also articulated in Mariner, supra note 95, at 116.

98 See id.

99 SECRETARY's TASK FORCE, supra note 77, at VI-7.

100 See, e.g., id. at VI-5 (“Informed consent in the research setting functions as a recognition of a protection for a person's integrity and autonomy, but does not imply a waiver of the right of the person to compensation in the event of injury.”); Childress, supra note 32, at 25 (“The requirement of consent is based on fairness and respect for the autonomy of persons.”); Emanuel, Wendler & Grady, supra note 66, at 2706 (“Informed consent embodies the need to respect persons and their autonomous decisions.”).

101 See, e.g., INST. OF MED., supra note 72, at 191 (“It has been argued that a participant relinquishes his or her right to compensation when giving informed consent, but in the committee's view, a right to compensation for research-related injury should not be subject to waiver.”); SECRETARY's TASK FORCE, supra note 77, at VI-5 (“[I]nformed consent does not negate or waive the obligation to provide compensation.”); Childress, supra note 32, at 25 (“[W]hile consent is a necessary moral condition for ethically justified research in normal circumstances, … [i]ts presence does not remove society's moral obligation of compensatory justice … .”). Regulations governing research expressly forbid informed consent documents from requiring research participants to waive legal rights. See General Requirements for Informed Consent, 45 C.F.R. § 46.116 (2011).

102 For the general requirements for informed consent, see 45 C.F.R. § 46.116 (“No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights … .”).

103 See, e.g., SECRETARY's TASK FORCE, supra note 77, at VI-7 (“Volunteers for experimentation have a reasonable interest in requiring compensation as a condition for participation in an experiment. It is the type of debt a volunteer should require from a researcher.”).

104 See NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 123-24 (noting that OHRP provides guidance for researchers to craft noncompensatory language without running afoul of the ban on exculpatory clauses).

105 It may also signify that participants do not fully understand their rights. Studies have shown that the reading level of an average research participant is sixth to eighth grade; the average informed consent document is written at a tenth grade reading level; and the section pertaining to compensation is written at an even higher level. See Resnik, supra note 89, at 270.

106 Given that informed consent language and research procedures are approved by IRBs, research participants may not actually have the power to negotiate for compensation.

107 The language in most informed consent documents—that participants do not surrender their legal rights by participating in research—is confusing at best.

108 See, e.g., Owen Schaefer, G. & Wertheimer, Alan, The Right to Withdraw from Research, 20 Kennedy Inst. Ethics J. 329, 338 (2010).Google Scholar

109 See, e.g., NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 123 (“[E]ven if consent forms and the disclosures within them are comprehensive, completely unforeseen iatrogenic harms might occur in research.”).

110 A substantial proportion of participants confuse the treatment they receive in research with that of standard medical care. Horng, Sam & Grady, Christine, Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconceptions, Therapeutic Misestimation & Therapeutic Optimism, 25 Irb: Ethics & Hum. Res. 11, 12 (2003).CrossRefGoogle ScholarPubMed Despite being informed about study design implications, including random assignment to a control or comparison group, research participants may still believe that every aspect of research is designed for personal benefit. See, e.g., id.; Mandava, Amulya et al., Mapping the Landscape: The Data on Informed Consent, 38 J. Med. Ethics (forthcoming 2012)CrossRefGoogle ScholarPubMed (finding substantial variation in participant understanding of research in both developing and developed countries, particularly with regard to randomization, placebo-controlled designs, and side effects); Litton & Miller, supra note 16, at 572.

111 See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46, at 528 (“The Advisory Committee recommends … a mechanism for the satisfactory resolution of this longstanding social issue.”); NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 123 (“A comprehensive system of oversight of human research should include a mechanism to compensate participants for medical and rehabilitative costs resulting from research-related injuries.”); SECRETARY's TASK FORCE, supra note 77, at II-2 (“Human subjects who suffer physical, psychological, or social injury … should be compensated … .”); PUB HEALTH SERV., supra note 76, at 41 (“An insurance plan should be devised and implemented for the compensation of subjects harmed as a consequence of their participation in research activities.”).

112 See, e.g., PRESIDENTIAL COMM’N, supra note 82, at 70 (“The Commission recognizes that previous presidentially appointed bioethics commissions and other duly appointed advisory bodies have made similar recommendations regarding compensation or treatment for research-related injuries; yet no clear response by the federal government has been issued.”).

113 See, e.g., id. at 125 (noting that the Federal Government would not implement a proposal “[i]n the absence of a finding that a significant number of modern research subjects are unfairly denied compensation”); SECRETARY's TASK FORCE, supra note 77, at III-2 (explaining that past no-fault proposals had not been accepted due to a lack of data).

114 See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46, at 528 (“The Advisory Committee recommends that the Human Radiation Interagency Working Group review the area of compensation for research injuries … .”); NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 125 (“More information is needed about the nature and extent of research-related injuries and uncompensated research injuries.”); Opening Letter to PRESIDENT's COMM’N, supra note 43 (“To determine the need for, and practical feasibility of, a compensation program, the Commission recommends that a small experiment be undertaken over a three to five-year period.”); SECRETARY's TASK FORCE, supra note 77, at VI-1 to VI-2; PRESIDENTIAL COMM’N, supra note 82, at 67-69.

115 See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46, at 528 (“No policy exists even today … .”); NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 125 (“The availability, circumstances, and procedures for compensating injured research participants have remained unchanged from those observed by the Tuskegee Advisory Panel.”); PUB HEALTH SERV., supra note 76, at 23 (“No policy for the compensation of research subjects harmed as a consequence of their participation in research has been formulated.”); PRESIDENTIAL COMM’N, supra note 82, at 70.

116 See Basic HHS Policy for Protection of Human Research Subjects, 45 C.F.R. § 46.116(a) (2005).

117 See, e.g., NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 125-26 (“[I]njured research participants alone bear both the cost of lost health and the expense of medical care … . [T]he costs of research injuries should not be borne by the injured participants … .”).

118 See infra notes 132-37 and accompanying text.

119 See, e.g., NAT’L BIOETHICS ADVISORY COMM’N, supra note 81, at 125 (“[E]ven when warranted and successful, such lawsuits are costly and slow and thus are of limited value at the time the injury is incurred.”); PRESIDENT's COMM’N, supra note 43, at 88 (“But if research subjects should, on ethical grounds, be compensated for their injuries, despite the lack of negligence by an investigator, the rules of negligence law will be patently inappropriate.”); SECRETARY's TASK FORCE, supra note 77, at V-2 (“Given the fact that the very nature of research is a venture into the unknown, it is unlikely that harm resulting from effects that were not reasonably foreseeable would be a basis for liability, and adequately drafted consent forms would likely obviate liability for anticipated risks.”); PUB HEALTH SERV., supra note 76, at 36-37 (“Those subjects whose injury does result from negligence are faced with the usual difficulties and uncertainties inherent in a lawsuit.”).

120 Gainotti, Sabina & Petrini, Carlo, Insurance Policies for Clinical Trials in the United States and in Some European Countries, 1 J. Clinical Res. & Bioethics 1, 2–3 (2010).CrossRefGoogle Scholar

121 For more information about institutional compensation policies, see the discussion and data included in supra Part II.A.

122 See source cited supra note 117.

123 See, e.g., INST. OF MED., supra note 72, at 190-91; Ian McEwin, R., No-Fault Compensation Systems, in Encyclopedia Of Law & Economics § 3600, at 737, 739 (Boudewijn Bouckaert & Gerrit De Geest eds., 1999)Google Scholar, available at http://encyclo.findlaw.com/tablebib.html; Mariner, supra note 95, at 121; O’Connell, Jeffrey, Tort Versus No-Fault: Compensation and Injury Prevention, 19 Accident Analysis & Prevention 63 (1987)CrossRefGoogle ScholarPubMed (“The attempt to achieve a fair and rational method for the compensation of victims has been displaced by a form of litigation lottery.”).

124 For more information and a discussion about assumption of risk, see infra note 161 and accompanying text.

125 See Gainotti & Petrini, supra note 120, at 2.

126 See Kiobel v. Royal Dutch Petroleum Co., 621 F.3d 111 (2d Cir. 2010); Abdullahi v. Pfizer, Inc., 562 F.3d 163 (2d Cir. 2009), cert denied, 130 S. Ct. 3541 (2010).

127 See Reverby, supra note 10.

128 See Basic HHS Policy for Protection of Human Research Subjects, 45 C.F.R. § 46.116(a)(6) (2005). For institutions that will not provide compensation or treatment, the Office of Human Research Protection suggests the following language: “This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.” “Exculpatory Language” in Informed Consent, OFFICE FOR HUMAN RESEARCH PROTS., U.S. DEP't OF HEALTH & HUMAN SERVS. (Nov. 15, 1996), http://www.hhs.gov/ohrp/policy/exculp.html.

129 THE LEWIN GRP., TASK ORDER NO. 2: CARE/COMPENSATION FOR INJURIES IN CLINICAL RESEARCH ES-2 (2005).

130 Id.

131 Id.; see also Gainotti & Petrini, supra note 120, at 3 (discussing a study conducted by Department of Health and Human Services that found that 51.2 percent of academic medical centers “provided no free care to the injured subjects”); Paasche-Orlow, Michael K. & Brancata, Frederick L., Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for Research-Related Injury, 118 Am. J. Med. 175, 177 (2005)CrossRefGoogle ScholarPubMed (finding that only one-half of research participants enrolled in research at medical schools have their medical bills for researchrelated injuries covered).

132 See Gainotti & Petrini, supra note 120, at 3. Under the plan, medical expenses are covered up to $10,000, and other expenses, including economic losses, may also be covered. For a claim to proceed, the research participant must sign a document releasing the university from tort liability. See id.; HUMAN SUBJECTS DIV., UNIV. OF WASH., RESEARCH CARE PLAN – POLICY SUMMARY AND IMPLICATIONS (2008), available at http://www.washington.edu/research/hsd/docs/557; see also HUMAN SUBJECTS DIV., UNIV. OF WASH., UW COMPENSATION PLAN ADVERSE FLOW CHART (2010), available at http://www.washington.edu/research/hsd/docs/467.

133 See Treatment of Research-Related Injuries to Human Subjects, 38 C.F.R. § 17.85 (1998) (“VA medical facilities shall provide necessary medical treatment to a research subject injured as a result of participation in a research project … .”).

134 See, e.g., OFFICE OF HUMAN SUBJECTS RESEARCH, NAT’L INSTS. OF HEALTH, SHEET 6— GUIDELINES FOR WRITING INFORMED CONSENT DOCUMENTS ¶ 4(s) (2006), available at http://ohsr.od.nih.gov/info/sheet6.html (“The Clinical Center of the NIH will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided … .”).

135 U.S. DEP't OF DEF., DEPARTMENT OF DEFENSE INSTRUCTION NUMBER 6000.8: FUNDING AND ADMINISTRATION OF CLINICAL INVESTIGATION PROGRAMS ¶ 6.2.4 (2007), available at http://www.dtic.mil/whs/directives/corres/pdf/600008p.pdf (“All CIP investigators shall … for research involving more than minimal risk … include in every intramural (in-house) CIP protocol an arrangement for treatment of any research-related injuries.”).

136 A discussion of these policies is presented in INST. OF MED., supra note 72, at 188; THE LEWIN GRP., supra note 129, at 16-19; Gainotti & Petrini, supra note 120, at 3; PRESIDENTIAL COMM’N, supra note 82, at 65.

137 Scott, Larry D., Research-Related Injury: Problems and Solutions, 31 J.L. Med. & Ethics 419, 421-22 (2003).Google ScholarPubMed

138 See Gainotti & Petrini, supra note 120, at 3; THE LEWIN GRP., supra note 129, at app. A.

139 See, e.g., THE LEWIN GRP., supra note 129, at ES-3 (“In the absence of showing fault, in fact, insurance serves as the primary vehicle for compensation of such injuries in the United States.”).

140 See, e.g., NAT’L CANCER INST., NAT’L INSTS. OF HEALTH, Clinical Trials and Insurance Coverage, http://www.cancer.gov/clinicaltrials/payingfor/insurance-coverage (May 8, 2009) (“Even if you have health insurance, your plan may not cover all of the costs related to receiving treatment in a clinical trial. This is because some health insurance companies define clinical trials as ‘experimental.’”).

141 This situation will change as additional provisions of the Patient Protection and Affordable Care Act come into force. Under section 10103(c) of the Patient Protection and Affordable Care Act, requirements are imposed on group health plans and health insurance issuers to provide for coverage of routine patient costs associated with approved clinical trials. The provision does not address research-related injuries. See Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations, MOSES & SINGER LLP (May 2010), available at http://mosessinger.com/articles/files/HealthcareReformLawClinicalTrials.pdf. Nevertheless, some currently uninsured individuals are likely to become insured as a result of the new policy measures.

142 See sources cited supra note 123.

143 See Jansson, Roger L., Research Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 Wash. L. Rev. 229, 230 (2003)Google ScholarPubMed (“[F]ew cases have generated reported decisions; thus the case law interpreting tort liability of researchers is scarce.”); Traynor, Michael, Clinical Trials: Emerging Products Liability And Insurance Issues, SB16 Ali-Aba 179, 181 (1996)Google Scholar (“So far, there are very few reported cases involving liability for injury or death in clinical trials.”).

144 See, e.g., Traynor, supra note 143.

145 Estimates suggest that ninety percent of cases involving potential research liability are dropped or settled, a figure comparable to the rate of medical malpractice suits that are dropped or settled. Haavi Morreim, E., Clinical Trials Litigation: Practical Realities as Seen from the Trenches, 12 Accountability Res. 47, 52 (2005).Google Scholar

146 In cases for which no informed consent was obtained, individuals have successfully sued for battery, an intentional tort that gives rise to punitive damages. See, e.g., Morreim, supra note 17, at 478 (noting that battery “requires no expert testimony, no finding that the procedure was performed negligently, and no causal connection between the battery and the injuries.”). In some instances, the failure to obtain informed consent was deemed sufficient to be considered a constitutional violation. See Heinrich v. Sweet, 62 F. Supp. 2d 282, 313-15 (D. Mass. 1999) (“Failure to provide adequate disclosure of a potentially deadly medical experiment to subjects who were induced to participate on the basis of fraud constitutes a procedural irregularity sufficient to trigger the protections of the Fifth Amendment.”); Stadt v. Univ. of Rochester, 921 F. Supp. 1023, 1027-28 (W.D.N.Y. 1996) (“The Constitution, and more specifically, the Due Process Clause of the Fifth Amendment clearly established a right to be free from non-consensual, governmental experimentation on one's body … .”); In re Cincinnati Radiation Litig., 874 F. Supp. 796 (S.D. Ohio 1995) (finding a constitutional violation where plaintiffs were not informed that the radiation they were receiving was part of a military experiment rather than treatment of their cancer); cf. Bibeau v. Pac. Nw. Research Found., Inc., 188 F.3d 1105, 1112 n.6 (9th Cir. 1999) (finding that there was no constitutional violation of the right to bodily integrity because the litigants knew they were serving as experimental subjects rather than receiving treatment); Wright v. Fred Hutchinson Cancer Research Ctr., 269 F. Supp. 2d 1286, 1295 (W.D. Wash. 2002) (“[I]n the absence of allegations that defendants hid the true nature of the experiments and/or conducted them for non-therapeutic reasons, there is no constitutional claim.”).

147 See, e.g., Morreim, supra note 17, at 478.

148 See, e.g., THE LEWIN GRP., supra note 129, at 39 (“Over time, negligence theory has replaced common law battery as the basis for malpractice litigation except in those cases in which no consent at all was obtained.”). Injured research participants have brought suit alleging a wide variety of claims, including negligent and intentional infliction of emotional distress, fraud, breach of confidentiality, breach of contract, breach of privacy, product liability, and negligent conduct and monitoring of research. See, e.g., Mello, Michelle M. et al., The Rise of Litigation in Human Subjects Research, 139 Annals Internal Med. 40 (2003)CrossRefGoogle ScholarPubMed; THE LEWIN GRP., supra note 129, at 40. Claims have expanded to include alleged violations of rights based on the Nuremberg Code, the Declaration of Helsinki, the U.S. Constitution, or the federal civil rights acts, though courts have generally been reluctant to expand the rights in this way. See, e.g., Robertson ex rel. Robertson v. McGee, No. 01-CV-60-C, 2002 WL 535045 (N.D. Okla. Jan. 28, 2002); Heinrich ex rel. Heinrich v. Sweet, 49 F. Supp. 2d 27 (D. Mass. 1999); White v. Paulsen, 997 F. Supp. 1380 (E.D. Wash. 1998). But see Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 835 (Md. 2001) (suggesting that a duty of care might arise from principles stated in the Nuremberg Code).

149 See, e.g., Childress, supra note 32, at 21 (“[M]alpractice suits depend on a standard duty of ‘due care’ which may be unclear in research settings.”). One major research liability case, Grimes v. Kennedy Krieger, went so far as to suggest that the duty owed by researchers to research participants should be determined on a case-by-base basis. Grimes, 782 A.2d at 858. Grimes, however, has come under considerable scrutiny and has faced significant criticism. See, e.g., Hoffman, Diane E. & Rothenberg, Karen H., 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).Google Scholar For an argument that the duties of physician-researchers should not be different from the duties owed by physicians providing clinical care, see Cranley Glass, Kathleen & Waring, Duff, The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials, 33 J.L. Med. & Ethics 575 (2005).CrossRefGoogle Scholar

150 Morreim, supra note 17, at 477 (noting that a researcher's “goal is not the betterment of any particular participant”).

151 See id. (“The standard of care for medical practice emphasizes conformity to customary and prevailing practices … . In contrast, research cannot be judged by its conformity to customary practice since it is, by definition, an express deviation from those routines, taken to gather generalizable knowledge.”) (internal citations omitted). While courts once held that a physician experimented “at his peril” if his patients were harmed thereby, see PUB. HEALTH SERV., supra note 76, at 25; Morreim, supra note 17, at 476, courts have increasingly recognized that medical progress requires experimentation, within permissible limits. See, e.g., Fortner v. Koch, 261 N.W. 762, 765 (Mich. 1935).

152 See, e.g., Daum v. SpineCare Med. Grp., 61 Cal. Rptr. 2d 260 (Cal. Ct. App. 1997) (holding that the federal regulations designed to protect human research participants provided the standard of care); Whitlock v. Duke Univ., 637 F. Supp. 1463 (M.D.N.C. 1986) (holding that the Common Rule established the standard of care for an informed consent claim against researchers), aff’d, 829 F.2d 1340 (4th Cir. 1987); Vodopest v. MacGregor, 913 P.2d 779 (Wash. 1996) (adopting the Common Rule as the standard of care for informed consent claims).

153 See, e.g., Jansson, Roger L., Research Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 Wash. L. Rev. 229, 247 (2003)Google ScholarPubMed (“[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.”); Morreim, supra note 17, at 477.

154 See, e.g., Ferguson, supra note 41, at 43 (noting that healthy British volunteers injured in infamous trials of TGN1412 could have trouble succeeding in a negligence lawsuit if the sponsors complied with research regulations).

155 See, e.g., Resnik, supra note 89, at 266 (“[I]t may be difficult to determine whether an injury was caused by a research study, the subject's underlying illness, the subject's failure to follow instructions, or some other cause.”).

156 See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46, § III, ch. 17.

157 See, e.g., Moore Thompson, Melissa, Comment, Causal Inference in Epidemiology: Implications for Toxic Tort Litigation, 71 N.C. L. Rev. 247, 280-82 (1992)Google Scholar (noting that with epidemiological calculations “population-based calculations should not be extrapolated directly to the individual”).

158 See, e.g., PRESIDENT's COMM’N, supra note 43, at 96 (“This often complex and scientifically demanding task typically must be performed to the satisfaction of a lay jury … .”). That is not to say that injured research participants should be able to forego proving causation. In fact, the proposal set forth in Part V.C requires that an injured research participant show, on balance of the probabilities, that the research caused the participant's injury. One key difference is that under the proposal, the causation element is evaluated by doctors and scientists most knowledgeable about the research intervention and the underlying disease rather than judges or juries.

159 General Requirements for Informed Consent, 45 C.F.R. § 46.116 (2005).

160 Id.

161 See, e.g., Slater v. Optical Radiation Corp., 961 F.2d 1330, 1334 (7th Cir. 1992) (“Provided the risks, including any loss of tort remedies, were adequately explained … [,] he cannot complain that the risks materialized.”); Schneider v. Revici, 817 F.2d 987, 996 (2d Cir. 1987) (signing an informed consent form for unorthodox cancer treatment created a jury question regarding patient's assumption of risk); PRESIDENT's COMM’N, supra note 43, at 86 (“An injured subject may also be required to overcome the claim that he or she assumed the risk of injury in agreeing to participate in the research.”); Coleman, Carl H., Duties to Subjects in Clinical Research, 58 Vand. L. Rev. 387, 410-11 n.98 (2005)Google Scholar (“Arguably, if a subject's explicit agreement to accept the inherent risks of research can be established, whether through the consent form or otherwise, the analytical framework would shift from primary implied assumption of risk to express assumption of risk … .”); Haavi Morreim, E., Consumer-Defined Health Plans: Emerging Challenges from Tort and Contract, 39 J. Health L. 307, 311 (2006)Google Scholar (“[I]nformed consent conversations will likely evolve … . [D]octrines like assumption of risk and contributory negligence/comparative fault can provide considerable insulation from tort claims … .”). But see Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 835 (Md. 2001) (“Researchers cannot ever be permitted to completely immunize themselves by reliance on consents … . .”); Childress, supra note 32, at 25 (noting that assumption of risk requires that an individual know and understand the risk being incurred, an obligation arguably not satisfied in some research).

162 See sources cited supra note 161.

163 INST. OF MED., supra note 72, at 188.

164 Strict liability for research-related injuries has been considered, but rejected. See, e.g., SECRETARY's TASK FORCE, supra note 77, at V-3 (“While the concept of strict liability has been expanded in recent years, … [t]here is no indication that the courts are prepared to impose such strict liability upon the research community.”); PRESIDENT's COMM’N, supra note 43, at 94 (“[T]he proposition that research with human subjects is an ‘abnormally dangerous activity’ subject to strict liability standards finds no clear support in the empirical evidence or in legal precedent.”).

165 PRESIDENT's COMM’N, supra note 43, at 83-84.

166 This category is limited primarily to federally conducted research, and does not include all federally funded research. See SECRETARY's TASK FORCE, supra note 77, at V-1 (exploring “[f]ederally conducted, supported (by grant or contract), and regulated research, particularly research covered by the Federal Food, Drug, and Cosmetic Act”). Private entities receiving federal funds to conduct research will be treated as non-federal entities, except to the extent they are so closely supervised to be considered deputized federal agents. See, e.g., Heinrich ex rel. Heinrich v. Sweet, 62 F. Supp. 2d 282 (D. Mass. 1999) (finding that Associated Universities—a private corporation founded by Harvard, Yale, and a number of other universities to operate research laboratories—could be considered governmental for purposes of immunity due to the supervision and control exercised by the government).

167 See, e.g., Hyer, Andrew, The Discretionary Function Exception to the Federal Tort Claims Act: A Proposal for a Workable Analysis, 2007 Byu L. Rev. 1091, 1094-95 (2007)Google Scholar (discussing governmental protection from liability under the discretionary function exception); Niles, Mark C., “Nothing but Mischief”: The Federal Tort Claims Act and the Scope of Discretionary Immunity, 54 Admin. L. Rev. 1275, 1279-80 (2002)Google Scholar (arguing that the FTCA, though meant to extend liability in cases of federal employees and officers committing torts, has not been applied as such); infra note 169 and accompanying text.

168 See Niles, supra note 167, at 1292 (noting that courts hear cases in which the government has violated a “regulation, statute, or Constitutional provision”).

169 See, e.g., Hercules, Inc. v. United States, 516 U.S. 417, 417 (1996) (“The United States, as sovereign, is immune from suit save as it consents to be sued and the terms of its consent to be sued in any court define that court's jurisdiction to entertain the suit.”) (internal citations omitted); FDIC v. Meyer, 510 U.S. 471, 471 (1994) (“Absent a waiver, sovereign immunity shields the Federal Government and its agencies from suit.”); Federal Hous. Admin. v. Burr, 309 U.S. 242, 244 (1940) (“[T]he United States cannot be sued without its consent.”).

170 See cases cited supra note 169.

171 See Liability of United States, 28 U.S.C. § 1346(b)(1) (2010). An exception to Sovereign Immunity that will not be discussed in detail in this Article is the Tucker Act, which waives governmental immunity when the government enters into a contract. See Claims against United States generally, 28 U.S.C. § 1491 (2011). An injured research participant might pursue a claim under the Tucker Act on the theory that the informed consent document creates a contract, the terms of which bind the U.S. government. Though there is some support for the “informed consent as contract” argument, see, e.g., Dahl v. Hem Pharm. Corp., 7 F.3d 1399 (9th Cir. 1993) (holding that a consent form in a research protocol formed a unilateral contract); Grimes v. Kennedy Kriger Inst., Inc., 782 A.2d 807, 843 (Md. 2001) (noting that an informed consent document can create a contract); Alvino, Lori A., Note, Who's Watching the Watchdogs? Responding to the Erosion of Research Ethics by Enforcing Promises, 103 Colum. L. Rev. 893, 919-20 (2003)CrossRefGoogle ScholarPubMed, the Tucker Act explicitly excludes cases that sound in tort, see 28 U.S.C. § 1491(a)(1). Given that the underlying claim could sound in tort, an action may be precluded by statutory language. To the extent the informed consent document governs, any injury that is disclosed in the informed consent document could preclude recovery.

172 See Niles, infra note 167, at 1279 (“The FTCA is a revolutionary statute which purports to ‘waive’ the sovereign immunity of the United States in cases arising out of torts committed by its employees and officers.”).

173 See Exceptions, 28 U.S.C. § 2680(a) (2010). Once governmental actions have been labeled discretionary, it is immaterial whether or not actions are performed negligently. 14 CHARLES ALAN WRIGHT ET AL., FEDERAL PRACTICE AND PROCEDURE § 3658.1 (3d ed. Supp. 2011).

174 See, e.g., Berkovitz v. United States, 486 U.S. 531, 538 (1988) (according this analysis “with Congress's purpose in enacting the exception: to prevent ‘judicial intervention in … the political, social, and economic judgments’ of governmental … agencies” (quoting United States v. Varig Airlines, 467 U.S. 797, 820 (1984))).

175 See, e.g., Hyer, supra note 167, at 1108 (“[M]any contend that the Supreme Court's current approach unfairly leaves an injured party without a remedy simply because the injury was caused by a government actor … .”); Niles, supra note 167, 1279 (“[The FTCA] had been interpreted by the United States Supreme Court to allow for a restriction on federal tort liability that is … essentially identical to that applicable before the law was passed.”).

176 See, e.g., Merando v. United States, 517 F.3d 160 (3d Cir. 2008) (holding that the discretionary-function exception applies to the National Forest Service's decision not to cut down dead trees); Childers v. United States, 40 F.3d 973 (9th Cir. 1994) (holding that the decision of the National Park Service not to post warnings or close a trail was discretionary); In re “Agent Orange” Prod. Liab. Litig., 818 F.2d 210 (2d Cir. 1987) (holding that the government's decision to use Agent Orange as a defoliant was discretionary); Ramirez v. U.S. Postal Serv., 893 F. Supp. 121 (D.P.R. 1995) (holding that implementation of security measures for a post office is discretionary).

177 See, e.g., Bibeau v. Pac. Nw. Research Found., Inc., 339 F.3d 942 (9th Cir. 2003) (holding that the United States's decision not to supervise government-funded research experiments testing the effects of radiation on human testicular function was discretionary); Hagy v. United States, 976 F. Supp. 1373 (W.D. Wash. 1997) (holding that the government's decision to delegate safety and warning responsibilities to independent medical researchers was discretionary).

178 E.g., In re Consol. U.S. Atmospheric Testing Litig., 820 F.2d 982 (9th Cir. 1987); Allen v. United States, 816 F.2d 1417 (10th Cir. 1987).

179 See cases cited supra note 177.

180 In re Consol. U.S. Atmospheric Testing Litig., 820 F.2d at 997.

181 Id. at 998.

182 Allen, 816 F.2d at 1424.

183 See supra notes 175-77 and accompanying text.

184 See, e.g., Heinrich ex rel. Heinrich v. Sweet, 62 F. Supp. 2d 282, 323 (D. Mass. 1999) (internal citations omitted) (“An act is not discretionary if a federal statute, regulation, or policy mandates a course of action for an employee to follow … .”). Even negligently conducted research may not give rise to liability if the original act was discretionary because once governmental actions have been labeled discretionary, it is immaterial whether those actions have been performed negligently—the government is immune from suit. WRIGHT ET AL., supra note 173, § 3658.1.

185 See, e.g., WRIGHT ET AL., supra note 173; sources cited supra note 175.

186 See supra notes 167-68 and accompanying text.

187 See Exceptions, 28 U.S.C. § 2680(k) (2005). The foreign country exception was interpreted broadly in the Supreme Court's recent decision Sosa v. Alvarez-Machain, 542 U.S. 692 (2004).

188 See, e.g., Industria Panificadora, S.A. v. United States, 957 F.2d 886, 887 (D.C. Cir. 1992) (dismissing on sovereign immunity grounds the ATS claims against the United States); Goldstar (Panama), S.A. v. United States, 967 F.2d 965, 967-69 (4th Cir. 1992) (same); Canadian Transp. Co. v. United States, 663 F.2d 1081, 1091-92 (D.C. Cir. 1980) (same).

189 Reverby, supra note 10.

190 See id. at 22 (noting the worldwide outrage sparked upon learning of the Guatemala study).

191 U.S. Sued Over Syphilis Tests in Guatemala, CBC NEWS (Mar. 14, 2011, 1:22 PM), http://www.cbc.ca/news/health/story/2011/03/14/syphilis-guatemala-obama-lawsuit.html.

192 Class Action Complaint for Injunctive Relief and Damages, Garcia v. Sebelius, No. 1:11-cv- 00527-RBW (D.D.C. Mar. 14, 2011).

193 E.g., Nedra Pickler, US Argues It Is Immune from STD Experiment Lawsuit, ASSOCIATED PRESS, Jan. 9, 2012, available at http://www.boston.com/yourtown/wellesley/articles/2012/01/10/us_argues_it_is_immune_from_std_experiment_lawsuit/.

194 See discussion infra Part III.C.3.

195 For more information about the ATS, see infra Part III.C.3.a.

196 For more information about forum non conveniens, see infra Part III.C.3.b.

197 See Abdullahi v. Pfizer, Inc., 567 F.3d 163, 169 (2d Cir. 2009), cert denied, 130 S. Ct. 3541 (2010).

198 See id.

199 Id.

200 Id.

201 Id.

202 Id.

203 Id.

204 Id.

205 Purportedly some of the subjects were deliberately given a reduced dose of Ceftriaxone, so their deaths were likely a result of the underlying disease and could have been avoided with a proper dose of the drug. See id.

206 See Stephens, supra note 6, at A01.

207 Abdullahi, 562 F.3d at 170.

208 See Alien's Action for Tort, 28 U.S.C. § 1350 (2006).

209 Sosa v. Alvarez-Machain, 542 U.S. 692 (2004); see also Abdullahi, 562 F.3d at 173.

210 Sosa, 542 U.S. at 715.

211 Abdullahi, 562 F.3d at 172-74.

212 Id. at 174.

213 Id. at 180-82 (finding sufficient universality because the principle had been embedded in U.S. law by Congress, had been embedded in the laws of eighty-four other countries, and had been articulated in a number of international treaties).

214 Id. at 184 (concluding that a “norm forbidding nonconsensual human medical experimentation is every bit as concrete—indeed even more so—than the norm prohibiting piracy … or interference with the right of safe conducts and the rights of ambassadors … “).

215 Id. at 186 (finding sufficient mutuality because the administration of unethical biomedical research had potential for cross-border implications that threatened international peace and security). The Trovan trials apparently engendered distrust among the local population and contributed to an eleven-month-long boycott of a polio vaccination campaign in 2004, which impeded international and national efforts to vaccinate the population. As a result, between 2003 and 2006, a polio outbreak that originated in Nigeria triggered a major international outbreak, causing polio to spread and to re-infect twenty previously polio-free countries. Id. This possibility for global catastrophes, as well as the possibility of unethical research generating substantial anti-American animus and hostility, led the court to the conclusion that the norm was sufficiently mutual. Id. at 187.

216 Although the holding in Abdullahi has been challenged as imprudently racing to declare a new form of international law, the right to be free from non-consensual experimentation on one's body has been recognized throughout U.S. history. See, e.g., Albright v. Oliver, 510 U.S. 266, 272 (1994) (internal citation omitted) (finding that “the protections of substantive due process have for the most part been accorded to matters relating to marriage, family, procreation, and the right to bodily integrity”); Schmerber v. California, 384 U.S. 757, 772 (1966) (“The integrity of an individual's person is a cherished value of our society … .”); Union Pac. R.R. v. Botsford, 141 U.S. 250, 251 (1891) (finding that “no right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others … “).

217 See Joe Stephens, Pfizer to Pay $75 Million to Settle Nigerian Trovan-Testing Suit, WASH. POST, July 31, 2009, at A15.

218 Kiobel v. Royal Dutch Petroleum Co., 621 F.3d 111 (2d Cir. 2010).

219 Id. at 120. The court noted that suits “against the individual perpetrators of violations of customary international law—including the employees, managers, officers, and directors of the corporation” may still be brought under the ATS. Id. at 122.

220 See id. at 124 (“We have, in the past, decided ATS cases involving corporations without addressing the issue of corporate liability.”).

221 See id. at 125-27.

222 See id. at 145.

223 See id. at 162 (noting a 1907 U.S. Attorney General opinion that held that corporations could be liable under the ATS).

224 See id. at 152 (“[T]he imposition of civil liability on corporations serves perfectly the objective of civil liability to compensate victims for the wrongs inflicted on them and is practiced everywhere in the world.”); see also Choudhury, Barnali, Beyond the Alien Tort Claims Act: Alternative Approaches to Attributing Liability to Corporations for Extraterritorial Abuses, 26 Nw. J. Int’L L. & Bus. 43, 54–55 (2005)Google Scholar (noting that Canada, Australia, and England have held corporations liable for human rights violations committed abroad); Mamolea, Andrei, The Future of Corporate Aiding and Abetting Liability Under the Alien Tort Statute: A Roadmap, 51 Santa Clara L. Rev. 79, 97 (2011)Google Scholar (noting that laws imposing criminal liability on corporations for violations of international law are widespread. Over half a dozen countries, including Australia, Canada, France, the Netherlands, Norway, and the UK, impose criminal liability on corporations for violations of international law.). The dissent pointed to policy reasons that would warrant holding corporations liable under the ATS. The ATS is an important tool to ensure the protection of fundamental human rights. Immunizing corporations from civil liability under the ATS could incentivize bad behavior. See Kiobel, 621 F.3d at 149-50.

225 Cases permitting corporate liability under the ATS had been decided by the Court of Appeals for the Second Circuit. See, e.g., Presbyterian Church of Sudan v. Talisman Energy, Inc., 582 F.3d 244, 261 n.12 (2d Cir. 2009) (“We will also assume, without deciding, that corporations … may be held liable for the violations of customary international law that plaintiffs allege.”); Khulumani v. Barclay Nat’l Bank Ltd., 504 F.3d 254, 282 (2d Cir. 2007) (Katzmann, J., concurring) (“[Courts have] repeatedly treated the issue of whether corporations may be held liable under the [ATS] as indistinguishable from the question of whether private individuals may be.”); Wiwa v. Royal Dutch Petroleum Co., 226 F.3d 88 (2d Cir. 2000) (reversing the district court's dismissal of ATS complaint against corporations on forum non conveniens grounds); Jota v. Texaco, Inc., 157 F.3d 153, 155 (2d Cir. 1998) (vacating district court's dismissal of ATS case against corporation on forum non conveniens grounds).

District courts within the Second Circuit had repeatedly held that corporations could be liable under the ATS. See, e.g., In re S. Afr. Apartheid Litig., 617 F. Supp. 2d 228, 254 (S.D.N.Y. 2009) (“On at least nine separate occasions, the Second Circuit has addressed [ATS] cases against corporations without ever hinting—much less holding—that such cases are barred.”); In re “Agent Orange” Prod. Liab. Litig., 373 F. Supp. 2d 7, 58 (E.D.N.Y. 2005) (“A corporation is not immune from civil legal action based on international law.”); Presbyterian Church of Sudan v. Talisman Energy, Inc., 374 F. Supp. 2d 331, 335 (S.D.N.Y. 2005) (“Talisman's argument that corporate liability under international law is not … sufficiently accepted in international law to support an ATS claim is misguided.”).

Cases in both the Ninth and Eleventh Circuits concluded that corporations could be liable under the ATS. See, e.g., Sinaltrainal v. Coca-Cola Co., 578 F.3d 1252, 1263 (11th Cir. 2009) (“In addition to private individual liability, we have also recognized corporate defendants are subject to liability under the ATS and may be liable for violations of the law of nations.”); Romero v. Drummond Co., 552 F.3d 1303, 1315 (11th Cir. 2008) (“The text of the Alien Tort Statute provides no express exception for corporations … and the law of this Circuit is that this statute grants jurisdiction from complaints of torture against corporate defendants.”); Sarei v. Rio Tinto, PLC, 487 F.3d 1193 (9th Cir. 2007), vacated in part on other grounds, 550 F.3d 822 (9th Cir. 2008) (en banc) (concluding that claims against an international mining corporation were sufficient to warrant exercise of federal jurisdiction under the ATS); Doe I v. Unocal Corp., 395 F.3d 932, 947 (9th Cir. 2002) (concluding that a corporation may be subject to suit under the ATS for aiding and abetting violations of customary international law), reh’g en banc granted, 395 F.3d 978 (9th Cir. 2003), appeal dismissed, 403 F.3d 708 (9th Cir. 2005).

District courts in several other circuits have concluded similarly. See, e.g., Al-Quraishi v. Nakhla, 728 F. Supp. 2d 702, 755 (D. Md. 2010) (“[T]here is broad judicial agreement that the ATS provides for corporate liability.”); In re XE Servs. Alien Tort Litig., 665 F. Supp. 2d 569, 588 (E.D. Va. 2009) (“Nothing in the ATS or Sosa may plausibly be read to distinguish between private individuals and corporations; indeed, Sosa simply refers to both individuals and entities as ‘private actors.’”).

226 See Abagninin v. Amvac Chem. Corp., 545 F.3d 733, 741-42 (9th Cir. 2008).

227 See, e.g., Mastafa v. Chevron Corp., 759 F. Supp. 2d 297, 300-01 (S.D.N.Y. 2010) (dismissing suit brought under the ATS stating that, under Kiobel, corporations cannot be liable under the ATS); see also Doe v. Nestle, 748 F. Supp. 2d 1057, 1116 (C.D. Cal. 2010) (dismissing an ATS action holding that customary international law does not apply to corporations).

228 The Supreme Court expressed interest in deciding the issue of corporate liability under the ATS once Abdullahi v. Pfizer was decided, and invited the solicitor general to file a brief expressing the views of the United States. Pfizer v. Abdullahi, 130 S. Ct. 534 (2010) (mem.) (inviting the solicitor general to file a brief expressing the views of the United States). The Supreme Court ultimately denied certiorari at the behest of the solicitor general. Abdullahi v. Pfizer, 562 F.3d 163 (2009), cert. denied, 130 S. Ct. 3541 (2010); Brief for the United States as Amicus Curiae at 1, Abdullahi, 562 F.3d 163 (No. 09-34). The Kiobel decision also creates a circuit split with regards to corporate liability under the ATS, with recent decisions by the D.C. Circuit, the Seventh Circuit, the Ninth Circuit, and the Eleventh Circuit holding that corporations can be liable under the ATS. See Doe v. Exxon Mobil Corp., 654 F.3d 11, 57 (D.C. Cir. 2011) (“[I]t would create a bizarre anomaly to immunize corporations from liability for the conduct of their agents in lawsuits brought for ‘shockingly egregious violations of universally recognized principles of international law.’” (quoting Zapata v. Quinn, 717 F.2d 691 (2d Cir. 1983))); Flomo v. Firestone Nat’l Rubber Co., 643 F.3d 1013, 1017 (7th Cir. 2011) (holding that corporations can be liable under the ATS, and calling Kiobel an “outlier”); Sinaltrainal, 578 F.3d at 1263 (“In addition to private individual liability, we have also recognized corporate defendants are subject to liability under the ATS and may be liable for violations of the law of nations.”); Romero, 552 F.3d at 1315 (“The text of the Alien Tort Statute provides no express exception for corporations … and the law of this Circuit is that this statute grants jurisdiction from complaints of torture against corporate defendants.”); Sarei, 487 F.3d at 1193.

229 Kiobel v. Royal Dutch Petroleum Co., No. 10-1491, 2011 WL 4905479 (U.S. Oct. 17, 2011).

230 See, e.g., Citizens United v. FEC, 130 S. Ct. 876 (2010) (holding that corporations are entitled to First Amendment protection for political speech). But see FCC v. AT&T, Inc., 131 S. Ct. 1177 (2011) (holding that corporations are not persons for purposes of the personal FOIA exemption).

231 See, e.g., Morrison v. Nat’l Austl. Bank Ltd., 130 S. Ct. 2869 (2010) (limiting the extraterritorial application of the Securities Exchange Act of 1934); EEOC v. Arabian American Oil Co., 499 U.S. 244, 248 (1991) (“[L]egislation of Congress, unless a contrary intent appears, is meant to apply only within the territorial jurisdiction of the United States.” (citing Foley Bros. v. Filardo, 336 U.S. 281, 285 (1949))).

232 For a thoughtful and fulsome argument that corporations should be held liable under the ATS, see, for example, Mamolea, supra note 224. For an argument to the contrary, see Ku, Julian, The Curious Case of Corporate Liability Under the Alien Tort Statute: A Flawed System of Judicial Lawmaking, 52 Va. J. Int’L L. 353 (2011).Google Scholar

233 (Maxi) Adamski, Theresa, The Alien Tort Claims Act and Corporate Liability: A Threat to the United States’ International Relations, 34 Fordham Int’L L.J. 1502, 1522 (2011)Google Scholar (“[T]he Second Circuit … has heard a substantial number of ATCA cases and, consequently, handed down a series of important decisions concerning corporate liability.”).

234 See, e.g., Ford, Jolyon & Tomossy, George, Clinical Trials in Developing Countries: The Plaintiff's Challenge, L. Soc. Just. & Global Dev. J. 1 (2004)Google Scholar, available at http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2004_1/ford/.

235 Among the factors a court may consider in deciding whether to decline jurisdiction on the grounds of forum non conveniens, some of which might argue in favor of a foreign forum, are: the location of potential witnesses, the location of relevant evidence and records, possible undue hardship for the defendant, availability of adequate alternative forums for the plaintiff, the expeditious use of judicial resources, the choice of law applicable to the dispute, and the location where the cause of action arose. See, e.g., Piper Aircraft Co. v. Reyno, 454 U.S. 235 (1981).

236 See Abdullahi v. Pfizer, Inc., 562 F.3d 163, 169 (2d Cir. 2009), cert. denied, 130 S. Ct. 3541 (2010).

237 Id. at 170.

238 Id.

239 Id. at 170-72.

240 Id.

241 Id.

242 Ford & Tomossy, supra note 234, § 3.3.

243 Id.

244 Id.

245 Id. § 1.

246 Given these circumstances, courts should take efforts to ensure that plaintiffs have a genuine possibility of legal remedy in a foreign tribunal before dismissing cases on the ground of forum non conveniens. Jolyon Ford and George Tomossy argue that “it is difficult to accuse injured subjects … of inconvenient ‘forum shopping’ where they seek to sue a defendant research corporation in its home jurisdiction, where that defendant might itself have been shopping around for a foreign trial site holding the least likelihood of … legal accountability.” Id. § 3.3.

247 See Glickman et al., supra note 13, at 816-17.

248 Id. at 817-18.

249 PRESIDENTIAL COMM’N, supra note 82, at app. IV.

250 Glickman et al., supra note 13, at 816.

251 Id. at 818. Western Europe was home to forty percent of trials in 1995, and thirty-six and a half percent of trials in 2005. Id.

252 Id. at 816.

253 Id.

254 See Hathaway, Carolyne R. et al., Looking Abroad: Clinical Drug Trials, 63 Food & Drug L.J. 673 (2008).Google ScholarPubMed

255 ADRIANA PETRYNA, WHEN EXPERIMENTS TRAVEL: CLINICAL TRIALS AND THE GLOBAL SEARCH FOR HUMAN SUBJECTS 13 (2009).

256 Id.

257 Hathaway et al., supra note 254, at 674.

258 For a general discussion of the limited rights provided to research participants in the United States contrasted with rights provided in European clinical trials, see Steinbrook, Robert, Compensation for Injured Research Subjects, 354 New Eng. J. Med. 1871 (2006)CrossRefGoogle ScholarPubMed (noting that “despite decades of discussion and recommendations by national commissions, sponsors and institutions are not required to provide either free medical care or compensation … . In contrast, many European countries mandate the provision of clinical-trials insurance, through which subjects are often covered regardless of fault.”).

259 See EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE, THE PROCEDURE FOR THE ETHICAL REVIEW OF PROTOCOLS FOR CLINICAL RESEARCH PROJECTS IN EUROPE AND BEYOND: QUESTION 31 (2010) [hereinafter EUROPEAN FORUM].

260 See INDIAN COUNCIL OF MED. RESEARCH, ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS 29 (2006) (India); MED. RESEARCH COUNCIL OF S. AFR., GUIDELINES ON ETHICS FOR MEDICAL RESEARCH: GENERAL PRINCIPLES app. IV, § 1.1 (2002) (South Africa); NAT’L HEALTH & MED. RESEARCH COUNCIL, NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH 38 (2007) (Australia); NAT’L HEALTH COUNCIL, RESOLUTION NO. 196/96 ON RESEARCH INVOLVING HUMAN SUBJECTS (1987) [hereinafter BRAZIL COMPENSATION] (Brazil); UGANDA NAT’L COUNCIL FOR SCI. & TECH., NATIONAL GUIDELINES FOR RESEARCH INVOLVING HUMANS AS RESEARCH PARTICIPANTS 28 (2007) (Uganda); GOOD CLINICAL PRACTICE (BOARD ORDER NO. 3), Art. 43 (2003) (China) (cited in PRESIDENTIAL COMM’N, supra note 82, at app. IV).

261 See Council Directive 2001/20, 2001 O.J. (L 121) 34 (EC).

262 Id. at arts. 3.2(f), 6.3(h). E.U. member states were required to transpose the directive into national laws, regulations, and procedures by May 2003 and to implement them by May 2004. Id. at art. 22(1).

263 For example, countries have established various insurance minimum thresholds. Poland has adopted a graduated approach to insurance requirements. For research trials with fewer than ten participants, insurance coverage must total at least €500,000. For trials with more than 100 participants, insurance must cover at least €5 million. EUROPEAN FORUM, supra note 259, at 31-35. Spain requires insurance coverage of at least €250,000 per subject. Id. at 31-36.

The European Union is currently revisiting its approach. Because the directive granted member states flexibility in implementing requirements, it has “led to a situation where Member States have slightly divergent national provisions based on identical concepts” in ways that “make multinational clinical trials more burdensome and expensive.” EUROPEAN COMM’N OF HEALTH & CONSUMERS DIRECTORATE-GENERAL, REVISION OF THE ‘CLINICAL TRIALS DIRECTIVE’ 2001/20/EC: CONCEPT PAPER SUBMITTED FOR PUBLIC CONSULTATION 8 (2011), available at http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf [hereinafter EUROPEAN COMM’N]. Under proposed revisions, sponsors of research that poses only minimal risk of harm to participants may not be obligated to provide insurance or indemnification. The revision could also result in member states indemnifying directly any damages resulting from clinical trials within their borders. Id. at 12.

264 INST. OF MED., supra note 72, at 189.

265 Id.

266 Id.

267 See, e.g., Arzneimittelgesetz [AMG] [Medicinal Products Act], Dec. 12, 2005, BUNDESGESETZBLATT, Teil I [BGBL. I] at 3394, § 88, last amended by Gesetz [G], May 25, 2011, BGBL I at 946, art. 1 (Ger.).

268 Gainotti & Petrini, supra note 120, at 5.

269 See, e.g., INST. OF MED., supra note 72, at 189.

270 Id.

271 Gainotti & Petrini, supra note 120, at 6.

272 MINISTRY OF HEALTH, WELFARE & SPORT, INTERNATIONAL PUBLICATION SERIES HEALTH, WELFARE AND SPORT, NO. 2, THE MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS ACT § 4.1 (2000).

273 Id. § 5.1.

274 Id. § 5.3.

275 Id. § 3.1.

276 Id. § 7.1.

277 See supra note 260 and accompanying text.

278 UGANDA NAT’L COUNCIL FOR SCI. & TECH., supra note 260.

279 Id.

280 See BRAZIL COMPENSATION, supra note 260. Brazil has implemented a more comprehensive view of the right to health. The Brazilian Constitution of 1988 granted the right to health to all citizens, and mandated the creation of a national healthcare system. Biehl, João et al., Judicialisation of the Right to Health in Brazil, 373 Lancet 2182, 2183 (2009)CrossRefGoogle ScholarPubMed (“The Brazilian Constitution of 1988 granted the right to health to all citizens and mandated the creation of a national health-care system.”).

281 BRAZIL COMPENSATION, supra note 260, § II.8.

282 Id. § V.5.

283 Id. § V.6.

284 Thatte, U.M. et al., Review of Policies for Injuries to Research Participants in India, 35 J. Med. Ethics 133, 138 (2009).CrossRefGoogle ScholarPubMed

285 SING. MINISTRY OF HEALTH, NATIONAL MEDICAL ETHICS COMMITTEE's RECOMMENDATIONS ON CLINICAL TRIALS: UPDATE FOCUSING ON PHASE I TRIALS § 16(a) (2007), available at http://www.moh.gov.sg/content/dam/moh_web/Publications/Guidelines/National%20Medical%20Ethics%20Committee%20Guidelines/2007/NMEC%20Compn%20Clin%20Trials_24%20May%2007_final_public_clean.pdf.

286 Id.; Thatte et al., supra note 284, at 138.

287 See Glickman et al., supra note 13, at 817-18 (showing numbers of clinical trial locations by country); supra Part III.B.

288 Neaton, James D. et al., Regulatory Impediments Jeopardizing the Conduct of Clinical Trials in Europe Funded by the National Institutes of Health, 7 Clinical Trials 705, 707-08 (2010).CrossRefGoogle ScholarPubMed

289 Id. at 712.

290 Id.

291 Id. at 713.

292 Malaria Vaccine Dev. Branch Div. of Intramural Research, Clinical Trial Insurance for Phase 1 and 2 Vaccine Trials (Mar. 22, 2006) (presentation on file with the author). In May 2004, a collaborative research enterprise between the National Institute of Allergy and Infectious Diseases, an institute within the NIH, and a university in Mali was set to begin trials of a potential malaria vaccine. Because insurance/self-insurance was required under the law of Mali, conducting research without an insurance/self-insurance system in place rendered the research noncompliant. Id.

293 Id.

294 Kounteya Sinha, Clinical Trials Claimed 25 Lives in 2010, Only 5 Paid Compensation, TIMES OF INDIA (June 6, 2011, 1:40 AM), http://articles.timesofindia.indiatimes.com/2011-06-06/india/29624892_1_clinical-trials-drug-controller-general-dcgi.

295 Id.

296 This Article does not seriously consider modifying the tort system. Modifications to the tort system would likely be unduly burdensome to implement and would be insufficient to protect injured research participants. Modifications to the tort system would not be able to overcome the barriers posed by the requirement of fault, assumption of risk, sovereign immunity, forum non conveniens, and Kiobel v. Royal Dutch Petroleum, discussed in more detail in Part III.

297 The language generally used is: “You will not be giving up any of your legal rights by signing this consent form” or “you have the right to pursue legal remedy if you believe that your injury justifies such action.”

298 See, e.g., Gainotti & Petrini, supra note 120, at 2.

299 Id.

300 See Scott, supra note 137, at 423; Resnik, supra note 89, at 283-85.

301 See McEwin, supra note 123, at 737; O’Connell, supra note 123, at 63 (“The attempt to achieve a fair and rational method for the compensation of victims has been displaced by a form of litigation lottery.”).

302 See, e.g., INST. OF MED., supra note 72, at 190-91; Hager, Mark M., No-Fault Drives Again: A Contemporary Primer, 52 U. Miami L. Rev. 793, 807 (1998)Google Scholar (noting that no-fault pays a higher proportion of premium income to claimants than does the tort system, reduces over- and undercompensation, and delivers compensation more quickly than does the tort system); Mariner, supra note 95, at 121; McEwin, supra note 123, at 739 (“Many studies have demonstrated that the tort system is not only slower to provide compensation than no-fault but also tends to overcompensate small losses and undercompensate large losses.”).

303 See, e.g., Resnik, supra note 89, at 283.

304 See infra Part V.D for more information on the cost-effectiveness of no-fault compensation systems for research-related injuries.

305 See supra Part IV.B.

306 See, e.g., Hager, supra note 302, at 794-95 (“No-fault's disadvantages are chiefly two-fold: (1) loss of tort law's purported role in deterring unsafe driving; and (2) loss of tort law's purported corrective justice function in securing recompense for injury victims from culprits who inflict injury.”); Huang, Henry & Soleimani, Farzad, What Happened to No-Fault? The Role of Error Reporting in Healthcare Reform, 10 Hous. J. Health L. & Pol’Y 1, 7–8 (2009)Google Scholar (“Critics also argue that no-fault systems produce the wrong incentives for doctors and victims. Simply put, without fault in the compensation process, there is no (or at least less) stigma associated with fault, and therefore less incentive to prevent mistakes.”).

307 See, e.g., Hager, supra note 302, at 808 (“Existing no-fault has not brought reduced premiums, despite claims by advocates that it should.”); Huang & Soleimani, supra note 306, at 7 (“Despite these harsh criticisms of tort, the no-fault alternative has ample detractors. One of its biggest sticking points is cost.”).

308 See, e.g., Schwartz, Gary T., Auto No-Fault and First-Party Insurance: Advantages and Problems, 73 S. Cal. L. Rev. 611, 651 (2000)Google Scholar (“[N]o-fault's denial of pain and suffering compensation to the victims of negligent driving is a denial that raises a fairness problem with no-fault.”); Stamm, Lindsay J., The Current Medical Malpractice Crisis: The Need for Reform to Ensure a Tomorrow for Oregon's Obstetricians, 84 Or. L. Rev. 283, 306 (2005)Google Scholar (“Critics of no-fault, notably plaintiff's attorneys, argue it would shortchange victims who could fare better under the existing tort system.”).

309 See, e.g., Hager, supra note 302, at 806 (noting that studies have “found existing nofault schemes superior to tort for rational and efficient delivery of compensation”).

310 For this reason, a number of scholars have advocated no-fault compensation in the area of research-related injuries. See, e.g., Michael Traynor & Erin Wallace, Clinical Trials: Emerging Issues Regarding Globalization of Pharmaceutical Research, Insurance, Informed Consent, Securities Litigation, and Public Policy, Presentation at CLE Seminar on Emerging Issues in Biotechnology Law (Sept. 6-7, 2007), available at http://www.cooley.com/files/tbl_s5SiteRepository/FileUpload21/1348/Article%20-%20Sep%2007%20-%20Traynor%20-%20Clinical%20Trials.pdf (“[University of Washington's no-fault compensation system] bears serious consideration in the U.S. as evolving ethical standards here as well as legal requirements in foreign countries call for it to be implemented. Although the empirical data is lacking, this approach might hold the promise of reducing the incidence of substantial tort liability claims and attendant increased liability insurance costs.”).

311 See, e.g., PRESIDENT's COMM’N, supra note 43, at 127.

312 See Limitations on Expending and Obligating Amounts, 31 U.S.C. § 1341(a)(1)(A) (2010) (forbidding the obligation of funds not already appropriated).

313 See No contracts or purchases unless authorized or under adequate appropriation, 41 U.S.C. § 11(a) (2010) (forbidding the government to obligate itself by contract “unless the same is authorized by law or is under an appropriation adequate to its fulfillment”).

314 See 31 U.S.C. § 1341(a)(1)(A); 41 U.S.C. § 11(a).

315 See, e.g., Marwick, Charles, Compensation for Injured Research Subjects, 297 JAMA 1854, 1854 (1998)CrossRefGoogle Scholar (justifying the NIH's policy of non-compensation because it is unable “to provide funding for health care costs that go beyond the contract period”); What Else Should I Know About Clinical Research?, NAT’L INST. OF CHILD HEALTH & HUMAN DEV. (Feb. 9, 2011), http://www.nichd.nih.gov/health/clinicalresearch/aboutclinicalresearch.cfm (citing the Anti- Deficiency Act and the Adequacy of Appropriations Act research as the reason why “participants in a federally funded study can not [sic] sue the federal government for a claim of injury, loss, or damage”).

316 See, e.g., PRESIDENTIAL COMM’N, supra note 82, at app. IV.

317 Though subject to the criticism discussed below, workers’ compensation systems have also been heralded as an “enormous boon to efficiency” that addresses the goals of efficiency, deterrence, corrective justice, and distributive justice, and “coincided with an enormous reduction in industrial accident rates.” O’Connell, Jeffrey & Linehan, John, Neo No-Fault Early Offers: A Workable Compromise Between First and Third-Party Insurance, 41 Gonz. L. Rev. 103, 133-34 (2005).Google Scholar

318 See, e.g., Council Directive 2001/20, 2001 O.J. (L 121) 34 (EC), art. 3.2(f).

319 THE LEWIN GRP., supra note 129, at 19.

320 Cf. id. (“In exchange for the certainty of reasonably speedy compensation on a no-fault basis, injured employees are required to give up their rights to sue their employers.”).

321 See, e.g., O’Connell & Linehan, supra note 317, at 133-34.

322 Cf. id. at 134 (noting that under workers’ compensation, “producers retain an incentive to provide a safe workplace environment” as “reflected in the employer's experience-rated premiums”).

323 Id. (noting that those injured exchange “the guarantee of prompt, but limited, pay-outs” for the “indeterminate opportunity for tort's riches”).

324 See, e.g., SECRETARY's TASK FORCE, supra note 77, at V-4 (“[I]f institutions chose to fund such a system with insurance, the premiums ascribable to the insurance could be paid from grant or contract funds under current department policies.”).

325 1 OFFICE OF THE GENERAL COUNSEL, U.S. GEN. ACCOUNTING OFFICE, PRINCIPLES OF FEDERAL APPROPRIATIONS LAW 4-176 (3d ed. 2004), available at http://www.gao.gov/special.pubs/d04261sp.pdf.

326 PRESIDENTIAL COMM’N, supra note 82, at Appendix IV.

327 See, e.g., Marwick, supra note 315, at 1854 (“One possible avenue for funding any compensation for adverse events in clinical trials would be to set up a mechanism similar to the Vaccine Injury Compensation Act.”).

328 See, e.g., THE LEWIN GRP., supra note 129, at 1 (“[T]o this day the only national standard for no fault procedures and federal compensation guidelines is the National Childhood Vaccine Injury Act … .”).

329 Vaccine Program/Office of Special Masters, U.S. COURT OF FED. CLAIMS, http://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Nov. 17, 2011) [hereinafter Vaccine Program]; Statement on National Vaccine Injury Compensation Program: Before the House Committee on Criminal Justice, Drug Policy, and Human Resources, 106th Cong. (1999) (statement of Thomas E. Balbier, Jr., Director, Nat’l Vaccine Injury Comp. Program, U.S. Dep't of Health & Human Servs.), available at http://www.hhs.gov/asl/testify/t990928b.html (“42 percent of petitions adjudicated under the Program have been awarded compensation. This compares to a compensation rate of only 23 percent for those who file medical malpractice lawsuits through the usual tort system. On average, it takes only two years to resolve claims and issue any appropriate payments.”).

330 See, e.g., Vaccine Program, supra note 329.

331 THE OFFICE OF SPECIAL MASTERS, U.S. COURT OF FED. CLAIMS, GUIDELINES FOR PRACTICE UNDER THE NATIONAL VACCINE INJURY COMPENSATION PROGRAM 8 (2004), available at http://www.uscfc.uscourts.gov/sites/default/files/OSM.Guidelines.pdf.

332 Id. at 4.

333 See, e.g., Gainotti & Petrini, supra note 120, at 3.

334 Critiques of the vaccine court system generally relate to the fact that rates of compensation have not been adjusted since implementation, and that the system is still more adversarial than anticipated. See, e.g., Henson, Rob, Inoculated Against Recovery: A Comparative Analysis of Vaccine Injury Compensation in the United States and Great Britain, 15 Tulsa J. Comp. & Int’L L. 61, 89–92 (2007).Google Scholar

335 Gainotti & Petrini, supra note 120, at 3.

336 See, e.g., Scott, supra note 137, at 422. At the time, large jury awards had forced several vaccine manufacturers to consider the potential costs of lawsuits; many concluded that they could no longer afford to stay in business. Most vaccine manufacturers ceased production, and the last remaining major manufacturer threatened to do so. The vaccine court was thus seen as a timely solution to an imperiled supply of vaccines. Id.; Gainotti & Petrini, supra note 120, at 3.

337 See, e.g., ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, supra note 46; PRESIDENT's COMM’N, supra note 43; SECRETARY's TASK FORCE, supra note 77.

338 See, e.g., EMANUEL ET AL., supra note 9; Levine, supra note 1; Reverby, supra note 10; Stephens, supra note 6.

339 Compare Anti-Deficiency Act, 31 U.S.C. § 1341(a)(1)(A) (2006), and Adequacy of Appropriations Act, 41 U.S.C. § 11(a) (2006), with National Injury Compensation Program, 42 U.S.C. §§ 300aa-1 to -34 (2006).

340 Sugarman, Stephen D., Cases in Vaccine Court — Legal Battles over Vaccines and Autism, 357 New Eng. J. Med. 1275 (2007)CrossRefGoogle ScholarPubMed, available at http://www.nejm.org/doi/full/10.1056/NEJMp078168.

341 See Radiation Exposure Compensation Act (RECA), U.S. DEP't OF JUSTICE, http://www.justice.gov/civil/torts/const/reca/about.htm (last updated Aug. 6, 2011) [hereinafter RECA].

342 Id.

343 42 U.S.C. § 2210 (2006).

344 RECA, supra note 341.

345 Id.

346 Id.

347 September 11th Victim Compensation Fund of 2001, 67 Fed. Reg. 11,233, 11,236 (Mar. 13, 2002) (codified at 28 C.F.R. pt. 104).

348 Id.

349 Id. §§ 104.41-.47.

350 Id. § 104.31(b)(1).

351 Id. § 104.33.

352 About the Fund, BP CLAIMS FUND ASSISTANCE (July 21, 2010), http://www.thebpclaimsfund.com/.

353 Kenneth R. Feinberg, The September 11th Victim Compensation Fund, 32 LITIGATION 14, 17 (2006).

354 Id.

355 The Patient Protection and Affordable Care Act may alter the number of uninsured people living in the United States. MOSES & SINGER LLP, supra note 141.

356 THE ASS’N OF THE BRITISH PHARM. INDUS., CLINICAL TRIAL COMPENSATION GUIDELINES § 1.2 (Jan. 1, 1994), available at http://www.abpi.org.uk/our-work/library/guidelines/Pages/ctcompensation.aspx.

357 Thatte et al., supra note 284, at 133.

358 SING. MINISTRY OF HEALTH, supra 285, § 16(a) (“Most of the centres themselves or the sponsors of the trial follow the guidelines of the Association of British Pharmaceutical Industry (ABPI) on compensation for adverse events resulting from participation in a clinical trial.”).

359 Karen Moe, Director and Assistant Vice Provost For Research, Univ. of Wash., Presentation to the President's Commission for the Study of Bioethical Issues (Nov. 17, 2011), available at http://bioethics.gov/cms/meeting-seven (noting that the University of Washington performed this analysis and concluded that self-insurance was the more cost-effective option).

360 For a discussion of various adverse event reporting systems, see WORLD ALLIANCE FOR PATIENT SAFETY, WORLD HEALTH ORG., WHO DRAFT GUIDELINES FOR ADVERSE EVENT REPORTING AND LEARNING SYSTEMS (2005); INT’L CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARM. FOR HUMAN USE, MAINTENANCE OF THE ICH GUIDELINE ON CLINICAL SAFETY DATA MANAGEMENT: DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS E2B(R2) (Feb. 5, 2001).

361 O’Connell & Linehan, supra note 317, at 134.

362 See, e.g., ASS’N OF THE BRITISH PHARM. INDUS., supra note 356, § 4.3 (“In any case where the company concedes that a payment should be made to a patient but there exists a difference of opinion between company and patient as to the appropriate level of compensation, it is recommended that the company agrees to seek at its own cost … the opinion of a mutually acceptable independent expert, and that his opinion should be given substantial weight by the company … .”).

363 See, e.g., Netherlands Decree of 23 June 2003 containing rules for compulsory insurance in medical research involving human subjects, art. 4(1), available at http://www.ccmo.nl/download/verzekeringsbesluit_2003-eng.pdf (“If the committee responsible for assessing the trial protocol in question believes the clinical trial represents no risk to the subjects, at the sponsor's request it may, upon its approval of the protocol, exempt the sponsor from the obligation to take out insurance.”); EUROPEAN COMM’N, supra note 263, § 2.4.2 (considering “[r]emoving insurance/indemnisation requirements for low-risk trials: This policy option would remove the insurance requirement for clinical trials which typically pose a low risk for trial subjects”).

364 See, e.g., PRESIDENT's COMM’N, supra note 43, at 132-35.

365 The European Union is currently reconsidering its decision not to exempt minimal risk research. EUROPEAN COMM’N, supra note 263, § 2.4.2.

366 See, e.g., Gainotti & Petrini, supra note 120, at 4 (noting that France has different standards for therapeutic and nontherapeutic research).

367 See, e.g., PRESIDENT's COMM’N, supra note 43, at 132-35.

368 This approach is consistent with the opinions of the 1977 Task Force. See, e.g., SECRETARY's TASK FORCE, supra note 77, at VI-9 (concluding that participants in both therapeutic and nontherapeutic research should be entitled to no-fault compensation, provided that injury is defined narrowly).

369 The only question presented in the workers’ compensation system “is whether or not the injury ‘arose out of and in the course of employment’ … .” O’Connell & Linehan, supra note 317, at 132 (internal citations omitted).

370 PRESIDENTIAL COMM’N, supra note 82, at 69.

371 Using serious adverse event reporting as a trigger appropriately confines the compensation mechanism to non-trivial injuries. See, e.g., ASS’N OF THE BRITISH PHARM. INDUS., supra note 356, § 1.4 (“Compensation should only be paid for the more serious injury of an enduring and disabling character … and not for temporary pain or discomfort or less serious or curable complaints.”); PRESIDENT's COMM’N, supra note 43, at 129 (limiting benefits to “nontrivial bodily injuries or death as a result of their participation in covered research”). Research-related injuries that are not serious, e.g., bleeding or bruising from a blood draw, should be treated on-site. These injuries would not generally otherwise be compensable in court. See, e.g., PRESIDENT's COMM’N, supra note 43, at 81 (“For subjects with minor, short-lived injuries (who constitute a large proportion of injured subjects), the provision of free, on-the-spot medical care dispenses with any need for formal ‘compensation’ for research injuries.”).

372 See, e.g., ASS’N OF THE BRITISH PHARM. INDUS., supra note 356, § 1.2.

373 See, e.g., id. § 3.2.

374 See supra Part III.

375 See, e.g., PRESIDENT's COMM’N, supra note 43, at 129 (“Benefits should be reduced or eliminated when injury results from the failure of the subject reasonably to conform to the provisions of the research.”) (emphasis added).

376 These parameters are in line with compensation systems of other nations and with the compensation provided by other U.S. no-fault compensation systems. See, e.g., The Danish Liability for Damages Act, pt. I (2007) (Den.), available at http://www.patientforsikringen.dk/en/Love-og-Regler/Lov-om-klage-og-erstatningsadgang/Behandlingsskader.aspx (compensating for personal injury, loss of earnings, pain and suffering, permanent injury, and loss of earning capacity, among other areas); Injury Prevention, Rehabilitation, and Compensation Act 2001 (amended 2007), pt. 2, § 26(1) (N.Z.) (compensating for the death of a person, physical injuries suffered by a person, and mental injury); BRAZIL COMPENSATION, supra note 260, at art. II.8 (compensating injuries to the “physical, psychic, moral, intellectual, social, cultural, or spiritual dimensions of the human subject”).

377 This is how the 9/11 Compensation Fund was implemented. Feinberg, supra note 353, at 15.

378 See, e.g., Danish Act on the Right to Complain and Receive Compensation within the Health Service (2009), pt. 4, § 50 (Den.), available at http://www.patientforsikringen.dk/en/Love-og-Regler/Lov-om-klage-og-erstatningsadgang/Lægemiddelskader.aspx (capping damages to individual injured research participants at DKK5 million per injured person, approximately one million U.S. dollars); Medical Research (Human Subjects) Compulsory Insurance Decree, Stb. 2003, p. 66, art. 3(1) (Neth.). (capping insurance payments at €450,000 per subject and €3,500,000 per clinical trial).

379 See, e.g., Medical Research (Human Subjects) Compulsory Insurance Decree, supra note 378, at 66, art. 3(1).

380 See, e.g., Danish Act on the Right to Complain and Receive Compensation within the Health Service¸ supra note 378, at pt. 4, § 46 (permitting claims that exceed DKK3000, approximately five hundred U.S. dollars).

381 Those institutions with sufficient funds will be permitted to indemnify injured research participants. See, e.g., Suz Redfearn, Clinical Trial Insurance (Aug. 14, 2007), available at http://www.clinpage.com/article/clinical_trial_insurance/ (“[M]ost big pharmaceutical companies don't buy clinical trial insurance. Some may instead have a dedicated risk management division on the premises. Or they know that their cash reserves are enough to handle any settlements that need to be made.”).

382 See, e.g., Jamie Summers, Legal and Practical Barriers to a No-Fault Compensation Program for Research Related Injuries (unpublished manuscript) (on file with the author).

383 OFFICE OF THE GENERAL COUNSEL, supra note 325, at 4-164.

384 There are exceptions to this general policy that, if applicable, would allow government agencies to purchase private insurance without a statutory grant of authority. See id. at 4-180.

385 See, e.g., Resnik, supra note 89, at 284-85.

386 Id. See also text in Parts V.D.1-D.3.

387 See, e.g., Resnik, supra note 89, at 284 (“A major reason no-fault systems are not popular in the United States is that institutions and sponsors do not want to bear the burden of financing these plans.”).

388 See, e.g., id.

389 See, e.g., INST. OF MED., supra note 72, at 191 (“The main impediment to the implementation of a compensation program for research-related injuries in the United States is that, despite decades of discussion and studies by a number of federal commissions, there remains little quantitative information regarding the number and severity of potentially compensable injuries and about the costs of implementing compensation programs.”).

390 See, e.g., Scott, supra note 137, at 420.

391 In an unidentified member state with approximately 200-1000 clinical trial applications per year, only fourteen claims for compensation were granted over a period of nine years. In Finland, out of almost 300,000 trial participants, the Finnish Patient Insurance Centre and the Finnish Pharmaceutical Insurance Pool received only nineteen requests for compensation between 2005 and 2010; only four led to compensation. Denmark received only twenty-seven claims for compensation over a period of ten years. See EUROPEAN COMM’N, supra note 263, at 23. It is important to note that data from Europe create an imperfect comparison; many European countries have national healthcare, under which medical bills are generally covered. Additionally, some of the plans, including the German plan, do not provide compensation for pain and suffering. Nevertheless, given that the lack of empirical data has been used to prevent implementation of compensation systems in the United States, it is also important to use the empirical data available.

392 Denmark, at the high end of the scale, paid €550,000 over a period of ten years to injured research participants, or €55,000 per year. Relative to Denmark's annual research budget of €385 million per year, the cost of compensating injured research participants is 0.01 percent of the health research budget. See DANISH RESEARCH AGENCY, FIGURES FOR RESEARCH 2005 (Jan. 2006), available at http://en.fi.dk/publications/2006/figures-for-research-statistics-2005/figures-for-researchstatistics-2005.pdf (showing the research expenditures of Denmark to be DKK2.846 billion).

393 The cost of insurance per patient per annum in Europe ranges from a low of €14.50 in Belgium, to a high of €75 in France and Germany. See EUROPEAN COMM’N, supra note 263, at 23. Relative to the other costs of conducting a biomedical research trial, these costs are negligible—even for very large trials. Some data suggest that the costs of purchasing insurance may be less than the costs of compensating research-related injuries directly. In an unidentified member state, the total amount of compensation paid out in fourteen claims over nine years was €43,000. The administrative cost for the insurers was approximately €38,000, and the total cost for the policy was approximately €235,000. Id.

394 PRESIDENT's COMM’N, supra note 43, at 65-80; NAT’L BIOETHICS ADVISORY COMM’N,, supra note 81, at 123-25.

395 PRESIDENT's COMM’N, supra note 43, at 80 (“Although the evidence consistently suggests that the incidence of serious injury is small, nonetheless, it is clear that at least some subjects sustain injuries as a result of their participation in federally funded or regulated research. For them, … the question of compensation is real and of immediate importance.”).

396 Dolgin, Janet L. & Dieterich, Katherine R., Social and Legal Debate About the Affordable Care Act, 80 Umkc L. Rev. 45, 48–49 (2011).Google Scholar

397 Id. at 52 (“The [Patient Protection and Affordable Care] Act promises to extend health care coverage to millions of people. Health care coverage will be made available to many not now insured.”).