Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects

45 C.F.R. § 46.116(a) (2012).

The Willowbrook Hepatitis Study involved intentionally exposing mentally disabled children at a state institution to hepatitis to track the development of the viral infection and the protective mechanism of gamma globulin injections. Robinson W. M. Unruh B. T. , “The Hepatitis Experiments at the Willowbrook State School,” in Emanuel E. J. , eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): At 80. The Tuskegee Syphilis Study enrolled more than 600 African-American men in a decades-long study that observed the natural progression of syphilis without providing readily available and proven therapy. Department of Health Education, and Welfare, Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel (April 1973) [hereinafter Tuskegee Syphilis Study];

J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993);

S. Reverby, Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (Chapel Hill, NC: University of North Carolina Press, 2009).

Beauchamp T. L. , “The Belmont Report,” in Emanuel E. J. , eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): At 149, 150;

Moreno J. D. , “Protectionism in Research Involving Human Subjects,” in National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants: Vol. II, I–1 (August 2001);

Mastroianni A. Kahn J. , “Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research,” The Hastings Center Report 31, no. 3 (May-June 2001): 21–28.

The best-known academic institutional policy is the University of Washington's no-fault Compensation Plan for Adverse Effects to Human Subjects. Moe K. E. , Presentation to the President's Commission for the Study of Bioethical Issues, November 17, 2011, available at <http://bioethics.gov/sites/default/files/Moe.pdf> (last visited April 29, 2013). The Department of Veterans Affairs, the Department of Defense, the National Institutes of Health Clinical Center, and Medicare also cover some costs associated with medical care for injured research subjects. 38 C.F.R. § 17.85(a) (2012) (“VA medical facilities shall provide necessary medical treatment to a research subject injured as a result of participation in a research project approved by a VA Research and Development Committee and conducted under the supervision of one or more VA employees.”);

U.S. Department of Defense, DOD Instruction Number 6000.08: Funding and Administration of Clinical Investigation Programs, sec. 6.2.4 (December 3, 2007) (“Because subjects may be injured while participating in CI research, for research involving more than minimal risk as determined by the IRB having jurisdiction over the study, include in every … protocol an arrangement for treatment of any research-related injuries.”);

Office of Human Subjects Research, National Institutes of Health, Sheet 6: Guidelines for Writing Informed Consent Documents (November 20, 2006) (“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. …”);

Centers for Medicare and Medicaid Services, National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) (July 9, 2007) (“Medicare covers the routine costs of qualifying clinical trials … as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.”).

A study commissioned by HHS found that fewer than one in five academic research institutions provide free medical care to subjects who are harmed during clinical trials, and none offer compensation for lost wages or pain and suffering. The Lewin Group, Final Report: Task Order No. 2: Care/Compensation for Injuries in Clinical Research, ES-2 (May 18, 2005).

See also Paasche-Orlow M. K. Brancati F. L. , “Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for Research-Related Injury,” American Journal of Medicine 118, no. 2 (2005): 175–180, at 177 (finding that only 22% of medical schools engaged in non-industry sponsored research offered coverage for medical bills associated with research-related injuries, and of those, only half covered the costs of emergency care).

See Elliott C. , “Justice for Injured Research Subjects,” New England Journal of Medicine 367, no. 1 (2012): 6–8, at 7;

Pike E. R. , “Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants,” American Journal of Law & Medicine 38, no. 1 (2012): 7–62, at 23–29;

Resnik D. B. , “Compensation for Research-Related Injuries: Ethical and Legal Issues,” Journal of Legal Medicine 27, no. 3 (2006): 263–287, at 268.

See Tuskegee Syphilis Study, supra note 2, at 24.

National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in Research Involving Human Participants, Vol. 1 (August 2001): At 124 [hereinafter Ethical and Policy Issues] (describing the actions of the 1973 Medical Malpractice Commission).

Department of Health, Education, and Welfare, Secretary's Task Force on the Compensation of Injured Research Subjects (1977) [hereinafter Compensation of Injured Research Subjects];

Department of Health Education and Welfare, “Institutional Review Boards: Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,” 43 Fed. Reg. 56,174 (November 30, 1978).

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, Volume I (1982): At 4 [hereinafter Compensating for Research Injuries].

Advisory Committee on Human Radiation Experiments (ACHRE), Final Report, Recommendation 14 (1995) [hereinafter Final Report]

NBAC, Ethical and Policy Issues, supra note 8, at 123–126

Institute of Medicine (IOM), Responsible Research: A Systems Approach to Protecting Research Participants (2002) [hereinafter Responsible Research].

“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Fed. Reg. 44,512–44,531 (July 26, 2011).

Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (December 2011): At 61–62 [hereinafter Moral Science].

Basken P. , “Federal Overhaul of Rules for Human Research Hits Impasse,” Chronicle of Higher Education (March 7, 2013), available at <http://chronicle.com/article/overhaul-of-rules-for-human/137811/> (last visited April 29, 2013).

Moral Science, supra note 13, at 64

Responsible Research, supra note 11, at 191

Ethical and Policy Issues, supra note 8, at 126

Compensating for Research Injuries, supra note 10, at 103.

Beecher H. K. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354–1360.

See also Katz J. , Experimentation with Human Beings (New York: Russell Sage Foundation, 1972) (setting forth the history of research abuses and proposed policy changes).

In 1995, ACHRE examined unethical research that took place from 1944 to 1974, and in 2011, the Presidential Commission discussed the unethical Guatemalan STD studies, in which the U.S. Public Health Service intentionally exposed and infected vulnerable populations to sexually transmitted diseases without the subjects' consent. See ACHRE, Final Report, supra note 11 (discussing the radiation experiments)

Presidential Commission for the Study of Bioethical Issues, “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 (2011) [hereinafter Ethically Impossible] (discussing the STD studies). Both of these research scandals predate the Common Rule.

See Resnik , supra note 6, at 264.

Childress J. , “Compensating Injured Research Subjects,” Hastings Center Report 6, no. 6 (1976): 21–27, at 21.

See Pike , supra note 6, at 26–29.

See Tuskegee Syphilis Study, supra note 2.

See ACHRE, Final Report, supra note 11.

See Ethically Impossible, supra note 19.

Clinton W. J. , “Remarks in Apology to African-Americans on the Tuskegee Experiment,” Public Papers of the Presidents 1997, no. 1 (July 16, 1997): At 607.

James M. , “President Obama Apologizes to Guatemalan President for ‘Shocking,’ ‘Tragic,’ ‘Reprehensible’ Syphilis Study,” ABC News, available at <http://abcnews.go.com/blogs/politics/2010/10/president-obama-apologizes-to-guatemalan-president-for-shocking-tragic-reprehensible-syphilis-study/> (last visited April 29, 2013).

See Moral Science, supra note 13, at 63.

See Clinton , supra note 24, at 608 (announcing a planning grant to establish a center for bioethics at Tuskegee University).

See Moral Science, supra note 13, at 63.

See Childress, supra note 19, at 22.

See Ethical and Policy Issues, supra note 8, at 125.

Id., at 123.

Id., at 125.

See Compensating for Research Injuries, supra note 10, at 60.

Id., at 63.

See Compensation of Injured Research Subjects, supra note 9, at VI–4.

Id., at VI-4–5.

See also Childress, supra note 19, at 22.

See Compensating for Research Injuries, supra note 10, at 60.

Air Transportation Safety and System Stabilization Act of 2001, Pub. L. No. 107–42, 115 Stat 230 (codified as amended in scattered sections of 49 U.S.C.) [hereinafter ATSSSA] (creating the Fund).

Department of Justice, Final Report of the Special Master for the September 11th Victim Compensation Fund of 2001, Vol. I (November 17, 2004): At 8.

Id., at 80.

Claimants who participated in the Fund waived their right to seek compensation for their claims through the tort system. See ATSSSA, supra note 38, § 405(c)(3)(B)(i), 49 U.S.C. § 40101 note;

Schneider v. Feinberg, 345 F.3d 135, 139 (2d Cir. 2003).

See Final Report of the Special Master for the September 11th Victim Compensation Fund of 2001, supra note 39, at 79.

See Moral Science, supra note 13, at 56.

Id.

Id., at 56. See also id., at 61 (“If research subjects are entitled to such primary protection [at the start of clinical trials], they should also be extended secondary protection if they are harmed as a result of their participation.”).

Id., at 61.

Id., at 186–190.

Id.

University of Washington, Human Subjects Manual, Section VII (G), available at <http://staff.washington.edu/brz/MANUAL/99-VII.htm#VII-g> (last visited May 20, 2013).

Wake Forest University Health Sciences Institutional Review Board, Research Related Injury (2007): At 2.

UCLA Office of the Human Research Protection Program, Guidance and Procedure: Treatment and Compensation for Research-Related Injury (last updated April 8, 2013): At 2.

See Childress, supra note 19, at 22.

Id., at 24.

Hart H. L. A. , “Are There Natural Rights?” in Lyons D. , ed., Rights (Belmont, MA: Wadsworth Publishing Company, 1979), at 21.

See Ethical and Policy Issues, supra note 8, at 125 (contending that “[i]f they are injured by research participation, those who benefit from the research … bear some obligation to compensate participants who risked and suffered injury on their behalf”);

Compensating for Research Injuries, supra note 10, at 53 (noting that “[r]esearch subjects are already doing more than their fair share,” and concluding that the costs of any injuries they suffer should “be shouldered by the potential beneficiaries who have contributed neither time nor health to the research effort”);

Compensation of Injured Research Subjects, supra note 9, at VI-4–5 (explaining that “society is both the beneficiary and the sponsor of research”).

See Ethical and Policy Issues, supra note 8, at 126.

See Responsible Research, supra note 11, at 194.

See Moral Science, supra note 13, at 56.

Id., at 67.

See Compensation of Injured Research Subjects, supra note 9, at VI-4-5.

Id., at II-2.

See Moral Science, supra note 13, at 59.

See Ethical and Policy Issues, supra note 8, at 126.

See Compensating for Research Injuries, supra note 10, at 143.

See Responsible Research, supra note 11, at 193.

See Compensation of Injured Research Subjects, supra note 9, at VI-12.

See Compensating for Research Injuries, supra note 10, at 135–136.

See Responsible Research, supra note 11, at 193

Compensating for Research Injuries, supra note 10, at 145.

See Ethical and Policy Issues, supra note 8, at 123.

See Compensation of Injured Research Subjects, supra note 9, at VI-6.

Id., at VI–9.

Id., at VI–8.

Id.

See Compensating for Research Injuries, supra note 10, at 133.

Id., at 133–134.

Id., at 134.

There are other important variables for any compensation scheme to consider, including for example, who qualifies as a claimant, whether there will be caps on awards, and whether the compensation system precludes tort litigation. These questions can be answered within any of the four compensation models discussed.

DHEW Secretary's Commission on Medical Malpractice, Medical Malpractice (1973), at 79.

Id.

See Responsible Research, supra note 11, at 194.

National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99–660.

Scott L. D. , “Research-Related Injury: Problem and Solutions,” Journal of Law Medicine & Ethics 31, no. 3 (2003): 419–428, at 422.

The Office of Special Masters, U.S. Court of Federal Claims, Guidelines for Practice Under the National Vaccine Injury Compensation Program (2004), available at <http://www.uscfc.uscourts.gov/sites/default/files/OSM.Guidelines_0.pdf> (last visited May 2, 2013).

Jasper M. C. , Workers' Compensation Law (New York: Oxford, 2008): At 33.

Id., at 8.

Id., at 9.

See Elliott , supra note 6, at 7.

See Resnik , supra note 6, at 284.