In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.
Get full access to this article
View all access options for this article.
References
1.
L.McManus, A.Davis, R.L.Forcier, and J.A.Fisher. “Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events,”Journal of Law, Medicine & Ethics47, no. 2 (2019): 323-333.
2.
D.Butler and E.Callaway, “Scientists in the Dark after French Clinical Trial Proves Fatal,”Nature529, no. 7586 (2016): 263-264.
3.
The Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (December2011; updated edition June 2012), at 58 [hereinafter Moral Science].
4.
The Presidential Commission for the Study of Bioethical Issues, Research Across Borders: Proceedings of the International Resarch Panel of the Presidential Commission for the Study of Bioethical Issues (September2011), at 11 [hereinafter Research Across Borders].
5.
U.S. Department of Health, Education and Welfare, Public Health Service, Tuskegee Syphilis Study Ad Hoc Advisory Panel, Final Report on Charge III (April1973), available at <https://biotech.law.lsu.edu/cphl/history/reports/tuskegee/report3.pdf> (last visited November 13, 2019); for additional references see C.Elliott, “Justice for Injured Research Subjects,”New England Journal of Medicine367, no. 1 (2012): 6-8.
6.
See Moral Science, supra note 3, at 8 and 9.
7.
See Moral Science, supra note 3, at 62.
8.
G.R.Chingarande and K.Moodley, “Disparate Compensation Policies for Research Related Injury in an Era of Multinational Trials: A Case Study of Brazil, Russia, India, China and South Africa,”BMC Medical Ethics19, no. 1 (2018): 8.
9.
See Moral Science, supra note 3, and references in Elliott, supra note 5.
L.M.Henry, M.E.Larkin, and E.R.Pike, “Just Compensation: A No-Fault Proposal for Research-Related Injuries,”Journal of Law and the Biosciences2, no. 3 (2015): 645-668 and Pike, 2012, supra note 8 at 25.
U.S. Department of Health and Human Services, Food and Drug Administration, Office of Good Clinical Practice, “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors: Draft Guidance” (July2014), available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent> (last visited November 25, 2019), at p. 5–6
16.
See Pike, 2012, supra note 8.
17.
See Committee, supra note 5.
18.
J.Shepherd, “Uncovering the Silent Victims of the American Medical Liability System,”Vanderbilt Law Review67 (2014): 151-195.
K.E.Moe, Presentation to the President's Commission for the Study of Bioethical Issues, Transcript, Meeting 7, Session 8, Presidential Commission for the Study of Bioethical Issues, November 7, 2011, Boston, MA, available at <https://bioethicsarchive.georgetown.edu/pcsbi/node/391.html> (last visited November 13, 2019). (In her 2011 testimony to the PCSBI, Karen Moe, Director & Assistant Vice Provost for Research, University of Washington Human Subjects Division, challenged the assumption that private insurers or Medicare cover the costs from research-related injury. “Medicare will cover the cost of ‘routine complications’ for clinical trials that are covered,” she said. “That doesn't cover a lot of unanticipated problems. Private insurers are even more reluctant to cover the costs of adverse events that occur in clinical trials.”); Also see H.L.Cho, M.Danis, and C.Grady, “The Ethics of Uninsured Participants Accessing Healthcare in Biomedical Research: A Literature Review,”Clinical Trials15, no. 5 (2018): 509-521, at 517. (“Some authors from the 1990s cancer literature noted that even patients with insurance were prevented from enrolling in cancer clinical trials because of costs and insurance reimbursement policies.”)
29.
L.A.Malek and J.E. Anderson, Moses & Singer LLP, “Client Alert: Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations,”May2010, available at <https://www.mosessinger.com/uploads/HealthcareReform-LawClinicalTrials.pdf> (last visited November 13, 2019); See Cancer.Net Editorial Board, supra note 25.
30.
See Cho, Danis, and Grady, “The ethics of uninsured…”, 2018, supra note 28.
31.
H.L.Cho, M.Danis, and C.Grady, “Post-Trial Responsibilities Beyond Post-Trial Access,”Lancet391, no.10129 (2018): 1478-1479, at 1479.
See Choet al., “The ethics of uninsured…”, 2018, supra note 28, at 517 (quote) and 518.
34.
R.Dal-Ré, A.Rid, E.Emanuel, and D.Wendler, “The Potential Exploitation of Research Participants in High Income Countries who Lack Access to Health Care,”British Journal of Clinical Pharmacology81, no. 5 (2016): 857-864.
35.
R.Delaney, D.Austin, and A.Ruff, Aurora Health Care and Hall, Render, Killian, Health & Lyman, “The Buck Stops Here… Or Does It? Medicare Secondary Payer and Beneficiary Inducement,”HCCA Resaerch Compliance Conference (June 2016), available at <https://www.hcca-info.org/Portals/0/PDFs/Resources/Conference_Handouts/Research_Compliance/2016/102_BuckStops_2.pdf> (last visited November 13, 2019) at 8 (quoting from CMS Clinical Trials Medicare Secondary Payer May 26, 2010 instruction: “When payments are made by sponsors of clinical trials for complications or injuries arising out of the trials, such payments are considered to be payments by liability insurance (including self-insurance) and must be reported.”); See also Centers for Medicare and Medicaid Services, MMSEA Section 111 Medicare Secondary Payer Mandatory Reporting, Liability Insurance (Including Self-Insurance) No-Fault Insurance and Workers' Compensation USER Guide Chapter III: Policy Guidance Version 3.4 (July3, 2012), available at <https://www.cms.gov/Medicare/Coordination-of-Benefits/MandatoryInsRep/Downloads/NGHPUserGuideVer34Ch3Policy.pdf> (last visited November 13, 2019), at 9.
A.Ruskin and A.W.Shay, MorganLewis, “Minimizing Financial Risks From Clinical Trial Subject Injury: Hospital Industry Viewpoint,”June23, 2015, available at <https://www.morganlewis.com/pubs/minimizing-financial-risks-from-clinical-trial-subject-injury> (last visited November 13, 2019). (“Historically, it was the practice for clinical trial sponsors to state that they would pick up any costs related to subject injuries that the payer would not. Then, several years ago, the Centers for Medicare & Medicaid Services (CMS) stated that a sponsor could not make itself secondarily liable. If a manufacturer offers to pick up any injury-related costs that an insurer (governmental or not) will not reimburse, CMS views that sponsor as primarily liable to Medicare.”)
D.B.Resnik, E.Parasidis, K.Carroll, J.M.Evans, E.R.Pike, and G.E.Kissling, “Research-Related Injury Compensation Policies of U.S. Research Institutions,”IRB36, no. 1 (2014): 12-19.
51.
Id.
52.
Id.
53.
R.Steinbrook, “Compensation for Injured Research Subjects,”New England Journal of Medicine354 (2006): 1871-1873; see also, Elliott, supra note 5.
54.
Lovell, Pinto, and Polston, supra note 36.
55.
Id.
56.
Id.
57.
Id.
58.
Id.
59.
See Moral Science, supra note 3, at 64.
60.
Lovell, Pinto, and Polston, supra note 36.
61.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research,”Kennedy Institute of Ethics Journal5, no. 1 (1979): 83-84.
62.
Moral Science, supra note 3, at 58.
63.
National Commission, supra note 61.
64.
See Henry, supra note 12 at 416; Moral Science, supra note 3.
65.
See Henry, supra note 12 at 415.
66.
Id.
67.
See Moral Science, supra note 3, at 58.
68.
See Moral Science, supra note 3, at 59.
69.
G.R. Chingarande and K. Moodley, supra note 8.
70.
See I.Berlin and D.A.Gorelick, “The French Law on ‘Protection of Persons Undergoing Biomedical Research’: Implications for the US,”Journal of Law, Medicine & Ethics31, no. 3 (2003): 434-441, at 435.
71.
Id.
72.
See Henry, supra note 12 at 414.
73.
See Henry, supra note 12 at 413.
74.
See Moe, supra note 28.
75.
See Moe, supra note 28.
76.
See Moral Science, supra note 3.
77.
See Moral Science, supra note 3, at 57.
78.
See Research Across Borders, supra note 4, at page 11.
79.
See Chingarande and Moodley, supra note 8.
80.
Director-General, Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Resarch Involving Human Participants. New Delhi, India: Director-General, Indian Council of Medical Research, October, 2017:1-187, available at <https://www.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf> (last visited November 13, 2019).
81.
M.Urooj, G.M.Husain, M.A.Khan, and M.H.Kazmi, “Compensation to Clinical Trial Participants in India: A Gap Analysis,”International Journal of Pharmaceutical Investigation7, no. 2 (2017): 41-46.
See Urooj et al., supra note 81; See also Chingarande and Moodley, supra note 69.
86.
India Ministry of Health and Family Welfare, supra note 84.
87.
India Ministry of Health and Family Welfare, supra note 84, at 234.
88.
Id., at 234.
89.
Id., at 234.
90.
Id., at 234.
91.
Id., at 234-235.
92.
Department of Health, “South African Good Clinical Practice Guidelines (Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa),”2006, available at <http://www.kznhealth.gov.za/research/guideline2.pdf> (last visited November 13, 2019).
93.
Id.
94.
Id.
95.
Id.
96.
Id.
97.
Id., at 42.
98.
Id.
99.
Id.
100.
Id.
101.
P.D.Kamalo, L.Manda-Taylor, and S.Rennie, “Appropriateness of No-Fault Compensation for Research-Related Injuries from an African Perspective: An Appeal for Action by African Countries,”Journal of Medical Ethics42, no. 8 (2016): 528-533, at 529.
102.
Id.
103.
See Moral Science, supra note 3, at 58.
104.
See Kamalo et al., supra note 101, at 530.
105.
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines, Chapter 7 Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials - Article 44, Compulsory Insurance of Life and Health of the Patient Involved in Clinical Trial of Medicinal Product for Medical Use, available at <http://www.consultpharma.ru/index.php/en/documents/drugs/159-fz61glava7> (last visited November 13, 2019).
106.
See Chingarande and Moodley, supra note 8.
107.
Id.
108.
Id.
109.
See Moral Science, supra note 3; see Scott, supra note 5; see Elliott, supra note 5; see Henry, supra note 12.
Sama-Resource Group for Women and Health, Compensation in Clinical Trials: A Comparative Analysis of Seven Countries (New Delhi, India, 2016): at 236-238.
U.S. Health Resources and Services Administration, “National Vaccine Injury Compensation Program,” date last reviewed June2019, available at <https://www.hrsa.gov/vaccine-compensation/index.html> (last visited November 13, 2019).
124.
“September 11th Victim Compensation Fund” website, available at <https://www.vcf.gov/>, (last visited November 13, 2019).
125.
E.Berkowitz, “The Problematic Role of the Special Master: Undermining the Legitimacy of the September 11th Victim Compensation Fund,”Yale Law & Policy Review24, no. 1 (2006): 1-41.
126.
R.Bhattacharyya, Special Master, September 11th Victim Compensation Fund, “Seventh Annual Status Report and Third Annual Reassessment of Policies and Procedures,”February2019, available at <https://www.vcf.gov/pdf/VCFStatus-ReportFeb2019.pdf> (last visited November 13, 2019).
127.
N. FEngstrom, “A Dose of Reality for Specialized Courts: Lessons from the VICP,”University Pennsylvania Law Review163 (2015):1631-1717, at 1643.
128.
E.Parasidis, “Unpacking the Shortcomings of the Vaccine Injury Compensation Program,”Jotwell: The Journal of Things We Like (2017):1-2.
129.
See Engstrom, supra note 127 at 1699.
130.
See Henry, Larkin, and Pike, supra note 12.
131.
Id.
132.
Id., at 661.
133.
Id., at 668.
134.
M.Lamkin and C.Elliott, “Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation”Journal of Law, Medicine & Ethics46, no. 1 (2018):52-63.
135.
See Henry, Larkin, and Pike, supra note 12, at 653.
136.
See Henry, Larkin, and Pike, supra note 12, at 654.
137.
See Kamalo et al., supra note 101, at 530.
138.
See Henry, 2013, supra note 12, at 414.
139.
See Martin et al., supra note 20; Cogburn Law, supra note 40.
140.
See Lamkin and Elliott, supra note 134.
141.
See Martin et al., supra note 20.
142.
F.J.Hellinger and G.J.Young, “Health Plan Liability and ERISA: The Expanding Scope of State Legislation,”American Journal of Public Health95, no. 2 (2005):217-223; “ How to Appeal a Health Insurance Denial,” August 6, 2009, available at <http://guides.wsj.com/health/health-costs/how-to-appeala-health-insurance-denial/> (last visited November 13, 2019).
