Hostname: page-component-848d4c4894-ttngx Total loading time: 0 Render date: 2024-04-30T19:38:42.631Z Has data issue: false hasContentIssue false
  • English
  • Français

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal

Published online by Cambridge University Press:  01 January 2021

Carolyn Riley Chapman ,
Sangita Sukumaran ,
Geremew Tarekegne Tsegaye ,
Yelena Shevchenko  and
Arthur L. Caplan
Get access Rights & Permissions [Opens in a new window]

Abstract

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.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 4: Symposium 1 - The Promise and Challenges of Microbiome-based Therapies. Symposium 2 - Regulation on International Direct-to-Participant Genomic Research , Winter 2019 , pp. 732 - 747
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Tang, E. et al., “Comparison of Serious Adverse Events Posted at ClinicalTrials.gov and Published in Corresponding Journal Articles,” BMC Medicine 13, no. 1 (2015): 189; Adam, D., “First, Do Harm,” Knowable Magazine, June 14, 2019, available at <https://www.knowablemagazine.org/article/health-disease/2019/human-challenge-trials> (last visited November 8, 2019); McManus, L., Davis, A., Forcier, R.L., and Fisher, J.A.. “Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events,” Journal of Law, Medicine & Ethics 47, no. 2 (2019): 323-333.CrossRefGoogle Scholar
News article, “CAR-T death strikes Kite,” Nature Biotechnology 35, no. 6 (2017): 492; “After Patient Death, FDA Places Clinical Hold on Cellectis CAR-T Candidate UCART123,” Genetic Engineering & Biotechnology News, September 5, 2017, available at <https://www.genengnews.com/topics/drug-discovery/after-patient-death-fda-places-clinical-hold-on-cellectis-car-t-candidate-ucart123/> (last visited November 13, 2019); “Manufacturer Suspends Trial of Fitusiran for Hemophilia After Patient Death,” ASH Clinical News, November 1, 2017, available at <https://www.ashclinicalnews.org/news/manufacturer-suspends-trial-fitusiran-hemophilia-patient-death/> (last visited November 13, 2019); Taylor, N.P., “Patient Death in Phase 3 Raises Doubts about Safety of Roche's Potential Hemophilia Blockbuster Emicizumab,” FierceBiotech, February 24, 2017, available at <https://www.fiercebiotech.com/r-d/patient-death-phase-3-raises-doubts-about-safety-roche-s-potential-hemophilia-blockbuster> (last visited November 13, 2019); Boffey, D., “Eleven Babies Die after Dutch Women Given Viagra-Like Drug in Trial,” The Guardian, July 24, 2018, available at <https://www.theguardian.com/world/2018/jul/24/eleven-babies-die-dutch-women-viagra-drug-trial> (last visited November 13, 2019); Butler, D. and Callaway, E., “Scientists in the Dark after French Clinical Trial Proves Fatal,” Nature 529, no. 7586 (2016): 263-264.Google Scholar
The Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (December 2011; updated edition June 2012), at 58 [hereinafter Moral Science].Google Scholar
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 (September 2011), at 11 [hereinafter Research Across Borders].Google Scholar
Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials, Division of Health Sciences Policy, Institute of Medicine, “Review of the Fialuridine (FIAU) Clinical Trials,” Manning, F.J. and Swartz, M., eds. (National Academy Press, Washington, D.C., 1995), available at <https://www.ncbi.nlm.nih.gov/books/NBK232098/> [hereinafter, Committee]; Scott, L.D., “Research-Related Injury: Problems and Solutions,” Journal of Law, Medicine & Ethics 31, no. 3 (2003): 419–428; U.S. Department of Health, Education and Welfare, Public Health Service, Tuskegee Syphilis Study Ad Hoc Advisory Panel, Final Report on Charge III (April 1973), available at <https://biotech.law.lsu.edu/cphl/history/reports/tuskegee/report3.pdf> (last visited November 13, 2019); for additional references see Elliott, C., “Justice for Injured Research Subjects,” New England Journal of Medicine 367, no. 1 (2012): 6-8.Google Scholar
See Moral Science, supra note 3, at 8 and 9.Google Scholar
See Moral Science, supra note 3, at 62.Google Scholar
See Elliott, supra note 5; 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, available at <https://www.ncbi.nlm.nih.gov/pubmed/22497093> (last visited November 13, 2019); Pike, E.R., “In Need of Remedy: US Policy for Compensating Injured Research Participants,” Journal of Medical Ethics 40, no. 3 (2014): 182-185; Chingarande, G.R. and Moodley, K., “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 Ethics 19, no. 1 (2018): 8.Google Scholar
See Moral Science, supra note 3, and references in Elliott, supra note 5.Google Scholar
45 CFR 46.116; 21 CFR 50.25.Google Scholar
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), “Guidance for Industry: Protecting the Rights, Safety and Welfare of Study Subjects” (October 2009), available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects> (last accessed November 25, 2019).+(last+accessed+November+25,+2019).>Google Scholar
See references in Henry, L.M., “Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects,” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 411–423; 38 C.F.R. 17.85(a) (2012); U.S. Department of Defense DOD Instruction Number 6000.08: Funding and Administration of Clinical Investigation Programs, sec 6.2.4 (December 3, 2007); See also Henry, L.M., Larkin, M.E., and Pike, E.R., “Just Compensation: A No-Fault Proposal for Research-Related Injuries,” Journal of Law and the Biosciences 2, no. 3 (2015): 645-668 and Pike, 2012, supra note 8 at 25.CrossRefGoogle Scholar
21 CFR 50 — Subpart B-Informed Consent of Human Subjects, available at <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.20.2> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline: guidelines for Good Clinical Practice E6 (R1) Current Step 4 version (June 10 1996), available at <https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf> (last visited November 13, 2019), at 15.+(last+visited+November+13,+2019),+at+15.>Google Scholar
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” (July 2014), available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent> (last visited November 25, 2019), at p. 5–6+(last+visited+November+25,+2019),+at+p.+5–6>Google Scholar
See Pike, 2012, supra note 8.Google Scholar
See Committee, supra note 5.Google Scholar
Shepherd, J., “Uncovering the Silent Victims of the American Medical Liability System,” Vanderbilt Law Review 67 (2014): 151–195.Google Scholar
See Pike, 2012, supra note 8, at 23.CrossRefGoogle Scholar
United Healthcare, “Routine Costs in Clinical Trials (NCD 310.1),” Approval date: November 14, 2018, available at <https://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/r/routine-costs-clinical-trials.pdf> (last visited November 13, 2019); Martin, P.J. et al., “Responsibility for Costs Associated With Clinical Trials,” Journal of Clinical Oncology 32, no. 30 (2014): 3357–3359; American Society of Clinical Oncology, “Insurance Coverage of Clinical Trials,” available at <https://www.asco.org/research-progress/clinical-trials/insurance-coverage-clinical-trials> (last visited November 13, 2019).CrossRefGoogle Scholar
United Healthcare, “Routine Costs in Clinical Trials (NCD 310.1),” supra note 20; American Society of Clinical Oncology, “Insurance Coverage of Clinical Trials,” supra note 20.Google Scholar
American Society of Clinical Oncology, “Insurance Coverage of Clinical Trials,” supra note 20; American Society of Clinical Oncology, “Guarantee Coverage of Clinical Trials Participation for Medicaid Patients,” available at <https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/Medicaid-coverage-clinical-trials.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
American Society for Clinical Oncology, “ASCO Answers: Clinical Trials Coverage Through the Affordable Care Act,” available at <https://www.cancer.net/sites/cancer.net/files/clinical_trials_coverage_aca_fact_sheet.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
Patient Protection and Affordable Care Act § 2709(d)(1) 124 STAT. 894; Cancer.Net Editorial Board, “Health Insurance Coverage of Clinical Trials,” Cancer.Net, approved 10/2018, available at <https://www.cancer.net/research-and-advocacy/clinical-trials/health-insurance-coverage-clinical-trials> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
See Martin et al., supra note 20; “Health Insurance Coverage of Clinical Trials,” Cancer.Net Editorial Board, supra note 24.Google Scholar
United Healthcare, “Clinical Trials,” Effective date: July 1, 2019, available at <https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/clinical-trials.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
American Society of Clinical Oncology, “Affordable Care Act and Coverage of Clinical Trials: Frequently Asked Questions,” 2012, available at <https://www.asco.org/sites/new-www.asco.org/files/content-files/research-and-progress/documents/faq-clinical-trials-coverage-statute.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
Moe, K.E., 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 Cho, H.L., Danis, M., and Grady, C., “The Ethics of Uninsured Participants Accessing Healthcare in Biomedical Research: A Literature Review,” Clinical Trials 15, 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.”)Google Scholar
Malek, L.A. and Moses, J.E. Anderson & Singer LLP, “Client Alert: Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations,” May 2010, available at <https://www.mosessinger.com/uploads/HealthcareReform-LawClinicalTrials.pdf> (last visited November 13, 2019); See Cancer.Net Editorial Board, supra note 25.Google Scholar
See Cho, , Danis, , and Grady, , “The ethics of uninsured…”, 2018, supra note 28.Google Scholar
Cho, H.L., Danis, M., and Grady, C., “Post-Trial Responsibilities Beyond Post-Trial Access,” Lancet 391, no.10129 (2018): 1478–1479, at 1479.CrossRefGoogle Scholar
“Uninsured Research Subjects Raise Multiple Ethical Issues,” Relias Media, May 1, 2008, available at <https://www.relias-media.com/articles/11530-uninsured-research-subjects-raise-multiple-ethical-issues> (last visited November 13, 2019); L.A. Malek and J.E. Anderson, supra note 29.+(last+visited+November+13,+2019);+L.A.+Malek+and+J.E.+Anderson,+supra+note+29.>Google Scholar
See Cho, et al., “The ethics of uninsured…”, 2018, supra note 28, at 517 (quote) and 518.Google Scholar
Dal-Ré, R., Rid, A., Emanuel, E., and Wendler, D., “The Potential Exploitation of Research Participants in High Income Countries who Lack Access to Health Care,” British Journal of Clinical Pharmacology 81, no. 5 (2016): 857–864.CrossRefGoogle Scholar
Delaney, R., Austin, D., and Ruff, A., 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 (July 3, 2012), available at <https://www.cms.gov/Medicare/Coordination-of-Benefits/MandatoryInsRep/Downloads/NGHPUserGuideVer34Ch3Policy.pdf> (last visited November 13, 2019), at 9. (last visited November 13, 2019), at 9.' href=https://scholar.google.com/scholar?q=Delaney,+R.,+Austin,+D.,+and+Ruff,+A.,+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++(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+(July+3,+2012),+available+at++(last+visited+November+13,+2019),+at+9.>Google Scholar
Lovell, B.H., Pinto, P.N., and Polston, M.D., King and Spalding LLP, “2018 Life Sciences & Healthcare: Ouch! Navigating Payment for Research-Related Injuries - How to Avoid the Potholes on the Road to Recovery,” October 30, 2018 online webinar (CRC and SS in attendance), description available at <https://www.kslaw.com/news-and-insights/ouch-navigating-payment-for-research-related-injuries-how-to-avoid-the-potholes-on-the-road-to-recovery> (last visited November 13, 2019).Google Scholar
Ruskin, A. and Shay, A.W., Lewis, Morgan, “Minimizing Financial Risks From Clinical Trial Subject Injury: Hospital Industry Viewpoint,” June 23, 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.”)Google Scholar
See Lovell, Pinto, and Polston, supra note 36.Google Scholar
See Moral Science, supra note 3; See Committee, supra note 5; see example in Relias Media article, supra note 32; WCG PFS Clinical, “Subject Injury Language: What you need to know,” January 27, 2017, available at <https://pfsclinical.com/blog/2017/1/27/subject-injury-language-what-you-need-to-know> (last visited November 13, 2019); see also University of Illinois at Chicago (UIC) Office for the Protection of Human Research Subjects, Institutional Review Board, “Sponsor Payment for Costs to Subject Injury in Industry-Sponsored Clinical Trials Guidance,” March 27, 2015, available at <https://research.uic.edu/human-subjects-irbs/policies/sponsor-payment-for-costs-related-to-subject-injury-in-industry-sponsored-clinical-trials-guidance> (last visited November 25, 2019), at 1.+(last+visited+November+13,+2019);+see+also+University+of+Illinois+at+Chicago+(UIC)+Office+for+the+Protection+of+Human+Research+Subjects,+Institutional+Review+Board,+“Sponsor+Payment+for+Costs+to+Subject+Injury+in+Industry-Sponsored+Clinical+Trials+Guidance,”+March+27,+2015,+available+at++(last+visited+November+25,+2019),+at+1.>Google Scholar
Cogburn Law, “Who Pays for Research-Related Injuries,” January 23, 2018, available at <https://www.cogburncares.com/research-related-injuries/> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
McManus et al., supra note 1.Google Scholar
University of Washington Office of Research, Human Subjects Division. Human Subjects Assistance Program, last updated February 5, 2018, available at <https://www.washington.edu/research/policies/human-subjects-assistance-program-2/> (last visited November 13, 2019), at 1.+(last+visited+November+13,+2019),+at+1.>Google Scholar
Id.; Moe, supra note 28.Google Scholar
University of Washington Office of Research, supra note 42.Google Scholar
Id.Google Scholar
Wake Forest School of Medicine, Human Research Protection Program and Institutional Review Board Policies and Procedures,” October 16, 2019, available at <https://ctsi.wakehealth.edu/Portals/0/Human%20Research%20Unsecure/IRB_SOP.pdf> (last visited November 25, 2019), at 49 (section 14).+(last+visited+November+25,+2019),+at+49+(section+14).>Google Scholar
Id.Google Scholar
Id.Google Scholar
The University of Chicago IRB Frequently Asked Questions and Submission Guidance: Policy on Research-Related Injury, available at <https://biologicalsciences.uchicago.edu/irbfaqs-and-guidance> (last visited November 25, 2019).+(last+visited+November+25,+2019).>Google Scholar
Resnik, D.B., Parasidis, E., Carroll, K., Evans, J.M., Pike, E.R., and Kissling, G.E., “Research-Related Injury Compensation Policies of U.S. Research Institutions,” IRB 36, no. 1 (2014): 12–19.Google Scholar
Id.Google Scholar
Id.Google Scholar
Steinbrook, R., “Compensation for Injured Research Subjects,” New England Journal of Medicine 354 (2006): 1871–1873; see also, Elliott, supra note 5.Google Scholar
Lovell, Pinto, and Polston, supra note 36.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Moral Science, supra note 3, at 64.Google Scholar
Lovell, Pinto, and Polston, supra note 36.Google Scholar
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 Journal 5, no. 1 (1979): 83–84.Google Scholar
Moral Science, supra note 3, at 58.Google Scholar
National Commission, supra note 61.Google Scholar
See Henry, supra note 12 at 416; Moral Science, supra note 3.Google Scholar
See Henry, supra note 12 at 415.Google Scholar
Id.Google Scholar
See Moral Science, supra note 3, at 58.Google Scholar
See Moral Science, supra note 3, at 59.Google Scholar
G.R. Chingarande and K. Moodley, supra note 8.Google Scholar
See Berlin, I. and Gorelick, D.A., “The French Law on ‘Protection of Persons Undergoing Biomedical Research’: Implications for the US,” Journal of Law, Medicine & Ethics 31, no. 3 (2003): 434–441, at 435.CrossRefGoogle Scholar
Id.Google Scholar
See Henry, supra note 12 at 414.Google Scholar
See Henry, supra note 12 at 413.CrossRefGoogle Scholar
See Moe, supra note 28.Google Scholar
See Moe, supra note 28.Google Scholar
See Moral Science, supra note 3.Google Scholar
See Moral Science, supra note 3, at 57.Google Scholar
See Research Across Borders, supra note 4, at page 11.Google Scholar
See Chingarande and Moodley, supra note 8.Google Scholar
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).+(last+visited+November+13,+2019).>Google Scholar
Urooj, M., Husain, G.M., Khan, M.A., and Kazmi, M.H., “Compensation to Clinical Trial Participants in India: A Gap Analysis,” International Journal of Pharmaceutical Investigation 7, no. 2 (2017): 41–46.CrossRefGoogle Scholar
Barnes, M. and Flaherty, J., “India Finalizes Rules Regarding Compensation for Subjects Injured in Clinical Trials and Post-Trial Access to Study Drugs,” April 23, 2019, available at <https://www.jdsupra.com/legalnews/india-finalizes-rules-regarding-69576/> (last visited November 13, 2019).Google Scholar
Id.Google Scholar
India Ministry of Health and Family Welfare (Department of Health and Family Welfare), “The Gazette of India-Extraordinary: Notification,” Regd. No. D.L.-33004/99, March 19, 2019, New Delhi, India, see pages 162–163, available at <https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
See Urooj et al., supra note other; See also Chingarande and Moodley, supra note 69.Google Scholar
India Ministry of Health and Family Welfare, supra note 84.Google Scholar
India Ministry of Health and Family Welfare, supra note 84, at 234.Google Scholar
Id., at 234.Google Scholar
Id., at 234.Google Scholar
Id., at 234.Google Scholar
Id., at 234-235.Google Scholar
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).+(last+visited+November+13,+2019).>Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 42.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Kamalo, P.D., Manda-Taylor, L., and Rennie, S., “Appropriateness of No-Fault Compensation for Research-Related Injuries from an African Perspective: An Appeal for Action by African Countries,” Journal of Medical Ethics 42, no. 8 (2016): 528–533, at 529.CrossRefGoogle Scholar
Id.Google Scholar
See Moral Science, supra note 3, at 58.Google Scholar
See Kamalo et al., supra note 101, at 530.Google Scholar
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).+(last+visited+November+13,+2019).>Google Scholar
See Chingarande and Moodley, supra note 8.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Moral Science, supra note 3; see Scott, supra note 5; see Elliott, supra note 5; see Henry, supra note 12.Google Scholar
See Moral Science, supra note 3 at 62.Google Scholar
Mayer, E., “Compensation Expert Addresses Commission,” blog.Bioethics.gov (The Blog of the 2009-2017 Presidential Commission for the Study of Bioethical Issues), November 17, 2011, available at <https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/11/17/compensation-expert-addresses-commission/index.html> (last visited November 13, 2019).Google Scholar
Id.Google Scholar
See Henry, supra note 12 at 417; See Moral Science, supra note 3, at 67.Google Scholar
See Henry, supra note 12 at 412.Google Scholar
Id., at 412.Google Scholar
KFF (Henry J. Kaiser Family Foundation), “Health Insurance Coverage of the Total Population: Timeframe 2017,” available at <https://www.kff.org/other/state-indicator/total-population/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
Presidential Commission for the Study of Bioethical Issues, “Compensation: Background,” September 30, 2016, available at <https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/1%20Compensation%20background%209.30.16.pdf> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
Sama-Resource Group for Women and Health, Compensation in Clinical Trials: A Comparative Analysis of Seven Countries (New Delhi, India, 2016): at 236–238.Google Scholar
Shankar, R., “Approvals for Clinical Trials Decline Sharply from 529 in 2010 to 253 in 2012,” Pharmabiz.com, February 23, 2013, available at <http://www.pharmabiz.com/News-Details.aspx?aid=73945&sid=1> (last visited November 13, 2019); Shelar, J., “After a Lull of Five Years, Clinical Trials on the Rise in India,” The Hindu, June 2, 2018, updated June 3, 2018, available at <https://www.thehindu.com/news/national/after-a-lull-of-five-years-clinical-trials-on-the-rise-in-india/article24069487.ece> (last visited November 13, 2019).Google Scholar
Central Drugs Standard Control Organization, “List of FDC and New Drugs Approved For Marketing in India,” available at <https://cdsco.gov.in/opencms/opencms/en/Approval_new/FDC-New-Drugs-Marketing/> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
See Urooj et al., supra note 81.Google Scholar
See Kamalo et al., supra note 101.Google Scholar
U.S. Health Resources and Services Administration, “National Vaccine Injury Compensation Program,” date last reviewed June 2019, available at <https://www.hrsa.gov/vaccine-compensation/index.html> (last visited November 13, 2019).+(last+visited+November+13,+2019).>Google Scholar
“September 11th Victim Compensation Fund” website, available at <https://www.vcf.gov/>, (last visited November 13, 2019).,+(last+visited+November+13,+2019).>Google Scholar
Berkowitz, E., “The Problematic Role of the Special Master: Undermining the Legitimacy of the September 11th Victim Compensation Fund,” Yale Law & Policy Review 24, no. 1 (2006): 1–41.Google Scholar
Bhattacharyya, R., Special Master, September 11th Victim Compensation Fund, “Seventh Annual Status Report and Third Annual Reassessment of Policies and Procedures,” February 2019, available at <https://www.vcf.gov/pdf/VCFStatus-ReportFeb2019.pdf> (last visited November 13, 2019).Google Scholar
Engstrom, N. F, “A Dose of Reality for Specialized Courts: Lessons from the VICP,” University Pennsylvania Law Review 163 (2015):1631–1717, at 1643.Google Scholar
Parasidis, E., “Unpacking the Shortcomings of the Vaccine Injury Compensation Program,” Jotwell: The Journal of Things We Like (2017):1–2.Google Scholar
See Engstrom, supra note 127 at 1699.Google Scholar
See Henry, Larkin, and Pike, supra note 12.Google Scholar
Id.Google Scholar
Id., at 661.Google Scholar
Id., at 668.Google Scholar
Lamkin, M. and Elliott, C., “Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation” Journal of Law, Medicine & Ethics 46, no. 1 (2018):52–63.CrossRefGoogle Scholar
See Henry, Larkin, and Pike, supra note 12, at 653.Google Scholar
See Henry, Larkin, and Pike, supra note 12, at 654.Google Scholar
See Kamalo et al., supra note 101, at 530.Google Scholar
See Henry, 2013, supra note 12, at 414.Google Scholar
See Martin et al., supra note 20; Cogburn Law, supra note 40.Google Scholar
See Lamkin and Elliott, supra note 134.Google Scholar
See Martin et al., supra note 20.Google Scholar
Hellinger, F.J. and Young, G.J., “Health Plan Liability and ERISA: The Expanding Scope of State Legislation,” American Journal of Public Health 95, 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).CrossRefGoogle Scholar