{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T13:21:39Z","timestamp":1773840099328,"version":"3.50.1"},"reference-count":143,"publisher":"Cambridge University Press (CUP)","issue":"4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":731,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2019]]},"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.1177\/1073110519897737","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T07:11:06Z","timestamp":1579504266000},"page":"732-747","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["The Quest for Compensation for Research-Related Injury in the United States: A New Proposal"],"prefix":"10.1017","volume":"47","author":[{"given":"Carolyn Riley","family":"Chapman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sangita","family":"Sukumaran","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geremew Tarekegne","family":"Tsegaye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yelena","family":"Shevchenko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur L.","family":"Caplan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S107311050002595X_bib7","unstructured":"7. See Moral Science, supra note 3, at 62."},{"key":"S107311050002595X_bib48","unstructured":"48. Id."},{"key":"S107311050002595X_bib12","doi-asserted-by":"publisher","DOI":"10.1111\/jlme.12052"},{"key":"S107311050002595X_bib112","unstructured":"112. Id."},{"key":"S107311050002595X_bib51","unstructured":"51. Id."},{"key":"S107311050002595X_bib100","unstructured":"100. Id."},{"key":"S107311050002595X_bib97","unstructured":"97. Id., at 42."},{"key":"S107311050002595X_bib117","unstructured":"117. Presidential Commission for the Study of Bioethical Issues, \u201cCompensation: Background,\u201d 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)."},{"key":"S107311050002595X_bib129","unstructured":"129. See Engstrom, supra note 127 at 1699."},{"key":"S107311050002595X_bib37","unstructured":"37. Ruskin, A. and Shay, A.W. , Lewis, Morgan , \u201cMinimizing Financial Risks From Clinical Trial Subject Injury: Hospital Industry Viewpoint,\u201d June 23, 2015, available at <https:\/\/www.morganlewis.com\/pubs\/minimizing-financial-risks-from-clinical-trial-subject-injury> (last visited November 13, 2019). (\u201cHistorically, 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.\u201d)"},{"key":"S107311050002595X_bib72","unstructured":"72. See Henry, supra note 12 at 414."},{"key":"S107311050002595X_bib74","unstructured":"74. See Moe, supra note 28."},{"key":"S107311050002595X_bib28","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1177\/1740774518792277","article-title":"\u201cThe Ethics of Uninsured Participants Accessing Healthcare in Biomedical Research: A Literature Review,\u201d","volume":"15","author":"Moe","year":"2018","journal-title":"Clinical Trials"},{"key":"S107311050002595X_bib71","unstructured":"71. Id."},{"key":"S107311050002595X_bib49","unstructured":"49. 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)."},{"key":"S107311050002595X_bib11","unstructured":"11. 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), \u201cGuidance for Industry: Protecting the Rights, Safety and Welfare of Study Subjects\u201d (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)."},{"key":"S107311050002595X_bib30","unstructured":"30. See Cho, , Danis, , and Grady, , \u201cThe ethics of uninsured\u2026\u201d, 2018, supra note 28."},{"key":"S107311050002595X_bib20","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.57.1422"},{"key":"S107311050002595X_bib60","unstructured":"60. Lovell, Pinto, and Polston, supra note 36."},{"key":"S107311050002595X_bib121","unstructured":"121. See Urooj et al., supra note 81."},{"key":"S107311050002595X_bib93","unstructured":"93. Id."},{"key":"S107311050002595X_bib139","unstructured":"139. See Martin et al., supra note 20; Cogburn Law, supra note 40."},{"key":"S107311050002595X_bib6","unstructured":"6. See Moral Science, supra note 3, at 8 and 9."},{"key":"S107311050002595X_bib45","unstructured":"45. Id."},{"key":"S107311050002595X_bib91","unstructured":"91. Id., at 234-235."},{"key":"S107311050002595X_bib50","first-page":"12","article-title":"\u201cResearch-Related Injury Compensation Policies of U.S. Research Institutions,\u201d","volume":"36","author":"Resnik","year":"2014","journal-title":"IRB"},{"key":"S107311050002595X_bib114","unstructured":"114. See Henry, supra note 12 at 412."},{"key":"S107311050002595X_bib44","unstructured":"44. University of Washington Office of Research, supra note 42."},{"key":"S107311050002595X_bib8","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1177\/009885881203800101","article-title":"\u201cRecovering from Research: A No-Fault Proposal to Compensate Injured Research Participants,\u201d","volume":"38","author":"Pike","year":"2012","journal-title":"American Journal of Law and Medicine"},{"key":"S107311050002595X_bib54","unstructured":"54. Lovell, Pinto, and Polston, supra note 36."},{"key":"S107311050002595X_bib31","doi-asserted-by":"crossref","first-page":"1478","DOI":"10.1016\/S0140-6736(18)30761-X","article-title":"\u201cPost-Trial Responsibilities Beyond Post-Trial Access,\u201d","volume":"391","author":"Cho","year":"2018","journal-title":"Lancet"},{"key":"S107311050002595X_bib35","first-page":"9","author":"Delaney","year":"2012","journal-title":"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"},{"key":"S107311050002595X_bib41","unstructured":"41. McManus et al., supra note 1."},{"key":"S107311050002595X_bib1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0430-4"},{"key":"S107311050002595X_bib2","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1038\/nbt0617-492","article-title":"\u201cCAR-T death strikes Kite,\u201d","volume":"35","author":"Taylor","year":"2017","journal-title":"Nature Biotechnology"},{"key":"S107311050002595X_bib78","unstructured":"78. See Research Across Borders, supra note 4, at page 11."},{"key":"S107311050002595X_bib34","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12879"},{"key":"S107311050002595X_bib66","unstructured":"66. Id."},{"key":"S107311050002595X_bib36","unstructured":"36. Lovell, B.H. , Pinto, P.N. , and Polston, M.D. , King and Spalding LLP, \u201c2018 Life Sciences & Healthcare: Ouch! Navigating Payment for Research-Related Injuries - How to Avoid the Potholes on the Road to Recovery,\u201d 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)."},{"key":"S107311050002595X_bib89","unstructured":"89. Id., at 234."},{"key":"S107311050002595X_bib98","unstructured":"98. Id."},{"key":"S107311050002595X_bib75","unstructured":"75. See Moe, supra note 28."},{"key":"S107311050002595X_bib136","unstructured":"136. See Henry, Larkin, and Pike, supra note 12, at 654."},{"key":"S107311050002595X_bib82","unstructured":"82. Barnes, M. and Flaherty, J. , \u201cIndia Finalizes Rules Regarding Compensation for Subjects Injured in Clinical Trials and Post-Trial Access to Study Drugs,\u201d April 23, 2019, available at <https:\/\/www.jdsupra.com\/legalnews\/india-finalizes-rules-regarding-69576\/> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib88","unstructured":"88. Id., at 234."},{"key":"S107311050002595X_bib130","unstructured":"130. See Henry, Larkin, and Pike, supra note 12."},{"key":"S107311050002595X_bib90","unstructured":"90. Id., at 234."},{"key":"S107311050002595X_bib105","unstructured":"105. Russian Federation Law \u211661-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)."},{"key":"S107311050002595X_bib19","doi-asserted-by":"publisher","DOI":"10.1093\/beheco\/ars018"},{"key":"S107311050002595X_bib9","unstructured":"9. See Moral Science, supra note 3, and references in Elliott, supra note 5."},{"key":"S107311050002595X_bib107","unstructured":"107. Id."},{"key":"S107311050002595X_bib86","unstructured":"86. India Ministry of Health and Family Welfare, supra note 84."},{"key":"S107311050002595X_bib15","unstructured":"15. U.S. Department of Health and Human Services, Food and Drug Administration, Office of Good Clinical Practice, \u201cInformed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors: Draft Guidance\u201d (July 2014), available at <https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/informed-consent> (last visited November 25, 2019), at p. 5\u20136"},{"key":"S107311050002595X_bib57","unstructured":"57. Id."},{"key":"S107311050002595X_bib63","unstructured":"63. National Commission, supra note 61."},{"key":"S107311050002595X_bib135","unstructured":"135. See Henry, Larkin, and Pike, supra note 12, at 653."},{"key":"S107311050002595X_bib122","unstructured":"122. See Kamalo et al., supra note 101."},{"key":"S107311050002595X_bib77","unstructured":"77. See Moral Science, supra note 3, at 57."},{"key":"S107311050002595X_bib25","unstructured":"25. See Martin et al., supra note 20; \u201cHealth Insurance Coverage of Clinical Trials,\u201d Cancer.Net Editorial Board, supra note 24."},{"key":"S107311050002595X_bib115","unstructured":"115. Id., at 412."},{"key":"S107311050002595X_bib56","unstructured":"56. Id."},{"key":"S107311050002595X_bib55","unstructured":"55. Id."},{"key":"S107311050002595X_bib81","doi-asserted-by":"publisher","DOI":"10.4103\/jphi.JPHI_31_17"},{"key":"S107311050002595X_bib39","unstructured":"39. See Moral Science, supra note 3; See Committee, supra note 5; see example in Relias Media article, supra note 32; WCG PFS Clinical, \u201cSubject Injury Language: What you need to know,\u201d 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, \u201cSponsor Payment for Costs to Subject Injury in Industry-Sponsored Clinical Trials Guidance,\u201d 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."},{"key":"S107311050002595X_bib52","unstructured":"52. Id."},{"key":"S107311050002595X_bib123","unstructured":"123. U.S. Health Resources and Services Administration, \u201cNational Vaccine Injury Compensation Program,\u201d date last reviewed June 2019, available at <https:\/\/www.hrsa.gov\/vaccine-compensation\/index.html> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib16","unstructured":"16. See Pike, 2012, supra note 8."},{"key":"S107311050002595X_bib95","unstructured":"95. Id."},{"key":"S107311050002595X_bib85","unstructured":"85. See Urooj et al., supra note other; See also Chingarande and Moodley, supra note 69."},{"key":"S107311050002595X_bib40","unstructured":"40. Cogburn Law, \u201cWho Pays for Research-Related Injuries,\u201d January 23, 2018, available at <https:\/\/www.cogburncares.com\/research-related-injuries\/> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib62","unstructured":"62. Moral Science, supra note 3, at 58."},{"key":"S107311050002595X_bib4","unstructured":"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 (September 2011), at 11 [hereinafter Research Across Borders]."},{"key":"S107311050002595X_bib67","unstructured":"67. See Moral Science, supra note 3, at 58."},{"key":"S107311050002595X_bib133","unstructured":"133. Id., at 668."},{"key":"S107311050002595X_bib111","unstructured":"111. Mayer, E. , \u201cCompensation Expert Addresses Commission,\u201d 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)."},{"key":"S107311050002595X_bib110","unstructured":"110. See Moral Science, supra note 3 at 62."},{"key":"S107311050002595X_bib131","unstructured":"131. Id."},{"key":"S107311050002595X_bib96","unstructured":"96. Id."},{"key":"S107311050002595X_bib102","unstructured":"102. Id."},{"key":"S107311050002595X_bib13","unstructured":"13. 21 CFR 50 \u2014 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)."},{"key":"S107311050002595X_bib23","unstructured":"23. American Society for Clinical Oncology, \u201cASCO Answers: Clinical Trials Coverage Through the Affordable Care Act,\u201d available at <https:\/\/www.cancer.net\/sites\/cancer.net\/files\/clinical_trials_coverage_aca_fact_sheet.pdf> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib118","unstructured":"118. Sama-Resource Group for Women and Health, Compensation in Clinical Trials: A Comparative Analysis of Seven Countries (New Delhi, India, 2016): at 236\u2013238."},{"key":"S107311050002595X_bib61","first-page":"83","article-title":"\u201cThe Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research,\u201d","volume":"5","year":"1979","journal-title":"Kennedy Institute of Ethics Journal"},{"key":"S107311050002595X_bib138","unstructured":"138. See Henry, 2013, supra note 12, at 414."},{"key":"S107311050002595X_bib142","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2004.037895"},{"key":"S107311050002595X_bib106","unstructured":"106. See Chingarande and Moodley, supra note 8."},{"key":"S107311050002595X_bib80","unstructured":"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\u2013187, available at <https:\/\/www.icmr.nic.in\/sites\/default\/files\/guidelines\/ICMR_Ethical_Guidelines_2017.pdf> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib113","unstructured":"113. See Henry, supra note 12 at 417; See Moral Science, supra note 3, at 67."},{"key":"S107311050002595X_bib92","unstructured":"92. Department of Health, \u201cSouth African Good Clinical Practice Guidelines (Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa),\u201d 2006, available at <http:\/\/www.kznhealth.gov.za\/research\/guideline2.pdf> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib128","unstructured":"128. Parasidis, E. , \u201cUnpacking the Shortcomings of the Vaccine Injury Compensation Program,\u201d Jotwell: The Journal of Things We Like (2017):1\u20132."},{"key":"S107311050002595X_bib134","doi-asserted-by":"publisher","DOI":"10.1177\/1073110518766008"},{"key":"S107311050002595X_bib116","unstructured":"116. KFF (Henry J. Kaiser Family Foundation), \u201cHealth Insurance Coverage of the Total Population: Timeframe 2017,\u201d 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)."},{"key":"S107311050002595X_bib141","unstructured":"141. See Martin et al., supra note 20."},{"key":"S107311050002595X_bib38","unstructured":"38. See Lovell, Pinto, and Polston, supra note 36."},{"key":"S107311050002595X_bib64","unstructured":"64. See Henry, supra note 12 at 416; Moral Science, supra note 3."},{"key":"S107311050002595X_bib132","unstructured":"132. Id., at 661."},{"key":"S107311050002595X_bib10","unstructured":"10. 45 CFR 46.116; 21 CFR 50.25."},{"key":"S107311050002595X_bib70","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-720X.2003.tb00106.x"},{"key":"S107311050002595X_bib108","unstructured":"108. Id."},{"key":"S107311050002595X_bib22","unstructured":"22. American Society of Clinical Oncology, \u201cInsurance Coverage of Clinical Trials,\u201d supra note 20; American Society of Clinical Oncology, \u201cGuarantee Coverage of Clinical Trials Participation for Medicaid Patients,\u201d 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)."},{"key":"S107311050002595X_bib87","unstructured":"87. India Ministry of Health and Family Welfare, supra note 84, at 234."},{"key":"S107311050002595X_bib101","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1136\/medethics-2014-102246","article-title":"\u201cAppropriateness of No-Fault Compensation for Research-Related Injuries from an African Perspective: An Appeal for Action by African Countries,\u201d","volume":"42","author":"Kamalo","year":"2016","journal-title":"Journal of Medical Ethics"},{"key":"S107311050002595X_bib42","unstructured":"42. 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."},{"key":"S107311050002595X_bib24","unstructured":"24. Patient Protection and Affordable Care Act \u00a7 2709(d)(1) 124 STAT. 894; Cancer.Net Editorial Board, \u201cHealth Insurance Coverage of Clinical Trials,\u201d 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)."},{"key":"S107311050002595X_bib120","unstructured":"120. Central Drugs Standard Control Organization, \u201cList of FDC and New Drugs Approved For Marketing in India,\u201d available at <https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Approval_new\/FDC-New-Drugs-Marketing\/> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib79","unstructured":"79. See Chingarande and Moodley, supra note 8."},{"key":"S107311050002595X_bib65","unstructured":"65. See Henry, supra note 12 at 415."},{"key":"S107311050002595X_bib109","unstructured":"109. See Moral Science, supra note 3; see Scott, supra note 5; see Elliott, supra note 5; see Henry, supra note 12."},{"key":"S107311050002595X_bib21","unstructured":"21. United Healthcare, \u201cRoutine Costs in Clinical Trials (NCD 310.1),\u201d supra note 20; American Society of Clinical Oncology, \u201cInsurance Coverage of Clinical Trials,\u201d supra note 20."},{"key":"S107311050002595X_bib53","doi-asserted-by":"crossref","first-page":"1871","DOI":"10.1056\/NEJMp068080","article-title":"\u201cCompensation for Injured Research Subjects,\u201d","volume":"354","author":"Steinbrook","year":"2006","journal-title":"New England Journal of Medicine"},{"key":"S107311050002595X_bib83","unstructured":"83. Id."},{"key":"S107311050002595X_bib5","first-page":"419","article-title":"\u201cResearch-Related Injury: Problems and Solutions,\u201d","volume":"31","author":"Manning","year":"1995","journal-title":"Journal of Law, Medicine and Ethics"},{"key":"S107311050002595X_bib126","unstructured":"126. Bhattacharyya, R. , Special Master, September 11th Victim Compensation Fund, \u201cSeventh Annual Status Report and Third Annual Reassessment of Policies and Procedures,\u201d February 2019, available at <https:\/\/www.vcf.gov\/pdf\/VCFStatus-ReportFeb2019.pdf> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib27","unstructured":"27. American Society of Clinical Oncology, \u201cAffordable Care Act and Coverage of Clinical Trials: Frequently Asked Questions,\u201d 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)."},{"key":"S107311050002595X_bib3","unstructured":"3. 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]."},{"key":"S107311050002595X_bib69","unstructured":"69. G.R. Chingarande and K. Moodley, supra note 8."},{"key":"S107311050002595X_bib124","unstructured":"124. \u201cSeptember 11th Victim Compensation Fund\u201d website, available at <https:\/\/www.vcf.gov\/>, (last visited November 13, 2019)."},{"key":"S107311050002595X_bib43","unstructured":"43. Id.; Moe, supra note 28."},{"key":"S107311050002595X_bib58","unstructured":"58. Id."},{"key":"S107311050002595X_bib76","unstructured":"76. See Moral Science, supra note 3."},{"key":"S107311050002595X_bib32","unstructured":"32. \u201cUninsured Research Subjects Raise Multiple Ethical Issues,\u201d 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."},{"key":"S107311050002595X_bib14","unstructured":"14. 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."},{"key":"S107311050002595X_bib68","unstructured":"68. See Moral Science, supra note 3, at 59."},{"key":"S107311050002595X_bib46","unstructured":"46. Wake Forest School of Medicine, Human Research Protection Program and Institutional Review Board Policies and Procedures,\u201d 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)."},{"key":"S107311050002595X_bib29","unstructured":"29. Malek, L.A. and Moses, J.E. Anderson & Singer LLP, \u201cClient Alert: Healthcare Reform Law May Impact Clinical Trial Billing and Contract Negotiations,\u201d 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."},{"key":"S107311050002595X_bib84","unstructured":"84. India Ministry of Health and Family Welfare (Department of Health and Family Welfare), \u201cThe Gazette of India-Extraordinary: Notification,\u201d Regd. No. D.L.-33004\/99, March 19, 2019, New Delhi, India, see pages 162\u2013163, available at <https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/NewDrugs_CTRules_2019.pdf> (last visited November 13, 2019)."},{"key":"S107311050002595X_bib26","unstructured":"26. United Healthcare, \u201cClinical Trials,\u201d 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)."},{"key":"S107311050002595X_bib125","first-page":"1","article-title":"\u201cThe Problematic Role of the Special Master: Undermining the Legitimacy of the September 11th Victim Compensation Fund,\u201d","volume":"24","author":"Berkowitz","year":"2006","journal-title":"Yale Law and Policy Review"},{"key":"S107311050002595X_bib17","unstructured":"17. See Committee, supra note 5."},{"key":"S107311050002595X_bib99","unstructured":"99. Id."},{"key":"S107311050002595X_bib59","unstructured":"59. See Moral Science, supra note 3, at 64."},{"key":"S107311050002595X_bib47","unstructured":"47. Id."},{"key":"S107311050002595X_bib104","unstructured":"104. See Kamalo et al., supra note 101, at 530."},{"key":"S107311050002595X_bib137","unstructured":"137. See Kamalo et al., supra note 101, at 530."},{"key":"S107311050002595X_bib73","doi-asserted-by":"publisher","DOI":"10.2307\/1524504"},{"key":"S107311050002595X_bib127","first-page":"1631","article-title":"\u201cA Dose of Reality for Specialized Courts: Lessons from the VICP,\u201d","volume":"163","author":"Engstrom","year":"2015","journal-title":"University Pennsylvania Law Review"},{"key":"S107311050002595X_bib140","unstructured":"140. See Lamkin and Elliott, supra note 134."},{"key":"S107311050002595X_bib18","first-page":"151","article-title":"\u201cUncovering the Silent Victims of the American Medical Liability System,\u201d","volume":"67","author":"Shepherd","year":"2014","journal-title":"Vanderbilt Law Review"},{"key":"#cr-split#-S107311050002595X_bib119.1","unstructured":"119. 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)"},{"key":"#cr-split#-S107311050002595X_bib119.2","unstructured":"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)."},{"key":"S107311050002595X_bib33","unstructured":"33. See Cho, et al., \u201cThe ethics of uninsured\u2026\u201d, 2018, supra note 28, at 517 (quote) and 518."},{"key":"S107311050002595X_bib94","unstructured":"94. Id."},{"key":"S107311050002595X_bib103","unstructured":"103. See Moral Science, supra note 3, at 58."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1073110519897737","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1073110519897737","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S107311050002595X","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T13:49:54Z","timestamp":1610632194000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S107311050002595X\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019]]},"references-count":143,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019]]}},"alternative-id":["S107311050002595X"],"URL":"https:\/\/doi.org\/10.1177\/1073110519897737","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019]]}}}