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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. et al., 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]; Jones, J. H., Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993); Reverby, S., Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (Chapel Hill, NC: University of North Carolina Press, 2009).Google Scholar

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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.”). (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.”).' href=https://scholar.google.com/scholar?q=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++(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.”).>Google Scholar

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