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'ETHICALLY IMPOSSIBLE': STD Research in Guatemala from ...

September 2011 ethically impossible STD Research in Guatemala from 1946 to 1948 ABOUT THE COVER:Detail taken from historical mapComplete map shown aboveAuthor: Schrader; Vivien St Martin, : 1937 Short Title: MexiquePublisher: Librairie Hachette, ParisType: Atlas MapImages copyright 2000 by Cartography AssociatesDavid Rumsey Historical Map , Commission for the Study of Bioethical Issues ethically impossible STD Research in Guatemala from 1946 to 1948 ETHIC A LLY impossible STD Research in Guatemala from 1946-1948iiiiA BOU T T HE PR E SIDEN T I A L COM MISSION FOR T HE ST U DY OF BIOET HIC A L ISSU E SThe Presidential Commission for the Study of Bioethical Issues (the Commission) is an advisory panel of the nation s leaders in medicine, science, ethics, religion, law, and engineering.

this report, “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948.In response to your request of November 24, 2010, the Commission oversaw a thorough fact-finding investigation into the specifics of the U.S. Public Health Service-led studies in Guatemala

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1 September 2011 ethically impossible STD Research in Guatemala from 1946 to 1948 ABOUT THE COVER:Detail taken from historical mapComplete map shown aboveAuthor: Schrader; Vivien St Martin, : 1937 Short Title: MexiquePublisher: Librairie Hachette, ParisType: Atlas MapImages copyright 2000 by Cartography AssociatesDavid Rumsey Historical Map , Commission for the Study of Bioethical Issues ethically impossible STD Research in Guatemala from 1946 to 1948 ETHIC A LLY impossible STD Research in Guatemala from 1946-1948iiiiA BOU T T HE PR E SIDEN T I A L COM MISSION FOR T HE ST U DY OF BIOET HIC A L ISSU E SThe Presidential Commission for the Study of Bioethical Issues (the Commission) is an advisory panel of the nation s leaders in medicine, science, ethics, religion, law, and engineering.

2 The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific Research , health care delivery, and technological innovation are conducted in a socially and ethically responsible more information about the Commission, please see TEN TSPR EFACE ..1 BACKGROU ND ..9 Terre Haute Prison Experiments, 1943-1944 ..13 Implementing the Experiments ..20 Developments in the Science and Prevention of Sexually Transmitted Diseases ..23 GUATEM A L A E X PER IMEN TS 1946- 1948 ..27 Initial Experiment Design.

3 28 Treatment Programs and Goodwill Efforts ..32 Serological Experiments ..36 Penitentiary ..37 Children ..38 Leprosarium ..40 Psychiatric Hospital ..41 Intentional Exposure Experiments ..41 Overview ..41 Gonorrhea Experiments ..43 Syphilis Experiments ..52 Chancroid Experiments ..69 Winding Down the Guatemala Experiments ..70 Extension of the Grant ..70 Disposition of the Laboratory ..71 Race and Secrecy during the Guatemala Experiments ..72 Issues of Race ..72 Concerns about Secrecy ..74T HE POST- CU T L ER CON T IN UAT ION OF T HE GUATEM A L A E X PER IMEN TS A ND FINA L R EPORTS 1948 -1955 ..81 Serology Experiments ..82 Continuing Observations ..83PU BLIC AT ION OF T HE GUATEM A L A DATA.

4 85A F TERWOR D ..87R EV IEW ING ET HIC A L STA NDA R DS IN CON TE X T ..91 Current Human Research Protections and Ethical Requirements of Our Own Time ..92 Longstanding Ethical Principles ..93 Contemporaneous Standards for Ethical Research in 1946- 1948 ..97 Evaluating General Mitigating Arguments ..101 Evaluating Historically Specific Mitigating Arguments ..104 ETHIC A LLY impossible STD Research in Guatemala from 1946-1948ivThe Guatemala Experiments Looking Back, Looking Ahead, and Apportioning Blame ..107TA BL E S A ND FIGU R E S ..109 Table 1: The Cutler Documents ..110 Table 2: Individuals Involved in the STD Experiments in Guatemala ..112 Table 3: Timeline of all Guatemala Experiments.

5 116 Table 4: Subject and Population Specific Data ..118 Figure 1: Organizational Chart of the Office of Scientific Research and Development ..120 Figure 2. Organizational Chart of the National Research Council ..121 Figure 3. Organizational Chart for the Public Health Service, 1946 ..122 Figure 4. Organizational Chart for the National Advisory Health Council, December 1946 ..123 Figure 5. Organizational Chart for the Syphilis Study Section ..124 Figure 6: Intentional Exposure Experiments Goals over Time ..125 Figure 7: Intentional Exposure Experiments over Time ..126 Figure 8: Methods of Exposure over Time ..127 GLOSSA RY OF K EY TER PPENDICE S ..137 Appendix I: Waiver Form Proposed in Preparation for the Terre Haute Experiments.

6 138 Appendix II: Chancroid Experiment Report Excerpt ..141 Appendix III: Investigation Methods ..142 Research in Guatemala ..146 Advisors to the Investigation ..146 Targeted Interviews ..148 Staff Delegation to Guatemala ..148 Translation ..148 Appendix IV: Subject Database Methods ..149 Creation of Subject Database ..149 Subject Database Quality Control ..151 Limitations ..153 Figures 6, 7, and V: Suggestions for Further Reading ..155 ENDNOTE S ..159 INDE X ..203vPresidential Commission for the Study of Bioethical IssuesPresident Barack ObamaThe White House1600 Pennsylvania Avenue, NWWashington, DC 20500 Dear Mr. President:On behalf of the Presidential Commission for the Study of Bioethical Issues, we present to you this report, ethically impossible : STD Research in Guatemala from 1946 to 1948 .

7 In response to your request of November 24, 2010, the Commission oversaw a thorough fact-finding investigation into the specifics of the Public Health Service-led studies in Guatemala involving the intentional exposure and infection of vulnerable populations. Following a nine-month intensive investigation, the Commission has concluded that the Guatemala experiments involved gross violations of ethics as judged against both the standards of today and the researchers own understanding of applicable contemporaneous practices. It is the Commission s firm belief that many of the actions undertaken in Guatemala were especially egregious moral wrongs because many of the individuals involved held positions of public institutional best thing we can do as a country when faced with a dark chapter is to bring it to light.

8 The Commission has worked hard to provide an unvarnished ethical analysis to both honor the victims and make sure events such as these never happen again. The Commission is also working to fulfill your other charge on human subjects Research a review of domestic and international contemporary human subjects protection rules and standards, to ensure federally funded scientific studies are conducted ethically and will submit a report to you in December. The Commission is honored by the trust you have placed in us and grateful for the opportunity to serve you and the nation in this ,Amy Gutmann, James Wagner, Vice-Chair1425 New Yor k Av enue, N W, Suite C-100, Wa shington, DC 20005 Phone 202-233-3960 Fa x 202-233-3990 w w ETHIC A LLY impossible STD Research in Guatemala from 1946-1948viviiPR E SIDEN T I A L COM MISSION FOR T HE ST U DY OF BIOET HIC A L ISSU E SA M Y GU TM A N N, , CH A IRPresident and Christopher H.

9 BrowneDistinguished Professor of Political Science, University of PennsylvaniaJA ME S W. WAGNER, , V ICE CH A IRPresident, Emory UniversityYOL A NDA A LI, A .Michael J. Fox FoundationFounder s Council; Emory NeurosciencesCommunity Advisory BoardA NITA L . A LL EN, , R. Silverman Professor of Law and Professor of Philosophy University of Pennsylvania Law SchoolJOHN D. A R R A S, Professor of BiomedicalEthics, Professor of Philosophy,University of VirginiaBA R BA R A F. AT K INSON, Vice Chancellor,University of Kansas Medical Center; Executive Dean, University of Kansas School of MedicineNITA A . FA R A H A N Y, , Kaplan Visiting Professor in Human Rights, Stanford Law SchoolAssociate Professor of Law; Associate Professor of PhilosophyVanderbilt UniversityALEX ANDER G.

10 GARZA, , Secretary, Office of HealthAffairs; Chief Medical Officer, Department of Homeland SecurityCHR IST INE GR A DY, R .N., Chief of the Department of Bioethics, National Institutes of Health Clinical CenterSTEPHEN L . H AUSER, A. Fishman Distinguished Professor and Chair of the Department of Neurology, University of California, San FranciscoR AJU S. K UCHER L A PAT I, C. Cabot Professor, Department of Genetics, Harvard Medical School; Professor, Department of Medicine, Brigham and Women s HospitalNEL SON L . MICH A EL , , , Medical Corps, Army; Director, Division of Retrovirology; Walter Reed Army Institute of Research ; Military HIV Research ProgramDANIEL P.


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