ETHICALLY IMPOSSIBLE” STD Research in Guatemala from 1946-1948 
20 It is important to recognize that “exposure” to an STD is not the same as “infection” with an STD. Sub- 
jects who were exposed to an STD by the researchers ran the risk of becoming infected with that STD, but 
many of the subjects that were exposed to an STD were not infected. 
21 PCSBI. (2011). Subject Database. This number represents the number of separate individuals exposed at 
least one time. Some individuals were exposed more than once. 
22 Ibid. 
23 All of the sex workers employed for the research were women. 
24 PCSBI. (2011). Subject Database. 
25 The available records show that the researchers did not inoculate the children in the orphanage or school 
with STDs. 
26 Stout, G.W., Cutler, J.C. (1951, September). Serology problems (syphilis) in Central America. Journal of 
Venereal Disease Information, 32(7): 238-239; Portnoy, J., Galvez, R., Cutler, J.C. (1952). Clinical and 
serologic studies with reference to syphilis in Guatemala, Central America. III. Studies of comparative 
performance of the Kahn, Kolmer, Mazzini, and VDRL slide tests among leprosy patients. American 
Journal of Syphilis, Gonorrhea, and Venereal Diseases 36(3):566-570. 
27 Lalcone, V.H., Harris, A., Olansky, S., Salvado, C., Cutler, J.C. (1953). A study of the Neurath Inhibition 
Phenomenon in the serodiagnosis of syphilis. American Journal of Syphilis, Gonorrhea, and Venereal 
Diseases 37(3):264-272. 
28 A lumbar or cisternal puncture is the removal of cerebrospinal fluid through a needle inserted between two 
vertebrae in the lower back (lumbar) or into the base of the skull (cisternal). 
29 Report on Serologic Lollow-up on Patients Done at CDC in 1953, Samples sent from Guatemala. (1953.) 
PCSBI HSPI Archives, CTLR_0001436. 
30 John Cutler to John Mahoney. (1947, September 18). Correspondence. PCSBI HSPI Archives, 
CTLR 0001231. 
31 Advisory Committee on Human Radiation Experiments. (1996). Final Report of the Advisory Committee 
on Human Radiation Experiments. New York: Oxford University Press; Moreno, J.D. (1999). Undue Risk: 
Secret State Experiments on Humans. New York: W.H. Ereeman & Co.; Faden, R.R., Beauchamp, T.L. 
(1986). A History and Theory of Informed Consent. New York: Oxford University Press; Rothman, D.J. 
(1991). Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision 
Making. New Brunswick: Aldine Transaction. 
32 See, e.g., World Medical Association. (1964). Code of Ethics of the World Medical Association: Declara- 
tion of Helsinki. Helsinki, Finland: World Medical Association; Drug Amendments of 1962, Public 
Law No. 87-781 (1962), codified at 21 U.S.C. 355 (requiring informed consent in certain FDA-regulated 
research); 21 C.F.R. 50 (same); National Research Act of 1974, Public Law No. 93-348 (1974), codified at 
42 U.S.C. 218 (requiring informed consent and independent review in HHS-sponsored research); 45 C.F.R. 
46 (same); Emanuel, E. J., Wendler, D., Grady, C. (2000). What makes clinical research ethical? JAMA 
283(20):2701-2711. 
33 See 45 CFR 46, Subparts B-D (allowing for research on vulnerable populations, including prisoners 
and children, provided additional protections are in place); 45 C.F.R. § 46.116(d) (allowing for waiver of 
informed consent when: the research involves no more than minimal risk, the waiver will not adversely 
affect subjects’ rights and welfare, the research could not practicably be conducted without the waiver, 
and, where appropriate, subjects are provided with additional information after participation). Today, 
intentional infection research is used for a variety of purposes, including proof of microbial pathogenicity, 
definition of protective antigens, identification of factors that influence disease acquisition and severity, 
assessment of vaccine efficacy, demonstration of infection-derived immunity, identification of protective 
immune responses, and refinement of vaccine formulation, schedule, and delivery. Kotloff, K.L. (2003). 
Human challenge studies with infectious agents. Journal of Investigative Medicine 51(Supp.): S6-S7. See 
also Cohen, M.S., Cannon, J.G. (1994). Human experimentation with Neisseria gonorrhoeae: Rationale, 
methods, and implications for the biology of infection and vaccine development. Journal of Infectious 
Diseases. 169:532-537 (providing an example of recent intentional infection research in gonorrhea). 
34 Kaempffert, W. (1947). Notes on science: Syphilis prevention. New York Times. April 27. 
162 
