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Presidential Commission for the Study of Bioethical Issues submits report of investigation into Guatemalan experiments to President

September 09, 2011

A report by the representatives of the Presidential Commission for the Study of Bioethical Issues, including University of Pennsylvania Law School Professor Anita Allen and University of Pennsylvania’s President Amy Gutman, was sent to the President in conclusion to its investigation into the U.S. Public Health Service (U.S. PHS) studies done in Guatemala in the 1940s.

According to the President’s Bioethics Commission, the revelation last fall that the U.S. Public Health Service (the precursor agency to the U.S. Department of Health and Human Services) supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, President Obama tasked the Bioethics Commission with two assignments: first, to oversee an investigation into the research in Guatemala that took place in the 1940s; and to seek assurances that current rules for research subjects are sufficient to protect people from harm or unethical treatment, both in the U.S. and in other countries.


Professor Anita Allen sat down with Penn Law’s Office of Communications to talk about this report and the Commission’s findings.

 

 

 

Transcript

I’m Anita Allen. I am a professor here at Penn Law School and I’m also a member of President Obama’s Bioethics Commission.
 
In the Guatemalan incident, which was between 1946-1948, U.S. Public Health Service doctors went to Guatemala, with the cooperation of the Guatemalan government, and began to study whether or not certain protocols could help to reduce the incidence of sexually transmitted diseases. But the research protocol they used involved infecting, deliberately infecting, people including prisoners, soldiers, sex workers, mental patients and others with diseases, syphilis and gonorrhea in particular. And some of the people who were infected were never actually treated.
 
The commission found that there were a number of problems with the research in Guatemala. It’s shocking, I know, just to even hear about it, but the specific problems were that the research protocols that were used were scientifically invalid. They were based on under-rationalized protocols and on inconsistent and ad hoc scientific approaches. Moreover, because the research did involve the failure to get the informed consent of the subjects, the research violated both contemporary and past ethical standards.
 
The report that the President will receive from the Commission in September will have a number of key findings. One of those finding will be that the scientific validity of the research that was conducted is limited. The second important finding is there was a lack of informed consent on the part of the researchers. We do know that in similar research that happened in the United States there were efforts to get informed consent and there were efforts to minimize risk. That did not happen in Guatemala. And the final finding is going to be that the standards of ethics that were in play in the 1940s were not adhered to. Ordinary morality was not adhered to. The principles that stem from the Nuremberg Nazi tribunals were not adhered to. And then finally there were at the time, recognized research standards that were promulgated through, for example the American Medical Association, which were not being adhered to. The Commission’s report will lay out all the ethical frameworks that could have been used in Guatemala which were not and will also explain the responsibility in terms of who was involved, why they were involved, and what we can do to make sure these things don’t happen again in the future.
 
Transcript edited for length.