In the 1940s, a team of medical researchers determined that Guatemala had all the characteristics they were looking for: A population with a “fixed character” and officials with a “highly cooperative attitude.” Research scientists, frustrated with the ethical constraints of testing new syphilis treatments, wanted a laboratory setting where they could be free from legal consequences and bad publicity. Between 1946 and 1948, researchers intentionally infected more than 1,300 people, ranging from soldiers to schoolchildren, without their knowledge or consent.
Investigators said the study was an unconscionable violation of ethical standards, but could it happen again?
Soon after evidence of the federally funded Guatemalan experiments emerged late last year, President Barack Obama requested a thorough examination of the project, and an in-depth review of current ethics standards for government backed studies.
In Sept. 2011, the Presidential Commission for the Study of Bioethical Issues released a report detailing how the secret project came to be, and the names of scientists and official organizations involved. In the commission’s latest report—“Moral Science: Protecting Participant’s in Human Subjects Research”—investigators examine modern ethics practices, and offer several recommendations on how to improve them.
The news is generally good. After nine months of intense investigation “The commission is confident that what happened in Guatemala in the 1940s could not happen today,” said Commission Chair Dr. Amy Gutmann in a statement.
“However, it is also clear that improvements can be made to protect human subjects going forward,” added Gutmann. “With the commission’s recommendations, society will continue to benefit from advances in quality of life made possible by human subjects research and ensure respect for the inherent dignity of individual research volunteers.”
With the federal government funding over 55,000 human subject research projects in 2010 alone, the “Moral Science” report holds a wide range of influence. The commission says that since so many advances are driven by studies involving human participants, a safe research environment is vital for future innovations.
According to the report, great caution is taken in particularly sensitive experiments. It states that while some studies do involve vulnerable populations, using deliberate exposure and infection, and are conducted without informed consent, such research projects have to be carefully justified, reviewed, and approved, and may still require additional protections.
But not all projects are subjected to the same scrutiny. The commission found that some federal agencies knew very little about the research they support. Investigators believe better protection is possible, and they offer several ideas for improving the system, including more transparency. The commission is calling for public access to information about government funded human subjects research.
The commission also recommends that federal agencies supporting studies with human subjects maintain a basic understanding of the programs they fund. They say that access to basic information—including the title and lead investigator of each project, the location of each study, and the amount appropriated for the research—would make for greater accountability and oversight.
According to the report, the events in Guatemala should “serve as a cautionary tale of how the quest for scientific knowledge without regard to relevant ethical standards can blind researchers to the humanity of the people they enlist into research.”
“A clear consensus has emerged that medical research must not violate human dignity or undermine the very human flourishing it seeks to advance in future patients,” states the report. “The Guatemala experiments and other troubling violations of this norm that have come to light in the last 60 years truly shock the conscience, precisely because of their medical context.”
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