Human Subjects and Stories
When protecting vulnerable populations conflicts with progress
Scientific progress is bounding forward in genetics and Alzheimer’s research, and at the center of many of these discoveries are human research subjects. Informed consent is meant to protect them, but sometimes in its drive to discover and cure, science leaves its subjects behind. Deborah Zoe Laufer’s play Informed Consent looks at the ways that progress and discovery can sometimes be achieved at the expense of vulnerable populations; cures can be found by studying these populations, but at what cost to the people being studied? The play was inspired by a major example of the friction between progress and protection, but it’s not the only such case where research was prized above the subjects.
Nuremberg Code
Informed consent is based on a set of ethics principles for human experimentation called the Nuremberg Code. The code exists as a result of the Nuremberg trials at the end of World War II, which tried doctors for human experimentation in concentration camps. Nazi experiments on prisoners included hypothermia tests, purposeful exposure to mustard gas and poisons to test cures or study the physical effects, and forced sterilization, among many other horrific tests. Most victims died; those who did not were left maimed and traumatized. The code that resulted from the trial consists of ten points aimed at avoidance of patient suffering. The first point on this list is informed consent.
Tuskegee Study of Untreated Syphilis in the African American Male
When this study began in 1932, informed consent was not yet part of a researcher’s toolkit. Conducted by the U.S. Public Health Service over 40 years, the study involved 600 poor African American men, of which 399 had syphilis and 201 did not. At the study’s inception, there was no known cure for syphilis, so the men were observed for six months and then treated with contemporary, toxic, and only mildly effective methods. None of the men were ever told they had syphilis, and none were treated, even after penicillin became a known cure in 1947; in fact, the doctors often actively worked to make sure the men did not receive treatment outside of the study. The men were given placebos and lured to submit themselves to painful, non-therapeutic spinal taps with the false promise of free treatment. The study only ended when a whistleblower went to the press in 1972. By then, just 74 of the test subjects were alive. Of the original 399 afflicted men, 28 had died of syphilis, 100 had died of related complications, 40 of their wives had been infected, and 19 of their children were born with congenital syphilis.
The outrage over this study led to the creation of the Office for Human Research Protections (OHRP) and to regulations requiring Institutional Review Boards to oversee studies involving human subjects.
Guatemalan STD studies
In 2011, researchers discovered that in 1946, U.S. Public Health Service scientists (including one who participated in the Tuskegee project) attempted to study the effects of penicillin on STDs by exposing more than 1,500 Guatemalans to various diseases including syphilis and gonorrhea. The subjects included prisoners, mental health patients, and soldiers; methods of infection included prostitution, injections, and purposeful contamination of open wounds. Though treatment was attempted, patients were never informed of what the researchers were doing or that they were being infected with diseases, and no efforts were made to track the long-term effects. It’s impossible to know how many of these patients may have died in the years after the study ended in 1948, nor how many people they may have in turn infected.
The same study had previously been performed on prison inmates in Indiana. In that case, however, the researchers got consent and only included volunteers. No such protections were extended to the Guatemalans.
SUPPORT Study
Informed consent guidelines have drastically reduced the number of cases like these, but have not eliminated all ethical concerns. In the recent SUPPORT project, 23 institutions studied the effects of varying levels of oxygen on upwards of 1,300 premature babies. While the study produced results that have drastically improved the treatment of these babies worldwide, the risks explained to the parents focused on abrasions from the oxygen equipment without addressing the potentially increased risks for blindness or death. After the results were published, the OHRP investigated and found that the consent forms did not properly address these risks. This case highlighted the divide that still exists between researchers and subjects. Many scientists disagreed with OHRP’s conclusions, noting that the risks were purely speculative at the time and that relaying them would have been irresponsible.
The abuses of the first half of the century would be largely impossible today. Informed consent procedures are firmly in place, and institutions tend to err on the side of caution rather than risk being sued. But as the SUPPORT study and the case at the center of Informed Consent prove, friction and uncertainty remain, potentially leaving vulnerable populations behind.
Join us for Informed Consent at Lantern Theater Company, January 12 — February 12. Visit our website for tickets and information.
