December 8, 2021
Informed consent and other processes to ensure the protection of humans involved in research resulted from past abuses of research subjects, Dr. Greg Bell, assistant professor of community medicine and population health, said during a Mini Medical School presentation in November.
Mini Medical School is a collaboration of The University of Alabama’s OLLI program and UA’s College of Community Health Sciences.
“All research conducted on humans must be accepted by the subjects through a procedure known as informed consent,” Bell said. “Informed consent is now a legal and ethical requirement for research, but that wasn’t always the case.”
Bell said it wasn’t until after World War II and negative publicity that government agencies began giving thought to protecting human research subjects. He noted past research studies that failed to protect human subjects:
Bell said there was also the U.S. Public Health Services Syphillis Study at Tuskegee. The study began in 1932 with 600 Black men as participants – 399 with syphilis and 201 without. The men were told they would receive free medical exams, meals and burial insurance, Gregg said.
“The men were told they were being treated for bad blood,” Bell said. At the time, bad blood was a local term used to describe such ailments as anemia and fatigue, in addition to syphilis.
By 1943, penicillin was the approved treatment for syphilis and becoming widely available, but the men in the Tuskegee study were provided other medications that were known to be ineffective, Bell said. “Many of these men could have been saved if treated effectively, but they were not,” he said. “The study was designed not to treat these men. The aim of the study was to record the natural progression of syphilis.”
In July 1972, an Associated Press reporter broke the story and a government advisory panel concluded that the study was “ethically unjustified.”
Bell said the 1947 Nuremberg Code first captured the principle of informed consent, a process by which a research subject voluntarily confirms their willingness to participate after having been informed of all aspects of the study. The informed consent principle was embedded in the later Declaration of Helsinki and Belmont Report.
“The voluntary consent of the human subject is absolutely essential,” Bell said.