In the Tuskegee Syphilis Study, the principal investigators recruited 399 African American men with syphilis and 201 without syphilis to be control subjects. They monitored the 600 men and assessed the natural progression of syphilis without treatment. Many infected men died, scores of others suffered debilitating complications like blindness, and others transmitted the disease to their spouses, who in turn spread it to their unborn babies. The study took a whooping 40 years’ period, and it didn’t come to a halt until Peter Buxton leaked it to the public through a reporter. In the aftermath of the study, several ethics committees and organisations sprout, and the subsequent trials have seen constant monitoring, especially those that the US federal government funds. The changes garnered global attention. Several institutional review boards oversee all clinical trials, as well as other research studies. In Uganda, the Uganda National Academy of Sciences oversees all the research activities that happen throughout the country.
In 1932, the US public health service physicians begun a study on 600 African American men in Macon County, Alabama, to assess how syphilis – a highly contagious sexually transmitted disease – could progress if left untreated. They were 399 men with syphilis and 201 men without syphilis – the latter could work as controls. The participants never signed any informed consent form, nor did they know the details of the study. The study doctors notified the participants that they were treating them for bad blood.
The health care providers monitored the sick men for forty years without giving them any definitive treatment despite penicillin being available as the mainstay treatment from 1947 to date. The men died, others became blind, suffered mental impairment, while others spread the disease to their spouses – who then transmitted the disease to their unborn babies. All this happened at Tuskegee University (then Tuskegee Institute).
After learning about the Tuskegee Syphilis Study in the 1960s, Dr Peter Buxton became concerned about the ethics of the trial – complained to the top officials at the public health service – which formed a committee. The committee reviewed the trial data and decided to continue it until all the participants had died and their dead bodies examined (autopsies) to analyse all the data.
Following the frustrations, Peter Buxton leaked the study details to Jean Heller, who worked for the Associated Press. In July 1972, Heller published the study details. Later that year, the US Public Health Service decided to shut down the study due to public outcry. Twenty-eight study participants had died of syphilis: one hundred had succumbed to syphilis-related complications, more than forty spouses had contracted the disease, as well as nineteen children, had acquired it at birth.
After several hearings in Congress in 1974, the study participants, including the heirs of those who had succumbed to the disease or its complications – got an out-of-court settlement of ten million US dollars. To curtail such similar endeavours, the federal government issued multiple new guidelines to protect human research participants – to add on to the other international policies like the 1964 Declaration of Helsinki. The National Centre for Bioethics in Research and Health Care at Tuskegee University sprout from such regulations.
There have been multiple studies carried out throughout the world that have violated the ethics of integrity of human research participants. However, all these have since shut down, and in this era, you cannot conduct such studies. It is because several institutional review boards must approve proposals and study protocols before any study commences. And during the course of the research, multiple supervisory works take place to ascertain the continued integrity of the ongoing trials. In Uganda, the Uganda National Academy of Sciences and various institutional review boards at hospitals and universities perform that role.