Archive for December, 2013
The Tuskagee Experiment.
An example of what *not* to do.
The Tuskagee experiment was a research project involving both the Tuskagee Institute and the US Public Health Service. Originally, this study was to last six months to study the progression of syphilis in Negro men under the project title “Tuskagee Study of Untreated Syphilis in the Negro Male”. Why just the Negro male, you’re asking? At the time it was believed that the disease progressed in a different manner in white males. They knew little about the natural progression of the disease in black males and they wanted to obtain enough data to justify a treatment program specifically for them. So, at the start they had good intentions. Although allowing anyone with a disease to go untreated for any length of time seems cruel, it is, however, the only way to study the natural progression. And, if a subject is fully aware of the risks and gives consent, then data collection can commence. However, although men consented to the study, there was no informed consent. The subjects were not told they had syphilis. They were told they had ‘bad blood’ and were seduced to take part by the offer of free health care, meals and burial insurance. At some points they were even discouraged from seeking treatment elsewhere. Further, the study ended up lasting more than the allotted six months. It ended up running for 40 years until an epidemiologist, Peter Buxtun, blew the whistle leading to an investigation. In 1972, these experiments were finally deemed “ethically unjustified” and the terminated. A nice piece by the CDC summaries the timeline for this project and the actions taken in the aftermath.
As horrific an example of unethical research this is, I don’t think the scientists that took part should be demonized as people that purposely chose to destroy the lives of many. If anything, they had utilitarian mindsets; they were essentially sacrificing a few in order to understand the disease more completely so they could develop a treatment that would protect and save so many, many more. Holding such a utilitarian mindset can be dangerous in allowing you to justify the means of any research you are performing. In science, we should remember to apply deontological ethics where we adhere to our obligation and duty to fully disclose information on a study to our subjects and to ensure that informed consent is truly informed and not misleading. This may mean we might not be able to attract as many subjects to high risk studies, but it is the only way to guard ourselves against repeating a Tuskagee situation.
Thanks to the 1974 National Research Act, the Presidential Bioethics Commission and the Office for Human Research Protections, this sort of thing should never happen again. What happened is so horrifying to those of us who practice science today that it seems we shouldn’t need to discuss it, that it must, surely, be impossible that anyone would even attempt to perform research in a manner even close to this. As I say this, I am only too aware that, although they may not be on a scale with the Tuskagee transgression, there are still ethical breaches.
This year, the SUPPORT study (Surfactant Positive Airway Pressure and Pulse Oximetry Trial) was found to fail in its duty to provide participants complete details of the risks involved and bringing into question the extent to which the participants consent could be considered informed. This study was to test the outcome of using different oxygen levels on premature babies, at the extremes used either blindness or death could result. Parents were informed of these risks, however, it was not made clear enough that if they did not take part in the study that their babies would have been treated with oxygen levels within these extremes where the risks of blindness and death were somewhat minimized. There are still risks involved for premature babies whatever course of care was taken but more detailed information about the risks in and out of the study should have been provided.
If we are to always function in an ethical manner, from time to time we need to examine the dark places in the scientific past and remember how easy it can be to fall into unethical situations when judgement is clouded by ambition towards a goal that once seemed honorable.