6.4 A Case Study – The Tuskegee Syphilis Experiment

There are different examples in the literature of unethical research that have been conducted in the past. Let’s review one of the studies.

One of the most famous pieces of unethical research undertaken in the United States was the Tuskegee Syphilis study. Officially known as the Tuskegee Syphilis Study – An American medical research study called Study of Untreated Syphilis gained attention for its unethical testing on African American patients in the rural South.¹² The U.S. Public Health Service (PHS) experiment, which ran from 1932 through 1972, looked at the untreated syphilis natural course among African American men.¹² The study aimed to find out if the natural course of syphilis in black males differed considerably from that in whites and to see if cardiovascular damage was more common from syphilis than neurological impairment. The participants were not informed that they had syphilis or that sexual activity may spread the illness. Instead, they were informed that they had “bad blood,” a phrase used locally to describe a variety of ailments. Informed consent was not collected from the participants.¹² Some patients received arsenic, bismuth, and mercury as part of the study’s initial treatment phase. However, when the initial research could not yield any valuable information, it was decided to keep track of the participants until they passed away and stop all therapy.¹² After penicillin became available in the middle of the 1940s, the sick men were refused medication; this was still the case 25 years later, in clear contravention of government regulations that required the treatment of venereal disease. More than 100 of the subjects are thought to have passed away from tertiary syphilis.¹²

Watch the YouTube video below which briefly describes this study.

Let’s now consider this research in relation to the key principles of research ethics. 

Research merit and integrity: The Tuskegee Syphilis Experiment violated the principle of merit and integrity because it lacked scientific merit. The study was based on outdated and flawed scientific assumptions and failed to contribute to the advancement of scientific knowledge. The study also lacked integrity because the researchers did not adhere to scientific standards of ethical conduct, including obtaining informed consent from the participants.

Respect: The experiment also violated the principle of respect for persons because the researchers did not respect the autonomy of the study participants. The participants were not informed of the nature of the experiment, and they were not given the option to refuse participation. The researchers also failed to respect the dignity and worth of the participants by denying them proper medical treatment.

Beneficence: The experiment violated the principle of beneficence because the researchers failed to maximize benefits and minimize harms to the participants. The participants were denied effective medical treatment, which caused them to suffer needless pain and suffering. The researchers also failed to provide the participants with adequate medical care, even when it became clear that they had contracted syphilis.

Non-maleficence: The men were subjected to invasive, painful procedures, including spinal taps. The men were not informed about their disease, leaving their spouses and other family members vulnerable to catching the disease from them. The study violated the principle of non-maleficence because the researchers did not take steps to avoid causing harm to the participants. The researchers knowingly withheld effective medical treatment from the participants, which caused them to suffer from severe health complications, including blindness, paralysis, and death.

Justice: The study violated the principle of justice because it treated the participants unfairly. The study was conducted exclusively on African American men from a state in the south of the United States, who represented a very vulnerable population and they were denied proper medical treatment. The study also failed to provide compensation or medical care to the participants after the experiment ended.

Overall, the Tuskegee Syphilis Experiment is a significant violation of research ethics. The experiment lacked scientific merit, failed to respect the autonomy of the participants, caused needless harm, violated the principle of non-maleficence, and treated the participants unfairly. The experiment highlights the need for ethical guidelines in research to protect the rights and welfare of research participants.

In Australia, the National Statement on Ethical Conduct in Human Research was enacted to ensure the ethical conduct of human research. The National Statement was developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia. Researchers must adhere to the National Statement on Ethical Conduct in Human Research, which provides guidelines for ethical research practices. This includes ensuring that the research is culturally sensitive, respectful, and acknowledges the rights of Indigenous participants. The National Statement provides guidelines for researchers, Human Research Ethics Committees (HRECs) and others conducting an ethical review of research. It also emphasises institutions’ responsibilities for the quality, safety and ethical acceptability of research that they sponsor or permit to be carried out under their auspices.⁸ 

The National Statement is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants

Before conducting a study, researchers must obtain ethics clearance from all relevant ethics governance bodies, including university bodies and medical institutions. When conducting human research, it is important to abide by the following requirements:

• An individual’s decision to participate in research must be voluntary and based on a well-informed and reasonable understanding of both the proposed research and the implications of participating in it.
• Voluntary and informed participation requires a proper understanding of research objectives, methods, requirements, risks and potential benefits.
• This information should be presented in a manner appropriate to each participant.
• The process of providing information to participants and obtaining their consent should not be just a matter of meeting formal requirements. Participants can ask questions and discuss information and decisions as needed.
• Consent can be expressed orally, in writing, or by other means (eg, survey or action reply implying implied consent).
• It is generally reasonable to reimburse participants for research participation costs such as travel, lodging, and parking. Participants may also be paid for their time. However, payments disproportionate to the time involved or other incentives designed to encourage participants to take risks are ethically unacceptable.

Now identify the ethical issues that may arise in the case scenario presented in the Padlet below