Research ethics

Medical research involves human subjects. In this respect, research ethics is concerned with upholding high ethical standards that promote and protect human participants involved in research studies.

For medical researchers, the Declaration of Helsinki, developed by the WMA, is a statement of ethical principles and guidance for medical research involving human subjects. At its core is the principle that it is the ‘duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject’.

(If you’re interested in this topic, you can read more about the Declaration of Helsinki (WMA, 2001).)

There are many examples of unethical medical experiments where the rights of participants have been violated. Well-known examples of notorious experiments include those done by the Nazis, the Stanford prison experiment and the Tuskegee syphilis study. The ethical standards that medical researchers around the world adhere to today aim to prevent malevolent experimentation on vulnerable people.

The activity below highlights why research ethics is important.

Activity 3: Considering the Tuskegee syphilis study

Timing: Allow about 15 minutes

In 1932, the US Public Health Service, in conjunction with the Tuskegee Institute, began a study that aimed to learn about the treatment of syphilis in African-American men. Six hundred men were enlisted as participants, 399 of whom had syphilis. As an enticement to participate, the men were offered free medical examinations, free meals and burial insurance as compensation, and were told that they would receive free medical care, including for syphilis.

However, the men were not informed that the study aimed to document the progression of syphilis without treatment, and they were not offered treatment during the study. Over the course of the study, penicillin became the standard treatment for syphilis, but was never offered to the participants. The researchers took steps to ensure that the participants would not receive proper treatment so that they could prove the hypothesis of their study.

Although the study was projected to last six months, it continued for 40 years, until 1972 – and only ended because of a public outcry that it was ethically unjustified. It is estimated that more than 100 participants died of syphilis or syphilis-related complications over the course of the study. It wasn’t until 1997 that then US President Bill Clinton offered a formal apology on behalf of the government.

Now identify and describe some clear ethical violations from the Tuskegee syphilis study.

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Discussion

The most serious ethical violation was withholding effective treatment (penicillin) from participants for research purposes.

A second important violation was that participants were not fully informed of the objectives of the research before agreeing to participate. Participants should have been able to give informed consent, meaning that they are fully aware of the purposes and procedures of research before deciding to participate.

The researchers did not inform participants that the purpose of research was to determine the natural course of untreated syphilis in African-American men. Instead – and in an additional violation – participants were recruited with misleading promises of treatment, meals and other benefits, which were not provided.

Medical/clinical ethics

Public health ethics