History and Ethical Principles
Research with human subjects has a long and often troubled history. Some of the most egregious examples of unethical research include (Hicks, 2020):
The Tuskegee Syphilis Study: In this study, which ran from 1932 to 1972, the U.S. Public Health Service withheld treatment from African American men with syphilis, even after penicillin became a widely available treatment. The men were not told the true nature of the study, and many of them died from syphilis or its complications.
The Nazi human experimentation program: During World War II, Nazi doctors and scientists conducted horrific experiments on concentration camp prisoners. These experiments included injecting prisoners with diseases, irradiating them, and performing surgery without anesthesia. Many of the prisoners died or were permanently injured as a result of these experiments.
The Willowbrook Study: This study, which ran from 1963 to 1974, involved intentionally infecting mentally disabled children with hepatitis in order to study the course of the disease. The children were not told about the study, and their parents were not given informed consent.
These abuses led to the development of ethical guidelines for research with human subjects. The most important of these guidelines are (Hicks 2020):
Informed consent: Research subjects must give their informed consent before participating in a study. This means that they must be told the purpose of the study, the risks and benefits of participating, and their right to withdraw from the study at any time.
Risk-benefit analysis: The risks of participating in a study must be outweighed by the potential benefits.
Respect for persons: Research subjects must be treated with respect and dignity.
Justice: Research subjects must be selected fairly and equitably.
These guidelines are designed to protect the rights and welfare of human subjects in research. They have helped to prevent many abuses, but there are still cases of unethical research that occur. It is important to be aware of these abuses and to work to prevent them from happening again.
The Nuremberg Code was developed in the wake of the Second World War to prevent future abuses of human subjects in research. It outlines ten points for conducting ethical research, including the importance of informed consent, the avoidance of unnecessary suffering, and the fair selection of subjects (Hicks 2020).
The Declaration of Helsinki is a code of research ethics developed by the World Medical Association. It is based on the Nuremberg Code and the physician's code of ethics known as the Declaration of Geneva (Hicks 2020).
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in the United States in response to the Tuskegee Syphilis Study. The Commission issued the Belmont Report in 1979, which outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence, and justice (Hicks 2020).
The Belmont Report informed the development of the U.S. Department of Health and Human Services (HHS) Code of Federal Regulations (45 CFR 46), which is the primary set of regulations governing research with human subjects in the United States (Hicks 2020).
The Belmont Report and the HHS regulations are based on the principle that all research with human subjects must be conducted in an ethical manner. This means that researchers must respect the autonomy of their subjects, avoid causing them unnecessary harm, and fairly select them for participation in research (Hicks 2020).
The Belmont Report and the HHS regulations are applicable to all research with human subjects, including research in the social and behavioral sciences, education, and the humanities (Hicks 2020).
References
Hicks, L. (2020). CITI - Collaborative Institutional Training Initiative. Citiprogram.org; CITI Program. https://www.citiprogram.org/members/index.cfm?pageID=665&ce=1#view
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