The need for a policy to protect human research subjects was prompted by a history of unethical medical research that led to devastating effects on subjects and even loss of life. One of the ways researchers can harm human subjects is through forceful administration of disease or toxins, especially when subjects have no freedom to consent (PHRP). An example is the Nazi War Medical crimes, where physicians conducted experiments using prisoners in concentration camps. The physicians took advantage of the prisoner status of the subject and forcefully administered poisons, viruses, and even gasoline to subjects. Most of these subjects had adverse reactions, and some lost their lives. Another way medical researchers can harm human subjects is through deception, as in the Syphilis Study at Tuskegee. The United States Public Health Service conducted research using six hundred black males who did not have full knowledge of the study and did not consent to it (Ogungbure, 2011). Four hundred men were infected with syphilis unknowingly and were deceived about the treatment administered. Also, the researchers harmed the subjects by withholding treatment from them despite knowing it would help patients.
Researchers can carry out research unethically by blackmailing subjects, especially those in desperate need. An example would be withholding benefits direly needed by subjects unless they take part in the study. An example is Willowbrook State School, where children were infected with hepatitis deliberately, with researchers claiming that they would inevitably get the virus even without a deliberate infection (PHRP). Parents who did not consent to their children getting infected with the virus had their children denied admission. This school was for mentally defective people; hence denying admission meant that children were denied help. Parents were, therefore, blackmailed into cooperation. These circumstances necessitated the need for a policy that protects human subjects from exploitation by researchers.
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While research subjects are expected to give consent, certain groups of people are considered vulnerable and therefore, cannot consent on their own. These groups of people include minors, terminally ill patients, fetuses, mentally or physically impaired people, refugees, educationally disabled people, and other groups of people who may be physically or mentally unfit to consent (Shivayogi, 2013). The Nuremberg Code provides guidelines for these patients. It states that research among vulnerable subjects should only be carried out when the research is necessary to help promote health within the population presented (PHRP). Besides, research among vulnerable people should only be carried out when it cannot be carried out in people who are legally competent to consent. When vulnerable people are to be involved in research, they should consent to the level that they can, and legal representatives or parents should also give permission or consent. The specific regulations are dependent on the particular group of vulnerable people.
The Belmont Report identified respect for persons, beneficence, and justice as the essential requirements in the ethical conduct of research on human subjects (Department of Health). I think all three are important, but respect for persons is the most crucial element. Respect for persons means that people are considered autonomous and are entitled to understanding the risks and benefits of taking part in the research. Besides, this element prohibits coercion or exercising undue influence on subjects. This is important because it is the element that gives power to the subject. It recognizes that the subject is in a place of power to analyze information about research and decide if they want to take part. Informed consent is built upon it. I think the second most crucial element is justice. It challenges researchers to treat all subjects fairly in terms of the burdens and benefits of research. I believe fair treatment is more critical than beneficence since beneficence highly relies on the researcher. However, beneficence is also vital as it ensures that the researcher does no harm and offers more benefits than harm to the subjects.
References
Department of Health, E. (2014). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. The Journal of the American College of Dentists , 81 (3), 4.
Ogungbure, A. A. (2011). The Tuskegee syphilis study: Some ethical reflections. Thought and Practice , 3 (2), 75-92.
PHRP. https://grants.nih.gov/sites/default/files/PHRP_Archived_Course_Materials_English.pdf
Shivayogi P. (2013). Vulnerable population and methods for their safeguard. Perspectives in clinical research , 4 (1), 53–57. https://doi.org/10.4103/2229-3485.106389
