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27/08/2022
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Unethical cow’s blood experiment
The Nuremberg Code is a set of 10 research ethical principles for human experimentation that was implemented after World War II. The first principle is the voluntary consent of a subject (Annas & Grodin, pp. 139). Dr. Cohn’s research subjects were not properly informed of their involvement with the research study, nor were they given a choice of participation. These patients should have been given written documentation with all the risks associated with participating in the study and given the opportunity to ask questions.
The Belmont Report is a general statement of principles for clinical research involving humans (Beauchamp, pp. 151). Similar to the principles in the Nuremberg Code, the principles of respect for person and beneficence were not honored in Dr. Cohn’s study. Dr. Cohn violated the justice principle by conducting his research on prisoners, which is considered a vulnerable population. The burden of this study was placed solely on the prisoners of a Massachusetts prison only because they were at the disposable of the Harvard professor. This made his clinical trial unwarranted (Beauchamp).
The Common Rule is a set of regulations that use the framework of the Belmont Report to implement a process to review, approve, and oversee the research of human subjects (Porter & Koski, pp. 156). Dr. Cohn’s study fell short of this set of regulations by not having an Institution Review Board review his trial. This would have alleviated many casualties, as I am sure many of his peers would not have agreed to the injection of cow’s blood into human subjects. According to the U.S. Department of Health and Human Services (HHS) (2009), 45 CFR 46 Subpart C of the Common Rule provides additional protection and guidelines for prisoners enrolled in human research. Research of prisoners is allowed if “the study presents no more than minimal risk and no more than inconvenience to the subjects” (HHS). The risks of this study far exceeded minimal risk as it caused more than half of the patients to develop a severe immune reaction and die. The risks of this study were not assessed prior to the start of this trial, which, in the end, was a huge inconvenience, even for those that survived.
Annas, G. J., Grodin, M A. (2008) The Nuremberg Code. In Emanuel ,E.J., Grady,C., Crouch, R.A., Lie, R. K., Miller, F.G., & Wendler, D. The Oxford Textbook of Clinical Research Ethics (p. 136-140). Oxford University Press.
Beauchamp, T.L. (2008) The Belmont Report. In Emanuel ,E.J., Grady,C., Crouch, R.A., Lie, R. K., Miller, F.G., & Wendler, D. The Oxford Textbook of Clinical Research Ethics (p. 149-155). Oxford University Press.
Porter, J.P., Koski G. (2008) Regulations for the Protection of Humans in Research in the Untied States: The Common Rule. In Emanuel ,E.J., Grady,C., Crouch, R.A., Lie, R. K., Miller, F.G., & Wendler, D. The Oxford Textbook of Clinical Research Ethics (p. 156-167). Oxford University Press.
U.S. Department of Health and Human Services. (2009). Code of Federal Regulations, Title 45, Part 46, Subpart C, §46.306: Permitted research involving prisoners. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.306
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