Week 4_ PART A - Reading assignments & questions on Willowbrook

Week 4: PART A - Reading assignments & questions on Willowbrook 1. Describe the meaning of Distributive Justice in selection of study subjects. Distributive justice in selecting study subjects means ensuring that the risks and benefits of a research study are shared fairly among participants. This fairness involves avoiding bias and discrimination based on factors like merit or societal contribution. It's crucial, especially when studying vulnerable groups like children or individuals with developmental disabilities, to provide equal opportunities for participation without unfair distinctions. In essence, it's about treating all participants fairly and equally in research studies, regardless of their background or circumstances (Yan & Münir, 2004). 2. Describe the ethical guidelines established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that conflict with one another. The ethical guidelines set by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research may not inherently clash with each other, but there are instances where they appear to be in tension. For instance, the principle of obtaining informed consent from research participants may conflict with the need to safeguard vulnerable populations, such as children or individuals with cognitive impairments, who may have difficulty providing meaningful informed consent. Similarly, the ethical principles of beneficence, which seeks to maximize benefits and minimize harm to participants, and autonomy, which emphasizes respecting individuals' decision-making autonomy, can sometimes create a dilemma. Balancing these principles is often necessary, with ethical review boards and researchers striving to ensure that research respects both participant autonomy and their well-being ( The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research , n.d.). 3. What are the pros & cons of the Willowbrook experiments described in the NIH document in assigned reading. A. What useful information was learned from the study? B. What was/were the ethical violations (by today's standards) The biggest pro of the Willowbrook experiments was that the pros outweighed the cons and did more benefit than harm. There was no “excessive risk” that the children were exposed to by the researchers. However, the con was that basic respect for persons was violated. Neither parents nor children were actually informed about the potential harm that could result from the study.

Also, there was no need to make children the subjects of the study; the study could have been done with adult subjects as well (Krugman, 1986). A) While the Willowbrook experiments were severely unethical, there was some data that was useful in understanding how hepatitis spreads and can be treated. The modes of transmission were identified as primarily the fecal-oral route. The serological markers were also studied in children who had been infected. This helped understand how Hepatitis A antibodies develop as a result of the infection. B) The study is confirmed to be highly unethical by today’s standards. There were a lot of ethical violations, like lack of informed consent- neither parents nor children were truly informed of the harm that could result from the study and were unethically coerced into the study. Once the children were infected with the disease, they were not given proper treatment or care. Also, the study did not have any clear benefits that could actually justify the unethical nature of the study. In conclusion, the entire study was not transparent and the parents and children were not informed about the nature of the study. 4. In assignment 1 above (" The Rationalization of Unethical Research ..".), what were the scientific claims made to rationalize the Tuskegee Study & the New Zealand "Unfortunate Experiment"? In assignment 1, there are three scientific claims that were made to rationalize the Tuskegee Study and the New Zealand “Unfortunate Experiment”. The first was that when the studies started, there was no certain treatment for syphilis and while bismuth and arsenic treatment carried its risks, it was less harmful than no treatment at all. In 1947, the efficacy of treatment using arsenic and bismuth was proven, but around that time, the Venereal Disease Division recommended penicillin because of its safety (Paul & Brookes, 2015). Hence, penicillin became the recommended route of syphilis treatment and there were no clinical grounds on which the study investigators would have withheld penicillin from the Tuskegee subjects. It was a claim that both the studies began because of uncertainty about the treatments available. The second defense claim was that there were other such studies in which treatment was withheld, and thereby these cases should not be solely subject to criticism. Although similar studies of withholding treatment from patients occurred during that time, those studies were subject to lesser bias. The third defense claim was that the morbidity and mortality rates of patients were not any worse because of being a part of the study. Had they not been participants in the study, they would have received no treatment at all. It can be noted here that the investigators believe that treatment was effective and the lack of such treatment on the other hand, was harmful.