Unethical research with human subjects in United States
This module’s textbook readings introduced you to a selected history of research with human subjects. Unfortunately, that only represents a small portion of human subject research seen as unethical.
For this discussion board, you will conduct an internet search looking for controversial/unethical human subject research studies conducted in the United States that were not identified in the textbook. You may also find the ASU Library’s article website helpful – https://lib.asu.edu/find-articles
Select a research study or series of studies that occurred between 2001 to present.
Your post should include all of the following:
Briefly describe the research. (limit 1 paragraph) (10 points) Be sure to include a description:
of the subject population
time period during which the research was conducted
researcher’s rationale for performing the study(ies)
sponsor or funding source, if applicable
Provide link for the selected study (make sure you list that in your references)
Comment on the cultural climate at the time of the research (i.e., patriarchal society, Cold War, etc.) and any influence it may have had on the research/researcher(s) (limit 1 paragraph) (5 points)
Identify the ethical issues with the research and describe whether it was compliant or non-compliant with at least two (2) of the codes, declarations, or other ethical guidances identified in this module’s readings. (limit 1 paragraph) (10 points)
Include whether or not the code, declaration or guidance was in effect at the time of the research and discuss whether change(s) could have been made to the
research to make it compliant or more compliant. (limit 1 paragraph) (10 points)
Topic reference link: https://www.justice.gov/opa/press-release/file/1348041/download
Book: The Ethics of Research with Human Subjects by David B Resnik
Chapter (1, 2 and 10)
ANSWER
Unethical Research with Human Subjects in the United States
Before the 21st century, numerous research centers used human subjects for scientific research and violated their basic human rights. In 1991, the institutional review board was tasked with ensuring that any research involving human subjects meets all the ethical standards before they begin research (Resnik, 2018). This does not mean that unethical human research is still not happening. It might not be as outright as the Tuskegee syphilis research, but it is still happening. An example of such unethical research is the iCOMPARE trial which started in July 2015 (Carome, 2015). The study involved studying the effects of many working hours on patient safety. It compares a 16-hour working limit on intern shifts with a longer overnight call period. The study involved 30-hour call shifts every fourth day.
The ethical issues sighted in this case was the lack of consent from the interns. The interns involved in this study were not asked to sign consent forms before signing up for the study. This meant that the hospital was putting them at risk of harming their patients due to fatigue. According to research, most medical errors, which can sometimes lead to the injury and death of patients, often result from fatigue. The patients were also not asked to sign consent forms, and one is left wondering whether the patients would have sought help from another hospital if they were aware of the experiment and the risk they were facing. In this case, the experiment deprived the patients of their autonomy and the power to decide whether or not they wanted to be involved in the experiment (National Institutes of Health). They also went against HIPAA laws on informed consent by failing to ask for their consent. If they had asked for their consent, this study would have been ethical as the patients and the interns would have agreed to be involved in the experiment.
References
Carome, M. (2015). Outrage of the Month: Unethical Human Experimentation in 2015 and Our Broken System for Protecting Human Research Subjects. https://www.citizen.org/news/outrage-of-the-month-unethical-human-experimentation-in-2015-and-our-broken-system-for-protecting-human-research-subjects/
National Institutes of Health. Clinical Research and the HIPAA Privacy Rule. https://privacyruleandresearch.nih.gov/clin_research.asp
Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust (Vol. 74). Springer.
