Human Experimentation in Medicine and Consent
-informed consent is the most important part of research ethics-
40-80 years ago
> government doctors thought it was fine to experiment on disabled people, poor people, and prisoners.
> experiments included giving hepatitis to mental patients, squirting a pandemic flu virus into noses of prisoners, and injecting cancer cells into chronically ill people
>some were a search for lifesaving treatment; some were amounted to curiosity satisfying experiments that hurt people but gave no helpful results
Doctors are required to explain the entire experiment to participants in order to obtain their voluntary consent
These doctors violated the concept of "first do no harm, " a fundamental medical principle that stretches back centuries
of pharmaceutical research was done on prison inmates without consent until the 1970's
mentally ill children were intentionally infected with hepatitis, so doctors could track the spread of the virus for research.
From 1956 to 1970, more than
men and women in prisons or institutions were infected with syphilis and gonorrhea unknowingly
Federal standards of informed consent were defined in the late 1970's. They were not published until 1981 and were enforced thereafter. They gave the requirements for researchers on consent. Up until this point researchers could choose how much information they gave their subjects.
400 black men suffering from syphillis were intentionally denied treatment in order for researchers to gather data. As many as 107 men died as a direct result.
If, for any reason, you are unable to give your consent a family member will be appointed to do so on your behalf .
Elements to ensure patients give full consent
1) a full explanation of the the purpose of the experiment
2)a description of the risks and discomforts as a result of the experiment
3)a description of any benefits that may come with the experiment
4)a statement describing the amount of confidentiality at which the patients results will be kept
5)a statement of whether any alternative treatment options are available
6)a description availability of medical therapy or financial compensation in case of injury due to the experiment
7)an opportunity to ask researchers questions about the experiment
8)assurance that the patient is allowed to refuse to participate and/or withdraw consent at any time with no penalty or loss of benefits involving the experiment
Research regulations authorize Institutional Review Boards (local review panels) to oversee all human research within their jurisdiction. This means they can approve, modify, or reject any of this research.
400 inmates from the Stateville Correctional Center were exposed to malaria by researchers in hope of finding a cure.
Groups Most ExperimentedOn
of the poor, rural farmers who took part in an experiment were never informed of the fact that they had been given syphilis and were also never treated.
Vollmann, J., & Winau, R. (1996, December 07). Informed consent in human experimentation before the Nuremberg code. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/8973233
Grad, R. M. (1984, October 15). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1483724/
Pain, Suffering, and the History of Human Experimentation. (n.d.). Retrieved from https://www.healthline.com/health-news/strange-the-sordid-history-of-human-experimentation-101213
What Are the Rules for Experimenting on Humans? (2001, July 24). Retrieved from http://www.slate.com/articles/news_and_politics/explainer/2001/07/what_are_the_rules_for_experimenting_on_humans.html
Chapter 2: The "Real World" of Human Experimentation. (n.d.). Retrieved from https://bioethicsarchive.georgetown.edu/achre/final/chap2_3.html
Figure 2f from: Irimia R, Gottschling M (2016) Taxonomic revision of Rochefortia Sw. (Ehretiaceae, Boraginales). Biodiversity Data Journal 4: E7720. https://doi.org/10.3897/BDJ.4.e7720. (n.d.). doi:10.3897/bdj.4.e7720.figure2f
Oakley, J. S. (2007, October 29). MEDICAL EXPERIMENTATION, INFORMED CONSENT AND USING PEOPLE. Retrieved from https://onlinelibrary.wiley.com/doi/full/10.1111/j.1467-8519.1994.tb00261.x