Informed Consent
The Belmont Report (Links to an external site.)Links to an external site. (U.S. Department of Health and Human Services, 1979) specifically describ es the ethical principles and guidelines for research involving human subjects, which came about due to the abuse of human subjects in biomedical experiments during World War II. A significant part of these guidelines relates to ensuring that the people participating in research fully understand the risks and benefits of being part of the study. We define the process of informing study participants of those risks and benefits as “informed consent”. Today, all research involving human subjects must involve informed consent. For this assignment, you will imagine that you are conducting a research study and will develop an informed consent form for it. To begin, read through the following scenario for a potential experiment. Then, using this week’s readings as a guide, draft a formal consent form that each participant will sign prior to agreeing to their participation in the research study.
Scenario:Imagine that you are the lead researcher at a pharmaceuticals laboratory. You have just discovered a new pill that has the potential to cure Type 1 diabetes in human beings. A five-year randomized controlled study using chimpanzees found that diabetes was cured in the animals who took a daily dose of 500mg of your new drug, DIA123. Specifically, the research found that:
After two years of taking 500mg of DIA123, diabetes was no longer an issue among 78% of the chimps, and they no longer needed insulin injections.
The dosage was decreased to 250mg for year three, and the diabetes never returned.
DIA123 was eliminated in years four and five, and the diabetes never returned.
No additional exercise or dietary restrictions aided in the study. Therefore, the analysis strongly supported the hypothesis that DIA123 was the primary cause of the elimination of diabetes.
While the diabetes issue was eliminated, the research discovered a few side effects:
2% of the chimps suffered from moderate to severe diarrhea, which started within a month of taking the pills. This led to the possibility of dehydration, so careful monitoring of liquids was necessary.
15% of the chimps suffered from excessive heart palpitations during the three years taking DIA123. Due to the length of the study, the long-term impacts of these heart palpitations are unknown.
18% of the chimps suffered from a loss of libido, which did not dissipate after discontinuing DIA123 in years four and five.
Must be one to two pages in length, formatted appropriately as an informed consent form.
Must include a separate title page with the following:
Date submitted
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