The Belmont Report (Links to an external site.) (U.S. Department of Health and Human Services, 1979) specifically describes 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:
While the diabetes issue was eliminated, the research discovered a few side effects:
Because of the public health implications of such a drug, the Centers for Disease Control and Food and Drug Administration approved a new five-year study with the use of male and female human subjects ages 18 to 55. An experiment will be done with humans that is identical to the one conducted with the chimpanzees. The participants will not receive any remuneration for their participation, which is fully voluntary.
Your job is to create the informed consent form for this study. Use one of the sample templates in the resource materials to help guide you. Make sure you address all of the necessary questions that are outlined in the Ethics and Informed Consent (Links to an external site.) (University of Connecticut, n.d.) document.
The Informed Consent Form
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