Informed Consent

The Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html#xinform)(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:

• 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.
• 25% of the chimps suffered from mild depression while taking DIA123 during years one through three. The depression dissipated for approximately half of the chimps after discontinuing DIA123 in years four and five, but continued for the other half.

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 (http://researchbasics.education.uconn.edu/)(University of Connecticut, n.d.) document.