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.
- 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 (Links to an external site.)Links to an external site. (University of Connecticut, n.d.) document.
- The Informed Consent Form
Must be one to two pages in length, formatted appropriately as an informed consent form.
Must include a separate title page with the following:
- Title of paper
- Student’s name
- Course name and number
- Instructor’s name
Date submitted
Expert Solution Preview
Introduction: Informed consent is an ethical requirement in research involving human subjects. It ensures that participants are fully aware of the risks and benefits of their participation before agreeing to be a part of the study. This assignment requires the development of an informed consent form for a hypothetical research study. The scenario involves a pharmaceutical laboratory conducting a five-year randomized controlled study on a new drug for treating Type 1 diabetes. The consent form should address all necessary questions outlined in the Ethics and Informed Consent guidelines.
Answer:
Informed Consent Form
Title of Study: Study on the Efficacy and Side Effects of DIA123 in Treating Type 1 Diabetes
Principal Investigator: [Insert Name]
Study Location: [Insert Study Location]
1. Purpose of the Study:
The purpose of this research study is to investigate the effectiveness and side effects of DIA123, a potential treatment for Type 1 diabetes, in human subjects. The study aims to replicate the findings observed in a previous study on chimpanzees, which showed promising outcomes in diabetes elimination.
2. Procedures and Duration of the Study:
Participants will be required to take a daily dose of 500mg of DIA123 for the first two years of the study. The dosage will be reduced to 250mg for the third year, and no medication will be administered in the fourth and fifth years. The study will have a total duration of five years, with periodic evaluations and assessments throughout the study period.
3. Potential Risks and Side Effects:
Participants should be aware of the potential risks and side effects associated with taking DIA123. These include:
– Moderate to severe diarrhea, which may lead to dehydration. Participants will be required to monitor their liquid intake carefully.
– Excessive heart palpitations, although the long-term impacts of these palpitations are currently unknown.
– Loss of libido, which may persist even after discontinuing the medication in years four and five.
– Mild depression experienced by some participants during the first three years of the study. While the depression may dissipate for some participants, it may continue for others.
4. Potential Benefits:
Based on the previous study with chimpanzees, the potential benefits of participating in this study include the elimination of Type 1 diabetes and the cessation of insulin injections.
5. Voluntary Participation and Withdrawal:
Participation in this study is entirely voluntary, and participants have the right to withdraw their consent at any time without penalty or loss of benefits.
6. Confidentiality:
All participant information will be kept strictly confidential. No identifiable information will be shared publicly or with any third party without explicit consent, except as required by law.
7. Contact Information:
If participants have any questions or concerns about the study, they may contact the Principal Investigator at [Insert Contact Information].
I have read and understood the information provided in this consent form, and I voluntarily agree to participate in this research study. I understand that I may withdraw my consent at any time without consequences.
Participant Signature: _______________________ Date: _______________
Printed Name: _________________________________________________
For Researcher’s Use Only:
Participant ID: ________________
