go to the following link to view 12 recorded webinars related to Human Research Protection on the U.S. Department of Health and Human Services YouTube channel:
Assignment Instructions: This week, reflect on what you learned from the NIH materials about protecting the rights of human research participants.
Discuss at least three of the following in your paper:
- Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.
- Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?
- The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.
- Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.
Expert Solution Preview
Introduction:
As a medical professor responsible for designing college assignments and providing feedback to medical college students, it is crucial to understand the importance of human research protection. This week, students were instructed to go through a series of 12 recorded webinars from the U.S Department of Health and Human Services YouTube channel related to human research protection. In this paper, we will discuss the importance of protecting the rights of human research participants and the three topics provided for this week’s assignment.
Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.
One of the most significant circumstances that influenced the need for a policy to protect human research subjects is the unethical experimentation that took place during World War II. The atrocities carried out by Nazi doctors in concentration camps led to the formation of the Nuremberg Code in 1947, which established ethical guidelines for human experimentation. The Tuskegee syphilis study is another example of unethical experimentation, where African American men were denied appropriate treatment for syphilis to observe the natural progression of the disease. Inappropriate selection of participants, lack of informed consent, inadequate protection during the research, and inadequate follow-up care are several ways in which human research subjects can be harmed by researchers.
Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?
The three vulnerable populations include children, prisoners, and pregnant women. There are special restrictions associated with human research among these groups. For children, parental consent and child assent are required for their participation. Extra provisions for safety and parental notification of adverse events are mandatory. For prisoners, additional safeguards for vulnerable decision-making are provided, and waivers of informed consent are typically prohibited. For pregnant women, there is a restriction on procedures that might harm the fetus, and participation can be authorized only after the risks and benefits have been thoroughly evaluated. I think the restrictions associated with these groups are adequate because they aim to protect people who might be unable to comprehend the risk associated with participation in medical research due to their lack of decision-making authority.
The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.
In my opinion, the order of importance for the three core principles identified in the Belmont report is as follows:
1. Respect for persons: Treating people as autonomous agents who have the right to make their own decisions is the most crucial ethical principle, in my opinion. Respect for persons involves obtaining informed consent, ensuring confidentiality, and protecting privacy.
2. Beneficence: This principle requires that researchers maximize the potential benefits to the research subjects while minimizing or avoiding the potential harm. This principle ensures that research participants’ welfare is protected during experimentation.
3. Justice: Ensuring that the benefits and burdens of research are shared equitably and that select groups are not exploited is also essential. However, it is considered less crucial in my opinion compared to the two other principles, as justice can be subjective and difficult to measure.
Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.
As a medical professor, it is essential to understand the rights and protections afforded to human research participants to ensure that students and researchers are aware of ethical guidelines and follow them. Awareness of ethical guidelines also ensures that researchers minimize potential harm to participants and maximize benefits to them. In addition, knowledge of these rights and protections will allow students to educate their patients and protect their patients’ welfare while conducting medical research. Educating students on human research protection also helps raise awareness of the importance of ethical research conduct.
