Reflect on what you learned from the NIH materials about protecting the rights of human research participants.
Discuss at least two of the following:
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.
Full Answer Section
These and other unethical studies highlighted the urgent need for ethical principles and safeguards to protect human research participants.
Ways Human Research Subjects Can Be Harmed:
- Physical Harm:
- Medical risks: Exposure to potentially harmful drugs, procedures, or interventions.
- Unforeseen side effects: Experiencing unexpected and potentially serious side effects from research participation.
- Psychological Harm:
- Emotional distress: Experiencing anxiety, fear, or other emotional distress due to research procedures or findings.
- Loss of privacy and confidentiality: Experiencing breaches of confidentiality or having personal information disclosed without consent.
- Social Harm:
- Stigma and discrimination: Facing social stigma or discrimination due to their participation in research.
- Loss of employment or insurance coverage: Experiencing negative consequences due to their participation in research.
Vulnerable Populations and Special Restrictions:
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Children:
- Special Restrictions: Require assent (agreement) from the child in addition to parental consent, ensure that research is appropriate for children, and minimize potential risks.
- Evaluation: These restrictions are generally adequate, as they aim to protect children from exploitation and ensure their best interests are considered.
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Pregnant Women:
- Special Restrictions: Require careful consideration of potential risks to the fetus and the mother, and often require additional oversight and approval processes.
- Evaluation: These restrictions are generally adequate, as they recognize the unique vulnerabilities of pregnant women and the potential impact of research on both mother and fetus.
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Prisoners:
- Special Restrictions: Require additional safeguards to ensure that participation is truly voluntary and not coerced, and that the research is relevant to the prisoners' health or well-being.
- Evaluation: While these restrictions aim to protect prisoners from exploitation, there may be ongoing debate regarding the extent to which prisoners should be involved in research.
Prioritizing the Belmont Report Principles:
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Respect for Persons: I believe this principle is of utmost importance. Respect for persons emphasizes individual autonomy and the right to make informed decisions about participation in research. It recognizes the importance of informed consent and protecting the rights and dignity of all research participants.
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Beneficence: This principle is also crucial, as it emphasizes the importance of maximizing potential benefits and minimizing potential harms to research participants.
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Justice: While important, I would prioritize respect for persons and beneficence slightly higher. Justice ensures that research burdens and benefits are distributed fairly and that vulnerable populations are not disproportionately burdened by research participation.
These principles provide a crucial ethical framework for conducting human research responsibly and ensuring the protection of human subjects.
Sample Answer
Circumstances Influencing the Need for Human Research Subject Protection:
The need for ethical guidelines in human research arose from historical instances of egregious human rights violations in research. Some notable examples include:
- The Tuskegee Syphilis Study: This study, conducted by the U.S. Public Health Service, followed the progression of untreated syphilis in African American men for decades, withholding effective treatment even after it became available.
- The Nazi Medical Experiments: During World War II, Nazi doctors conducted horrific experiments on prisoners in concentration camps, causing immense suffering and death.