Belmont Report Flashcards
What is the Belmont Report?
The Belmont Report is a foundational document in research ethics that outlines ethical principles and guidelines for conducting research involving human subjects.
What are the three core principles of the Belmont Report?
Respect for Persons
Beneficence
Justice
Explain “Respect for Persons” as a Belmont principle.
“Respect for Persons” means treating individuals as autonomous agents and protecting those with diminished autonomy. It involves obtaining informed consent and respecting privacy and confidentiality.
Describe “Beneficence” as a Belmont principle.
“Beneficence” requires researchers to maximize benefits and minimize harm to research participants. It involves conducting a risk-benefit analysis and ensuring the well-being of subjects.
What does “Justice” mean in the context of the Belmont Report?
“Justice” requires fair distribution of the benefits and burdens of research. It ensures that vulnerable populations are not disproportionately targeted for research and that participants are treated fairly.
What is informed consent according to the Belmont Report?
Informed consent is the voluntary and well-informed decision made by a competent individual to participate in research after understanding the purpose, risks, and benefits.
Explain the concept of “Assessment of Risks and Benefits” in Belmont’s Beneficence principle.
Researchers must assess and weigh the risks of research against the potential benefits to participants and society.
Risks should be minimized, and benefits maximized.
How does the Belmont Report address vulnerable populations in research?
The Belmont Report emphasizes the need for special protections for vulnerable populations, such as children, prisoners, and the cognitively impaired, to ensure their rights and well-being are safeguarded.
What role does the Institutional Review Board (IRB) play in relation to the Belmont Report?
The IRB is responsible for reviewing research protocols to ensure they adhere to the Belmont principles and protect the rights and welfare of human research subjects.
Why is the Belmont Report significant in clinical research and bioethics?
The Belmont Report provides the ethical framework that guides the conduct of research involving human subjects.
It ensures the ethical treatment of research participants and the integrity of research outcomes.
Give an example of how the Belmont principles might be applied in a clinical trial.
Ensuring that participants provide informed consent, monitoring for adverse events, and distributing the benefits of research fairly among participants are all ways the Belmont principles are applied in clinical trials.
Provide an example of respecting autonomy in clinical research.
Obtaining informed consent before enrolling participants in a research study.
Give an example of applying the principle of beneficence in a clinical trial.
Implementing safety measures and monitoring to ensure participants’ well-being during the study.
How might justice be applied in participant selection for a clinical trial?
Ensuring that participant selection is fair and doesn’t unduly favor or disadvantage any particular group.
List key elements that must be included in the informed consent process.
Purpose of the research, risks and benefits, alternatives, confidentiality, and the right to withdraw.
