Questions and Answers
What did The National Research Act of 1974 require?
What did The National Research Act of 1974 establish?
The National Commission
What was the purpose of the National Commission established by The National Research Act of 1974?
To identify guidelines, ethical principles, and regulations for human subjects research.
45 CFR 46 raised the US Public Health Service policy of 1966 to regulatory status.
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What principle is informed consent an application of?
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What does respecting individuals in the context of research involve?
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The Nuremberg Code included requirements for voluntary consent of subjects.
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Which event brought increased public attention to the problems with the IRB system?
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What was one of the results of the Beecher article?
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Why is the use of prisoners in research a concern under the Belmont principle of Justice?
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Which of the following is included in the Nuremberg Code?
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What does the Belmont Principle of Justice require?
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What realization came from the Beecher article?
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What was the primary result of the Beecher article?
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Study Notes
National Research Act of 1974
- Required uniform regulations across federal agencies for human subjects research.
- Established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- Resulted in guidelines and ethical principles from the National Commission’s deliberations.
45 CFR 46
- Raised the US Public Health Service policy on clinical research and human investigation to regulatory status in 1974.
- Represents a pivotal moment in formalizing ethical standards for research involving humans.
Informed Consent
- Connected to the Belmont principle of Respect for Persons, emphasizing individual autonomy in research participation.
- Implemented through the informed consent process, ensuring participants are fully aware of their rights and the nature of the research.
Nuremberg Code
- Mandated voluntary consent from research subjects, focusing on ethical treatment in research.
- Emphasized that ethical concerns extend beyond historical atrocities and are relevant in contemporary research practices.
Jesse Gelsinger Case
- His death during a research study highlighted significant issues within the Institutional Review Board (IRB) system.
- Triggered public discourse and scrutiny regarding the oversight and ethics in human subjects research.
Beecher Article Impact
- Resulted in the recognition of widespread ethical abuses in US research, not confined to historical cases like the Nazi regime.
- Led to the establishment of the National Commission, reinforcing the need for ethical oversight in research practices.
Belmont Principle of Justice
- Advocates for fair distribution of research benefits and burdens, emphasizing that vulnerable populations, such as prisoners, should not face disproportionate risks.
- Highlights the ethical requirement that research should benefit the participating population, not only the broader society.
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Description
Test your knowledge on the key concepts and history surrounding human subjects research with these flashcards. Focus on important regulations such as the National Research Act of 1974 and its impact on protecting research participants.
