Questions and Answers
Which of the following was the result of the Beecher article?
Which of the following concerns is related to the Belmont Principle of Justice?
Informed consent is considered an application of which Belmont principle?
Respect for persons
Which of the following is included in the Nuremberg Code?
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What did the National Research Act of 1974 establish?
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Which of the following brought increased public attention to the problems with the IRB system?
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Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?
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Study Notes
History of Human Research Ethics
- The Beecher article highlighted that ethical abuses in research extend beyond historical instances like the Nazi regime, underscoring the need for ethical scrutiny in all research contexts.
- The National Research Act of 1974 led to the formation of the National Commission, which was pivotal in shaping ethical guidelines for human research.
Belmont Principles
- The Belmont Principle of Justice emphasizes equitable distribution of research benefits and burdens, raising ethical issues when vulnerable populations, such as prisoners, participate in studies that only benefit the greater society.
- Informed consent is fundamentally tied to the Belmont principle of Respect for Persons, ensuring that participants are adequately informed and can voluntarily decide to participate in research.
Regulatory Framework
- The Nuremberg Code established crucial principles for research ethics, with voluntary consent being a foundational element that protects the rights of research participants.
- The ethical landscape of clinical trials was further impacted by the death of Jesse Gelsinger, which brought significant attention to the flaws and challenges within the Institutional Review Board (IRB) system.
Regulatory Status of Research Policies
- In 1974, the issuance of 45 CFR 46 elevated the US Public Health Service Policy from 1966 to formal regulatory status, setting essential standards for clinical research and investigations involving human subjects.
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Description
This quiz explores the history and principles of ethics in human research, focusing on significant frameworks such as the Belmont Principles and the Nuremberg Code. It investigates ethical abuses, informed consent, and the implications for vulnerable populations in research studies. Test your knowledge on the key guidelines that shape human research ethics today.