In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

• A. The Helsinki Declaration
• B. The Nuremberg Code
• C. The Common Rule
• D. The Belmont Report

Answer: (C)

In the U.S., the first federal regulations for protecting people in research were codified in 1981 as the Common Rule. This policy established the enforceable standards for human subjects research, including requirements for IRB review, informed consent, and extra protections for vulnerable groups. It sits on the ethical framework laid out by the Belmont Report, which identifies the principles of respect for persons, beneficence, and justice and guides how those protections are implemented. The Helsinki Declaration and the Nuremberg Code are influential international and historical documents, not U.S. regulations adopted in 1981, though they shaped ethical thinking.

In the U.S., the first federal regulations for protecting people in research were codified in 1981 as the Common Rule. This policy established the enforceable standards for human subjects research, including requirements for IRB review, informed consent, and extra protections for vulnerable groups. It sits on the ethical framework laid out by the Belmont Report, which identifies the principles of respect for persons, beneficence, and justice and guides how those protections are implemented. The Helsinki Declaration and the Nuremberg Code are influential international and historical documents, not U.S. regulations adopted in 1981, though they shaped ethical thinking.