Good Clinical Practice (GCP) Practice Exam

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What is the basis for the "Common Rule"?

Code of Ethics

Belmont Report

The basis for the "Common Rule" is the Belmont Report. This Report, published in 1979, outlines essential ethical principles and guidelines for research involving human subjects. It articulates three core ethical principles: respect for persons, beneficence, and justice. These principles have been foundational in shaping regulations related to the protection of human subjects in research and are directly reflected in the Common Rule, which governs federally funded research in the United States.

The Common Rule incorporates the Belmont Report's tenets into its regulatory framework, ensuring that ethical considerations are integrated into the research process. This connection emphasizes the importance of consent, risk minimization, and equitable selection of subjects, which are crucial for conducting ethical research.

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Helsinki Declaration

Nuremberg Code

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