Good Clinical Practice (GCP) Practice Exam

Which entity codified the "Common Rule" in separate regulations?

1. FDA

2. 15 Federal departments

3. World Health Organization

4. Institute of Medicine

The correct answer is: 15 Federal departments

The correct response highlights that the "Common Rule" is codified in separate regulations by various entities, specifically 15 federal departments. The Common Rule refers to the federal policy for the protection of human subjects involved in research, and it was established to ensure ethical considerations in research practices. This rule is essential because it sets forth standardized guidelines to protect the rights and welfare of research participants, ensuring consistency across various federal agencies. The 15 federal departments and agencies that have adopted the Common Rule include the Department of Health and Human Services (HHS), the Department of Education, and the Department of Defense, among others. By codifying it in separate regulations, these agencies enable uniform application and enforcement of ethical standards in research across different domains, which is vital for maintaining public trust and advancing scientific knowledge ethically. In contrast, other entities mentioned either engage in different aspects of research regulation or have a more specific role. For example, the FDA regulates drugs and medical devices but has separate regulations that can be distinct from the Common Rule. The World Health Organization provides international health guidance but does not codify U.S. regulations. The Institute of Medicine focuses on health and medicine but does not create regulations; rather, it offers recommendations and reports based on research findings. Understanding the