Good Clinical Practice (GCP) Practice Exam

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How many subparts are included in the HHS regulations concerning the "Common Rule"?

The correct answer is: 4

The correct answer reflects that the HHS regulations regarding the "Common Rule" actually comprise four subparts. The Common Rule is a federal policy in the United States regarding the protection of human subjects involved in research. It includes several key components that are essential for ethical considerations in research practices. These subparts outline the requirements for Institutional Review Boards (IRBs), informed consent, and the protections for specific populations, such as children, prisoners, and individuals with cognitive impairments. Each subpart is designed to address different aspects of research ethics and participant safety, thereby ensuring that research is conducted responsibly and ethically. Understanding the structure of these regulations is crucial for ensuring compliance and for protecting the rights and welfare of human subjects in research settings. This clear delineation into four subparts helps researchers, IRB members, and institutions navigate the complex landscape of federal regulations effectively.