What role does the HHS play in relation to the Common Rule?

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The HHS (Department of Health and Human Services) plays a critical role in the development and enforcement of the Common Rule, which is the federal policy regarding human subjects research. The Common Rule establishes the basic ethical principles and guidelines for conducting research involving human participants, ensuring their rights and welfare are protected.

Through its Office for Human Research Protections (OHRP), the HHS is responsible for the implementation and oversight of these regulations. This includes creating the framework of the Common Rule, which applies to federal government-supported research and to research conducted at institutions that receive federal funding. The HHS’s role ensures consistency in the ethical treatment of participants across various research environments and promotes responsible conduct in research.

The other options do not accurately reflect the HHS’s involvement. It is not accurate to say that HHS has no role, nor does it only oversee non-federal research, or limit its activities to compliance reviews of private institutions. The HHS is fundamentally involved in both the creation and enforcement of the Common Rule, which aligns directly with safeguarding ethical standards in research with human subjects.

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