Which organization is responsible for enforcing GCP regulations in the United States?

The Food and Drug Administration (FDA) is the organization responsible for enforcing Good Clinical Practice (GCP) regulations in the United States. The FDA oversees the conduct of clinical trials and ensures that they meet the necessary ethical and scientific standards to protect the rights, safety, and well-being of participants. This includes establishing requirements for informed consent, data integrity, and the overall conduct of research involving human subjects.

The FDA's role is crucial as it regulates the approval of drugs and medical devices, and it holds the authority to inspect clinical trials to ensure compliance with GCP standards. This ensures that clinical research can produce reliable results that contribute to the scientific knowledge base and ultimately lead to safe and effective medical products.

In contrast, while organizations like the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) play significant roles in public health and medical research, they do not enforce GCP regulations. The World Health Organization (WHO) provides guidance and frameworks for global health practices but does not have enforcement authority within the U.S. GCP regulations.