Which organization is tasked with protecting human subjects in research?

The organization that is primarily tasked with protecting human subjects in research is the Office for Human Research Protections (OHRP). This federal office, part of the U.S. Department of Health and Human Services, oversees compliance with the regulations that protect individuals participating in research conducted or supported by the department. OHRP establishes guidelines and ensures that human research is conducted ethically, with a focus on the rights and well-being of participants.

OHRP provides leadership in the protection of human subjects by supporting and guiding researchers and institutional review boards (IRBs) in implementing the necessary safeguards. The organization plays a vital role in promoting ethical research practices and ensuring that informed consent processes are properly conducted, thereby enhancing the integrity of the research landscape.

In contrast, while the FDA (Food and Drug Administration) does have a role in regulating clinical trials and ensuring drug safety and efficacy, its primary focus is on the approval and regulation of drugs and medical devices rather than exclusively protecting human subjects. The CDC (Centers for Disease Control and Prevention) mainly focuses on public health and disease prevention but does not specifically oversee human subject protections in research. The NCI (National Cancer Institute) conducts and supports cancer research, but like the FDA, it is not primarily focused on the protection