Office for Human Research Protections | Community Health

The Office for Human Research Protections (OHRP) is a crucial entity within the United States Department of Health and Human Services (DHHS) that oversees ethical standards in clinical research. Established to protect human subjects, OHRP implements regulations such as 45 CFR 46, guiding Institutional Review Boards (IRBs) in their ethical oversight of research conducted or funded by the DHHS, particularly through the National Institutes of Health (NIH). With its primary focus on ensuring compliance with the Federal Policy for the Protection of Human Subjects, also known as the 'Common Rule', OHRP plays a pivotal role in safeguarding the welfare of individuals participating in clinical research. By providing education, guidance, and oversight, OHRP ensures that research institutions adhere to stringent ethical standards, maintaining public trust in the research enterprise. As of 2024, OHRP continues to evolve its guidelines and educational resources to address emerging issues in human subjects research, such as the use of [[artificial-intelligence|artificial intelligence]] in clinical trials and the protection of [[genomic-data|genomic data]]. The office's work is closely aligned with that of the [[us-food-and-drug-administration|US Food and Drug Administration]] (FDA) and the [[national-institutes-of-health|National Institutes of Health]] (NIH), reflecting the interconnected nature of regulatory oversight in clinical research. Through its efforts, OHRP contributes significantly to the advancement of ethical research practices, ultimately benefiting public health and [[patient-safety|patient safety]].