What is the primary role of OHRP in clinical research?

The primary role of the Office for Human Research Protections (OHRP) is to protect the rights and welfare of human subjects participating in research. This involves ensuring that research is conducted ethically and in compliance with federal regulations, particularly those outlined in the Common Rule, which governs the conduct of research involving human subjects. The OHRP provides guidance to institutions, researchers, and Institutional Review Boards (IRBs) on ethical standards and regulatory compliance, promoting a culture of safety and respect for individuals who partake in clinical trials.

This focus on the protection of research subjects is crucial in the ethics of clinical research, as it underscores the need for informed consent, minimizes risks, and fosters the integrity of research practices. Ensuring that human subjects are adequately protected is fundamental to the credibility of clinical research and contributes to the responsible advancement of medical knowledge.