What is the purpose of the Office of Human Research Protection (OHRP) audit program?
The purpose of the Office of Human Research Protection (OHRP) Auditing and Compliance (A&C) program is to improve the quality of the human research subjects’ protections program. The program strives to increase the awareness of regulatory compliance and improve the ethical conduct of research. An institution that holds an approved Department of Health and Human Services (DHHS) Office for Human Research Protections Federal Wide Assurance (FWA) is required to assure it has procedures that “include formal mechanisms for monitoring compliance with human research subject protection requirements”. Research audit programs provide one mechanism for ensuring compliance with this requirement. The program is intended to be proactive, non-punitive, and focused on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research.
Related Questions
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- What is the purpose of the Office of Human Research Protection (OHRP) audit program?
