The IRB’s authority is empowered by regulatory statutes, institutional policies, ethical canons, and the perceptions of IRB members as it pertains to their community and professional standards. While interpretive differences between these governing principles may occur, it should be noted that regulations offering the most stringent guidelines are always followed for the protection of human subjects. These principles are upheld without regard to whether the research is subject to federal regulation, with whom the research is conducted, or the source of support for the research.
Access the KD Research Portal to submit new studies, modifications, or reports
Find details on basic and advanced human subjects' protection training for investigators and research personnel.
Federal Regulatory Documents
The IRB’s foundation and primary charge are supported in the Code of Federal Regulations. These regulations include, but are not limited to, the following:
Office for Human Research Protections (OHRP)
45 CFR 46 - Protection of Human Subjects
U.S. Food and Drug Administration(FDA)
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 312 - Investigational New Drug Application
21CFR 812 - Investigational Device Exemptions
Office for Civil Rights (OCR), within Health & Human Services (HHS)
National Standards to Protect the Privacy of Personal Health Information