The Institutional Review Board (IRB) operates under policies and procedures based on the Code of Federal Regulations (45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812), and on guidance from the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA):

• 45 CFR 46: Protection of Human Subjects (HHS)
• 21 CFR 50: Protection of Human Subjects (FDA)
• 21 CFR 56: Institutional Review Boards (FDA)
• 21 CFR 312: Investigational New Drug Application (FDA)
• 21 CFR 812: Investigational Device Exemptions (FDA)

The policies and procedures of the IRB are also informed by seminal statements regarding the rights of human research subjects:

• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978)
• World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

It is the responsibility of every investigator to understand the federal regulations that pertain to his/her research, as well as to understand the policies and procedures of the Pacific University Institutional Review Board.

Policies and Procedures: An updated Policies and Procedures document will be provided in November. In the meantime, please contact the IRB if you wish to review the IRB's Policies and Procedures.