WCU IRB Overview and Policies

• IRB Overview
• IRB Policies

Laws, Policies and Guidelines

Federal Regulations

• 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 56: Institutional Review Boards

Federal Guidelines

• National Institutes of Health (NIH)
• Guidelines on Women and Minorities
• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page
• Inclusion of Children Policy Implementation
• Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
• U.S. Department of Health and Human Services (HHS) ~ Office for Civil Rights (OCR)
• HIPAA – National Standards to Protect the Privacy of Personal Health Information
• Federal Advisory Committee on Human Subjects Research
• Secretary's Advisory Committee on Human Research Protections (SACHRP)
• Office for Human Research Protections (OHRP)
• IRB Guidebook
• Human Subject Regulations Decision Charts

Ethical Principles and Guidelines for Human Subjects Research

• Nuremberg Code (1949) https://history.nih.gov/research/downloads/nuremberg.pdf
• Declaration of Helsinki (1964) https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/
• Belmont Report (1997)  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html