IRB Resources

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/display/history/Nuremberg+Code
• 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