IRB Resources

William & Mary IRB Guidebook (2024)

In process of updates; publishing soon

William & Mary Consent Template

In process of updates; publishing soon

General Resources

• The Office for Human Research Protections (OHRP) works to protect the rights, welfare, and well being of volunteers who participate in research.
  
  • Join OHRP's mailing list
  • Decision Charts: 2018 Requirements
  • FAQs about Human Research Topics
  • Training Checklist for Someone Working with IRBs
  • Educational Resources for Investigators
  • Checklist of Resources for Learning about Research and Research Participation
  • OHRP Training Resources
• The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.

IRB Review Process

• How Do I Review Thee? Presentation from OHRP
• Expedited Review Procedures Guidance (2003).
• Exempt Research Determination FAQs

Consents

• Resource List: Participant-Centered Informed Consent Training
• Informed Consent FAQs

Post-2018 Common Rule (45 CFR 46)

The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) oversee operations of the IRB. 

Federal Regulation 45 CFR 46 Protection of Human Participants: applies to all research involving human participants conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Protection of Human Participants mandates research that involves human participants must be approved by an Institutional Review Board (IRB) to ensure the safety and the appropriate use of humans as participants in research studies.

• "To what does this policy apply?" (45 CFR 46.101)
• "General requirements for informed consent" (45 CFR 46.116)