Written Procedures for Institutional Review Boards (IRBs): Content and Organization

What You Need to Know? 👇

What are the mandatory written procedures that IRBs must establish under FDA and HHS regulations?

IRBs must establish written procedures for: (1) conducting initial and continuing review of research and reporting findings, (2) determining review frequency and verification requirements, (3) ensuring prompt reporting of proposed changes, and (4) reporting unanticipated problems, noncompliance, and suspension/termination of approvals.

How detailed should IRB written procedures be to meet regulatory compliance?

Written procedures should provide sufficient operational detail beyond simply restating regulations. They must help IRB members and staff understand how to carry out duties consistently and effectively, including specific processes, responsible parties by position title, and decision-making criteria.

What flexibility do institutions have in formatting their IRB written procedures?

Institutions have significant flexibility in format and content of written procedures. They may be electronic or paper-based, focus solely on regulatory responsibilities or incorporate broader institutional policies, and include varying levels of administrative detail based on organizational needs.

Are IRBs required to have written procedures for reviewing research involving vulnerable populations?

While not explicitly required by regulations, OHRP and FDA strongly recommend written procedures for reviewing research involving children, pregnant women, prisoners, and other vulnerable populations to ensure appropriate additional safeguards are consistently applied during IRB review.

How often should IRB written procedures be reviewed and updated?

Written procedures should be reviewed regularly and updated as necessary to reflect current institutional processes and regulatory changes. The guidance recommends establishing a systematic review schedule and assigning responsibility for maintaining procedures to specific position titles.

Can IRBs make their written procedures publicly available to investigators and sponsors?

Yes, institutions and IRBs may choose to make written procedures publicly available, often through websites, to help investigators and sponsors understand IRB requirements and facilitate compliance. This transparency can improve the quality of submissions and research conduct.

---

What You Need to Do 👇

Recommended Actions

1. Develop comprehensive written procedures covering all required regulatory elements
2. Ensure procedures include sufficient operational details beyond just restating regulations
3. Structure procedures to reflect institution’s specific organizational setup and research types
4. Include position titles rather than names to avoid frequent updates
5. Implement regular review and update process for written procedures
6. Make procedures accessible to relevant stakeholders (investigators, sponsors)
7. Establish training program on written procedures for IRB members and staff
8. Create documentation system for tracking compliance with written procedures
9. Develop contingency plans for IRB oversight transfer if needed
10. Establish process for verifying procedures are followed consistently

Key Considerations

Human Factors

• Written procedures for reviewing studies involving vulnerable populations
• Procedures for assessing additional safeguards for subjects likely to be vulnerable to coercion
• Process for reviewing informed consent forms and consent process

Safety

• Procedures for reviewing and reporting unanticipated problems involving risks to subjects
• Process for suspending or terminating approval of research associated with unexpected serious harm
• Procedures for emergency use of test articles
• Process for ensuring prompt reporting of changes needed to eliminate immediate hazards

Other considerations

• Procedures for initial and continuing review of research
• Process for determining review frequency and verification requirements
• Procedures for reporting proposed changes and obtaining IRB approval
• Requirements for IRB membership and operations
• Record keeping and documentation requirements
• Procedures for cooperative IRB review arrangements
• Process for handling subject complaints and concerns

---

Relevant Guidances 🔗

• Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
• IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
• Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
• Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
• Transfer of Clinical Investigation Oversight Between Institutional Review Boards
• IRB Registration Requirements and Procedures

---

Original guidance

• Written Procedures for Institutional Review Boards (IRBs): Content and Organization
• HTML / PDF
• Issue date: 2025-02-05
• Last changed date: 2025-02-05
• Status: FINAL
• Official FDA topics: Biologics, Medical Devices, Drugs, Good Clinical Practice (GCP), Investigation & Enforcement
• ReguVirta ID: e92052a1a825739b57074d4700714c3b