Ensuring the proper management and retention of Institutional Review Board (IRB) documentation is crucial for research institutions. Compliance with federal regulations and ethical standards demands that records be kept for an adequate amount of time to meet legal requirements, audit readiness, and ethical considerations. Here’s a detailed overview of how long you should retain IRB paperwork:
1. Retention of Protocols and Consent Documents
- General Rule: Protocols, amendments, and informed consent documents must be retained for at least three years after the completion of the study.
- For Studies Involving Children: If your research involves participants who were minors, keep records for three years past the age of majority, which varies by state but is commonly 18 years old in the US.
📝 Note: For multi-site studies, ensure that each site has its own protocol retention period, aligning with local regulations.
2. Sponsor and Funding Agency Requirements
When research is funded by external sources:
- Sponsors: Some sponsors might require records to be retained for longer than the standard three years, often to align with their legal or operational requirements.
- Federal Funding: Agencies like NIH, FDA, or other federal institutions might have specific requirements. For example, NIH requires retention for three years after the close of the grant.
3. Institutional Policies
Your institution might have additional guidelines or policies:
- University Retention Policies: Check for any university-specific policies regarding research data retention.
- IRB Standard Operating Procedures (SOPs): The IRB SOPs might specify an extended retention period for specific types of research or additional documentation requirements.
| Document Type | Minimum Retention Period | Possible Extensions |
|---|---|---|
| Consent Forms | 3 years post-study | + Age of majority for minors |
| Protocols and Amendments | 3 years post-study | May extend by sponsor or funding agency |
| Sponsor/Funding Agency Requirements | Varies | Longer if specified by the agency |
| Institutional Policies | Varies | Check SOPs or other guidelines |
4. Adverse Events and Safety Reports
Records related to adverse events, safety reports, and any correspondence with the IRB:
- Documentation of Adverse Events: These must be retained indefinitely or for a period specified by your IRB or regulatory body.
- IRB Correspondence: Communications regarding changes in study protocols or amendments should be kept with the study records.
📌 Note: Properly logging and categorizing adverse event documentation can streamline audits and ensure compliance.
5. Considerations for Long-Term Storage
When retaining records for an extended period, consider:
- Storage: Ensure the security and confidentiality of records through electronic or physical means.
- Compliance: Regulatory bodies or institutional policies might dictate specific methods of record storage.
The management of IRB paperwork plays an essential role in ensuring research integrity, participant protection, and compliance with regulations. By following these guidelines, research institutions can manage IRB documentation effectively:
- Adhere to the minimum three-year retention post-study completion.
- Extend retention for studies involving minors or as per sponsor or funding agency requirements.
- Align with institutional policies, which might have longer retention periods.
- Properly document and retain adverse event reports and safety communications indefinitely if necessary.
- Ensure long-term storage practices safeguard the confidentiality and integrity of the records.
Effective recordkeeping is not just a bureaucratic necessity; it's a fundamental part of ethical research practice, protecting both researchers and participants while maintaining the rigor and credibility of research efforts.
Can I dispose of IRB records after the study ends?
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You should retain IRB records for at least three years after the study ends. However, certain conditions like studies involving minors or specific sponsor requirements might necessitate longer retention.
What should I do if my institution’s policy conflicts with federal regulations?
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When in doubt, follow the more stringent guideline, which usually means adhering to federal or sponsor requirements over institutional policy.
Are electronic records acceptable for IRB documentation?
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Yes, electronic records are acceptable provided they are stored securely and in compliance with data protection regulations. Ensure backups and audit trails are in place.
How should I handle documentation of adverse events?
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Adverse events should be documented and kept with the study records. In some cases, these records may need to be retained indefinitely.
What are the risks of not retaining IRB documentation properly?
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Improper documentation retention can lead to non-compliance with regulatory requirements, jeopardizing funding, research integrity, and subjecting institutions to legal and ethical scrutiny.
