An investigator is required to keep consent documents, IRB correspondence, and research records for at least three years after the completion of the research according to HHS regulations (45 CFR 46.115(b)). This includes the informed consent documentation, which must also be kept for a minimum of three years after the research concludes unless waivers have been granted. Records may be retained in any accessible form (paper, electronic, etc.) and must be available for inspection by authorized representatives. Institutional policies or sponsoring agency requirements may mandate longer retention times. For example:
- Some institutions retain records, including IRB correspondence and administrative records, for up to 10 years after research completion.
- For FDA-regulated studies, records must be kept for 2 years after a marketing application is approved or for 2 years after the investigation is discontinued and the FDA notified.
If an investigator departs an institution, arrangements must be made for a successor to maintain the records for the required retention period. In summary:
- Standard minimum: 3 years after study completion.
- FDA-regulated research: longer retention of up to several years aligned with regulatory requirements.
- Institutional policies can require longer periods, such as 10 years for IRB documents in some places.
This minimum three-year period is widely regarded as the federal regulatory floor for record retention in human subjects research.