Records Retention
Regulations require each investigator to retain research data not only while the research is being conducted, but also after the research is completed. How long must the investigator retain records after the completion of the research? Unfortunately, there are several different regulations, each of which has different requirements. As a result, researchers must retain their records for as long as the applicable regulations state, so long as they meet the minimal requirements.
- OHRP Requirements: 45 CFR 46 requires research records to be retained for at least 3 years after completion of the research.
- HIPAA Requirements: Research that involves collecting identifiable health information by a covered entity is subject to HIPAA requirements. As a result, records must be retained for a minimum of 6 years after each subject signed an authorization.
- FDA Requirements: Any research that involves drugs, devices, or biologics being tested in humans must have records retained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. The length of time can be much greater than 2 years. You should receive written confirmation from the sponsor and/or FDA granting permission to destroy the records. (21 CFR 312.62.c).
- Sponsor Requirements (Grant or Contract): If your study is sponsored, you must ensure that you comply with any terms for record retention detailed in the contract with the sponsor. For example, it is not unheard of for a clinical trial sponsor to require that records be kept for 15 years or longer. Some sponsors may require researchers to keep records until notified by the sponsor.
- Professional Association Requirements: If your research falls within the guidelines of a particular profession (e.g. American Psychological Association), you may be required to retain records based on the association's practices.
The records retention period for a particular study must be communicated in both the researcher's narrative and any consent forms. If records will be kept indefinitely, this must be stated, along with detail on any future usage (i.e. de-identified database) and with whom the records will be shared. Approximate date of destruction must be stated, and how that destruction will take place (shredding, burning, erasing of tapes, etc.).
Policies & Procedures
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