There are two types of records associated with research projects: administrative records and research records, including data. The length of time records are retained varies according to a number of factors, such as the type of record and the type of research. In general:
- Research data and materials are to be retained by UNM/HSC for a period of at a minimum three (3) years.
- Research data and materials involving human subjects are to be retained by UNM/HSC for a period that is the greater of: (a) the retention period required by the sponsor in respect of a sponsored research project (as set forth in the definitive Clinical Trial Agreement with the Sponsor), or (b) in no such agreement exists, then seven (7) years from and after the closure of the study in question.
- For research data and materials involving Protected Health Information (PHI), the PI must retain the signed consent forms that contain the permission to use the PHI for six (6) years beyond the expiration date of the authorization (i.e. the consent form or authorization).
- Research data and materials involving minors aged eighteen (18) years of age and younger are to be retained by UNM/HSC until the minor reaches the age of 22.
- Research data and materials involving the research of drugs, devices, or biologics being tested in humans for FDA approval shall retain records 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."
- If there are two or more overlapping retention periods, then the applicable retention period is the longer (or longest) length of time between the two or more overlapping periods.
There are many exceptions to these general retention schedules (with times varying from one to thirty years), so a careful review of applicable policy and guidance is recommended.
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