Record Retention

All records relating to the research must be appropriately managed and retained. This includes records under the investigator's control, such as the informed consent document. The Principal Investigator is responsible for assuring appropriate maintenance of these records. 

The PI must maintain these records for a minimum of three years after the IRB has closed the research and a longer retention period may be required by law, contract, funding agency, university requirement or other requirements for certain projects, such as those that are sponsored or FDA regulated research.  The Principal Investigator is responsible for being aware of any other requirement that impacts record retention.

For research subject to federal oversight, records must be accessible for inspection and copying by authorized representatives such as the FDA or federal agency representatives at reasonable times and in a reasonable manner. The PI is responsible for ensuring that the records are accessible, including graduate student research.

Researchers are encouraged to review and follow the MSU best practices, Research Data: Management, Control, and Access.

For more information, see HRPP Manual 4-7-A, Recordkeeping for Investigators.