OSU’s IRB has adopted a consistent and conservative approach to the retention of human subjects research review records. A list of relevant references appears at the end of this section. All research-related records, regardless of funding source and review level, will be retained for a minimum of three years post-study termination.
All records described in this policy shall be accessible for inspection and copying by authorized representatives of the IRB, by authorized representatives of the federal funding agency, if any, and any federal oversight body with relevant authority.
Records retained by the IRB. Records document the review of research proposals that involve the use of human subjects. Reviews may be made by the entire review board (IRB), by selected members, the board’s chair, or by IRB staff. Records will be retained for three years post-study termination and may include, but are not limited to; approved protocols and consent forms; samples and/or approved test instruments; copies of grant proposals; review summaries; and related memoranda and correspondence.
IRB minutes are retained permanently. The electronic (born-digital) version is considered the record copy.
In accordance with 45 CFR 46.115 and 21 CFR 56.115, the IRB shall also prepare and maintain adequate documentation of IRB activities, including the following:
Records retained by the Principal Investigator. The principal investigator shall have primary responsibility for curating their research records for a minimum of three years post-study termination, including signed consent forms and completed surveys, research notebooks, as well as digital records or other media form.
For FDA-regulated research. In accordance with 21 CFR 312, an investigator or sponsor shall retain the records and reports for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
In accordance with 21 CFR 812, An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.
Departing faculty. In the event of exigent circumstances where the investigator cannot retain research records, or if the investigator intends to leave their position at the university, the investigator and their Department Head or Dean (not the IRB) should identify the successor responsible for maintaining those Institutional records, and for determining whether the original records or verified copies shall be retained by the university. In the event a researcher leaving their position at the university removes the original research data from the university, they must leave a verified copy and agree to provide access to the university to the original data, as well as to other individuals or entities having a legitimate need for access.
Please also see the IRB Data Security Guidance for additional information on data transfer and storage.