How to close finished IRB research studies

Faculty in the process of transitioning to another institution or retiring from Purdue need to be aware that their active human subject protocols must be appropriately closed or transferred to a new principal investigator. This is not a tricky process, but it is required by federal regulations.

Departing faculty with open Institutional Review Board protocols must (1) close the file, or (2) transfer oversight responsibility to another responsible IRB, or (3) be replaced on the protocol by a Purdue faculty member. It is not unusual for a combination of these actions to be necessary. Before a faculty member leaves Purdue, that person should request from the IRB a list of open protocols and decide how these protocols should be managed. Requests for a summary of open protocols can be sent to irb@purdue.edu. IRB is available to work with faculty to manage the transition of their studies, whether they are retiring or transferring to another institution.

Exempt research files should be closed with the IRB as soon as the research has been completed. To close a file, the PI should send an email to irb@purdue.edu stating that the file is to be closed and identifying the study by IRB number and title.

Record keeping requirements for closed studies

1. The PI is responsible for managing the regulatory files associated with human subject research.

2. Regulatory files must remain at Purdue for a minimum of three years after the close of the study at Purdue. This is required by federal regulation.

3. Department heads are responsible for maintaining access to the regulatory files (including consent forms) during the record holding period, should the PI leave Purdue.

Contact: Nancy L. Hathaway, IRB administrator, nhathaw@purdue.edu