Time for some succession planning. At the start of the academic year, you should identify who will take over the study, even though the goal is to finish the project in the year. When planning to pass along your study, consider:
Is there anyone on your Research Study team or in your program who might be interested in and able to replace you as PI? (Pro Tip: think through if anyone in the year behind you has an interest in research and/or your study topic.) Make changes in the IRB protocol application, as appropriate. Consider:
- What will happen to the data collected thus far?
- Is the location where the data are currently stored appropriate for the new PI to gain seamless access?
- Do you currently store any data that needs to be transferred to the new PI?
- What level of involvement do you want to have after you transfer off the study as PI? Would you want to be kept on as a sub-investigator?
- Do you want to be involved in any dissemination efforts?
Be sure to have direct conversations about these desires with the new PI.
Please see the CMH Institutional Review Board website on the intranet for information on how to close out a protocol.
Discuss with the GME Research Staff how study records and collected data will be protected after study closure.
- Records (including the approved IRB application, all amendments, continuing reviews, and signed informed consent forms) must be retained for at least three years per federal regulations.
- Deidentified data without codes attached can be stored indefinitely; keep this in mind in case data analysis is ongoing or you may want to revisit your data in the future.
- You will also need a plan for who will destroy any data and/or delete records no longer needed from your personal devices.
- You will need to decide what to do with any unused supplies/equipment.
Other conditions may apply based on your specific study so check in with GME Research Staff.