IRB Closeout Report Policy
Federal regulations require that primary investigators (PIs), or other principal parties, must file either a Continuing Review Application (CRA) or a Closeout Report prior to IRB approval expiration (date indicated on the approval letter). Upon approval of a Closeout Report, oversight by the SU IRB concludes.
A PI must submit a Closeout Report in the following circumstances:
1) the study is never initiated, and no enrollment takes place;
2) a Primary Investigator leaves SU without requesting a change in PI;
3) when the following conditions a) and b) are met:
a) the PI no longer interacts/intervenes with the subject regarding the closing study’s research data. (The PI may maintain contact information for new research study enrollment.)
b) All data analysis involving the research under SU IRB approval is complete, and data and/or samples are permanently de-identified.
Data has been permanently de-identified (with no possibility of future identification of subjects by code or otherwise). [This case typically applies to multi-site research, where a sponsor receives the de-identified data and authorizes SU IRB closure.]
Closeout Report Instructions
- Complete the Closeout Report form using MS Word or similar word-processing software (no handwritten applications).
- Respond to all items as applicable, and attach explanations as necessary, or the form may be returned to you for additional information, thereby causing a delay in processing your study closure.
- Obtain all necessary signatures before submitting your closeout report: PI, Faculty Advisor (if not the PI), and Co-Investigators.
- Submit all forms as 1) hard copy in a sealed envelope to: IRB, Office of Research Services & Sponsored Projects, University Services Building #203. (After business hours, place materials in mail slot.) OR 2) scanned and signed PDF documents sent to: email@example.com
- Studies are approved for 365 days only (see expiration date on the approval letter).
- Prior to study expiration, you must submit to the IRB either a Continuing Review Application (CRA) or a Closeout Report. Failure to do so will result in the expiration of IRB approval for the study: all research activities must cease and any further data collected without IRB approval must be destroyed.
- Prior to leaving SU, the PI must submit to the IRB either an Adverse Effects–Modification Form to request changing PIs or a Closeout Report.
- Following study closure, the PI may not contact study subjects for further research data collection. If the need for more data collection arises, the PI must inform the IRB immediately. The PI may request that the IRB re-open the study by means of continuing review or a new protocol submission and review may be required.
- All data must be permanently de-identified for study closure. If data is not de-identified, the PI must submit a Continuing Review Application for IRB approval.
- Lapses in IRB approval are considered by SU policy to represent non-compliance with the Federal regulations and the requirements of the IRB, and are handled according to SU IRB policy and procedures.