Policy Title / Final Report and IRB Initiated Study Closure

Policy

The PI is responsible for promptly submitting a final reportfor an IRB approved study if any of the following conditions exist:

  • All research/clinical investigation activities including data analysis and reporting are complete;
  • The PI never initiated the study;
  • Subject accrual is finished, all data collection is complete and the only remaining activity is analysis of the data, the data are de-identified, and there are no identifying links or codes to the de-identified data;
  • The PI plans to leave the institution in which the research is being conducted and intends to continue the research activities at another institution;
  • The study has been open for a period of three or more years and the PI has enrolled no subjects in the study.

The PI cannot submit a final report an active IRB approval if:

  • He/she is still following subjects or;
  • He/she is analyzing identifiable data (including data with codes or links to identifiers).

If a study has been open for a period of three or more years and the PI has not enrolled subjects in the study, the IRB requires study closure unless there are extenuating circumstances for keeping the project open (i.e., the study is about a rarely seen condition).

Procedures

  1. The PI or designee submits the Continuing Review Report (under “Check Action Requested of the IRB” check “Final/Close the Study”)
  1. Regardless of initial review type (full or expedited), final reports undergo expedited review by an IRB Co-Chair or designated IRB staff memberfor final review. The IRB reviewer may determine the circumstances surrounding the request for closure require full board review.
  1. The IRB agenda for convened meetings advises the IRB of final reports using the expedited review procedures.
  1. Final approval letters will be sent to the PI after the meeting on which the final study appears on the agenda.
  1. IRB staff code the protocol in the IRB database as final and record the date the study appeared on the agenda. IRB staff removes the protocol files from the active files. Final protocol files are kept on site for a minimum of 3 months and then transferred to off site storage through Providence Sacred Heart Medical Center and Children’s Hospital Medical Records Department. The IRB keeps the protocol files for three years from final report date. After 3 years all documents are shredded through the IRB commercial shredding company.

IRB Initiated Study Closure

  1. If, at initial review, the PI fails to respond to the IRB’s request for additional information/ revisions within a specified period of time (e.g., approximately six months), the IRB will communicate with the PI or designee reminding him/her that the IRB has never approved the study and had requested revisions to the protocol.
  1. If the IRB has not received a response after one year from the date of original reviewa letter will be sent to the PI informing him/her that the IRB requires a new application if the PI wants consideration for IRB approval.
  1. If the PI fails to submit the Continuing Review Report or Final Report Form or fails to submit requested information, IRB staff send him/her a notification letter ending IRB approval. (See the Continuation Review SOP.)
  1. If, at the time of continuing review the PI reports no subject enrollment and the study has been open for a period of three or more years, the IRB may request the PI submit a final report. If there are extenuating circumstances for keeping a study open, the PI submits information to the IRB to justify that the study be kept open. If the IRB determines that the extenuating circumstances do not justify leaving the study open, the IRB may request the PI submit a final report. If the PI fails to submit the final report the IRB staff process withdrawal of IRB approval notification letter and send it to the PI.

Reactivating IRB Approval

  1. The PI may re-initiate research previously inactivated by the IRB by following the procedures for initial full review, expedited initial review, or continuing review, as determined by IRB Co-Chair.

REFERENCES

Not applicable

Form(s)

  • Final Report

Forms must be typed - hand written forms are not acceptable. Always download the most current version of the form from the IRB website at

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