Subject: Expired IRB Approval

Procedure:

1. Principal Investigator (PI) Responsibilities.
   1. Expired IRB Approval on a Minimal Risk Study.

      The PI shall place the study on Administrative Hold to all research activities and comply with the following, upon expiration of IRB Approval:

      1. Cease all research activities, including enrollment of new subjects, study interventions, data collection, and data analysis;
      2. Report to the IRB if research activity occurs after the expiration date;
      3. Submit a Final Report to close the study, and
      4. If the PI wishes to continue the research activities, a new study must be submitted.
      
      
      
   2. Expired IRB Approval on a Greater than Minimal Risk Study.
      1. If cessation of all study activities will not jeopardize the health or safety of any currently enrolled subject, the PI shall place the study on Administrative Hold to all research activities and comply with all requirements outlined in Section I.A of this Procedure upon expiration of IRB Approval.
      2. If cessation of all study activities would jeopardize the health or safety of a currently enrolled subject, the PI shall, after consultation with the Chair/Vice Chair-on-call, place the study on Administrative Hold to new enrollment. The PI shall not enroll any new subjects but may continue study interventions for currently enrolled subjects. In such cases, the PI shall submit a Continuing Review Report to the IRB within 5 calendar days.
   3. A PI who has a study with expired IRB approval, for which he/she is the Principal Investigator (PI), must not be included on any new study or modification to an existing study (in any capacity) being submitted to the IRB.
   4. Principal Investigators with two or more instances of IRB Approval expirations will be placed in the following corrective action plan:
      1. Will be reported to the OHRP, FDA or other applicable officials or agencies for continuing non-compliance, depending on the circumstances as assessed by the IRB Administrative Committee. Additional corrective actions in accordance with IRB Procedure II.A ^[1] may result in a second report to OHRP, FDA or other applicable officials or agencies.
      2. Will be required to attend a fully convened IRB meeting within 30 days of being notified by the IRB.
      3. Other recommendations may be set forth by the IRB.
2. IRB Medical Director/Chair/Vice Chair’s Responsibilities.

   (Applicable to Greater than Minimal Risk Study only)

   If the expired study has potential patient safety concerns, the IRB Coordinator will contact the Medical Director or the Chair/Vice Chair-on-call will contact the PI within 24 hours of assessment. The Medical Director/Chair/Vice Chair within 24 hours from contact with IRB Coordinator to determine whether cessation of all research activities would jeopardize the health or safety of currently enrolled subjects.

   1. If cessation of all research activities will not jeopardize the health or safety of any currently enrolled subject, the PI shall be advised to place the study on Administrative Hold to all research activities. The PI shall comply with requirements outlined in Section I.A of this Procedure.
   2. If cessation of all research activities would jeopardize the health or safety of a currently enrolled subject, the Medical Director/Chair/Vice Chair shall advise the PI to place the study on Administrative Hold to new enrollment. The PI shall not enroll any new subject but may continue study interventions for currently enrolled subjects. The Medical Director/Chair/Vice Chair must advise the PI to submit a Continuing Review Report to the IRB within 5 calendar days.
      The Medical Director/Chair/Vice Chair will call the IRB through telephone (77) 6-4000 stating the subject matter, PI name and the IRB identification number of the study concerned.
   
   
   
3. IRB Committee Responsibilities.

   The Committee will review Continuing Review Reports in accordance with IRB Procedure III.I.1.^[2]

4. IRB Administrator Responsibilities.
   1. The IRB must issue an Expiration Notice to the PI on the day of expiration of the IRB Approval. One of the four versions of the Expiration Notice will be used:
      1. Notice of Expiration of IRB Approval on a Greater than Minimal Risk study that expired prior to submission of a Continuing Review Report. The IRB ‘Owner-Specialist’ must also be notified. (refer to Appendix A.1 for content of notice)
      2. Notice of Expiration of IRB Approval on a Minimal Risk study that expired prior to submission of a Continuing Review Report. (refer to Appendix A.2 for content of notice)
      3. Notice of Expiration of IRB Approval on a Greater than Minimal Risk study that expired after the Continuing Review Report had been submitted. The IRB ‘Owner-Specialist’ must also be notified. (refer to Appendix B.1 for content of notice)
      4. Notice of Expiration of IRB Approval on a Minimal Risk study that expired after the Continuing Review Report had been submitted. The IRB ‘Owner-Specialist’ must also be notified. (refer to Appendix B.2 for content of notice)
   2. The IRBe system will be programmed to automatically classify a study with Expired IRB Approval as “Expired”. The PI concerned will not be able to submit a new study or be included on any new study or modification to an existing study (in any capacity) being submitted to the IRB.
   3. The IRB will maintain a log of IRB Approvals which expire prior to any submission of continuing review or final report. Principal Investigators who are found to have two or more instances* of IRB Approval expirations, will be referred for Directed Assessment for continuing non-compliance. If the IRB Committee confirms instances of continuing non-compliance, and if there are no extenuating circumstances that mitigate a determination of continuing non-compliance, it will be reported to the OHRP, FDA or other applicable officials or agencies.
5. IRB Staff Responsibilities.
   1. When a PI for a Greater than Minimal Risk study failed to submit a Continuing Review or Final Report prior to expiration of IRB Approval.
      
      Upon receiving the Notice of Expiration of IRB Approval on a Greater than Minimal Risk study that expired prior to submission of a Continuing Review Report in Section IV.A. of this Procedure or on learning about the matter through other means, the IRB Staff will call the PI concerned regarding the expiration of IRB Approval. The IRB Staff shall remind the Medical Director/Chair/Vice Chair to telephone the IRB (77) 6-4000 if the PI determines that cessation of all research activities will jeopardize subject safety, i.e., the study will be placed on Administrative Hold of new enrollment.
   2. Notification from the Medical Director/Chair/Vice Chair that the PI may continue with study treatment for currently enrolled subjects on a study with expired IRB Approval.
      
      Upon receiving a notification from the MD/Chair/Vice Chair that the PI may continue study treatment on currently enrolled subjects, the Site Administrator/ IRB Staff shall check if a Continuing Review Report for the study has been submitted.
      1. If the Continuing Review Report has been submitted, the Specialist will insert the Medical Director/Chair/Vice Chair’s notice using the “Already Enrolled Subjects May Continue Treatment” activity on the report. The Specialist will proceed to review the report and schedule it to the next available meeting agenda.
      2. If the Continuing Review Report has been created but is in a Pre-submission state, the Specialist will insert the Medical Director /Chair/Vice Chair’s notice using the “Already Enrolled Subjects May Continue Treatment” activity on the report.
      3. If no Continuing Review Report has been created or submitted yet, an IRB Site Administrator shall initiate a Continuing Review Report on behalf of the PI. The notice from the Medical Director/Chair/Vice Chair will be inserted using the “Already Enrolled Subjects May Continue Treatment” activity on the report. (A note will be sent to the PI with a link to the Continuing Review Report and a reminder to complete and submit the report within the stipulated timeframe).
   3. Continuing Review Report submitted prior to Expiration of IRB Approval.
      
      In the event that a Continuing Review Report had been submitted to the IRB prior to the expiration of IRB Approval, the Specialist will continue to process the submission and schedule it to the next available meeting agenda.
      1. Minimal Risk Study.
         The IRB Staff will contact the PI concerned to advise that the study be placed on Administrative Hold to all research activities. The Specialist will also advise the PI that the submitted Continuing Review Report will be scheduled on the next available meeting agenda.
      2. Greater than Minimal Risk Study.
         The IRB Staff will contact the PI concerned to advise that the study be placed on Administrative Hold to all research activities. The Staff will also advise the PI that the submitted Continuing Review Report will be scheduled on the next available meeting agenda. If there are any extenuating circumstances, the PI may contact the Medical Director to discuss the situation.If there is a patient safety issue, IRB Staff will contact and request the Medical Director or Chair/Vice Chair-on-call to inform the PI concerned regarding the expiration of IRB Approval, and to advise the PI to put the protocol on Administrative Hold to new enrollment.
   4. Continuing Review Report submitted after Expiration of IRB Approval.
      
      Upon receipt of a Continuing Review Report for an expired study, the Specialist will check (within the history log for the Continuing Review Report) whether the Medical Director/Chair/Vice Chair had given notice to the IRB regarding his/her agreement that study treatment on currently enrolled subjects be continued.
      1. If yes, the Specialist will proceed to process the Continuing Review Report in accordance with IRB Procedure III.I.^[3]
      2. If no, the Specialist will advise the PI to comply with Section I of this Procedure.

      The Specialist will return to the sender any new study submitted by a PI who has a study with expired IRB approval. The Specialist will advise the PI to comply with Section I of this Procedure.

^[1] IRB Procedure II.A

^[2] IRB Procedure III.I.1

^[3] IRB Procedure III.I.1