Version
3.2
Date Updated
Tuesday, January 5, 2016
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair


POLICY


  1. Investigators, or other responsible parties, must file either a continuing review application or a final report in advance of the expiration date of IRB approval.
  2. UIC OPRS strongly recommends submitting the continuing review application or final report application 30-45 calendar days from the date of expiration of IRB approval for expedited submissions.  For convened review protocols, investigators are strongly recommended to submit the continuing review application 45-60 calendar days from the date of expiration while also taking into account the submission deadlines for the appropriate board meeting.

  3. Department Heads, Unit Heads, and Faculty Sponsors are responsible for ensuring that PIs leaving UIC submit a Final Report form for each of their active protocols or transfer the responsibility to another qualified investigator to serve as PI by submitting an amendment form.  For additional information, please refer to the UIC HSPP policies Final Report of IRB Activities for Study Closure and Managing Research Prior to Departure, Sabbatical, Medical Leave, or Other Absence.

  4. Lapse in IRB approval represents a failure to obtain approval of a final report or obtaining continuing review approval prior to the expiration date assigned by the IRB.  After expiration of IRB approval, all research activities must stop, including any research related interventions, recruitment, data collection, data sharing/reporting and analysis of data, and no new subjects may be enrolled. 

  5. If the research is closed due to lapse in IRB approval, a new submission is required to re-open it.

  6. After the IRB approval for a study has lapsed, any follow-up interventions or interactions with some or all subjects during a lapse require the submission of a request to the IRB for a protocol exception.  Interventions are allowed to continue only when it is in the best interest of the subjects and approved by the IRB.  To request the continuation of certain aspects of the research, the investigator must submit a UIC OPRS Protocol Exception form to clearly distinguish and explain what research activities from which he or she will refrain as part of the lapse and what research activities require continuation.  The investigator must also explain the underlying reasons for which the protocol exception is requested for each activity and each subject where an over-riding safety concern or ethical issue indicates that it is in the best interests of the individual to continue participating during a lapse.  (Refer to UIC HSPP policy and procedure Protocol Exceptions). An exception must be requested even if a continuing review application has been submitted.  A protocol exception does not replace or represent continuing IRB review of the research.

  7. Lapses in IRB approval are not considered by OHRP to be a suspension or termination of IRB approval.  Therefore, such expirations of IRB approval do not need to be reported to OHRP as suspensions or terminations of IRB approval under the HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5). However, the UIC HSPP policy considers the lapses to represent non-compliance with the requirements of the IRB and are handled according to the UIC HSPP policy and procedure, Handling Complaints and Allegations of Potential Non-Compliance with Human Subject Protection Regulations, including consideration of whether the non-compliance is serious and/or continuing.  The IRB applies the terms “continuing non-compliance” and “serious non-compliance” as defined in the UIC HSPP policy and procedure Reporting of Unanticipated problems, Suspensions, Terminations, and Non-Compliance.  

  8. Please note that repeated lapses and/or continuation of research activities during a lapse without an approved exception may represent serious and/or continuing non-compliance and hence be subject to the IRB reporting requirements.

  9. IRB members, OPRS staff, and OVCR staff may use the most effective means of communication necessary with respect to contacting investigators as to lapse in IRB approval on an as-needed basis.  Documentation of oral and written communications must be filed in the protocol file.