Version
2.0
Date Updated
Wednesday, January 11, 2017
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  150
AAHRPP Elements:  II.2.D.2, II.2.E.2


POLICY


  1. IRB-approved research be reviewed at intervals appropriate to the degree of risk and in compliance with applicable federal regulations and sponsor guidelines. 
  2. UIC policy and federal reguations required that IRB-approved research be reviewed at a minimum of once per year.
  3. Research that is not reviewed prior to the expiration date is deemed to be lapsed in IRB approval and a notice of expiration of IRB approval is issued.  Refer to UIC HSPP policy Lapse in IRB Approval for more information and specific consequences of lapse in approval.
  4. Continuing review of research must be substantive and meaningful. The IRB bases its continuing review of the research on the approval criteria at 45 CFR 46.111 (and at subparts B, C, and D of 45 CFR part 46, when applicable) or 21 CFR 56.111. These criteria include determinations by the IRB regarding minimizing risks, risks reasonable in relation to potential benefits, equitable selection of subjects, obtaining and documenting informed consent, monitoring safety, protection of privacy and maintenance of confidentiality, and additional safeguards for subjects likely to be vulnerable to coercion or undue influence.  These criteria must be met when the IRB conducts the continuing review of research either at a convened meeting or under an expedited review procedure.
  5. Continuing review is allowed to stop only when a Final Report has been submitted and approved by the IRB.  Refer to UIC HSPP policy Final Report of IRB Activities for Study Closure for more information and specific closure criteria.
  6. ​As a courtesy, the OPRS utilizes several measures to notify the Principal Investigator (PI) of continuing review for previously approved human subjects research in the following manner:
    1. Approval letters to investigators include a link to Investigator Responsibilities which reminds investigators that they are responsible for ensuring that a continuing review application or final report is submitted to OPRS prior to the expiration date to prevent a lapse of IRB approval.
    2. Investigators receive email reminders from OPRS at approximately 90, 60, and 30 days prior to the expiration of the approval period. This is accomplished as the RiSC database management software has a mechanism for the Assistant Director (AD) for each IRB (or designee) to monitor the status of the board’s protocols on a weekly or bi-weekly basis.
  7. The PIs and faculty sponsors are ultimately responsible for being aware of the expiration date of the protocol and for the timely submission of continuing review materials. 
  8. After the IRB approval for a study has lapsed, any follow-up interventions or interactions with subjects during a lapse require the submission of a request to the IRB for a protocol exception via a UIC OPRS Protocol Exception form.   Refer to UIC HSPP policy and procedure Protocol Exceptions for additional information. 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.
  9. Continuing reviews are not required nor accepted for Claims of Exemption or Determinations of Whether an Activity Represents Human Subject Research at UIC.  Investigators are required to submit a new Claim of Exemption to extend an exemption period beyond three years.  (Refer to the UIC HSPP policy Claims of Exemption for more information.)