Version
3.0
Date Updated
Thursday, April 12, 2018
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 (i.e., maximum one year approval period) if the research meets any of the following criteria:
    1. Federal funding (including no cost extension),
    2. Research is under the oversight of FDA, DoJ, DoE, or other agencies that require continuing review at a minimum of once per year,
    3. Greater than minimal risk,
    4. Review by the Convened IRB,
    5. Certificate of Confidentiality has been obtained for the research,
    6. Development Only proposal,
    7. Center or Training grant, or
    8. As per IRB determination.
  3. As UIC is not obligated to apply the Common Rule to research that is not federally funded, research that does not meet the criteria in item II above may be eligible for an extended approval period of a maximum of three (3) years rather than the one (1) year (or less) period beginning April 16, 2018.  
    1. The IRB will determine whether research that currently has a one-year approval may be eligible for the extended approval period at the time of the next Continuing Review.
  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) and/or 21 CFR 56.111. 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. ​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. For all research requiring continuing review, regardless of the review period:
      1. ​Initial Review and subsequent Continuing Review approval notices specify the protocol approval period (start and end dates). 
      2. 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.
      3. Investigators receive email reminders from OPRS at approximately 90, 60, and 30 days prior to the expiration of the approval period.
    2. Investigators whose research receives a three-year approval period will also receive an annual notice to remind the PI to submit amendments, prompt reports, and a final report as applicable based on UIC policy, federal regulations, and sponsor guidelines. 
  6. Amendments and Prompt Reports must continue to be submitted as applicable in the interim.
    1. Amendments that change a protocol’s eligibility for the three-year approval period (as stated in item II above) will change the expiration date of the research.  For instance, if the amendment adds federal funding to the research then the three-year approval period will be reduced to a one-year approval period.
      1. The expiration date will be one year from the date of the approval of the amendment.  Approved documents will be stamped with the new approval date or approval period. 
      2. Investigators are responsible for ensuring that the most recently approved versions of the documents are being used for recruitment and enrollment purposes.
    2. Amendments that eliminate the criteria preventing the protocol’s eligibility for the three-year approval period (as stated in item II above) will not increase the approval period as an increase in approval period can only be determined during the Continuing Review.
      1. For instance, an amendment removes federal funding and now could be eligible for a three-year approval as it does not include any of the criteria from item II above.  The amendment would be granted approval without changes to the approval period as an increase in the approval period can only be granted during the Continuing Review.
  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. Research that has not received continuing review approval or has not been closed via final report 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.
    1. Any follow-up interventions or interactions with subjects during a lapse require the submission of 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 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.
  10. Research has never enrolled any subjects and/or has not enrolled subjects in three (3) consecutive years but indicates that subjects will continue to be enrolled may be administratively closed by the IRB.
    1. Investigators may provide a rationale on the Continuing Review form as to why the research should remain open.   
    2. Administratively closed research that is federally funded and/or FDA regulated will be reported to applicable agencies as per the UIC HSPP policy Reporting of Unanticipated Problems, Suspensions, Terminations and Non-Compliance