Version
3.1
Date Updated
Monday, January 21, 2019
Descripton

Approved by:  Human Protections Administrator and Director of OPRS
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. The 2018 Common Rule (45 CFR 46) or “2018 Requirements” will go into effect on January 21, 2019 and will affect all research approved on and after this date and that falls under the entities that have agreed to follow the 2018 Requirements.
    1. Research approved prior to January 21, 2019 will continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the “pre-2018 Requirements”) unless documented otherwise by the IRB on or after January 21, 2019. 
    2. The following federal entities have agreed to follow the 2018 Requirements:
      1. Department of Homeland Security;
      2. Department of Agriculture;
      3. Department of Energy;
      4. National Aeronautics and Space Administration;
      5. Department of Commerce;
      6. Consumer Product Safety Commission;
      7. Social Security Administration;
      8. Agency of International Development;
      9. Department of Housing and Urban Development;
      10. Department of Labor;
      11. Department of Defense;
      12. Department of Education;
      13. Department of Veterans Affairs;
      14. Environmental Protection Agency;
      15. Department of Health and Human Services;
      16. National Science Foundation; and
      17. Department of Transportation.
      18. In addition, UIC will process unfunded research in the same manner as funded research following the 2018 Requirements.
    3. Research involving federal entities who have not agreed to follow the 2018 Requirements (i.e., FDA, DOJ) will proceed under their most recent regulations and guidance (e.g., pre-2018 Requirements).
      1. If the research falls under the purview of multiple entities with one or more entities agreeing to follow the 2018 Requirements and one or more entities who do not agree to follow the 2018 Requirements (e.g., NIH funded research testing FDA regulated products), the research will be reviewed under the pre-2018 Requirements.
  3. The 2018 Requirements include a “no continuing review” provision which eliminates the need for a continuing review for research that meets the following criteria:
    1. Minimal risk research reviewed by the expedited review procedures; or
    2. Greater than minimal risk research that is closed to enrollment, where the remaining activities under the specific IRB-approved protocol are limited to one of the following:
      1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, (e.g., expedited category 8c), or
      2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care (e.g.., expedited category 8a).
    3. The IRB has the authority to determine that subsequent continuing review is required for research meeting the criteria above (items A or B).
    4. Based on recommendations from OHRP, the following research will continue to require continuing review at a minimum of once per year:
      1. Where no subjects have been enrolled and no additional risks have been identified (expedited category 8b), and
      2. Where (i) the research is not being conducted under an investigational new drug application or investigational device exemption, (ii) categories two (2) through eight (8) of the OHRP Expedited Review Categories (1998) do not apply, and (iii) the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified (expedited review category 9).
    5. Research that implements the “no continuing review” and that is funded by an agency that has adopted the Common Rule (federally funded) must transition to and follow all of the 2018 Requirements. 
  4. The IRB will determine whether currently approved research may be eligible for the “no continuing review” provision at the time of the next Continuing Review.   
    1. The IRB will determine whether Initial Reviews approved on or after January 21, 2019 may be eligible for the “no continuing review” provision.
    2. The IRB’s determination will be documented on the applicable review guide or in the convened meeting minutes.
  5. Mechanism for review of research that will follow the 2018 Requirements:
    1. Research initially approved prior to January 21, 2019:
      1. Research Reviewed by Convened Review
        1. Continues to require continuing review via convened review at a minimum of once per year.
        2. Research that was originally reviewed by the convened IRB, is closed to enrollment, and where the remaining activities under the specific IRB-approved protocol are limited one of the following may move to “no continuing review” (unless the IRB justifies and documents within the meeting minutes that additional continuing reviews are required):
          1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, (e.g.., expedited category 8c) or
          2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care (e.g.., expedited category 8a).
          3. For either condition, the IRB must document that the remaining research activities are no greater than minimal risk and that the research no longer requires continuing review. 
      2. Research Reviewed by Expedited Review
        1. Will require at least one continuing review in order to transition the research to “no continuing review” if applicable.
        2. If the “no continuing review” determination cannot be implemented for a specific protocol, the IRB reviewer must document and justify this determination on the review guide.
          1. Research reviewed under expedited categories 8b or 9 must continue to require continuing review at a minimum of once per year.
    2. Research initially approved on or after January 21, 2019:
      1. Research Reviewed by Convened Review
        1. Continues to require convened review via convened review at a minimum of once per year.
        2. Research that was originally reviewed by the convened IRB, is closed to enrollment, and where the remaining activities under the specific IRB-approved protocol are limited one of the following, then the research may move to the “no continuing review” (unless the IRB justifies and documents within the meeting minutes that additional continuing reviews are required):
          1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, (e.g.., expedited category 8c) or
          2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care (e.g.., expedited category 8a).
          3. For either condition, the IRB must document that the remaining research activities are no greater than minimal risk and that the research no longer requires continuing review.
      2. Research Reviewed by Expedited Review
        1. During Initial Review or at Continuing Review, the IRB can determine that continuing review is not required.
        2. If the “no continuing review” determination cannot be implemented for a specific protocol, the IRB reviewer must document and justify this determination on the review guide.
          1. Research reviewed under expedited categories 8b or 9 must continue to require continuing review at a minimum of once per year.
  6. Research conducted or supported by federal entities that have not agreed to the 2018 Requirements (i.e., FDA, Department of Justice) will continue to require continuing review at a minimum of once per year regardless of whether the research is reviewed by Expedited or Convened Review.
  7. Continuing review is allowed to stop when:
    1. Minimal risk research, initially approved by expedited review on or after January 21, 2019, follows the 2018 Requirements; or
    2. Existing minimal risk research (initially approved by expedited review prior to January 21, 2019) is subsequently approved for continuing review on or after January 21, 2019, the IRB has determined that research no longer requires a continuing review, and the research follows the 2018 Requirements; or
    3. The research has been closed either via a Final Report, or the research was administratively closed (e.g., non-compliance, failure to enroll, etc.).
  8. 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.
  9. OPRS utilizes several measures to notify the Principal Investigator (PI) of their approval periods, remind the PI of their responsibilities, and send courtesy reminders for continuing review (as applicable) in the following manner:
    1. Initial Review and subsequent Continuing Review (as applicable) approval notices specify the protocol approval period (start and end dates, as applicable).
    2. Approval letters to investigators include a link to Investigator Responsibilities which reminds investigators of their responsibilities, including (when applicable) the submission of a continuing review application or final report prior to the expiration date to prevent a Lapse of IRB Approval.
    3. For all research requiring continuing review, regardless of the review period (including three year approvals, refer to Appendix 1, for eligible research approved 4/16/18 – 1/20/19):
      1. Investigators receive email reminders from OPRS at approximately 90, 60, and 30 days prior to the expiration of the approval period.
    4. Investigators whose research received a three-year approval period or who no longer require a continuing review will 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.
      1. Every three years, the PI of IRB-approved research that no longer requires a Continuing Review will receive and be asked to complete an Institutional Status Report.  If the PI does not submit an Institutional Status Report, the research may be administratively closed by the IRB.
  10. The PIs and Faculty Sponsors are ultimately responsible for being aware of the expiration date (as applicable) of the protocol and for the timely submission of continuing review materials and/or Institutional Status Reports.
  11. Research that has not received continuing review approval or has not been closed via approved 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 that need to continue during a lapse as they are in the best interest of the subject (i.e., continuation of study drugs, continuation of study visits to assess adverse events, etc.) 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.
  12. Research that 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 appeal to the IRB by providing a rationale on the Continuing Review form as to why the research should remain open.