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 with the exception of the agencies that have not harmonized with the Common Rule.
    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. 
      1. Research (with the exception of the agencies that have not harmonized with the Common Rule) approved prior to January 21, 2019 will transition to the 2018 Requirements at the time of Continuing Review unless documented otherwise by the IRB.
      2. Unfunded or non-federally funded research may be transitioned to a variation of the 2018 Requirements.   Specifically, the research may be transitioned to no continuing review without revisions to the prior approved informed consent document.
    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.
    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 “no continuing review” provision will be determined by the IRB, and documented on the applicable review guide or in the convened meeting minutes, during the following processes:   
    1. Initial Review for research approved on or after January 21, 2019, or
    2. At the time of the Continuing Review for research approved prior to January 21, 2019.
  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 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 and are limited to one of the following may move to “no continuing review” (unless the IRB determines that additional continuing review is 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 determine 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 on or after January 21, 2019 in order to transition the research to “no continuing review” if applicable.
          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 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 and are limited to one of the following, may move to the “no continuing review” (unless the IRB determines that additional continuing review is 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 determine 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 may determine that continuing review is not required.
          1. Research reviewed under expedited categories 8b or 9 must continue to require continuing review at a minimum of once per year.
      3. Informed Consent Requirements:
        1. Federally funded research approved prior to January 21, 2019 will be transitioned to the 2018 Requirements.  The consent document will be revised at the time of the next continuing review.
        2. Non-federally funded research approved prior to January 21, 2019 will transition to the 2018 Requirements; however, revisions of the consent document will not be required unless otherwise determined by the IRB.
        3. Regardless of funding, initial reviews approved on or after January 21, 2019 that require a consent form must utilize the most current version of the consent form.
        4. For research approved prior to January 21, 2019 that will transition to “no continuing review,” the IRB should re-evaluate and document any changes to previous determinations related to waiver and/or alteration of consent, as applicable.
  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.
  7. 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) and/or 21 CFR 56.111, as applicable. 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.
  8. 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 during the period of time 4/16/18 through 1/20/19):
      1. OPRS will periodically send PIs courtesy email reminders prior to the expiration of the protocol. 
    4. For research that received a three-year approval period or that no longer require a continuing review, OPRS will send an annual reminder notice of Investigator Responsibilities.
      1. For research that does not require a continuing review, a Status Report will be required every three years to determine whether the research is ongoing. If a Status Report is not provided, the research may be administratively closed by OPRS.
  9. 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 Status Reports.
  10. 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.
  11. Research that has no enrollment and/or has not enrolled subjects in three (3) consecutive years 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.