Effective January 21, 2019 some research will no longer require continuing review, unless the IRB specifically determines otherwise.
Continuing review is not required in the following circumstances:
- Research eligible for expedited review process, no more than minimal risk and in accordance with 45 CFR 46.110;
- Research reviewed by the IRB in accordance with the limited IRB review (see later section on exemptions requiring such review);
- Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
MHC Transition and Implementation Process
For existing expedited protocols - Most studies that were originally expedited by the IRB under the old rule will not require a continuing review but will require a quick study status update on an annual basis. If your study currently has an expiration date, you will still be required to submit a continuing review application in 2019. At time of renewal, the IRB will assess whether additional renewals are required or not. In addition, at the time of the next renewal or significant modification affecting the informed consent form that occurs after 1/21/2019, you will be requested to update the consent form to meet the new requirements. If your study does not require continuing review, Research Integrity will require an Institutional Annual Status Report form every year to keep the study active.
For new studies approved by expedited review on or after January 21, 2019, the MHC IRB’s expedited reviewer will determine the need for continuing review. Most expedited studies will not require continuing review.
Why would an IRB determine that continuing review is required, when the Common Rule allows otherwise? Some reasons include:
- Required by other applicable regulations (e.g., FDA)
- Required by the terms of a grant, contract, or other agreement
- The research involves topics, procedures, or data that may be considered sensitive or controversial
- The research involves particularly vulnerable subjects or circumstances that increase subjects’ vulnerability
- An investigator has minimal experience in research or the research type, topic, or procedures; and/or
- An investigator has a history of serious or repeated noncompliance.
- An amendment or report reveals new findings that require additional oversight
Study Team Responsibilities and Annual Status Report Procedure
When the continuing review is not required, the study team must:
- Complete an Annual Status Report so that we can know if the study is still active (allowing for post-approval monitoring), and institutional requirements can be assessed (training and COI status of current research team etc.). Failure to complete this report will be consider non-compliance.
- Remember that the requirement to submit modifications, changes to personnel, changes to recruitment material, reportable events, and final reports to the IRB have not changed.
- Take note that when you submit a modification, reportable event or annual status report the MHC IRB may evaluate if continuing review is required.
- Watch for eProtocol system automated reminder when the annual status report is due.
- Once the project is completed, submit a final report in eProtocol.