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Institutional Review Board (IRB)

Standard Operating Procedure
Continuing Review of IRB-Approved Research

Purpose | Policies | Procedures | Continuing Review of IRB-Approved Research (PDF format)

Purpose

This Standard Operating Procedure (SOP) is written to comply with Department of Health and Human Services (DHHS) regulations 45 CFR 46 and Food and Drug Administration (FDA) CFR parts 50 and 56 as well as with CPMC’s Federalwide Assurance (FWA) and IRB Policies and Procedures.

Policies

It is the responsibility of the Principal Investigator (PI) to track his/her study's expiration date and submit the continuing review report in enough time to receive IRB review and reapproval prior to the study's expiration.

The IRB requires the PI to submit a progress or final report at an interval determined by the IRB not to exceed one year.

The IRB considers the following factors when determining the review interval: The type and nature of the study, the degree of risk to research participants, the vulnerability of the study population, and the research experience of the investigator.

A complete progress or final report will include:
- a) one copy of each IRB-approved consent/assent form most currently in use (with subject's name blacked out);
- b) a summary of all unanticipated adverse events experienced by CPMC study participants during the review period, regardless of whether the events were serious or causally related to the study;
- c) a summary of all protocol violations, deviations and exceptions that occurred during the review period; and
- d) a summary of any audit findings (from sponsors and/or regulatory agencies) during the review period.

According to federal regulations, expedited review for continuing reviews may be conducted:
- When the study was determined to be minimal risk and qualified for expedited review at the time of initial review and no additional risks have been identified since the initial review; or
- Where the study is permanently closed to enrollment of new participants, and where all participants have completed research-related interventions, and where the research remains active only for long-term follow-up; or
- Where no participants have been enrolled during the current review period and no additional risks have been identified; or
- Where the remaining research activities are limited to data analysis only.

Procedures

The IRB Continuing Review Process
1. If the continuing review does not qualify for expedited review or if the IRB Chair or designee did not approve the study for continuation in the expedited review process, the IRB staff will prepare the continuing review materials for full IRB review at a convened meeting.
  
  NOTE: The continuing review materials are the same for expedited review and full IRB review. See the CPMC SOP on Expedited Review for information on expedited review of continuing review applications.
2. The IRB will evaluate the continuing review materials for the following:
  - Completeness of the progress or final report;
  - For studies with informed consent documents: whether the most recently approved version of each consent form is attached (submit one copy of every consent/assent form being used in the study with the subject's name blacked out);
  - Whether modifications have received prior approval by the IRB;
  - Whether adverse events experienced by study participants suggest a change in the risk/benefit ratio of the study;
  - Whether there have been significant deviations from the approved study;
  - Whether the PI has responded to requests for information by the IRB; and
  - Whether there is new information that suggests a change in the risk/benefit ratio for participants.
3. If concerns or questions arise during the continuing review, the reviewer may request additional information from the PI, the sponsor, or someone external to the study that is in a position to observe the conduct of the study or verify information provided about the study

Reporting the Continuing Review to the IRB
1. A reviewer will report on his/her continuing review at a convened meeting of the IRB.
2. A reviewer will identify and discuss elements of the continuing review report that require further clarification from the PI or sponsor, or require consent form or other study changes. The IRB will have available at the meeting all of the materials reviewed by the primary reviewer and, upon request, the complete study file.
3. A reviewer will recommend whether or not to continue approval and for what interval based on the criteria in this SOP, or recommend other action to be taken. The reviewer may recommend that research participants be notified of new information that could affect their willingness to participate in the study. The reviewer will explain the reasons for the recommendations, including an approval interval of less than one year.

IRB Decision Making
1. The IRB will approve the study to continue for up to one year if a complete and accurate progress report is received in time to conduct a continuing review before the current approval expires; the required documents and signatures are provided; no new risks to participants have been identified; no new information has been reported to suggest that the risk to participants has increased during the review period; and the most recent approval interval was one year,
2. When a complete and accurate progress report is received in time to conduct a continuing review before the current approval expires yet the most recent approval interval was less than one year, or new risks to participants have been identified, or there is new information to suggest that risks to participants have increased during the review period, the IRB may:
  - Reapprove the study for an interval of one year or less,
  - Require a modification to the study,
  - Require a consent form revision,
  - Defer the study pending further review,
  - Suspend the study pending further review,
  - Terminate the study, or
  - A combination of the above.
3. If a complete and accurate final report is received in time for the report to be reviewed before the current approval expires, and there are no concerns about the safety, welfare or rights of participants, and required documents and signatures are provided, the report will be accepted, and the study will be closed. If the IRB has concerns about the study, it may request additional information from the PI.
4. If a complete and accurate progress or final report is not received in time for the IRB to conduct a continuing review before the current approval expires, the PI will receive written notification of the expiration and be instructed to stop all study-related activities in a manner that will not cause harm to currently enrolled participants. For expired studies, the CPMC PI will be required to report to the IRB all study-related activities that were continued after study expiration and the reason for their continuation.
5. If a complete and accurate progress or final report is received in time for the IRB to conduct a continuing review before the current approval period expires, but the IRB has unanswered questions about the project that do not involve concerns for the safety, welfare or rights of study participants, the study may be conditionally reapproved pending the investigator's response to the IRB questions.
  - If adequate clarifying information or consent form(s) are not received during the approval period, the project approval will expire. The PI will be notified to submit the required information or consent form immediately to the IRB.
6. The IRB may, at any time and at its discretion, based on concerns for the rights, safety or welfare of one or more human subjects, deny reapproval of a study and require that the study be modified, suspended, suspended to further enrollment, or terminated. Such a decision must be made by a quorum of the IRB members present during the convened IRB meeting, not to include any members with a conflicting interest in the study.

Documentation and Notification of Continuing Review
1. The CPMC PI will be notified in writing (electronically or hardcopy letter) about IRB actions concerning continuing reviews, including any reasons for conditionally approving or not approving the study for continuation, or of modifications required to the study or consent form.
  - If IRB approval has expired, the PI will be notified and instructed to stop all study-related activity except those the cessation of which would negatively affect the safety or welfare of study participants. The PI will be notified to submit a progress or final report immediately to the IRB. As noted above, for expired studies, the CPMC PI will be required to report to the IRB all study-related activities that were continued after study expiration and the reason for their continuation.
    
    Information on study-related activities continuing after project expiration will be submitted to the IRB for review and approval or other appropriate action.
    
    Non-response to the IRB's request will be reported to the IRB at the next meeting and, unless extenuating circumstances have been identified, will be determined to be in noncompliance with IRB policies and procedures.
    
    The PI will notify all sub-investigators of this expiration in writing within five business days of receipt of notification.
2. If the study is suspended, the study sponsor and appropriate federal regulatory agencies will be notified by the IRB. In addition, the IRB will also notify the following CPMC officials: the PI's Department Chair, the Research Institute's Scientific Director and/or other CPMC officials as determined to be appropriate by the IRB Chair. For suspended studies, the CPMC PI will be required to report to the IRB all study-related activities that were continued after study suspension and the reason for their continuation.
  - Information on study-related activities continuing after project suspension will be submitted to the IRB for review and acceptance or other action.
3. If the study is terminated, the study sponsor and appropriate federal regulatory agencies will be notified by the IRB. In addition, the IRB will also notify the following CPMC officials: the PI's Department Chair, the Research Institute's Scientific Director and/or other CPMC officials as determined to be appropriate by the IRB Chair. For terminated studies, the CPMC PI will be required to report to the IRB all study-related activities that were continued after study termination and the reason for their continuation.
  - Information on study-related activities continuing after project termination will be submitted to the IRB for review and acceptance or other action.
4. If a consent form change is required as part of the continuing review, the IRB will determine whether the reconsenting of currently-enrolled study participants is required.
5. The PI will be required to notify the co/sub-investigators and sponsor of any protocol or consent form changes required by the IRB.

Continuing Review of IRB-Approved Research (PDF format)