Continuing Review

Revised Common Rule (2018 Requirements)

Continuing renewed approval is required at least annually for research that requires review by the convened IRB, unless it meets the criteria listed below. The IRB may require additional review at more frequent intervals if the assessment of risk warrants it. 

Unless the IRB determines otherwise, continuing renewed approval is not required for:

  • Research eligible for expedited 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.

Modifications, reportable events (e.g. unanticipated problems involving risks to subjects or others, noncompliance) and study closure must still be submitted to the IRB, even if the study does not require continuing renewed approval. The IRB will also typically require a status check to determine if the human subject research activities are still ongoing or if the study could be closed.

The IRB will include whether renewed continuing review is required in the IRB approval letter.

Pre-2018 Common Rule 

IRB approval is valid for a maximum period of one year. However, the IRB may require additional review at more frequent intervals if the assessment of risk warrants it.

Requirements When Renewed Approval is Required

Principal investigators (PI) who would like to continue non-exempt human research and/or a clinical investigation beyond the expiration of IRB approval must receive renewed approval prior to the research study’s expiration. The approval period will be listed on approval letters sent to researchers, including both the approval date and the approval end (expiration) date.

Continuing review is required as long as remaining activities involve human subject research, including data collection, analysis of identifiable private information or identifiable biospecimens, or follow-up of subjects, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions.

All human research activities, including analysis of private identifiable information, identifiable biospecimens, or enrollment of new subjects, must stop upon expiration of the research approval, unless the IRB finds an overriding safety concern or it is in the best interest of the currently enrolled subjects to continue. Therefore, it is important to submit the request for continuing review at least three to four weeks prior to expiration to allow adequate time for review and approval by the IRB.

The PI is responsible for submitting a request for continued approval before the project expires.  Requests for Continuing Review are made through the ClickTM Research Compliance System.

How to Submit

  1. In Click, open the Study to modify.
  2. Create a Modification/CR.
    1. For the submission type, select Continuing Review. NOTE: if you also would like to Modify the study, select Modification and Continuing Review. If this is a Legacy Study and this is the first submission in Click, you must select Continuing Review and Modification. See the Modification page for information about modifications.
  3. Complete the Continuing Review SmartForm page.
  4. Complete and upload the following templates as appropriate:
    1. HRP-527 - Template - Explanation(s) for Items Left Unchecked in Question 4
      1. Complete if you left items unchecked in the Continuing Review submission, Question 4,
      2. Upload HRP-527 template (Continuing Review/Study Closure Information SmartForm page).
    2. HRP-510 - Template - Legacy Protocol
      1. Complete for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review.
      2. Upload HRP-510 template (Basic Information SmartForm page).
  5. Within the Continuing Review SmartForm, upload any data safety monitoring reports, etc. You do not need to upload your consent forms if there are no changes. If there are changes, a Continuing Review and Modification submission must be submitted.
  6. Submit the Continuing Review.

Click Templates

  • As Appropriate:
    • HRP-527 - Template - Explanation(s) for Items Left Unchecked in Question 4 (within the Continuing Review submission, if you left items unchecked in Question 4, complete this template)
    • HRP-510 - Template - Legacy Protocol (use for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review)

Available at the Click Templates page.

Click Quick Guides

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit HRPP Manual 8-7, Renewed Approval.

 

 

How to Submit