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U-M Implementation: Continuing Review

Image showing the text explaining the 2018 Common Rule change to the Continuing Review requirementEffective on January 21, 2019, Continuing Review will no longer be required for:

  • Most studies that qualify for the expedited review process.
  • Studies (regardless of review path) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.

Blue info iconRemember:  Studies qualifying for expedited review must be of no more than minimal risk and meet one of the OHRP Expedited Review Categories.

Eliminating continuing review for qualifying minimal-risk research reduces administrative burden for both the study team and IRB staff without impact to the human subjects.

U-M Transition Process

Existing Studies

For existing expedited studies that are approved on or before January 20, 2019 and for full board studies that no longer involve subject intervention/interaction, the U-M IRBs will evaluate the need for continuing review at the time of the next amendment or scheduled continuing review (SCR) submission.

Image displaying U-M's evaluation plan for existing HUMs to determine continuing review in 2018

Warning iconDo not file an amendment only to convert an existing project to a "No CR" status.

 

New Studies

For new studies approved via expedited review on or after January 21, 2019, the U-M IRB's expedited reviewer will determine the need for continuing review and set the "Continuing Review (CR) / No Continuing Review (No CR)" flag.  Most expedited studies will not require continuing review.  Some reasons for maintaining the continuing review requirement include:

  • The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review
  • The project involves additional regulatory oversight, such as conflict of interest (COI) management
  • The research will be conducted internationally or at non-UM sites
  • An amendment or incident report reveals new findings that require additional oversight
  • The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance 

Reporting Project Status:  Annual Status Report & Project Termination

Annual Status Report

In the absence of requiring the Scheduled Continuing Review (SCR) process for qualified expedited and other "No CR" studies, U-M has implemented a brief three-question Annual Status Report activity/email in the eResearch Regulatory Management (eRRM) system to:

  • Confirm whether recruitment/enrollment and interactions/interventions with participants are ongoing, and
  • Remind the study team of their responsibility to submit amendments for project changes, report adverse effects and other incidents (AEs/ORIOs), and to terminate the project once it ends, or when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed.

An automated system email with a link to the activity is sent on the anniversary approval date for the study.  Follow-up emails will be sent 14 and 28 days after the initial notification if the Annual Status Report activity has not been completed.  

Exempt studies, secondary-use studies, and studies in a "non-ongoing" status (e.g., studies that previously reported the completion of participant interaction/intervention) do not need to report recruitment/enrollment progess to a U-M IRB.  As a reminder to the study team of their responsibility to file amendments and incidents and/or to terminate a project, a similar annual system email without the link to the Status Report is sent on the anniversary approval date for the study.  

The U-M IRBs will review the Annual Status Reports and contact investigators if additional information or action by the study team is needed.  The U-M IRBs may re-evaluate its CR/No CR decision for a project depending on the type of change(s) proposed in an amendment (e.g., protocol change that increases subject risk), or as an outcome of the IRB's review of Adverse Events or ORIOs.

Termination Report

Image showing the Termination Report submission option in eRRMTermination Report submission option in the HUM workspace allows the Principal Investigator (PI) or Faculty Advisor (for studies where a student serves as the PI) to close projects upon completion of the research.  

Previously, study termination was initiated through the SCR process, which has caused some confusion per study teams' feedback.  Offering a separate termination process simplifies and clarifies both the continuing review and project closure functions going forward.  For convenience, the Termination Report option also will be available for exempt studies.

References and Resources

Questions?

To ask a question, express concerns, or provide suggestions about human subjects research protections at U-M, please send a message to hrppumich@umich.edu