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UMKC Implementation: Continuing Review

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Effective 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.
Remember:  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.

UMKC Transition Process

Existing Studies

For existing expedited studies that were approved prior to January 18, 2018 and for full board studies that no longer involve subject intervention/interaction, the UMKC IRB will evaluate the need for continuing review at the time of the next amendment (AME) or scheduled continuing review (SCR) submission.  Do not file an amendment only to convert an existing project to a "No CR" status.

Existing Studies: Transition Process
  • Expedited: At next AME/SCR, expedited reciew determines CR/no CR
  • Full Board: At next AME/SCR, full board determines CR/no CR

New Studies

For new studies approved via expedited review on or after January 21, 2019, the UMKC IRB expedited reviewer(s) will determine the need for continuing review and designate the study as "Continuing Review (CR) / No Continuing Review (No CR)".  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
  • The research will be conducted internationally or at non-UMKC 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 

New Processes:  Study Team Responsibilities & Project Termination

Even when continuing review is not required for a project, the study team must still:

  • Submit amendments for project changes,
  • Report Unanticipated Problems, and
  • Terminate the project once it ends.

In the absence of the CR process for qualified expedited studies, UMKC is considering the implementation of an automated annual email reminding the study team of these responsibilities.  The email would be sent prior to the anniversary approval date for the study.

The UMKC IRB 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 Unanticipated Problems.