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U-MIC

2. Continuing review Changes under the revised Common Rule (2018)
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U-MIC
University of Michigan IRB Collaborative

3. Continuing review changes
Revised Common Rule
scheduled to take effect January 19, 2018
continuing review no longer required for
most studies that qualify for expedited review
no more than minimal risk
must meet federal criteria for an expedited review category
studies that have completed subject intervention/interaction and in which activity is limited to
final analysis of identifiable data and biospecimens
accessing follow-up clinical data
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U-MIC

4. Continuing review changes
Existing studies
U-M IRBs will evaluate need for continuing review at next amendment/scheduled continuing review for
expedited studies that were approved prior to January 19, 2018
full-board studies in which subject intervention/interaction is complete
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U-MIC

5. New studies Continuing review changes
approved via expedited review on or after January 19, 2018
U-M IRB’s expedited reviewer will
determine need for continuing review
set "Continuing Review (CR) / No Continuing Review (No CR)" flag
Most expedited studies will not require continuing review.
When requiring continuing review of studies that meet regulatory No CR criteria, IRB should
state reasons for requiring continuing review
document reasons
FDA-regulated or sponsor requires continuing review
involves additional regulatory oversight, e.g., conflict of interest (COI) management
research conducted internationally / at non-UM sites
amendment or incident report reveals findings that require additional oversight
investigator has had previous serious noncompliance or a pattern of non-serious noncompliance
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U-MIC

6. Reminder e-mail Continuing review changes
Even when continuing review is not required, study team must
submit amendments for study changes
report adverse events/ORIOs
terminate study
once it ends
when personal identifiers are removed from data/biospecimens and all codes and keys are destroyed
In absence of SCR process
automated annual reminder
issued prior to anniversary approval date
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U-MIC

7. Continuing review changes
U-M IRBs may re-evaluate CR/No CR decision depending on
type of changes proposed in amendment
such as a protocol change that increases risk
as outcome of review of adverse events/ORIOs
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U-MIC

8. Continuing review changes under the revised Common Rule (2018)
Developed by:
U-MIC

9. Thank you. Brian Seabolt IRBMED
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U-MIC