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Developed by:
U-MIC

2. Revised Common Rule Effective January 21, 2019 Developed by: U-MIC
University of Michigan IRB Collaborative

3. Common Rule Revised Common Rule 45 CFR 46 subpart A
Department of Health and Human Services (HHS)
investigators conducting research involving human subjects
IRBs
2018 revision
implementation date: January 21, 2019
New studies with federal funding
subject to all revised Common Rule requirements
At UM, new studies without federal funding
subject to all Common Rule provisions
except requirement to post consent materials to public website
Developed by:
U-MIC

4. Common Rule revisions Revised Common Rule apply only to no bearing on
HHS requirements (45 CFR 46)
no bearing on
FDA requirements (21 CFR 50 and 56)
HIPAA requirements (45 CFR 164)
Developed by:
U-MIC

5. Revised Common Rule Revised Common Rule continuing review
exempt research
informed consent
other aspects of research
Developed by:
U-MIC

6. Continuing review Revised Common Rule
no longer required for some minimal risk research
most studies that qualify for expedited review
other studies (expedited or convened-board review) if
all subject intervention/interaction complete
remaining activity confined to
final analysis of identifiable data or biospecimens
accessing follow-up clinical data
still required for studies subject to
FDA regulations
ICH-GCP E6 standards
Developed by:
U-MIC

7. Exemptions Revised Common Rule modification of existing categories
expansion of existing categories
addition of new categories
UM implementing only one
research involving only benign behavioral intervention
new exempt determination processes
limited IRB review
similar to expedited review
self-determination of exemption
PI may issue system-generated exemption determination letter
eResearch will indicate whether self-determination is permissible
permissible for some exempt research
not permissible for research involving
HIPAA-covered component
for research subject to limited IRB review
Developed by:
U-MIC

8. Informed consent Revised Common Rule key information section
details most likely to assist in consent decision
new required elements
changes to waiver criteria and documentation
other process changes
broad consent
unspecified future use of identifiable data/biosopecimens
UM not implementing broad consent
Developed by:
U-MIC

9. new required elements of consent
Revised Common Rule
new required elements of consent
identifiable private information/biospecimens
whether identifiers may be removed
whether de-identified information/biospecimens may be used/shared
use of biospecimens
whether biospecimens may be used for profit
whether subject will share in profit
clinically relevant results
whether results returned to subject
under what conditions
whole-genome sequencing
statement that research will/might include whole-genome sequencing
Developed by:
U-MIC

10. IRBMED standard informed consent template
Revised Common Rule
IRBMED standard informed consent template
available on IRBMED website
complies with all revised Common Rule requirements
key information section
new required elements of consent
Developed by:
U-MIC

11. New informed consent waiver provisions
Revised Common Rule
New informed consent waiver provisions
use of identifiable private information/biospecimens
must explain why use of identifiers is necessary
use of identifiable information/biospecimens for recruitment
allowed under certain circumstances
waiver of consent no longer necessary
HIPAA authorization requirements may still apply.
Developed by:
U-MIC

12. Public posting of approved informed consent materials
Revised Common Rule
Public posting of approved informed consent materials
required for federally-sponsored clinical trials
after recruitment
no later than 60 days after last study visit
publicly available federal website
ClinicalTrials.gov
FederalRegister.gov
Developed by:
U-MIC

13. Revised Common Rule
Revised Common Rule
Developed by:
U-MIC

14. Thank you.
Brian Seabolt
IRBMED
Developed by:
U-MIC