1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.
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U-MIC

2. Informed consent changes
under the revised Common Rule (2018)
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U-MIC
University of Michigan IRB Collaborative

3. Final Common Rule Consent changes under revised Common Rule
scheduled to take effect January 19, 2018
includes consent-related changes
key study information at beginning of consent document
new required elements of consent
changes to waiver criteria and documentation
“Broad Consent” option
consent templates and guidance to address new requirements
Use newest template or guidance available.
Approved/enrolling studies may be required to update consent documents.
supplemental cover page (IRBMED)
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U-MIC

4. Key Study Information Consent changes under revised Common Rule
elements likely to promote understanding of study and whether to participate
statement that project is research and participation is voluntary
summary of research, including
purpose
duration
procedures
risks
benefits
alternatives
How this requirement is applied depends on study complexity.
brief informed consent documents
Ensuring key information is presented at beginning may suffice.
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U-MIC

5. New Consent Elements Consent changes under revised Common Rule
four new required elements of informed consent
For research that involves collection of identifiable private information or identifiable biospecimens, indicate that after identifiers are removed, de-identified information and/or biospecimens may be used or shared for future research without additional consent
unless certain no such future use will take place
For research involving use of biospecimens, state whether
biospecimens may be used for commercial profit
subject will share in that profit
For research expected to generate clinically relevant results, indicate whether/under what conditions subject will receive clinical results
For research involving whole-genome sequencing, state that research will/might include whole genome sequencing
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U-MIC

6. Changes to Consent Waiver requirements
Consent changes under revised Common Rule
Changes to Consent Waiver requirements
waiver of consent for secondary use of identifiable private data/biospecimens
Indicate why use of identifiers is necessary.
use of identifiable information/biospecimens for screening
consent waiver no longer necessary under certain circumstances
HIPAA Authorization may still be necessary.
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U-MIC

7. Consent documents Consent changes under revised Common Rule
federally-sponsored clinical trials
copy of the consent document must be posted to a publicly available, federal website
post-recruitment
within 60 days of last study visit
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U-MIC

8. Broad Consent Consent changes under revised Common Rule
optional alternative consent process
for storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for unspecified future research
U-M templates and guidance do not address this option at this time.
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U-MIC

9. Informed consent changes under the revised Common Rule
Consent changes under revised Common Rule
Informed consent changes
under the revised Common Rule
Office of Research Ethics and Compliance “Common Rule and Other Changes” page:
Developed by:
U-MIC

10. thank you.
Brian Seabolt
IRBMED
Developed by:
U-MIC