Revised Common Rule

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. Developed by: U-MIC

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

3. 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 Revised Common Rule Developed by: U-MIC

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

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

6. Continuing review • 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 Revised Common Rule Developed by: U-MIC

7. Exemptions • 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 • notpermissiblefor research involving • HIPAA-covered component • for research subject to limited IRB review Revised Common Rule Developed by: U-MIC

8. Informed consent • 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 Revised Common Rule Developed by: U-MIC

9. new required elements of consent • identifiable private information/biospecimens • whether identifiers may be removed • whether de-identified information/biospecimensmay 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 Revised Common Rule Developed by: U-MIC

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

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

12. 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 Revised Common Rule Developed by: U-MIC

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

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