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

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

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

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

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

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

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

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

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

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

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

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

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

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