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REVISED COMMON RULE Effective January 21, 2019 Developed by: U-MIC University of Michigan IRB Collaborative
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 3
Revised 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) Developed by: U-MIC 4
Revised Common Rule • • continuing review exempt research informed consent other aspects of research Developed by: U-MIC 5
Revised Common Rule 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 E 6 standards Developed by: U-MIC 6
Revised Common Rule 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 • e. Research 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 7
Revised Common Rule 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 Developed by: U-MIC 8
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 9
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 10
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 11
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 • Clinical. Trials. gov • Federal. Register. gov Developed by: U-MIC 12
Revised Common Rule Developed by: U-MIC 13
THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 14
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