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

Informed consent changes under the revised Common Rule (2018) Developed by: U-MIC University of Michigan IRB Collaborative

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) Developed by: U-MIC

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. Developed by: U-MIC

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 Developed by: U-MIC

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. Developed by: U-MIC

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 Developed by: U-MIC

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. Developed by: U-MIC

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: http://research-compliance.umich.edu/human-subjects/common-rule-other-changes Developed by: U-MIC

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