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

Exemption changes Exempt research subset of research involving human subjects does not require comprehensive IRB review per full regulatory criteria not subject to continuing review amendments required only if changes could alter exempt determination does not lessen investigators’ ethical obligations including human subjects protections training PEERRS or equivalent distinct from “not regulated” not considered research involving human subjects Developed by: U-MIC

2017 revisions to the Common Rule Exemption changes 2017 revisions to the Common Rule scheduled to become effective January 19, 2018 changes to existing exemption categories addition of some new categories opportunity to streamline IRB application (HUM) utilize eRRM "smartform logic“/routing functionality Developed by: U-MIC

Exemption changes Standard application type renamed “Human Subjects research involving interaction or intervention” Exemption screener questions in this application help identify whether an exemption category applies route application along exemption paths or comprehensive IRB review Developed by: U-MIC

Exemption changes Secondary Use application renamed “Secondary research uses of private information and/or biospecimens” routes secondary use studies through correct IRB review/determination path not regulated exempt comprehensive IRB approval Developed by: U-MIC

Exemption changes Self-determination letter of exemption investigators may generate Self-determination letter for some studies qualifying for exemption 1, 2, or 3 main interaction/intervention exemptions Situations that don’t qualify for self-determination PHI for screening projects involving deception Developed by: U-MIC

Exemption changes Exemption 1: Educational Exemption applies to research conducted in educational settings involving normal educational practices benefit students/support that setting’s curriculum revised Common Rule clarifies eligibility language Developed by: U-MIC

Exemption changes Exemption 2: Surveys, Interviews, Educational Tests, Focus Groups, and Observation of Public Behavior applies to research confined to interactions involving educational tests cognitive diagnostic aptitude achievement survey/interview/focus group procedures observation of public behavior Not allowed: interventions specimen collection other data collection methods Applicability to research with children is limited. Revised Common Rule expands scope to include collection of sensitive and identifiable data if a “limited IRB review” approves the study’s plans to protect subject privacy and data confidentiality “Limited IRB review” does not address full IRB regulatory criteria. Developed by: U-MIC

Exemption changes Exemption 3: Benign Behavioral Intervention new exemption permits benign behavioral intervention on adult subjects in conjunction with data collection methods employed in Exemption 2 may include alterations in subject’s physical or sensory environment computer game must be brief may not involve medical or physical intervention not even non-invasive monitoring (e.g., blood pressure cuff, EEG) applies mainly to studies of psychological states and processes cognition, ideas, and attitudes behavior Not allowed: specimen collection linking to additional data sources research involving deception unless subjects are advised in advance that deception will be employed Sensitive/identifiable data permissible with “limited IRB review” approval of privacy/confidentiality protection plans Developed by: U-MIC

Exemption changes Exemption 4: Secondary Research with Identifiable Private Information and/or Biospecimens revised Common Rule expands exemption 4 to facilitate secondary-use-only research on identifiable private information/biospecimens that have been/will be generated for non-research purposes from research other than proposed study includes studies where identifiers are accessed, but no direct or indirect identifiers are recorded secondary analysis of Protected Health Information (PHI) Medical chart review may qualify if Privacy Board review grants HIPAA authorization waiver. Developed by: U-MIC

Exemption changes Exemption 5: Federal Research and Demonstration Projects / Exemption 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies rarely used at U-M Exemptions 7 and 8 new used in conjunction with revised Rule’s Broad Consent concept U-M not implementing “Broad Consent” Developed by: U-MIC

Exemption changes under the revised Common Rule (2018) Developed by: U-MIC

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