Forms, Templates, Examples

Institutional Review Board (IRB) Forms, Templates & Examples

**Please be advised that the UM IRB is no longer accepting paper applications for new protocols. All new protocols must be submitted using Cayuse Human Ethics. Amendments and continuations for protocols submitted using the old system will continue to use the paper forms. Please contact the UM IRB office with questions.**

Forms

Additional Researchers Addendum (RA-108a)

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Word 

Continuation / Closure Report (RA-109) - Continuations approved no more than 30 days prior to expiration

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Word

Amendment Request (RA-110)

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Word

Permission to Gather Personal Health Information (HIPAA)

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Word

Statement of Confidentiality, signed by PI when using online survey software - submit with IRB application 

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Word

Unanticipated Problem / Adverse Event Report (RA-111)

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Word

Foreign Site Study Appendix (RA-112)

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Word

Data Use Agreement form - use for secondary data analysis with PHI

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 Word

Data Use Agreement form - FERPA

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Word

Individual Investigator Agreement - use for collaborative projects when the co-PI's company does not have an FWA

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Word

IRB Project Registration form - use to register a project with the UM IRB that will be overseen by another IRB

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Word

Templates & Examples

Informed Consent (45 CFR 46.117) - for adults

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Word

Parental Permission (45 CFR 46.408(b))

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Word

Minor's Assent (45 CFR 46.408(a)) - for children

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Word

Limits of Confidentiality

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Word

Examples of Approved UM Checklists/Applications

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IRB 8-09

IRB 187-09

IRB 152-10

IRB 204-10