Indicate Type: Full; Partial; Pending Requirements: Alteration Recommendations: Waiver of (Process of) Informed Present Comments: Consent. N/A Concerns: Required when waiving Pending Requirements: entire consent process (e.g., for Recommendations: retrospective data reviews, for Are criteria met for situations when one research waiver? (regardless if participant provides private waiver was submitted information about another, such to IRB) as future contact when participant YES NO is not available) Waiver of Required Element of Present Comments: Informed Consent. N/A Concerns: Required Pending Requirements: when waiving entire consent Recommendations: process (e.g., for not disclosing Are criteria met for purpose in deception research) waiver? (regardless if waiver was submitted to IRB) YES NO Waiver of Documentation Present Comments: (signature) of Informed Consent. N/A Concerns: Pending Requirements: Required when waiving Recommendations: documentation (e.g., signature) of Are criteria met for informed consent. NOTE: If PHI waiver? (regardless if is involved, the IRB may accept waiver was submitted the HIPAA waiver form to to IRB) document a request to waive YES NO informed consent. Recruitment Materials (including, Present Comments: but not limited to advertisements, N/A Concerns: flyers, brochures, ads, Pending Requirements: telephone script, etc.) Recommendations: Subject Recruitment Present Comments: Authorization Form (Signed by N/A Concerns: patient). Pending Requirements: Recommendations: Physician’s Documentation of Present Comments: Patient’s Verbal Authorization. N/A Concerns: Pending Requirements: Recommendations: Are ICH-GCP standards required No Comments: to be following by the sponsor for Yes Concerns: this study? Requirements: Recommendations: Does this trial involve an IND or No Comments: IDE? Yes Concerns: Requirements: Recommendations: Is this an Applicable Clinical No Comments: Trial? Yes Concerns: Requirements:
Indicate Type: Full; Partial; Alteration Pending Requirements: Recommendations: Waiver of (Process of) Informed Consent. Required when waiving entire consent process (e.g., for retrospective data reviews, for situations when one research participant provides private information about another, such as future contact when participant is not available) Present N/A Pending Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO Comments: Concerns: Requirements: Recommendations: Waiver of Required Element of Informed Consent. Required when waiving entire consent process (e.g., for not disclosing purpose in deception research) Present N/A Pending Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO Comments: Concerns: Requirements: Recommendations: Waiver of Documentation (signature) of Informed Consent. Required when waiving documentation (e.g., signature) of informed consent. NOTE: If PHI is involved, the IRB may accept the HIPAA waiver form to document a request to waive informed consent. Present N/A Pending Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO Comments: Concerns: Requirements: Recommendations: Recruitment Materials (including, but not limited to advertisements, flyers, brochures, ads, telephone script, etc.) Present N/A Pending Comments: Concerns: Requirements: Recommendations: Subject Recruitment Authorization Form (Signed by patient). Present N/A Pending Comments: Concerns: Requirements: Recommendations: Physician’s Documentation of Patient’s Verbal Authorization. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Are ICH-GCP standards required to be following by the sponsor for this study? No Yes Comments: Concerns: Requirements: Recommendations: Does this involve an IND or IDE? No Yes Comments: Concerns: Requirements: Recommendations: Is this an Applicable Clinical Trial? No Yes Comments: Concerns: Requirements: trial
IRBChecklistInformedConsentReview06.16.2017_000.docx