If >MR with children, check if risk is a minor increase over minimal risk What types of benefits are described in the IRB protocol/IRB application or other materials? No direct benefit anticipated to participants; future benefits to society only Non-Therapeutic Direct Benefits to research participants Direct Therapeutic Benefits to research participants Other (explain): Are the benefits described in consent form are consistent with all other IRB application materials? Yes No Pending Comments: Concerns: Requirements: Recommendations: Financial Conflict of Interest (fCOI) Disclosures for PI and other “investigators for the purposes of COI” (See IRB Office Review Worksheet) No COI/No Issues Disclosures pending; Significant Financial Interest (SFI) disclosed fCOI Committee Approved Management Plan in place SFI disclosed appropriately in ICF Comments: Concerns: Requirements: Recommendations: Assent Form (s). Generally required if you are planning to enroll participants age 7-12. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Information Sheet (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is NOT involved. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Information Sheet, including authorization to access, use, or disclose IIHI or PHI (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. Present N/A Pending Comments: Concerns: Requirements: Recommendations: Short Form(s). May be used for certain studies when enrolling non-English speaking participants or those with Limited English Proficiency (LEP). Indicate languages: Arabic; Simplified Chinese; Traditional Chinese; English; Haitian Creole; Spanish Present N/A Pending Comments: Concerns: Requirements: Recommendations: HIPAA Waiver(s). Present N/A Comments: Concerns:
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