If >MR with children, if risk is a minor increase over minimal risk What types of benefits are Are the benefits Comments: described in the IRB protocol/IRB described in consent Concerns: application or other materials? form are consistent Requirements: No direct benefit anticipated to with all other IRB Recommendations: participants; future benefits to application materials? society only Yes Non-Therapeutic Direct Benefits No to research participants Pending Direct Therapeutic Benefits to research participants Other (explain): Financial Conflict of Interest No COI/No Issues Comments: (fCOI) Disclosures for PI and Disclosures pending; Concerns: other for the Significant Financial Requirements: “investigators purposes of COI” (See IRB Interest (SFI) Recommendations: Office Review Worksheet) disclosed fCOI Committee Approved Management Plan in place SFI disclosed appropriately in ICF Assent Form (s). Present Comments: Generally N/A Concerns: required if you are planning to Pending Requirements: enroll participants age 7-12. Recommendations: Information Sheet (if applicable). Present Comments: N/A Concerns: Required when requesting a Pending Requirements: waiver of documentation of Recommendations: informed consent, when IIHI or PHI is NOT involved. Information Sheet, including Present Comments: authorization to access, use, or N/A Concerns: disclose IIHI or PHI (if Pending Requirements: applicable). Recommendations: 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. Short Form(s). Present Comments: May be used for N/A Concerns: certain studies when enrolling Pending Requirements: non-English speaking participants Recommendations: or those with Limited English Proficiency (LEP). Indicate Arabic; Simplified languages: Chinese; Traditional Chinese; English; Haitian Creole; Spanish Waiver(s). Present Comments: N/A Concerns:
If >MR with children, 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: Waiver(s). Present N/A Comments: Concerns:
IRBChecklistInformedConsentReview12.22.2017-Pilot.docx