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:
Pending Comments: Concerns: Requirements: Recommendations: (D) To the extent possible, technical, medical, legalese, and scientific concepts should be explained in lay (i.e. understandable to the people being asked to participate), especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits. Typically, the consent should be understandable to someone who is educated to the 6th to 8th grade level. Avoid long sentences and medical/technical jargon, and define any technical terms clearly whenever they are used. If the definitions of technical terms are lengthy, describe in separate sentences. Recommendations met N/A Pending Comments: Concerns: Requirements: Recommendations: (G) The IRB should review the adequacy and appropriateness of all wording in the consent materials, as well as the overall length and presentation of information. Consent forms that are long, complex, legalistic, and have a high reading level may overwhelm potential subjects and may inhibit reading of the full document and understanding of the relevant information. Recommendations met N/A Pending Comments: Concerns: Requirements: Recommendations: (G) Pictures or diagrams may be used to improve understanding of medical terms or how an investigational product functions. IRBs may wish to evaluate, through subject interviews, how well the consent materials communicate critical information. Recommendations met N/A Pending Comments: Concerns: Requirements: Recommendations: (G) DO NOT Use the first-person tense (e.g., "I understand that ..."), as it can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Recommendations met N/A Pending Comments: Concerns: Requirements: Recommendations: (F) An investigator seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. All requirements met Some requirements not met. Explain below. Comments: Concerns: Requirements: Recommendations: (F) The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. All requirements met Some requirements not met. Explain Comments: Concerns: trial.