Pending Comments: Concerns: Requirements: Recommendations: (D) To the extent possible, technical, medical, legalese, and Recommendations met scientific concepts should be explained in lay (i.e. N/A understandable to the people being asked to participate), Pending especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits. Comments: Typically, the consent should be understandable to someone who Concerns: is educated to the 6th to 8th grade level. Avoid long sentences Requirements: and medical/technical jargon, and define any technical terms Recommendations: clearly whenever they are used. If the definitions of technical terms are lengthy, describe in separate sentences. (G) The IRB should review the adequacy and appropriateness of Recommendations met all wording in the consent materials, as well as the overall length N/A and presentation of information. Consent forms that are long, Pending complex, legalistic, and have a high reading level may overwhelm potential subjects and may inhibit reading of the full document Comments: and understanding of the relevant information. Concerns: Requirements: Recommendations: (G) Pictures or diagrams may be used to improve understanding Recommendations met of medical terms or how an investigational product functions. N/A IRBs may wish to evaluate, through subject interviews, how well Pending the consent materials communicate critical information. Comments: Concerns: Requirements: Recommendations: (G) DO NOT Use the first-person tense (e.g., "I understand that Recommendations met ..."), as it can be interpreted as suggestive, may be relied upon as N/A a substitute for sufficient factual information, and can constitute Pending coercive influence over a subject. Comments: Concerns: Requirements: Recommendations: (F) An investigator seek such consent only under All requirements met circumstances that provide the prospective participant or the Some requirements not met. Explain below. representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue Comments: influence. Concerns: Requirements: Recommendations: (F) The information that is given to the participant or the All requirements met representative shall be in language understandable to the Some requirements not met. Explain trial. participant or the representative. 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.
IRBChecklistInformedConsentReview12.22.2017-Pilot.docx