N/A Short Form(s) Long Form(s) (E.g., amendment needed for translated written consent document, information sheet, etc) All IRB application materials are congruent with one another: N/A Yes NO: Changes requested below. Marked-up copy of the consent document/information sheet attached: N/A Yes NO: Changes requested below. Criteria met for IRB approval: N/A Yes NO: Changes requested below. CHANGES REQUESTED: Specific Changes needed for Conditional Approval: (PLEASE BE AS SPECIFIC AS POSSIBLE) 1) 2) General Modifications Required: 1) 2) Recommendations (optional/not required): 1) 2) Comments: 1) 2) Approval Decision: For Expedited Reviews: Approval. Approval as submitted, no changes required. Conditional Approval or Modifications Required. The revised submission returned for review by an expedited reviewer. Refer for additional review by IRB member with the following area of expertise: Refer to IRB Chair. IRB Chair to resolve controverted issue(s) with PI. Refer to Full Board. PI not willing or not able to make requested changes. For Full Board Reviews: Approval. Approval as submitted, no changes required. Conditional Approval. Approval is subject to verification of specific requested revisions required to meet all approval criteria. Revisions submitted back to an expedited reviewer before final approval granted. Modifications Required. General changes submitted back to the full board). Disapproval (the submission is not approvable). Approval Period: on the assessed degree of risk and other factors outlined in (page 73-74), specify the approval period for this study: 12 months. If not 12 months, list the number of months (not to exceed 12): If less than 12 months, please explain: 1)
N/A Short Form(s) Long Form(s) (E.g., amendment needed for translated written consent document, information sheet, etc) All IRB application materials are congruent with one another: N/A Yes NO: Changes requested below. Marked-up copy of the consent document/information sheet attached: N/A Yes NO: Changes requested below. Criteria met for IRB approval: N/A Yes NO: Changes requested below. CHANGES REQUESTED: Specific Changes needed for Conditional Approval: (PLEASE BE AS SPECIFIC AS POSSIBLE) 1) 2) General Modifications Required: 1) 2) Recommendations (optional/not required): 1) 2) Comments: 1) 2) Approval Decision: For Expedited Reviews: Approval. Approval as submitted, no changes required. Conditional Approval or Modifications Required. The revised submission returned for review by an expedited reviewer. Refer for additional review by IRB member with the following area of expertise: Refer to IRB Chair. IRB Chair to resolve controverted issue(s) with PI. Refer to Full Board. PI not willing or not able to make requested changes. For Full Board Reviews: Approval. Approval as submitted, no changes required. Conditional Approval. Approval is subject to verification of specific requested revisions required to meet all approval criteria. Revisions submitted back to an expedited reviewer before final approval granted. Modifications Required. General changes submitted back to the full board). Disapproval (the submission is not approvable). Approval Period: on the assessed degree of risk and other factors outlined in (page 73-74), specify the approval period for this study: 12 months. If not 12 months, list the number of months (not to exceed 12): If less than 12 months, please explain: 1)
IRBMemberChecklistforFullorExpeditedReview06.25.2018.docx