IRB EXPEDITED REVIEW TEMPLATE 10/2016 Reviewer: Date of Review: Principal Investigator: Are there any Concerns Regarding Financial Conflict of Interest? No Yes Protocol Title: Materials Reviewed: General Review Comments: Expedited Review Category Determined By Reviewer (select 1-7 from page 5):______ Review Type: Recommendation: Approval Period: Annual Approve as presented Initial Six Months Approve with required changes Re-Review Defer to Full Board Continuing Review Modification, reason(s): Review: Scientific Hypothesis and Design (Required) Acceptable Risks to Subjects are Minimized 45 CFR 46.111.1-2 Needs Changes/Clarifications: and Risk/Benefit Ratio is For Overall Study acceptable. N/A 45 CFR 46.111.1-2 For devices only: Risks to Non-significant Risk Device Subjects are Minimized and Devices: separate Significant Risk Device Risk/Benefit Ratio is acceptable. vote on SR vs. NSR Needs Changes/Clarifications: N/A An Adequate Data & Safety 45 CFR 46.111.6 Acceptable Monitoring Plan is in Place (for Needs Changes/Clarifications: greater than minimal risk) Subject Population (Required) Acceptable 45 CFR 46.111.3 Selection of Subjects is Needs Changes/Clarifications: Equitable Acceptable 45 CFR 46.111.7 Privacy of Subjects is Needs Changes/Clarifications: Adequately Protected Acceptable Other: Needs Changes/Clarifications: Informed Consent (Required) Acceptable 45 CFR 46.111.4-5 Informed Consent will be Waiver/Alteration of Consent is Requested Sought/ Documented Reconsent? If so, when/how: Needs Clarifications: N/A Elements of Informed Consent 45 CFR Acceptable 46.116(a)(b) are Included in Consent Form Needs Changes/Clarifications: (complete checklist below)
IRB EXPEDITED REVIEW TEMPLATE 10/2016 Reviewer: Date of Review: Principal Investigator: Are there any Concerns Regarding Financial Conflict of Interest? No Yes Protocol Title: Materials Reviewed: General Review Comments: Expedited Review Category Determined By Reviewer (select 1-7 from page 5):______ Recommendation: Approval Period: Review Type: Approve as presented Annual Initial Approve with required changes Six Months Re-Review Defer to Full Board Continuing Review Modification, reason(s): Review: Scientific Hypothesis and Design (Required) 45 CFR 46.111.1-2 For Overall Study Risks to Subjects are Minimized and Risk/Benefit Ratio is acceptable. Acceptable Needs Changes/Clarifications: 45 CFR 46.111.1-2 Devices: separate vote on SR vs. NSR For devices only: Risks to Subjects are Minimized and Risk/Benefit Ratio is acceptable. N/A Non-significant Risk Device Significant Risk Device Needs Changes/Clarifications: 45 CFR 46.111.6 An Adequate Data & Safety Monitoring Plan is in Place (for greater than minimal risk) N/A Acceptable Needs Changes/Clarifications: Subject Population (Required) 45 CFR 46.111.3 Selection of Subjects is Equitable Acceptable Needs Changes/Clarifications: 45 CFR 46.111.7 Privacy of Subjects is Adequately Protected Acceptable Needs Changes/Clarifications: Other: Acceptable Needs Changes/Clarifications: Informed Consent (Required) 45 CFR 46.111.4-5 Informed Consent will be Sought/ Documented Acceptable Waiver/Alteration of Consent is Requested Reconsent? If so, when/how: Needs Clarifications: 45 CFR 46.116(a)(b) Elements of Informed Consent are Included in Consent Form (complete checklist below) N/A Acceptable Needs Changes/Clarifications: