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2.2 Full IRB Review
Last Revised: 6/12/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Full Board Review 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for: 1) submission of item...
2.3 Expedited Review
Last Revised 1/24/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Expedited Review 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for using expedited review p...
2.4 IRB Review of Changes in Previously Approved Research
Last Revised 1/18/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Change Requests 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB review of changes in ...
2.5 Criteria for IRB Approval
Last Revised: 8/5/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: IRB Approval Criteria 1.0 Purpose The purpose of this policy is to describe the Organization’s criteria for approval of human subje...
2.6 Exempt Research
Last Revised: 1/7/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Exempt Research 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for determining...
2.7 Continuing Review of Research
Last Revised 1/12/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Continuing Review 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for continuing review of ap...
2.8 Limited IRB Review
Last Revised: 6/5/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and procedure for limited IRB review. 2.0 Policy It is the policy of the Organization that the Organization does not utilize limited review as describ...
2.9 Closure of On-Going Research
Last Revised: 08/10/2023 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Closure of Research 1.0 Purpose The purpose of this policy is to describe the criteria for, and process of, closing an on-going h...
3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI
Last Revised: 1/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for determining the need for: 1) IRB review more often than annually, 2) increased monitoring, and 3) verification from sources other tha...
3.2 Data and Safety Monitoring
Last Revised 8/19/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Data and Safety Monitoring 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data and safet...
3.3 Privacy Interests and Confidentiality of Research Data
Last Revised 1/21/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Confidentiality For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Privacy 1...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Using PHI in Research 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for ensur...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Advertisements 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for recruitment of subjects t...
3.6 Subject Recruitment Through Direct Invitation
Last Revised: 3/12/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Recruitment 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for subject recruitment through ...
3.7 Finder’s Fees and Recruitment Bonuses
Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements related to finder’s fees and recruitment bonuses. 2.0 Policy HHS regulations at 45 CFR 46.116 and FDA regulations at 21 CFR 56.116 requ...
3.8 Research Subject Compensation and Reimbursement
Last Revised: 4/1/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Compensation For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Reimbursemen...
3.9 Contraception Requirements
Last Revised: 5/5/2025 1.0 Purpose The purpose of this policy is to describe the contraception requirements for subjects participating in research involving drugs, devices or biologics. 2.0 Policy It is the policy of the Organization that subjects must utiliz...
3.10 Pregnancy Testing
Last Revised: 7/9/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Pregnancy Testing 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for determining how and whe...