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1.23 HRPP Training Requirements
Last Revised: 8/13/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and opportunities for training personnel conducting human subject research. 2.0 Policy It is the policy of the Organization that all personnel invo...
1.24 HRPP Training Requirements for IRB Members
Last Revised: 7/14/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for training for IRB members and alternates. 2.0 Policy It is the policy of the Organization that IRB members and alternates will be qualified throug...
1.25 Financial Conflicts of Interest
Last Revised: 9/15/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Financial COIs 1.0 Purpose The purpose of this policy is to describe the Organization’s procedures for identification, management,...
1.26 PI Qualifications and Responsibilities
Last Revised: 6/11/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: PI Qualifications and Responsibilities 1.0 Purpose The purpose of this policy is to describe the qualifications and responsibiliti...
1.27 Research Personnel Qualifications and Responsibilities
Last Revised: 11/26/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Research Personnel Qualifications and Responsibilities 1.0 Purpose The purpose of this policy is to describe the qualifications a...
1.28 External Investigator Assurance
Last Revised: 10/7/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for initiating a collaborating individual or institutional investigator agreement (previously External Investigator Agreement; XIA). 2.0 Policy It is...
1.29 ClinicalTrials.gov Reporting
Last Revised: 3/20/2023 1.0. Purpose The purpose of this policy is to describe the requirements for registration and compliance with ClinicalTrials.gov. 2.0. Policy It is the policy of the Organization that: 2.1. FDA regulated trials that meet the definit...
1.30 Use of the Rapid Response IRB
Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution of, the criteria for use of, and the procedures for review by, the Rapid Response IRB (RR-IRB; IRB-03). 2.0 Policy It is the policy of the Organization that 2.1. ...
1.31 Observers at IRB Meetings
Last Revised: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for allowing observers at a convened IRB meeting. For this policy, potential IRB members and persons who routinely attend to represent another regul...
1.32 Confidentiality of the Review Process
Last Reviewed: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and practices for assuring confidentiality of the process of review of human subjects research 2.0 Policy It is the policy of the Organization that...
1.33 Posting of Clinical Trial Consent Forms
Last Revised: 9/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for posting of clinical trial consent forms, per requirements of 45 CFR 46.116(h). 2.0 Policy 2.1. It is the policy of the Organizati...
2.1 Submission for Items for Review by the IRB
Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requirements for submission and pre-review of all applications and research related forms and reports. 2.0 Policy It is the policy of the Organization that all submis...
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: 1/24/2018 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 and procedure is to describe the Organization’s criteria for IRB appr...
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...