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1.17 Retention of Research Records
Last Revised: 12/17/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Retention of Research Records 1.0 Purpose The purpose of this policy is to describe the requirements for retention of research re...
1.18 Review and Approval of HRPP Policies
Last Revised: 11/13/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the review and approval of HRPP policies. 2.0 Policy It is the policy of the Organization to continually assess the adequacy of existent policie...
1.19 IRB Signature Authority
Last Revised: 2/18/2026 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granting signature authority for Office of Regulatory Affairs (ORA) and IRB correspondence. 2.0 Policy It is the policy of the Organization that ...
1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)
Last Revised: 1/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s outreach activities to enhance the public’s understanding of research, obtain feedback about any community concerns, disseminate results of research conducted by t...
1.21 Post-Approval Monitoring of Research
Last Revised: 11/17/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Post-Approval Monitoring of Research 1.0. Purpose The purpose of this policy is to describe the Organization’s requirements for p...
1.22 Assessment of the Effectiveness and Efficiency of the HRPP
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for assessment of the quality, effectiveness, efficiency and support of the Organization’s HRPP in carrying out its mission to ensure protection of hu...
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 and IRB Analysts
Last Revised: 3/4/2026 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for training for IRB members and alternates, and IRB Analysts. 2.0 Policy It is the policy of the Organization that IRB members and alternates, and IR...
1.25 Financial Conflicts of Interest
Last Revised: 8/17/2026 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: 3/9/2026 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 definition ...
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: 3/16/2026 1.0 Purpose The purpose of this policy 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 Organization that, for n...
2.1 Submission for Items for Review by the IRB
Last Revised: 6/26/2026 1.0 Purpose The purpose of this policy is to describe Organization’s requirements for submission and processing of applications and research related forms and reports for review by the IRB/ORA. 2.0 Policy It is the policy of the Organi...