Advanced Search
Search Results
284 total results found
Policies
1.11 HRPP Access to Legal Counsel
Last Revised: 2/11/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law. 2.0 Policy It is the policy of the Organization that ...
1.12 Sponsored Research
Revised: 6/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for research sponsored by an external funding agency or commercial sponsor for which the UNMC IRB is the IRB of record. Organization and Sponsor requireme...
Investigator Toolkit
1.13 Compliance with ICH-GCP Guidelines
Last Revised: 10/17/2025 1.0. Purpose The purpose of this policy is to describe the Organization’s requirements for compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6 Guidelines. 2.0. Policy It is the policy of...
1.14 Research Subject to Department of Defense Regulatory Requirements
Last Revised: 1/10/2024 1.0 Purpose The purpose of this policy and procedure is to specify the Organization’s requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Defense (DoD) and...
1.15 Research Subject to Department of Justice Regulatory Requirements
Last Revised: 11/12/2025 1.0 Purpose The purpose of this policy is to specify the Organizations requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Justice (DoJ) and the Federal B...
1.16 ORA Record Keeping Requirements
Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities. Retention of records by the investigator is described in HRPP policy 1.17 (Retention of R...
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: 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...