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Clinical Trial Contracts
Getting Started Who can help me with industry-sponsored clinical trials? Your department administrator and the UNeHealth Contracts Office Associate should be notified as soon as you identify a study in which you plan to participate. Web: unmc.edu/spa/clinic...
Industry Sponsored Research
Who can help me with industry-sponsored research? Your department administrator and the SPAdmin Contracts Associate should be notified as soon as you identify a study in which you plan to participate. Web: unmc.edu/spa/contracts/non-clinical Phone: 402-559-...
1.1 Human Research Protection Program (HRPP)
Last Revised: 2/18/2026 1.0 Purpose The purpose of this policy is to provide a basic description of the Organization’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all hum...
1.2 Authority Granted to the IRB and/or the Office of Regulatory Affairs (ORA) by the Organization
Last Revised: 12/17/2025 1.0 Purpose The purpose of this policy is to describe the authority granted by the Organization for the IRBs and the Office of Regulatory Affairs (ORA) operating within the HRPP. 2.0 Policy It is the policy of the Organization that: ...
1.3 UNMC IRB Serving as the Single IRB for Multisite Research
Last Revised: 4/21/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: sIRB 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to serve as the Single...
1.4 UNMC Ceding Review to an External Central IRB
Last Revised: 5/15/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: cIRB 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to cede review to an e...
1.5 Requirements for Research Conducted with International Sites
Last Revised: 6/10/2026 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: International Research 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for research conducte...
1.6 IRB Composition, Leadership, Qualifications, and Responsibilities
Last Revised: 2/15/2025 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB composition, leadership, member qualifications, and responsibilities. 2.0 Policy It the policy of the Organization that the mem...
1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the identification and management of IRB member, consultant, staff and guest potential conflicts of interest. For the purpose of this policy, sta...
1.8 Investigational Activities Requiring IRB Review and Approval
Last Revised: 5/9/2023 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: What Requires IRB Review and Approval 1.0 Purpose The purpose of this policy is to describe the investigational activities that req...
1.9 Resources Necessary to Protect Subjects
Last Revised: 1/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resources that are necessary for human subject protection, care of research participants, and safety during the conduct of research. 2.0 Policy I...
1.10 Scientific and Other Committee Review of Research
Last Revised: 4/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for scientific and scholarly merit review, and for review by other component committees of the HRPP, of all non-exempt human subject research conducted...
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...
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...