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1.23 HRPP Training Requirements
Last Revised: 8/17/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and opportunities for training for all personnel involved in conducting human subject research. 2.0 Policy It is the policy of the Organization that ...
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 1/22/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s procedures for identification, management, and minimization or elimination of financial conflict of interest (COI) of responsible personnel, senior administrators, ...
1.26 PI Qualifications and Responsibilities
Last Revised: 6/27/2022 1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and responsibilities of the PI during the conduct of research within the Organization and at external sites under the PI’s protocol. 2.0 Policy It i...
1.27 Research Personnel Qualifications and Responsibilities
Last Revised: 2/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and responsibilities of personnel conducting research within the Organization and at external sites under the jurisdiction of the UNMC IRB. 2.0 Poli...
1.28 External Investigator Assurance
Last Revised: 12/3/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA) (also referred to as a “Collaborating Institutional Investigator Agreement”). 2.0 Policy It i...
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: 2/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for allowing observers at convened IRB meetings. 2.0 Policy 2.1. It is the policy of the Organization that non-members who have a leg...
1.32 Confidentiality of the Review Process
Last Reviewed: 1/12/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements and practices for assuring confidentiality of the process of review of human subjects research 2.0 Policy 2.1. It is the policy of t...
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: 10/13/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for: 1) submission of items required for full IRB review; 2) organization, scheduling, and conduct of full IRB meetings; 3) IRB approval criteria; 4)...
2.3 Expedited Review
Last Revised 1/24/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for using expedited review procedures for consideration of: new research proposals; continuing review of previously approved research; minor changes i...
2.4 IRB Review of Changes in Previously Approved Research
Last Revised 1/18/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB review of changes in previously approved research, including single subject protocol deviations. 2.0 Policy It is the policy of the Organizati...
2.5 Criteria for IRB Approval
Last Revised: 1/24/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s criteria for IRB approval for human subject research, reviewed both by the full convened IRB or thorough an expedited review process. 2.0 Policy It ...
2.6 Exempt Research
Last Revised: 1/7/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for determining if a research proposal is eligible for exemption under 45 CFR 46.104(d) and 21 CFR 56.104, with appropriate protections i...
2.7 Continuing Review of Research
Last Revised 1/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for continuing review of approved research 2.0 Policy It is the policy of the Organization that: 2.1. Non-exempt research which is subject to the Com...
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 1.0 Purpose The purpose of this policy is to describe the criteria for, and process of, closing an on-going human research study, and to describe the Organization’s requirements of investigators when studies are closed. 2.0 Policy It ...