Search Results

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 human subjects and compli...

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 all personnel involved...

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 through initial and continui...

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, and the Organization i...

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 is the policy of the Or...

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 Policy It is the policy of...

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 is the policy of the Or...

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 of an "applicable ...

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. The Rapid Response IRB (...

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 legitimate reason, may be a...

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 the Organization that the ...

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 Organization that, for clinical tr...

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 submissions will be processe...

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) IRB actions; and 5) IRB...

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 in protocol; minor c...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review of changes in previously approved research, including single subject protocol deviations. 2.0 Policy 2.1. It is the policy of the Organization...

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 is the policy of the O...

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 in place for research s...

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 Common Rule or FDA Regul...

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 described in 45 CFR 46.104(d...