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1.0 Purpose The purpose of this policy and procedure is to describe the authority granted by the Organization for the IRBs operating within the HRPP. 2.0 Policy It is the policy of the Organization that: 2.1 All research involving human subjects conducte...

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to serve as the Single IRB (SIRB) for multisite research. 2.0 Policy It is the policy of the Organization that: 2.1. The UNMC IRB may serve as the SIRB for...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for the UNMC IRB to cede review to an external IRB. 2.0 Policy 2.1. It is the policy of the Organization that all non-exempt research under the authority of ...

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for research conducted with international sites. For the purposes of this policy, “Research conducted with International Sites” (international research) is defined as (1) r...

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 membership of its IRBs wi...

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, staff refers to IRB Analys...

1.0 Purpose The purpose of this policy is to describe the investigational activities that require IRB approval. 2.0 Policy It is the policy of the Organization that: 2.1. IRB review and approval is required for research involving human subjects which falls...

1.0 Purpose The purpose of this policy and procedure 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 2.1. It i...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for scientific and scholarly merit review, and review by other component committees of the HRPP, of all human subject research protocols (see HRPP policy 1.9 R...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law as needed. 2.0 Policy It is the policy of the Organization tha...

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 requirements when the UNMC ...

1.0 Purpose The purpose of this policy and procedure 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 2.1. It is the policy of the O...

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 the U.S. Department of...

1.0 Purpose The purpose of this policy and procedure 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 Bureau of P...

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 Research Records). 2.0 P...

1.0 Purpose The purpose of this policy is to describe the requirements for retention of research records by the investigator. 2.0 Policy It is the policy of the Organization that all research records must be maintained and stored securely, in accordance wit...

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 policies in consideration of new...

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 Organization’s policy that the IRB Executive Chair, th...

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 the Organization and enc...

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requirements for post approval monitoring of research. 2.0 Policy 2.1. It is the policy of the Organization that a Post Approval Monitoring Program will be conducted in o...