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Procedures
The IRB is committed to making the submission process as smooth as possible. In this section, you will find definitions, explanations and procedures for submitting an application and any other form that may be required during the course of a study.If you have ...
Education & Resources
The goal of the IRB Education Program is to facilitate research involving human subjects from initial submission to study completion through didactic and practical education. Whether it is for investigators, research study personnel, students or other institut...
Training
The topics found below will provide various learning resources for common IRB items.If there is a topic that you would like to learn more about but do not see it listed below, please contact us at 402-559-6463 or at irbora@unmc.edu.
Single & Central IRB
RSS For applications with due dates on or after Jan 25, 2018, and contract solicitations published on or after Jan 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt Human Subjects Research(HSR) funded by the NI...
SROC
In accordance with all Federal Guidelines, the University of Nebraska and Board of Regents policy, the Scientific Research Oversight Committee (SROC) must review and approve all research using hESC lines and ONLY lines from the NIH Human Embryonic Stem Cell Re...
Forms
The following sections (located in the menu below will assist researchers by providing various tools and resources.The IRB uses an electronic IRB submission system referred to as RSS. Never used the system before? Check the RSS Training section to learn more.T...
Policies & Procedures
The IBC is committed to making the application and review process as easy as possible for you. In the sections within this chapter, you will find definitions, explanations, policies and procedures relating to biosafety guidelines at UNMC. Beyond the sections ...
IRB Staff
This section will detail contact information for both IRB Staff and IRB Chairs.
Grants
Effective sponsored project management is a collaboration among Principal Investigator(s); Departmental Administrators and other research staff; Sponsored Programs Administration (SPAdmin); and Sponsored Programs Accounting (SPAccting). SPAdmin Role Provid...
Industry Contracts
SPAdmin negotiates a wide range of research-related agreements on behalf of UNMC faculty-investigators and is a resource to help determine who can best support your contracting needs. SPAdmin Negotiation Process When a contract is initiated, either the PI or...
Clinical Trials
Information relevant to clinical trials can be found on the pages within this section. While SPAdmin is involved in parts of these projects, the majority of the effort is handled by UNeHealth and the CRC's clinical research billing team. UNeHealth (Industry-S...
About Us
Sponsored Programs Administration (SPAdmin) offers services to faculty and grant administrators to support their pursuit and management of external funding. SPAdmin is the official authorized signature authority of UNMC for sponsored program grants and contra...
Policies
Administration of sponsored programs requires compliance with applicable UNMC and sponsor policies. The order of precedence is as follows: Award terms & conditions Program guidelines Sponsor/Agency terms & conditions Uniform Guidance Plus any applica...
Technology Transfer
Technology transfer Technology transfer is the transfer of knowledge and discoveries to the public. It can occur through publications, educated students entering the workforce, exchanges at conferences, and relationships with industry, among other things. For...
Human Subjects Protection Training
Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information. Training-related content can be found withi...
Institutional Review Board
Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information.
Developing a Budget
Information pertaining to Human Subject Research, Institutional Review Board, and the Office of Regulatory Affairs is no longer updated in this handbook. Visit the IRB Guidebook for the most up-to-date information. Content related to developing a clinical...
Resources for Clinical Research
Introduction UNMC has developed many resources for clinical and translational research through the Center for Clinical and Translational Research (CCTR) as well as partnerships with other collaborators. Center for Clinical and Translational Research (CCTR) ...
Clinical Trial Monitoring
Data Safety Monitoring All human subject research should have an appropriate data safety monitoring plan to ensure subject safety regarding the risks, complexity, and nature of the research. Appropriate monitoring may include a data safety monitoring plan, as...
Managing Clinical Trials
ClinicalTrials.gov Registry Required Registration Registration is required for trials that meet the FDAAA 801 definition of an "applicable clinical trial" that include the following: Trials of drugs and biologics. Controlled clinical investigations, other...
Cancer Related Trials
Introduction The oncology Clinical Trials Office (CTO) provides central management and oversight functions for all cancer-related trials that involve human subjects conducted on campus. The CTO is staffed by project coordinators, research nurse coordinators, ...
Drug/Device Trials
Introduction All clinical trials that use an approved drug or investigational product supplied to the institution from a sponsor must have the protocol reviewed by the Medical Staff Pharmacy and Therapeutics Committee (P&T Committee). P&T Committee F...
Off-campus Trials
Special Considerations As the sponsor of a multi-center trial, additional considerations may be necessary, including the following: Choosing sites for the trial and ensuring that the sites: have the needed patient population conduct a feasibility assessm...
Training and Oversight
Training Requirements Federal regulations require institutions to provide training in the humane practice of animal care and use, and in instruction in research and testing methods that minimize the number of animals required to obtain valid results and to mi...
Institutional Animal Care and Use Committee
Key Contacts The Office of Regulatory Affairs (ORA) answers all questions and assists with the IACUC submission process. Web: unmc.edu/iacuc Phone: 402-559-6046 Email: iacucora@unmc.edu Research Requiring IACUC Approval Prior to project initiation, every...
Procurement and Management
Pricing Information Current pricing for Comparative Medicine charges can be found on the Comparative Medicine Pricing page. Ordering Animals Comparative Medicine uses a Web-interfaced system, the Comparative Medicine Business Management System (CMMS), for a...
Facilities
Available Facilities Comparative Medicine operates seven animal housing and/or support facilities. All facilities for housing animals are registered research facilities under the Animal Welfare Act and are inspected regularly by the United States Department ...
Core Facilities and Service Centers
Research Service Centers/Core Facilities To assist researchers in basic, translational and clinical research, UNMC provides extensive Core Facilities on campus. A directory of core facilities/service centers has been made available. In addition to institutio...
Research Support and Resources
Radiologic Images for Research Studies Can the institution upload radiology images electronically to send to a central lab? Yes. Who is responsible for uploading radiology images that I have to send to a central lab? Research coordinators and other study s...
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)
1.0 Purpose The purpose of this policy and procedure 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 human subject...
1.2 Authority Granted to the IRB by the Organization
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 conducted a...