Compliance and Policies
The Office of Research and Creative Activity manages several areas of compliance, including human subject research, animal subject research, research involving hazardous materials, conflicts of interest in research, responsible conduct of research education, export controls, and research integrity. For human subject research, animal research, and research involving hazardous materials, there are three regulatory compliance committees that are shared with the University of Nebraska Medical Center where the committees’ administrative offices are located. UNO faculty serve as campus representatives on these committees.
Human Subject Research
If you have questions regarding whether your research fits the definition of human subject research, or want to know if any exemptions apply, contact ORCA’s Research Compliance Officer, or submit the online form “Does My Project Require IRB Review?” directly to the IRB.
You may also consult the OHRP Decision Flow Charts to help you in making a determination; however, we still strongly recommend consultation with an IRB Administrator to assure compliance.
IRB Revised Common Rule
The changes to the Common Rule have significant and far-ranging effects on the regulation of human subject research at UNMC, Nebraska Medicine, UNO, Bellevue Medical Center, and Children's Hospital & Medical Center. Some of the revisions are more visible to investigators than others, including:
- Changes to consent form format and boilerplate language including the requirement for a "concise and focused presentation of the key information" (an "Executive Summary" no more than two pages).
- Elimination of the requirement for Continuing Review for certain classes of research.
All new research submitted on or after January 21, 2019, and any research submitted before January 21, 2019, but not approved is subject to the new rule.
The IRB has addressed the changes through an extensively revised IRB application compliant with the new rule, and with consent form templates available in RSS. We've worked hard to ensure investigators are covered.
To facilitate the transition to the new rule, applications already started may be continued and completed or may be transferred to the new online application.
Single IRB: The use of a single IRB of record for multi-site studies where each site will conduct the same protocol will help streamline the IRB review process and remove redundant hurdles to the initiation of such studies.
- Request to Rely on UNO/UNMC IRB: You must submit your single IRB request to the IRB by email to email@example.com, prior to submission.
- Relying on Another Institution's IRB: For multicenter studies, the central IRB is the IRB that conducts reviews on behalf of all study sites that agree to participate in the centralized review process. For sites at institutions that have an IRB that would ordinarily review research conducted at the site, the central IRB should reach agreement with the individual institutions participating in centralized review and those institutions' IRBs about how to apportion the review responsibilities between local IRBs and the central IRB (21 CFR 56.114). For more information about central IRB applications, please visit the Central IRB page.
Continuing Review Submission Change: Studies that require submission of the last-signed consent form with a Continuing Review no longer have to redact (remove) the subject’s name, initials or signature.
RSS Procedure Change: When a student submits an IRB application, the faculty advisor now must be listed on the application as a faculty advisor AND as a secondary investigator.
UNO Environmental Health and Safety is responsible for monitoring regulatory compliance and safety oversight of research programs that include biohazardous materials (e.g. human, animal or plant pathogens; human cell lines, blood or tissues), recombinant DNA/transgenic organisms, hazardous materials, and radioactive materials.
Conflicts of Interest in Research
Conflicts of Interest: The guiding principle of UNO's Conflicts of Interest (COI) policy is that apparent or actual conflicts of interest must be identified and managed and/or eliminated as appropriate. In many cases, disclosure of the COI constitutes management of the conflict. Certain federal agencies including NIH require current COI training and periodic disclosure at specific times during the proposal submission and award process. UNO requires disclosure of any conflicts by all employees and all persons who are "investigators", on University research projects or sponsored programs.
Mandatory Conflict of Interest Disclosure: In an effort to simplify the disclosure and record-keeping process, UNO has a module in MavGrants wherein all Conflict of Interest disclosures must be made on an annual basis. These disclosures are mandated by law for all Public Health Service (PHS) funding, and required of all faculty, professional staff, administrators, and others as set forth in UNO's COI Policy, regardless of funding source.
We appreciate your cooperation with this process and welcome questions.
Research Integrity and Misconduct: The University of Nebraska at Omaha is committed to maintaining an academic environment based on intellectual honesty and integrity. UNO expects ethical conduct from all those engaged in research. UNO is committed to preventing misconduct in research and creative activity, and supporting good faith efforts to intervene and remedy any such misconduct. UNO's policy on Integrity in Research and Creative Activity can be found here.
Misconduct in research means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
To report a concern or complaint about research compliance matters, please contact the Office of Research and Creative Activity at 402.554.2286, or the Research Compliance Officer at 4002.554.2702.
Responsible Conduct of Research (RCR): In response to a January 2010 federal certification requirement, the Office of Research and Creative Activity, with administrative support from the Office of Sponsored Programs and Research, oversees the delivery of appropriate training in the responsible and ethical conduct of research to undergraduate, graduate, and postdoctoral researchers who conduct research with the support of any National Science Foundation funding and certain types of National Institutes of Health funding. Further information on Responsible Conduct of Research:
Export control includes laws that regulate the transfer of controlled information outside the United States or to foreign persons in the United States. In recent years, attention to compliance with export control regulations has increased because of heightened security concerns, and leaks of U.S. technology to economic competitors.
All institutions of higher education and their faculty, staff, and students must comply with export control laws, which are designed to ensure that sensitive information, technology, software, biological and chemical agents, equipment, and know-how are not employed for purposes other than their intended use. In case of violations, criminal sanctions, including substantial fines and even prison terms, can be applied. Further information on Export Controls:
- Educational Export Control Training Video (approximately 2 minutes)
- UNO Export Control Policy
- International Travel Checklist
- Best Practices for Academic Traveling Overseas
Export Control Training
Purpose: It is the policy of the University of Nebraska at Omaha (UNO) that all personnel involved in or supporting export-controlled activities comply with all applicable U.S. laws and regulations while teaching, conducting research, or participating in other activities at or on behalf of the university. In order to promote compliance with federal laws and regulations governing exports (collectively, “export controls”), UNO provides a training regimen for personnel who do or may engage in activities subject to export controls.
Such personnel must complete training through the Collaborative Institutional Training Initiative Program (CITI), an online training platform. The Export Control Office (ECO) requires a passing score of 80% for each assigned module to validate training through CITI.
Scope: This program applies to all UNO personnel engaged in or proposing to engage in activities subject to export controls. Activities subject to export controls include, without limitation:
- Research subject to restrictions on the dissemination of results;
- Research subject to restrictions on participation by foreign persons;
- Research involving the use of items subject to export controls;
- Travel to embargoed or sanctioned countries for the purpose of conducting, presenting, or otherwise supporting research or other activities on behalf of UNO;
- Travel to destinations subject to U.S. State Department Level 3 or 4 travel advisories for the purpose of conducting, presenting, or otherwise supporting research or other activities on behalf of UNO;
- Establishing institutional relationships with restricted entities, or entities in embargoed or sanctioned countries; and
- Exporting controlled items, including international travel with items subject to export controls, and deemed exports.
Cohort 1: Research and Academic Personnel (Key Research Personnel, Departmental Research Administrators, Deans, Chiefs, and Associate Deans for Research)
Cohort 2: Administrative Personnel (ORCA, Purchasing, Information Technology Security, Human Resources, Environmental Health and Safety, International Programs administrators, Staff/Administrators screening international students, visiting faculty, graduate students, post-docs)
Cohort 3: Other Personnel (faculty, staff, and students who travel internationally—especially to embargoed countries—or provide support for export-controlled activities that does not place them in another cohort)
Cohort 4: Export Control Office (personnel in the ECO must stay up to date on regulatory and policy changes, and therefore must complete all CITI EC modules)
- Required modules are marked with a red R. All required modules must be completed to fulfill the cohort’s training requirements.
- Elective modules are marked by a yellow E. The ECO may assign elective modules in addition to a cohort’s required modules, depending on the nature and sensitivity of the activity triggering the training requirement.
- Supplemental modules, marked by a green S, may be completed voluntarily in addition to any required and elective modules.
For more information about the training program, its requirements, and details about each cohort, see the Export Control Training Program outline.
For more detailed information about international shipping, visit the Transporting & Shipping Internationally site.
All international shipments should be accompanied by a Request for Export Controls Review Application. Including a completed form with the international package will help prevent unnecessary delays for the shipment.
The University of Nebraska’s Export Control Director, Sam Padilla, is available to help all NU campuses maintain compliance with export control regulations. For export control and international shipping questions, please contact Sam at firstname.lastname@example.org, or contact UNO’s Research Compliance Officer, Brenda Kolobara, at email@example.com.
Other Regulatory Compliance
Uniform Guidance: The Uniform Guidance (UG) applies to all new federal awards issued on or after December 26, 2014. Modifications adding new funding to awards issued prior to that date may also include a clause updating the terms of the award to fall under UG.
On December 26, 2013, the Office of Management and Budget (OMB) released its final rule of “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” (2 CFR Chapters I, II, Part 200, et al), and later provided interim updates. This guidance to federal agencies consolidates and replaces eight OMB Circulars such as the A-110 (Administrative requirements), A-21 (Cost principles), and A-133 (Audit requirements).
Further information on Uniform Guidance can be found here.
Intellectual Property: Intellectual Property (IP) includes inventions and other creative works and/or materials that may be protected under the patent, trademark, and/or copyright laws. The Board of Regents owns all inventions made by UNO employees while working under a grant or contract to UNO, or while using UNO resources. Further information on Intellectual Property:
Whistleblowing is defined as disclosing information that you reasonably believe is evident of gross mismanagement of a federal contract or grant, including gross waste of federal funds, abuse of authority relating to a federal contract or grant, danger to public health or safety, or a violation of law, rule, or regulation related to a federal contract or grant. UNO employees being paid from federally funded projects cannot be discharged, demoted, or otherwise discriminated against for whistleblowing. Further information can be found here.