Research Compliance

Research Compliance

For human subject research, and research involving hazardous materials, there are two 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. For animal subject research, the regulatory compliance committee is a UNO-only committee, with its office on UNO’s campus. Finally, 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.

The following links provide additional information about each of this regulatory compliance committees and offices:

Area	Overview
Institutional Review Board for the Protection of Human Subjects (IRB)	The IRB assures the protection of all human subjects in research projects conducted by anyone on the premises of UNO and provides oversight for all research that is conducted elsewhere by UNO faculty, students, staff, or other representatives. The IRB also protects the investigator and the institution through a comprehensive review process. All human subject research must be reviewed and approved by the IRB prior to beginning such research.
Institutional Animal Care and Use Committee (IACUC)	The IACUC assists faculty, students, and staff in upholding UNO’s determination to assure the finest care and most humane utilization of our laboratory animals. To this end, every research, testing, and teaching project involving the use of a live, vertebrate animal must be reviewed and approved by the IACUC prior to initiation.
Institutional Biosafety Committee (IBC)	The IBC ensures the health and safety of all personnel working with biohazardous agents. The IBC makes certain that research conducted at the Institution is in compliance with federal guidelines and policies and reviews individual research proposals for biosafety concerns. Any research involving hazardous or biohazardous materials (e.g. human, animal or plant pathogens; human cell lines, blood or tissues), recombinant DNA or transgenic organisms (plants or animals) must be submitted to the IBC for review and approval prior to beginning such research.
Environmental Health and Safety (EHS)	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.

National Institutes of Health (NIH) Proposal Requirements - Human Subjects

This guidance is to assist researchers in determining whether their research requires IRB approval, and more specifically, in meeting the 2018 NIH funding submission requirements. It does not address every aspect of the proposal questions that focus on human subjects’ research. It is meant to help address the questions or requirements that the NIH has changed or required further clarification at the time of proposal.

Below, there is also guidance for Data and Safety Monitoring, and IRB policy requirements regarding clinical trials.

*NOTE: Please remember that age of majority in Nebraska is 19 y/o. Thus, those younger than 19 are considered to be children and your project and IRB determination must address the vulnerable population information in the proposal if children are included.*

Guidance and/or Resources:

NIH Proposal Guidance: General Instructions for NIH and Other PHS Agencies; Definition of Human Subjects Research | grants.nih.gov

For information on: Exempt Studies, Clinical Trials, Data and Safety Monitoring

Decision Tool: Does my project require IRB review?

Information on IRB pilot testing

All of these criteria must be satisfied for something to be characterized as "pilot testing"

1. Pilot testing is limited to interventions intended to test the equipment or the methodology, or to refine the parameters of the protocol, or to train the student to use the equipment.
2. The pilot testing is not explicitly named as one of the aims of the research.
3. The data generated from the pilot testing is not retained after the completion of the specific goals of the pilot testing (as in #1 above)
4. The data generated from the pilot testing is not presented in any public format (abstract, poster, or publication) nor used as background material for a grant application or similar purpose.
5. Pilot testing will only involve healthy volunteers (preferably research staff) as participants.
6. Pilot testing procedures constitute no greater than minimal risk to participants

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

For examples of things that are minimal risk, see the list here

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).

Read more about Uniform Guidance.

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:

• Invention Disclosure Form

• UNO Copyright Form

• Trademark Disclosure Form

• Board of Regents Bylaw 3.10

• Board of Regents Policy 4.4.1

• Board of Regents Policy 4.4.2

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.