Office of Research Compliance Services

Institutional Review Board, Export Controls, Conflict of Interest, Responsible Conduct of Research & Research Misconduct

General # 402-472-6965

Institutional Review Board (IRB)

Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains:

• Data through intervention or interaction with the individual, or• Identifiable private information

IRB Guidebook includes:• Explanations of the Regulations• NUgrant• Terminology• Pointers Available On-line at:http://research.unl.edu/orr/forms.shtml

Hard copies are also available.

Points of Contact:Steve Goddard: Institutional OfficialSara Frizzell: RCS DirectorRachel Wenzl: Full Board and Expedited projectsBecky Freeman: Exempt projects/IRB trainingsLindsey Arneson: Expedited and Exempt projects

Review Categories:• Exempt: Don’t let the name fool you, still requires IRB review but much less rigorous. 6 exempt

categories. -Examples are anonymous surveys or interviews, retrospective chart review, passive observation of published behavior without collecting identifiers.

• Expedited: 9 categories, collection of data that’s not anonymous and involves no more than minimal risk. -Examples are studies of blood samples from healthy volunteers, analysis of voice recordings, study of existing pathological specimens with patient identifiers. Allows IRB Chair or members of the IRB to evaluate and approve the research.

• Full Board: Human subjects research which does not fall under exempt or expedited categories must be submitted for full-board review. Specific monthly meeting dates and application submission deadlines-on below website!

Policies, Guidance, and Forms Page (template docs, policies/procedures/guidance docs):

http://research.unl.edu/researchresponsibility

Submission of IRB applications/protocols via NuGrant.

Training requirements satisfied via CITI (citiprogram.org)

Export Controls• All institutions of higher education and their faculty, staff, and students must

comply with export controls, 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.

• Export regulations apply to all research activities, including grants, contracts and cooperative agreements. They also apply to all other aspects of the university – for example, in downloading of and gaining access to certain software programs.

• Fortunately, most UNL research activities are excluded from export controls by the fundamental research exemption. Fundamental research is defined as “basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community.” However, proprietary research and industrial development, design, production and product use, the results of which ordinarily are restricted for proprietary or national security reasons, are subject to export control regulations and are not exempt under the fundamental research exception.

Points of contact:Steve Goddard: Empowered OfficialSara Frizzell: RCS DirectorLissette Gilster: Export Control Coordinator

Main Regulatory Offices:

ITAR: Administered by US Dept of State. Any defense articles, defense services, and related technical data are regulated under this list, where a license is required to export goods and technologies contained in this list, including deemed exports. (Think research with military applications)

EAR: Administered by US Dept of Commerce Bureau of Industry and Security (BIS). Control export of “dual-use” items, those that have a commercial or non-military use and that also have the potential to be used in some way for defense-related purposes.

OFAC: Administered by the US Dept of Treasury. Enforces economic and trade sanctions based on the US foreign policy and national security goals against targeted foreign countries and regimes, terrorists, international narcotics traffickers, those engaged in activities related to the proliferation of WMDs and other threats to national security

How do these regulations apply to you?

-If you think your research is controlled (not freely publishable, foreign national restrictions, specific contract or grants where it references export controls, shipping items, collaboration, proprietary info, biological, chemical, encryption)

-If you are traveling internationally please complete a travel checklist before you travel: http://research.unl.edu/orr/docs/InternationalTravelChecklist.pdf

UNL EC website: http://research.unl.edu/researchresponsibility/export-control/

UNL EC policy: http://research.unl.edu/researchresponsibility/wp-content/uploads/sites/10/2013/06/ExportControlManagementPolicy.pdf

Please contact us! These regulations can be very difficult to navigate and we are happy to help you!

Conflicts of InterestConflicts of Interest are situations where a Covered Person’s direct or indirect personal financial interests may compromise, or have the appearance of compromising, the Covered Person’s professional judgment or behavior in carrying out his or her obligations to the University of Nebraska-Lincoln. This includes indirect personal financial interests of a Covered Person that may be obtained through third parties such as a Covered Person’s Immediate Family, business relationships, fiduciary relationships, or investments.

Covered Person means:

1) University administrative officers and employees, specifically including any University employees with delegated signature, purchasing or contracting authority on behalf of the University;

2)  University employees and faculty engaged in outside employment or other activities specified in this policy (technology transfer/use of University facilities or equipment) that may create a Conflict of Interest; and

3)  Sponsored Research investigators, including University employees, faculty, staff and support personnel (managerial/professional and office/service positions), volunteers, trainees, students, contractors and other persons under the direct control of the University of Nebraska, whether paid by the University of Nebraska or not, who participate in Sponsored Research as defined in Section 6 of the Board of Regents policy 3.2.8.

• UNL Conflict of Interest policy: http://research.unl.edu/orr/docs/UNL%20Conflict%20of%20Interest%20in%20Research%20Policy.pdf

• UNL COI website: http://research.unl.edu/researchresponsibility/conflict-of-interest /

• BOR Policy 3.2.8: “No employee of the University shall engage in any activity that in any way conflicts with duties and responsibilities at the University of Nebraska. The Board of Regents has adopted Regents Policy 3.2.8 and authorized the implementation of related policies and directives to properly avoid, disclose and manage potential conflicts of interest. (Outside Activities)

• Disclosure mechanism is the Interest and Outside Activity Reporting Form (IOARF) found on nugrant.unl.edu in the IAM module.

• CITI COI training is required for all those who are PHS funded (citiprogram.org)

Points of Contact:

Sara Frizzell: RCS Director

Stefani Brooks: Conflict of Interest Coordinator

Responsible Conduct of Research

The Responsible Conduct of Research (RCR) is a training initiative to educate undergraduates and graduate students, postdoctoral researchers, research staff and faculty. RCR is required when receiving funding from the National Science Foundation, the U.S. Department of Agriculture-National Institute of Food and Agriculture, and the National Institutes of Health.

At UNL, RCR training is primarily completed via online CITI RCR training modules (citiprogram.org). Topics covered include:

• Overview of Responsible Conduct of Research• Data management• Authorship• Mentoring• Peer review• Collaborative science• Conflict of interest• Data acquisition and monitoring• Ethics and regulations of research with humans and animals• The scientist as a responsible member of society• Export controls

Points of Contact:Steve Goddard & Sara Frizzell

NIH 8 Hour In-Person Training: Please note that the NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.  This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011.  This Notice applies to the following programs:  D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00,  KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R.   This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

All other awards with RCR training requirements can be satisfied via completion of the online CITI RCR training course.

UNL RCR website: http://research.unl.edu/researchresponsibility/responsible-conduct-of-research/

Research MisconductMisconduct in research harms the individuals directly responsible for the misconduct, but also threatens the integrity of department, college, university, and broader scientific community.   University policies and procedures regarding misconduct encompass the definition of what constitutes misconduct, the process of investigating misconduct and consequences of research misconduct.

According to the Office of Science & Technology of the President (OSTP):

“Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”

If an allegation is assessed by the RIO and determined to meet the definition of research misconduct and has supporting evidence, then the misconduct procedure follows with an inquiry, investigation, and determination.

Points of Contact: Steve Goddard: Research Integrity Officer (RIO) Sara Frizzell: RCS Director

Fabrication is making up data or results and recording or reporting them.

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Research misconduct does not include honest error or differences of opinion.

Authorship disputes are not research misconduct!

UNL research misconduct policy: http://research.unl.edu/orr/docs/PolicyforRespondingtoAllegationsofResMisconduct.pdf