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The public looks to university research as an independent, unbiased source of information. Because some university researchers also have private interests in entities that contribute to research, the federal government, the state of Nebraska, and UNL require disclosure of financial interests.

UNL requires disclosure of interests that appear to be related to your institutional responsibilities.  The following FAQs help to address any questions that you may have about the COI process at UNL:

What is a conflict of interest?

Broadly speaking, a conflict of interest is a situation in which a secondary interest may improperly influence or bias a primary interest. In the sponsored research setting, we are focused on ways in which personal financial interests may improperly influence the design, conduct, or reporting of research.

It is important to note that a conflict of interest is a situation. It does not mean an individual’s behavior is necessarily biased. Even a perceived conflict of interest, if unmanaged, can compromise the public’s trust in research results.

Who must disclose financial interests?

A UNL Interest and Outside Activity Reporting Form must be completed annually through NUgrant by all UNL faculty, staff, students and affiliates involved in research.

Why must I disclose?

Federal regulations require institutions that receive federal funding to establish policies and guidelines for the management of potential conflicts of interest. The purpose of these policies and procedures is to protect the credibility and integrity of UNL and to foster public trust and confidence.

The disclosure process is not intended to discourage participation in activities outside of UNL.

What financial interests must be disclosed?

Financial interests that reasonably appear to be related to your institutional responsibilities must be disclosed on an annual basis by filing an Interest and Outside Activity Reporting Form (IOARF) on NUgrant. Financial interests include, but are not limited to:

Such financial interests include interests related to a covered person’s immediate family, business relationships, fiduciary relationships, or investments.

What constitutes a significant financial interest that may require management?

Per the federal guidelines for Promoting Objectivity in Research (42 CFR 50 Subpart F), a significant financial interest (SFI) is defined as “A financial interest consisting of one or more of the following…that reasonably appears to be related to the Investigator’s institutional responsibilities”:

To apply the criteria to your own situation, visit the FCOI Assessment Flowchart found HERE.

Are there exceptions to what must be disclosed?

The following interests are not considered significant financial interests and do not need to be disclosed:

What are “institutional responsibilities”?

“Institutional responsibilities” are activities such as procurement, research, teaching, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Who is included in the definition of “immediate family”?

Immediate family is defined as your spouse, child, parent, brother, sister, grandchild, or grandparent, by blood, marriage, or adoption, or an individual who is your Adult Designee for purposes of employment benefits. Therefore, interests held by the parents of your spouse would be considered financial interests that would need to be disclosed if they are related to your institutional responsibilities.

Would I need to disclose income received from international universities or non-profit agencies?

Yes. Payments received from entities that are not exempt from the disclosure requirement (see above) must be disclosed.

If part of my salary is funded by a grant, would I need to disclose such a payment?

Funding that is routed through the appropriate University channels (such as the Office of Sponsored Programs) does not need to be reported. All payments you receive directly from an outside entity must be disclosed if they appear to be related to your institutional responsibilities.

What is the disclosure process?

Complete an Interest and Outside Activity Reporting Form (IOARF) prior to engaging in research. Disclose all interests and outside activities related to your institutional responsibilities at least annually.

How do I complete the Interest and Outside Activity Reporting Form?

Login to NUgrant using your UNL credentials. On the homepage, click on [add new] under the heading Interest and Activity Management to start a new form.

If you still have a question about completing the form, contact the COI Coordinator (2-6907, or, unlcoi@unledu) in Research Compliance Services.

What is the review process?

Your IOARF will be routed to your department chair/director and dean. It will then go to the Conflict of Interest Coordinator for review of financial interests and to your appropriate vice chancellor-level reviewer for review of outside activities. Often, disclosure of financial interests is sufficient. In situations where potential conflicts of interest must be managed beyond disclosure, Research Compliance Services will work with you to present your conflict to the Conflict of Interest in Research Committee to develop a custom management plan.

How are conflicts of interest managed?

Dependent on information disclosed, management plans can include, but are not limited to, disclosure in publications and presentations, internal peer review, or safeguards for students.

What should I do if my financial interests change prior to the expiration of my Interest and Outside Activity Reporting Form?

Your IOARF is valid for one year from the approval date. If your financial interests or circumstances change during the annual reporting period, a new IOARF should be completed to update your disclosure within 30 days of a change in your outside interests. The information from your previous form will be pre-populated so that you may quickly and easily make changes.

Can a conflict of interest delay or prevent me from doing research?

When conflicts of interest are properly disclosed and managed, it generally does not prevent you from conducting research. Delays in the ability to conduct research may occur, however, if you do not complete the IOARF and/or training in a timely manner or if you omit relevant interests from the form.

Do I need to complete an Interest and Outside Activity Reporting Form even if I do not have any outside interests related to my research activities?

Yes. An IOARF must be completed by each individual meeting the description of a covered person (above), even if they do not have any outside interests to disclose.

How should individuals that are not affiliated with UNL disclose outside interests?

Contact the COI Coordinator (2-6907, or Research Compliance Services to first ensure that you need to file a disclosure with UNL.

If you collaborate on a PHS funded UNL sponsored research project, but your institution does not maintain and enforce a conflict of interest policy in compliance with federal regulations, UNL may request that you complete the UNL Collaborator Interest Reporting Form and CITI conflict of interest training.

Are there penalties for not updating my Interest and Outside Activity Reporting Form within 30 days of a change in financial interests?

Maintaining an accurate and up-to-date IOARF is crucial in ensuring that UNL complies with state and federal reporting regulations. Failure to update your IOARF may result in loss of sponsored research funds and may require the University to conduct a retrospective review of the research to ensure no bias has been introduced into research activities.

Are there special guidelines for SBIR/STTR awards?

Many government agencies provide funding to small businesses to encourage R&D and the possible commercialization of ideas. They distribute these funds directly to the Small Business Concern (SBC) through one of two funding mechanisms:

The following agencies maintain SBIR and STTR programs. Please visit the respective websites for specific agency guidelines and solicitations.

SBIR participating agencies

STTR participating agencies

Restriction on SBIR/STTR PI role

At the University of Nebraska – Lincoln, a researcher may not serve as both the small business PI and the university PI. Some limited exceptions to these restrictions may apply, however, most university researchers have 100% of their time committed to their academic, research, and other commitments at UNL, and therefore, do not have the effort available to meet the requirements of serving as the company PI of an SBIR or STTR while also serving as the university PI.

Although these are collaborative awards, the STTR/SBIR policy, instructions, and effort requirements make it clear that a separation of roles is important. The company and collaborating institution are referred to as separate parties. Having the same individual as PI on both sides of the collaboration blurs the respective parties’ effort commitments and creates the concern for conflicts of interest.

Primary Employment Requirement

Per the guidelines, the PI of the company side of an SBIR award (and NSF STTR awards) must be primarily employed by the company.

Primary employment is determined by percentage employment. Therefore, university employees who have a university appointment or position of 50% (0.5 FTE) or greater may not serve as the company PI on SBIRs or NSF STTRs.

In some cases, an adjustment may be made via an agreement with your department chair/immediate supervisor and an approved reduction in FTE for the time necessary to complete the activity. Otherwise, an alternate PI must be named at the SBC involved in the project.

Please note that specific sponsor policies or requirements, if more restrictive, take precedence over university policies and this guidance.

Public Health Service Regulations

What are the Public Health Service regulations?

The Public Health Service has strict regulations regarding financial conflicts of interest in research funded by their awarding agencies. These regulations went into effect August 24, 2012. At UNL, researchers seeking or receiving PHS funding have additional requirements for maintaining compliance with these regulations.

What are PHS awarding agencies?

The Public Health Service (PHS) is the primary division of the U.S. Department of Health and Human Services. It administers the following agencies:

Please note that some private research sponsors have chosen to adopt the PHS regulations and apply these stricter rules.

What additional conflict of interest requirements exist for PHS-funded research?

According to the United States Department of Health and Human Services regulations, the public has the right to obtain information regarding conflicts of interest for any Public Health Services (PHS) funded Investigators or Key Personnel.  The University of Nebraska-Lincoln will supply this information, within five business days, upon receipt of a written request.