Conflict of Interest Guidance Topics (A-Z)

Conflict of Interest/Conflict of Commitment (COI/COC) Best Practices

COI/COC Disclosure Guidance for Reviewers

COI/COC Submission, Review & Management Process

Expert Witnesses

Foreign Influence/Talent Programs

Institutional Conflicts of Interest (ICOI)

Management Plans & Oversight Agreements

Organizational Conflicts of Interest (OCIs)

Outside Collaborators (Subawardees, External Research Board Members)

Outside Professional Activities (including consulting)

Public Disclosure

Public Health Service (PHS) and Department of Energy (DOE) Regulations

Purchasing Equipment or Services from Companies in Which University Employees Hold Interest(s)

Restrictions on PI roles

SBIR/STTR Awards

Start-ups & Other Small Ventures

Student/Post-doc/Trainee Involvement in Employee Outside Activities

Transparency in Research- Federal Agency Biosketch/Other Support Disclosure Requirements

Use of University Resources

Who is Required to Complete a COI/COC Disclosure

Conflict of Interest/Conflict of Commitment (COI/COC) Best Practices

The following are some best practices and general ethics that employees should follow regarding conflicts of interest and/or commitment. These principles apply regardless of whether the institutional or outside activity is funded or unfunded:

Remember, having a conflict is not an accusation of impropriety! It simply requires proactive disclosure(s), transparency, and a willingness to partner with compliance professionals to ensure the needs of the university are met. As stewards of public funds, all employees are responsible for protecting UNL’s resources and reputation.

Other Resources

COI/COC Disclosure Guidance for Reviewers (Department Heads/Chairs/Supervisors & Other Administrative Reviewers)

Conflicts of Interest and/or Conflicts of Commitment can come in many forms and often differ greatly between each disclosure. In general, supervisors or other reviewers should be reviewing disclosure information to ensure they are complete, accurate, and keeping in mind if the activities (regardless of funding involvement) could impact the employee’s institutional responsibilities, their primary time commitment to the university, their decision-making ability in their university role/on behalf of the university, student/trainee/postdoc involvement, or the unauthorized commitment/use of university recourses.

Supervisors are the initial reviewers of their employees’ disclosure forms and are also those who are best positioned to know whether or not the employee’s disclosure outside activities are reasonable given the employee’s available time and university responsibilities. Therefore, it is important that supervisors carefully review and request revisions to disclosure information where necessary, prior to approving and allowing the disclosure to move forward in the review process.

In addition, while it is easy to focus identification of COIs specific to financial involvement (i.e. the potential for an employee to benefit financially from an activity), there are certainly many cases that may not involve financial aspects that still pose a potential or actual conflict that must be addressed. The following is a very simple question that should always be addressed:

Below is a list of linked resources meant to help guide department, college, or other administrative reviewers on how to assess COI/COC disclosures.

COI/COC Submission, Review & Management Process

The following information summarizes the COI/COC disclosure, review, and management process.

  1. The first step in the conflict of interest/commitment process is submission and routing of your COI/COC Disclosure. The form must be submitted annually, at minimum, and should be completed online through NuRamp.
    • Once the first form has been submitted and approved, the NuRamp system will send automated reminder notifications when the next annual submission is due.
  2. After you submit the form, it will be routed to your department chair/director and dean for review and acknowledgement. It will then go to the Conflict of Interest staff for review of interests and to your appropriate vice chancellor-level reviewer for review of outside activities. Often, disclosure of interests is sufficient and nothing further is needed. However, in situations where disclosed information could create a potential, perceived, or actual conflict of interest, this information will be reviewed to determine if it must be managed, reduced, or eliminated, beyond disclosure.
  3. If the disclosed information creates a potential, perceived, or actual conflict that meets the threshold for being significant, COI staff will notify and work with you to present the information to the Conflict of Interest Committee. The threshold for significance pertains to value received within an identified period of time; the typical value is $5,000 and greater value within a 12-month window.
  4. Separately, the review and approval of outside activities (conflicts of commitment) that must be managed, reduced, or eliminated, beyond disclosure, are completed by the Vice-Chancellor level reviewer. If the responsible Vice-Chancellor level reviewer determines that the activity requires approval by the Board of Regents, they will submit the information for review as necessary.

Disclosures must be made at least annually, regardless of whether or not you have anything to disclose. New/changes to interests, remuneration, or commitments must be disclosed throughout the year and within 30 days of occurring.

Managing, reducing, or eliminating potential, perceived, or actual conflicts of interest is handled by the COI Committee through the implementation of management plans and other COI-related documents. The COI Committee is a standing committee selected by UNL’s designated Institutional Official acting on behalf of the Vice Chancellor for Research and Economic Development. The committee is composed of at least five University tenured or tenure-track faculty members, at least one individual from the Office of Business and Finance or Procurement Services, one individual outside of the University community, other individuals appointed at the discretion of the IO, as well as ex officio, non-voting members designated from the below: 

The committee meets on an as-needed basis depending on the existence of any newly proposed management plans or existing plans up for renewal. This equates to meetings being held approximately once per month during the academic year. 

COI/COC training is required for all those disclosing by the University of Nebraska-Lincoln policy and policies of the Public Health Service (PHS) and Department of Energy (DOE). Training shall be completed within 60 days of hire or prior to engaging in research and/or the receipt of sponsored funding, whichever occurs first.

The following are some examples of conflicts that may require management:

Serving as a consultant for a company while performing research at UNL on the company’s technology.

For example, say you are consulting for an outside company. As a result of this consulting relationship, the company wishes to extend an award to you in your capacity as a faculty member at UNL. This may require management, particularly if you have received $5,000 or more in consulting fees from the company.

Owning a company/equity/stock in a company, while performing research at UNL that is sponsored by the company.

For example, owning a company that wishes to provide a subaward/subcontract to your lab at UNL may require management. Management could include identifying an alternative PI, informing students involved with the project of your ownership interest in the company, your Department Chair’s notification or oversight, and identifying another investigator that can provide unconflicted oversight.

Please also note that UNL does not allow faculty/researchers to act as the PI on a project for both the company and in their role at UNL.

Performing federally-funded research that could affect the financial interests of a company in which you have a personal financial interest (i.e., stock or other equity ownership).

For example, if you own a company that commercializes a vaccine you developed and you are simultaneously performing a federally funded study to show the merits of said vaccine. This may require management, particularly if you have equity ownership of a non-publicly traded company.

Involving students/post-docs/trainees in work that could directly benefit a company in which you, as their supervisor, have a personal financial interest.

For example, having students/post-docs/trainees work on a project meant to verify the efficacy of an invention being commercialized by your company. This may require management. Management could include informing students/post-docs/trainees involved with the project of your interest in the company and recusing yourself from the master’s/doctoral Committee in some capacity.

Inventorship/Patents/Royalties received through licensing for technology while performing research on that technology.

For example, if you developed a technology that you are licensing to an outside company (or your own company) while also working on a privately or federally sponsored project focused on further testing or development of that technology. This may require management.

Expert Witnesses

It is not uncommon for university employees, particularly faculty, to serve as expert witnesses in legal proceedings. The following are a few best practices to keep in mind when engaging in this type of activity:

Foreign Influence/Talent Programs

The University of Nebraska-Lincoln is committed to facilitating open and publicly accessible research and scholarly pursuits of its faculty, staff, students with all manner of collaborators, both domestic and international but in some instances, restrictions may be placed on such activities in the interest of national security or protection of trade. Such restrictions may especially be necessary when federal funding is involved. Moreover, UNL prohibits any engagement, involvement, and/or affiliation with Foreign Talent Recruitment Programs.

Issues surrounding foreign influence and international activities in federally funded research have evolved rapidly in the last few years with the U.S. Government showing a growing concern for such activities and/or influence and more willingness to monitor, manage, or even prohibit such activities as appropriate. Federal research sponsors have provided clarifications and adjusted processes to assist universities in protecting against improper foreign interference in academic research. It is important that employees work with COI, OSP staff, and other UNL administrators to ensure thorough and candid disclosure of all forms of support for their research program(s) and/or labs — including any involvement in talent recruitment programs sponsored by a foreign government. Specific agency updates include:

The higher education associations remain very engaged on this topic and have published periodic communications to the research community, including the Council on Government Relations’ guidance on what should be disclosed to meet requirements.

In addition to these updates from federal sponsors, the following links provide information on nationally accepted best practices and UNL requirements:

Institutional Conflicts of Interest (ICOI)

UNL is committed to facilitating scientific discovery and advancing knowledge through innovative and translatable research. Consistent with this commitment, UNL faculty are entering the entrepreneurial space and working with industry in greater numbers to develop novel solutions to existing questions, problems, and disparities across a variety of fields. To that end, translating ideas and intellectual property from university labs and programs of research to the marketplace is a primary goal of not only the Office of Research and Innovation but also UNL more broadly. This focus allows our university community to connect with and benefit society in innovative and transformative ways.

However, this focus on facilitating the expanded reach of UNL’s academic developments and innovations into the broader marketplace creates greater opportunities for the development of institutional conflicts of interest (ICOI). An ICOI is a situation where an institution’s own financial interests pose risks of undue influence on decisions involving the research, education, business transactions, or other activities of an institution. ICOIs can also include the interests of senior administrators.

Inherent in these relationships and interactions are potential or actual conflicts of interest with respect to competing and/or conflicting institutional financial interests (including other, non-financial interests) and the university’s obligations as an institute of higher learning, including the promotion of rigorous, scientifically based research, education, and other responsibilities inherent to a publicly funded university. It is imperative that we balance promoting innovation and entrepreneurship with preserving our commitment to being responsible stewards of public funds and safeguarding the integrity and objectivity of research. We must protect against any appearance that any research or other activities conducted at UNL is anything less than objective due to institutional financial interests that the public could perceive as impacting research design, conduct, reporting, and oversight.

These guidelines have been developed to assist the University community and its research collaborators proactively navigate the complexities of a variety of requirements when operating in the distinct – yet at times overlapping – areas of University and external roles and relationships.

Activities Involving University Owned Intellectual Property

Activities involving the evaluation or validation of university-owned intellectual property presents the potential for an institutional conflict of interest (ICOI). This is particularly true when such intellectual property is licensed from the University to an external, for-profit entity – one that the University either has a financial interest in or stands to potentially directly benefit financially from research outcomes – that intends to commercialize the intellectual property. Additionally, Senior Administration with individual financial interests in such external entities also presents the potential for ICOIs.

There are common management strategies utilized to promote transparency with respect to such related relationships and financial interests and to mitigate the potential for any actual, perceived, or potential lack of objectivity in institutional  oversight, design, conduct, or reporting. It is critical to ensure that the rights and welfare of human research participants involved in affected research studies are protected against any actual, potential, or perceived lack of objective oversight and decision-making due to institutional financial interests.

The following are some strategies and/or protocols that should be considered when contemplating, proposing and designing research involving university-owned intellectual property or research/activities in which the University has other related financial interests; some or all of these strategies may apply:

Please note, some scenarios, such as proposed research which poses greater than minimal risk to subjects may not be deemed approvable due to concerns regarding whether or not the institution can appropriately protect research participants.

Activities Involving External Entities in which the University has Financial Interests

Because it may not be possible for individual personnel to remain aware of institutional financial interests (including intellectual property) that involve or relate to external entities that are engaged with or who would like to engage with the University, it is important that the Conflict of Interest staff, NUtech Ventures, the Office of Sponsored Programs, and others communicate and collaborate closely when an ICOI is present or may be present. When COI staff become aware of actual, potential, or perceived ICOIs, a process for managing, mitigating, or eliminating the effects of the conflict begins – but the earlier in the process that key players become engaged, the better.

To best facilitate an efficient ICOI review process, if researchers, employees, or administrators are involved in, or become aware of, proposed activities that present potential or actual ICOI issues, they should:

Facilitating Activities Where Institutional Conflicts of Interest Exist

Proposed research that presents potential ICOIs is reviewed on a case-by-case basis. While the nature and extent of the institutional interest(s) and the nature of the specific proposed work inform decisions, key considerations for allowing research when ICOIs exist include:

Additional Resources:

Management Plans & Oversight

Management plans are implemented when there appears to be overlap between an individual’s and/or the institution’s outside relationships and/or interests and their UNL responsibilities and/or sponsored programs.

A management plan’s purpose is to enhance transparency and create separation between UNL work and the work an individual and/or the institution may be doing outside of the university in order to avoid even the appearance of biased decision making or activities.

Management plans typically utilize standard clauses in order to ensure clarity and consistency among all active plans. However, every situation is unique and so the language or directives within a particular management plan may vary in order to properly manage, mitigate, or eliminate the underlying COI.

Examples of management plan clauses and/or directives include:

Examples of management strategies for affected projects include:

Please reference our Management Plan template below for sample language that may be included. Additionally, please reference the Guide to Determining Relatedness if you have a current management plan with one or more of the disclosure clauses.

Management of potential, perceived, or actual conflicts of interest is completed by the COI Committee. The purpose of the COI Committee is to review conflicts of interest and approve plans to manage, reduce, or eliminate them. The committee is composed of tenured or tenure track faculty members representing the various UNL Colleges and including the Faculty Senate President and Academic Rights and Responsibilities Committee Chair (or their designee). The committee is also advised by several ex officio members who provide expertise from Research Compliance Services, General Counsel, NUtech Ventures, and the Office of Sponsored Programs. The committee meets approximately once per month to discuss any relevant business.

When a disclosure is identified by COI staff as creating a potential, perceived, or actual conflict with institutional responsibilities and/or sponsored programs, the disclosure is referred to the COI Committee for review at their next available meeting. Committee voting members are assigned to review the disclosed information (designated reviewers) ahead of the meeting in order to provide their assessment of the situation at the meeting along with potential strategies to manage, reduce, or eliminate the disclosed activities. The Committee also extends meeting invitations to any individual going through a full board Committee review. This typically consists of faculty with a new, unmanaged COI or those whose management plans are going through the scheduled fourth-year full board COI review but not those management plans renewing through the expedited process. Invited employees typically provide a brief overview of their outside activities, including any ownership interests or remuneration events; the committee then asks them any additional questions to clarify any outstanding issues.

The Committee may find that additional documents are required beyond the management plan, such as student notification templates. The management plan will reference any such documents with copies attached as appendices. These documents do not replace the management plan but act to manage specific areas otherwise not defined in the management plan itself.

Typically, a management plan can be issued within a few days to a week following the committee’s meeting. Once issued, the affected employee has two weeks to review and then sign or appeal the management plan. If the employee requests to appeal the management plan or other requirements issued by the committee, the employee must provide specific information to COI staff, in writing, specifying the nature and reasoning for the appeal. COI staff will ensure appeal information is provided to the Committee at their next available convened meeting for consideration.

Additional Resources:

Organizational Conflicts of Interest (OCIs)

An Organizational Conflict of Interest is a circumstance in which UNL (or a representative thereof) may have unequal access to government information or the existence of a conflicting role(s) that might bias UNL’s judgment in the design, conduct, or reporting of research. 

For purposes of this guidance, OCIs occur only in relationship to government-sponsored research activities. 

Types of OCIs include, but are not limited to:  

Examples: 

Identification, Disclosure, and Management 

The objectives of an OCI program are to identify actual or perceived conflicts and, if appropriate, disclose them to the sponsor and mitigate or manage the conflict. The goal of this is to prevent or manage circumstances where UNL may have biased judgement or an unfair competitive advantage. 

UNL research personnel are required to disclose their activities that may give rise to an OCI. These activities (on behalf of the U.S. government) include but are not limited to: 

Such activities may have been undertaken as an employee of UNL or independently as a consultant or volunteer. Disclosure of such activities occurs as part of UNL’s annual conflict of interest disclosure process. In addition, any time a sponsored project requires certification specific to OCIs, all research personnel involved shall complete an additional OCI disclosure process. 

In the event a potential OCI is identified and related to proposed or ongoing research at the university, Research Compliance Services will work with the Office of Sponsored Programs, the government’s contracting officer/program manager, the impacted UNL personnel and their department, the COI Committee, and others as necessary to manage, reduce, or eliminate the OCI.

Additional Resources:

Outside Collaborators (Subawardees, External Research Board Members)

Outside Collaborators/Affiliates are individuals involved in University Research and/or individuals with identified University Responsibilities. There are certain situations in which Outside Collaborators/Affiliates are required to complete a UNL COI Outside Collaborator Form in NuRamp.

Outside Collaborators/Affiliates must complete a form if any of the following apply:

Additional Information on PHS rules and regulations:

Please contact COI Staff if you have any questions or believe you are required to complete a UNL COI Outside Collaborator Form by phone: (402) 472-6965 or email: unlcoi@unl.edu.

Outside Professional Activities (including consulting)

This information is intended to provide guidance on outside professional activities, including consulting, as they relate to an individual’s University research and responsibilities.

Engaging in outside professional activities (including consulting)

Pursuant to Board of Regents (BOR) Bylaw 3.4.5, the University of Nebraska-Lincoln encourages faculty and staff members (employees) to engage in professional activities outside the University as a means of contributing to the economic growth and development of the state, as well as broadening their experience and keeping them abreast of the latest developments in their specialized fields, provided such activities do not interfere with their regular duties at the University or represent a conflict of interest. Employees may accept temporary or occasional employment for professional services when such employment is recommended by the Dean of the college or director of the division involved, and approved by the Chancellor or President, or their designees.

Limitations or restrictions on outside professional activities

Under BOR Bylaw 3.4.5, specific approval of the Board is required before any members of the full-time professional staff:
(a) May be retained to provide professional services outside the University to an individual person, client, company, firm, or governmental agency over a time period lasting more than two (2) years.

(b) May accept professional employment requiring more than an average of two (2) days per month during the period of his or her full-time University employment.

If the outside professional activity exceeds the limitations described in (a) and/or (b) above, review and approval by the Board of Regents is required. To comply with these limitations, alternative arrangements may be made in consultation with appropriate individuals within your college/department. These alternative arrangements may include a reduction in FTE status.

Outside activities & Pre-approval

Prior to engaging in an activity which may result in an actual, potential, or perceived conflict of interest and/or conflict of commitment, all University employees shall disclose the activity to their supervisor via the University’s electronic conflicts of interest and commitment disclosure form. These activities, whether compensated or not, must be disclosed regardless of when they occur (e.g. summer for nine-month faculty, weekends, evenings, etc.).

Consulting as an Outside Professional Activity

Consulting is a very common form of an outside professional activity. Employees who engage in consulting work should endeavor to have their consulting activities memorialized in an agreement or contract that, at a minimum, clearly defines the technical scope, intellectual property commitments (if any), and financial terms (amongst other possible terms and conditions). Any such agreements are between you, in your personal capacity, and the contracting outside entity. UNL is not, and shall not be, a party to any such agreements. Therefore, you are solely responsible for ensuring that the agreement is consistent with your university employment obligations.

Employees are strongly encouraged to utilize UNL’s Addendum to Consulting Agreement (also linked below) as an addendum to any outside professional services agreements they enter into or plan to enter into. This Addendum helps to clarify, as much as possible, the nature and scope of activities employees may be called upon to perform in their engagement outside the University. The inclusion of this addendum is appropriate regardless of the agreement’s overall time commitment or amount of remuneration.

If the consulting arrangement is not formalized through a written agreement, the addendum should be modified accordingly, dated, and signed by a company representative and the employee.

As a service to employees, NUtech Ventures (402-472-1783) can provide advice as to whether your personal consulting agreement is consistent with the university’s intellectual property policies. Additionally, your unit director/head/chair is often the best source of advice regarding your outside professional activities and associated time commitments. UNL Research Compliance Services (RCS) (402-472-6965) can provide assistance on conflicts of interest (COIs) and other research-related matters as they relate to personal consulting agreements. Because outside activities, by definition, are outside of the university, if you have other questions about consulting work (and any associated contracts), you should seek the services of a qualified personal attorney for formal legal advice.

How to ensure your consulting activities do not conflict with university obligations:

You should avoid any external commitments which burden or interfere with your primary obligations and commitments to the University. Accordingly, any outside consulting agreements should include a scope of work that clearly describes your duties for the outside activity, specifies the business interests of the outside entity, and distinguishes the outside activity from relevant, ongoing University activities in which you are engaged.

Because outside activities can relate to, rely upon, and/or utilize your area of expertise, scholarship, and/or university employment (including responsibilities), the UNL Conflict of Interest Policy has been developed to identify and manage any actual, potential, or perceived conflicts of interests. UNL employees, including those involved in the design, conduct, reporting, and/or administration of research, are required to complete an annual COI/COC Disclosure form before initiation of any research sponsored by non-university (e.g., private industry) or federal sources. For more information on who at UNL is required to maintain an active, annual COI/COC Disclosure, please see the “Who is Required to Complete a COI/COC Disclosure Form” section of this A-Z Guidance below. The COI/COC Disclosure form is available via NuRamp.

The COI/COC Disclosure form is reviewed internally to determine whether and what type of management is required to reduce, eliminate, and/or manage any potential conflicts of interest as required by university policy and federal regulation. Please see the COI website for more information.

Intellectual Property & Consulting:

University employees, including faculty, postdocs, and graduate students are obligated to disclose to the university all inventions and discoveries, including those made in the course of outside professional activities. Generally, all inventions and discoveries arising from activities that fall within the scope of their UNL employment or utilize university resources must be assigned to the university. Please contact NUtech Ventures (402-472-1873) if you have questions or need further assistance.

Other Resources:

Public Disclosure

This information is intended to provide supplemental guidance to employees when their COI Committee-approved management plan stipulates specific requirements for public disclosure of a conflict of interest.

The requirement for public disclosure of conflicts in a management plan serves to protect both the employee and University against any accusations of wrongdoing by identifying all potential dual or competing interests that may appear to be in relation to research or other activities, and including these in a statement in publications, presentations, or other avenues for dissemination of knowledge. Full disclosure of this information helps prevent or clarify the perception that interests are being hidden from public view. Transparency regarding competing interests is extremely beneficial to employees and the University as a whole.

Employees are encouraged to contact the COI staff with any questions about these requirements, to discuss particular management plans, or to discuss how conflict of interest issues are being handled at UNL and/or other institutions. The Committee is willing to review changes in the language and also to discuss the parameters outlined in the management plan.

When is public disclosure required?

Public disclosure is required in any public presentations (see definitions below) of data/information that are related or appear to be reasonably related to the employee’s financial or other interests. A disclosure statement must be included as applicable for all authors on the publication or presentation. In addition, public disclosure may also include statements in the informed consent process as applicable with any involved human subjects protocols.

It is the responsibility of each author with a conflict to ensure that public disclosures are included in relevant public presentations or other dissemination of knowledge. Moreover, UNL expects that personnel will follow all journal requirements for submitting information, regarding conflicts, for publication.

What does a disclosure statement look like and how is it utilized?

When applicable, an employee’s Management Plan contains disclosure language that is applicable in most situations. In general, a public disclosure statement should include:

Generally, employees should follow the journal or scientific organization’s policy for submission of financial disclosure information.

What if the journal or scientific meeting host’s financial disclosure requirements are different than UNL’s?

So long as the public disclosure occurs, the exact wording and placement of that disclosure is very negotiable. Although the employee must complete any disclosure statements required by the journal or by the meeting host, the employee must also include a public disclosure statement in the article or presentation materials as described above. If the journal or meeting host wishes to modify the wording approved by the UNL committee that is fine.

UNL understands that there may be differing definitions of significant financial interest (SFI) among universities and journals. UNL’s definition is in keeping with the preponderance of current national regulations and guidance and thus may be more stringent in some cases, but less stringent in others.

What happens if an employee fails to include the public disclosure statement as required?

Following the annual update of the investigator’s disclosure form and prior to the renewal of their management plan, the COI Committee will request verification that the managed UNL employee has abided by the terms of their management plan, including making the correct public disclosure statements in applicable articles, presentations, etc… In addition to this formal verification request, the UNL Research Compliance Office may also conduct audits of the investigator’s published journal articles to check for the public disclosure statement in articles presenting research related to the conflict.

Should the Committee determine, through their review process that an affected investigator has failed to disclose their conflict or has provided an inadequate or misleading disclosure, the investigator will be required to contact the journal so a correction or erratum can be published addressing the omitted or inadequate disclosure. The Committee recommends that investigators confirm with the publisher, immediately before publication, that the correct disclosure statement is present. Additional corrective actions may also be required for non-compliance with management plan requirements.

How do employees disclose to collaborators, trainees, and/or other team members?

If disclosing a relationship to members of your lab, best practice would be to have an in-person meeting that allows members of the team to ask questions about the relationship and what impact it may have on work in the group, should they have any. If an in-person meeting is not practical, an email providing information about the relationship with a statement that if anyone has questions, they can ask you, the Chair/Dean’s Office, or COI Staff about the relationship would suffice.

Regardless of the disclosure method, the UNL employee subject to this notification requirement must obtain formal acknowledgment of the discussion from all affected lab and other members. The UNL employee should use the student/employee notification template provided by the COI Committee attached to their management plan in the appendix. Such signed notifications shall then be forwarded to the UNL employee’s Chair, Dean, and Research Compliance Services (COI Staff). Finally, the UNL employee must also upload a copy of the signed notifications to their most recent disclosure form – instructions for completing this upload are also contained within the faculty member’s management plan. For demonstrative purposes, sample text that could be used to communicate this notification of a potential, perceived, or actual conflict to lab members and other affected staff is provided below. However, the affected UNL employee should defer to their current management plan if their notification language differs from that below:

Finally, the UNL employee must also upload a copy of the signed notifications to their most recent disclosure form – instructions for completing this upload are also contained within the faculty member’s management plan. For demonstrative purposes, sample text that could be used to communicate this notification of a potential, perceived, or actual conflict to lab members and other affected staff is provided below. However, the affected UNL employee should defer to their current management plan if their notification language differs from that below:

I, [Insert Name] have a [Insert financial interests/remuneration/ownership etc] in [Insert company name and/or nature of IP], a company which could potentially benefit from the outcomes of this research/activity.  Because of the perception of a conflict of interest and in the interest of full transparency, I am disclosing my relationship with [insert company name and/or nature of IP] to my research team members and collaborators.  If you have questions or concerns about my interests as they relate to this research/activity, please let me know. 

If you have further questions or concerns about this information, data integrity or [research participant safety] at any time because of this conflict of interest, you may contact [Dept Chair/Dean’s Office] or the UNL Conflict of Interest Office (unlcoi@unl.edu or 402-472-6965).

How should this be communicated?

When should this disclosure be made?

Public Health Service (PHS) and Department of Energy (DOE) 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. The Department of Energy (DOE) released new regulations on December 21, 2021, similar to the PHS regulations. At UNL, research personnel seeking or receiving PHS/DOE funding have additional requirements for maintaining compliance with these regulations.

The Public Health Service (PHS) is the primary division of the U.S. Department of Health and Human Services. It administers the following agencies, which adhere to the 2012 PHS FCOI in research regulations (42CFR50 Subpart F):

Private and/or Non-profit Sponsors following PHS FCOI Regulations

Some private research sponsors have adopted the PHS FCOI regulations. See below list of such private sponsors; please note that this list is non-exhaustive and is subject to change. You need to independently verify the inclusion of PHS regulations in the proposal and/or award terms for each sponsor. If you become aware of sponsors not listed below that have adopted PHS FCOI regulations, please notify UNL Research Compliance Services COI staff at unlcoi@unl.edu.

The Department of Energy (DOE) COI Interim Policy is applicable to each non-Federal entity that applies for or that receives a DOE financial assistance award. The interim COI policy does not apply to the Office of Indian Energy or Phase I Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) applications and financial assistance awards.

Purchasing Equipment or Services from Companies in Which University Employees Hold Interest(s)

The University must perform due diligence around the selection and/or engagement of subcontractors and vendors, particularly when an employee involved in the purchase and/or activity has interests in the company. Sufficient documentation to support decisions around sole source justifications and/or selection of companies of university employees rather than comparative companies is important. When justifications involve scientific or technical specialization or superiority, it may also be critical to involve individuals with the relevant scientific/technical expertise to perform an assessment of the request and aid in the university’s decision. If a start-up company is being proposed or selected for a purchase by UNL, ensure the related interest of the faculty member (or other individual with company interests) is disclosed to the university (e.g., Procurement) or on to any forms as applicable (e.g., sole source justification form or bid documentation form).

Ensure selection of vendors for purchases follow University of Nebraska Board of Regents and Procurement policies. Some research sponsors consider conflicts of interest in procurement actions something that needs to be requested of or disclosed in advance to the sponsor or reported to the sponsor. Please engage UNL’s Office of Sponsored Programs and COI staff if there is a request or intent to purchase equipment or services from a company in which a faculty member on the award has interests.

Restrictions on PI roles

At UNL, an employee may not serve as PI for both the university and an outside entity on the same project. Although projects often involve collaborative awards or deliverables for both sides, clear separation of roles is important. The company and collaborating institution are 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.

Most university employees, particularly researchers, have 100% of their time committed to their academic, research, and other commitments at UNL, and therefore, do not have the availability to meet the requirements of serving as the PI of the outside entity while also serving as the university PI.

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 (SBIR/STTRs). These funding mechanisms share several similarities but also have some specific distinctions.

SBIR/STTRs must be American owned, independently operated, for-profit businesses, and must have 500 or less employees.

A university is not an SBC and is not eligible to be a direct recipient of SBIR or STTR, but the University does meet the criteria to serve as a RI for SBIRs and STTRs. Involvement of a university in either an SBIR or a STTR occurs via a subcontract from the SBC to the university. In cases where there is a collaboration/subcontract between the SBC and the RI, there will be a SBC PI and an RI PI (i.e. a PI for each side of the collaboration).

Small businesses certify in their SBIR and STTR applications and award documents to the federal government that the small business portion of the research and research development will occur in company facilities using company employees unless otherwise indicated in the SBIR or STTR application and approved in the funding agreement. Therefore, performing the company portion of such research in university space using university resources — unless specifically approved by the funding agency and allowed by the university under documented agreement – subjects the company to potential criminal, civil, or administrative sanctions.

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:

Only the above 5 agencies have STTR programs, and the PI eligibility requirements differ slightly for NSF. For NSF-funded STTRs, PI eligibility requirements are the same as they are on an SBIR project (i.e., the PI must be primarily employed by the small business). At the other four agencies, the PI can be primarily employed by either the small business applicant or the non-profit organization with which the small firm is collaborating on the STTR project.

Restriction on SBIR/STTR PI role

At UNL, an employee may not serve as both the small business PI and the university PI on the same project. Please see the guidance topic, Restrictions on PI roles, for additional details.

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 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 small business involved in the project.

The Same Individual Serving as PI on Respective Sides of SBIR/STTR Collaborations

The PI of the company portion of the research and the university portion of the research may not be the same individual. STTRs require that the company formally collaborate with a non-profit research institution (e.g., a university). STTR Phase I awards require that at least 40% of work on the project be performed by the company and that the collaborating university perform at least 30% of the work. STTR Phase I awards require that the company PI commit a minimum of 1.2 calendar months (10% effort) and must have a formal appointment with, or commitment to, the company. The collaborating university PI has no minimum effort requirement. Although STTRS/SBIRs are indeed collaborations, the STTR/SBIR policy, instructions, and project percentage requirements/effort make clear that establishing a separation of entities and roles is important. The company and collaborating research institution are referred to as separate parties.

University Personnel Serving as Company PI on SBIRs and as Company PI on NSF SBIRs and STTRs

The PI of the company side of SBIR awards must be primarily employed by the company. For NSF, this company primary employment requirement also applies to the company PI for STTRs.
Primary employment is measured and determined by percentage employment/appointment. Therefore, university employees who have a university appointment or position of 50% or greater may not serve as the company PI on SBIRs (or NSF STTRs) relative to research in which university is engaged. University employees serving as the company PI relative to SBIRs (or NSF STTRs) in which the university is party to the activity via proposed or contracted collaboration must have a university position or appointment no greater than 49%.

Special Note for Individuals Involved in SBIR/STTR Research Proposed To/Funded by NSF and/or NSF Innovation Corps program (I-Corps)

Please note that we have recently seen specific language in SBIR/STTR solicitations, budget guidance, and program officer requests with respect to SBIR/STTR proposals submitted to/awards funded by the National Science Foundation (NSF). This language relates to the ability of individuals with specific financial interests/relationships with the small business applicant/awardee to be involved with/compensated by the small business and be involved in the SBIR/STTR research.

We have seen NSF guidance that specified that “No person who is an equity holder, employee, or officer of the proposing small business may be paid as a consultant unless an exception is recommended by the Program Director and approved by the Division Director for the Division of Industrial Innovation and Partnerships,” and that “No person who is an equity holder, employee, or officer of the proposing small business may be paid through a subaward budget unless an exception is recommended by the Program Director and approved by the Division Director for the Division of Industrial Innovation and Partnerships.”

Therefore, please read all sponsor requirements for SBIR/STTR proposals and awards carefully, particularly NSF, and note what situations may be prohibited or that may require advance sponsor approval. Please notify the Office for Sponsored Research and COI Staff if such language is noted and action or certification is required with respect to the UNL portion of the research, if applicable.

In addition, NSF I-Corps funding requirements also detail COI certification and disclosure/reporting requirements. These particular funding sources frequently involve small businesses/startups and/or fairly clear business plans in order to apply for such funding. The very nature of I-Corps awards commonly involve COIs due to the involvement of business development plans, practices, or specific licensing/patent agreements. If you are planning on submitting a proposal for NSF I-Corps funding, please proactively discuss your project with COI staff so that appropriate disclosures and potential management of COIs can be discussed.

Start-ups & Other Small Ventures

Per the UNL COI policy, the creation of a new start-up company constitutes a change that must be disclosed within 30 days. Start-up companies must be disclosed because they generally meet the following criteria for review:

A few examples of issues, and the possible conflicts associated with them, are detailed in the table below:

ISSUECONFLICT
Having a financial interest or holding a management position in a company with a license to technology invented at UNL may lead to biased research results.Investigator(s) may be conflicted about: (a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation. (b) Censoring research findings that might damage the sponsoring company.
Accepting sponsored research from a company with a license to technology invented at UNL may lead to biased research results.Investigator(s) may be conflicted about: (a) Publishing potentially damaging research findings in the open literature without regard for the company’s reputation. (b) Censoring research findings that might damage the sponsoring company.
Having a financial interest or holding a management position in a company that rents university facilities and/or equipment for university employees.University employees may be conflicted about: (a) Spending time teaching and conducting research. (b) Spending time otherwise spent teaching on outside activities that produce supplemental income. (c) Use of university resources to the benefit of an outside entity.

Restriction on Start-Up PI Role

UNL employees may not serve as both the start-up PI and the university PI at the same time. Please see the guidance topic, Restrictions on PI roles, for additional details. For additional information on navigating startups and university research, please reference the following guidance:

Students, Trainees, & Postdoctoral Fellow Involvement in Employee Outside Activities

Involving students/post-docs/trainees in employee start-up or other outside activities can enhance the academic experience and be valuable to the work. However, these groups are in an inherently vulnerable position and care should be taken to ensure that they are engaged voluntarily, that the involvement is beneficial to their development, and that the activity does not interfere with their training and/or academic progress.

Questions to ask with respect to involving students/post-docs/trainees in start-up activities include, as applicable:

Prior to engaging students in any employee start-up/outside activities, the employee should engage in a discussion with their department and the student(s) around the above questions/situations. If an employee is the sole principal advisor for a student he or she wishes to involve in his or her external start-up activities, a different/un-conflicted principal co-advisor must be identified for the student. A co-advisor works with the student to develop a research topic, formulate ideas and structure for, and guides the progress of the thesis/prospectus/dissertation. It is the responsibility of the student’s academic program to approve the appointment of a different advisor. If the employee and the student mutually agree to proceed with the engagement, the employee must ensure appropriate approvals are secured within their department/college.

Prior to engaging postdoctoral fellows in any employee start-up/outside activities, the employee should have a discussion with the postdoctoral fellow around the topics included in this guidance. Postdoctoral fellows are considered staff members, and any external activities must be approved in advance by the individual’s supervisor. External activities must occur outside of UNL work hours (unless approved/appropriate leave time is detailed) and must not involve UNL resources. If a faculty member is the primary postdoctoral supervisor and also engages the postdoctoral fellow in their external start-up activities, a COI management plan may need to be established that adjusts the individual’s administrative reporting line or assigns independent oversight, as the faculty member may not be in the most objective position to assess whether the postdoctoral training and the activities within the start-up company are in conflict and whether the external activities are interfering with or detracting from the individual’s UNL responsibilities and engagement in postdoctoral training.

When a management plan is issued that addresses student/post-doc/trainee involvement in an employee’s outside activity, a template notification form will be provided for use by the conflicted employee. The notification form is expected to be provided to the student/post-doc/trainee in order to 1) disclose the nature of the conflict 2) ensure dialogue/understanding between the employee and student/post-doc/trainee and 3) ensure the student/post-doc/trainee has alternative contact information with COI staff and/or the employee’s unconflicted department Chair in case they have any concerns with the conflict and the impact on their academic/institutional responsibilities. As part of the management plan’s annual review/renewal, documentation regarding use of the template and notification to student/post-doc/trainee will be required to be provided by the conflicted employee.

If a student/post-doc/trainee would like to participate in the outside activities of an employee/advisor, the following agreement should be filled out and sent to the applicable Chair/Dean’s office for review and approval.

Transparency in Research- Federal Agency Biosketch/Other Support Disclosure Requirements

Federal agencies have established requirements and guidelines for research personnel to disclose all forms of research funding, in-kind support of research, and detailed information about significant research collaborations related to federally funded projects.

All forms of support must be reported, regardless of where it comes from or where the research is being performed. Federal sponsors are particularly interested in foreign collaborations on federally funded projects.

The below guidance documents, checklist, and FAQs are being provided through collaboration between UNL Sponsored Programs and Research Compliance Services in order to provide research personnel with timely information regarding agency directives, guidance, along with COI/COC disclosure requirements, where applicable. Please click on the information below for specific agency requirements for reporting information via Biosketches/Other Support.

Use of University Resources

Use of University Resources
University resources may not be used for the activities of entities outside the institution, including the company portion of a research or other collaboration in which the university is engaged, except under specific documented agreements between the company and university relative to use of space, equipment, etc. Agreements can take different forms depending on the situation and purpose, such as direct research agreements, testing agreements, manufacturing service agreements, equipment use agreements, memorandums of understanding, rental agreements, collaboration agreements, etc. The Office of Sponsored Programs may serve as a starting point for helping to assess the appropriate agreement for such arrangements (and in some cases, NUtech Ventures).  For example:

The university takes the following factors into consideration when making decisions regarding company requests for lease of university space:

It is important to note that University staff (e.g. the Research Compliance Office and/or the Office for Sponsored Programs (OSP)) may not assist companies/small businesses with the company portion of an SBIR/STTR or other company proposal or compliance requirements. Most University employees are hired to provide support services only for university research/activities.

UNL’s Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Scientific Research Oversight Committee (SROC), and other applicable committee services are for only UNL research activities (i.e. research projects awarded or contracted to UNL, directly or through subcontract from another institution, and/or other research activities (funded or unfunded) that involve UNL researchers acting in their UNL capacity) and are not for use by outside entities without clear institutional agreement.

UNL’s committees, as referenced above, and employees engaged in these areas, are heavily regulated through federal, state, and university requirements due to the significant responsibilities and risks associated with these types of protocols. In no circumstances may external entities or parties, such as faculty start-up companies, use the services of the committees and/or their administrative offices, unless UNL is engaged in a particular research project through a sub agreement with the company and/or there is a specific documented arrangement between the company and UNL in which the IRB, IACUC, IBC, SROC etc. need to be involved.

Who is Required to Complete A COI/COC Disclosure

The University of Nebraska System Wide Executive Memorandum No. 36 requires the following individuals to complete a COI/COC Annual Disclosure form:

Additionally, per UNL COI Policy and UNL BoR Policy, anyone who falls within the below descriptions must complete a COI/COC Annual Disclosure.

POSITION & DESCRIPTION MUST COMPLETE A DISCLOSURE IF
Adjunct Faculty
(Those under UNL employment or direct control but may not be considered full-time)		Adjunct Faculty are required to complete a UNL disclosure if any of the following apply:
·They are responsible for the design, conduct, administration, or reporting of research (funded or unfunded)
·They have an Outside Activity and/or receive funding/support from a foreign government, quasi-government, institution, or other foreign entity (including business)
· They have been issued a University purchasing card
· They have delegated signature authority
· They are a member of a UNL Research Oversight Committee (e.g., the IRB, COI Committee, SROC, IACUC, or IBC)
International Scholars
(J-1 & H-1B Visa Holders)		J-1 Visas
Given the nature of J-1 Visas, individuals may be students or employees of the University and they must assess whether to complete a COI/COC Annual Disclosure based on their current or anticipated status and responsibilities with the University.

J-1 Visa Student & Employees must complete a disclosure in any of the following apply:
·They are responsible for the design, conduct, administration, or reporting of research (funded or unfunded)
·They have an Outside Activity and/or receive funding/support from a foreign government, quasi-government, institution, or other foreign entity (including businesses)

H-1B Visas
Typically, individuals with an H-1B visa are, or are seeking to become employees of the University. Generally, the UNL Conflict of Interest (COI) Policy and Board of Regents (BoR) Policy will direct H-1B individuals to complete a disclosure.

H-1B Visa Employees must complete a disclosure if any of the following apply:
·Their position at the University is full-time faculty (including 9-month appointments) or their position is one of managerial/professional staff or administrators
·They are responsible for the design, conduct, administration, or reporting of research (funded or unfunded)
·They have an Outside Activity and/or receive funding/support from a foreign government, quasi-government, institution, or other foreign entity (including businesses)
Retired/Emeriti Faculty
(Those who have retired from UNL but may have decision making involving research, business dealings, or other UNL Activities)		Retired/Emeriti Faculty are required to complete a UNL disclosure if any of the following apply:
·They are responsible for the design, conduct, administration, or reporting of research (funded or unfunded)
· They are involved (e.g. own, consult, etc.) with an entity outside of UNL and that entity is, could be, or will be involved in any University activities
·They have delegated signature authority
·They are a member of a UNL Research Oversight Committee (e.g., the IRB, COI Committee, SROC, IACUC, or IBC)
OtherThe Office of Research and the Research Compliance Services Office reserve the right to require disclosure and COI training to others not listed herein, as determined through applicable policies, reasonable best practices, and the details of any given project/area in which someone may be involved.