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:
- An employee’s primary obligation is to their Home Institution (UNL).
- Employees must not use their position to benefit themselves, their immediate family members, business associates, or to the detriment of the University.
- Disclosure must occur at least annually, regardless of whether or not there is anything to disclose (i.e. all “No” answers). If any changes occur throughout the year, updates must be made within at least 30 days of the change. Pre-approval for outside activities is required.
- While outside activities are encouraged and allowed, preservation of university resources and intellectual property takes precedence. Diversion of resources or intellectual property to external entities via outside activities or for employee personal gain are strictly prohibited unless appropriate approvals are sought and documented. Such approvals may require rental agreements or reimbursements to the University to properly compensate for use of university resources.
- Intellectual property made in the performance of an employee’s duties is owned by the University.
- If there is any question regarding the relatedness of an outside activity to one’s institutional responsibilities, and the need for disclosure, the employee must always err on the side of transparency, disclosure, and request for pre-approval of the activity. No matter the type of outside activity, transparency and accountability are key with respect to the type, nature, and extent of an employee’s outside activities, including the identification, management, reduction, and/or elimination of any conflicts.
- Ensure that responsibilities to research sponsors are met. Employees, particularly those involved in federally funded research, must carefully track and understand their time commitments to ensure they are not over-committed. Transparency is also key in documenting Other Support being received and/or updating Biosketches as necessary.
- Ensure trainees (students/postdocs etc) and staff are not adversely impacted by employee participation in outside activities.
- Employees and administrators must safeguard the reputation and resources of the university and its faculty from a real or perceived appearance of dual loyalties or undue influence by an external entity.
- Protect against inappropriate foreign influence and foster the promotion of objectivity and transparency in research and other activities. Foreign Talent Recruitment Programs (FTRPs) are prohibited at UNL.
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.
- COI Guidebook
- COI Terms and Conditions Guide
- NSF COI Policies
- PHS FCOI Regulations
- DOE COI Interim Policy
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 than 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:
- Could the outside activity create the perception of, or an actual conflict/overlap with the employee’s primary responsibility to UNL?
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 Guidelines for Assessing Disclosures: This guidance document provides definitions to frequently used terms in the COI/COC Disclosure as well as guidance on what to look for in each section of the disclosure form.
- COI/COC Reviewer Checklist: This easy to follow checklist can be used to help reviewers determine if clarifying questions should be asked, revisions should be requested, or a form may be approvable. Simply download the document and click the Yes/No checkboxes for each applicable question to help guide your review process.
COI/COC Submission, Review & Management Process
The following information summarizes the process COI/COC disclosure, review, and management process.
- 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.
- 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 Coordinator 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.
- 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 in Research Committee (CIRC). 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.
- 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 related to research is handled by the CIRC through the implementation of management plans and other COI-related documents. The CIRC 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 seven tenured or tenure track faculty members representing the College of Arts and Sciences, College of Engineering, College of Law, Institute of Agriculture and Natural Resources (the Agricultural Research Division and/or the Cooperative Extension Division) and including the Faculty Senate President and Academic Rights and Responsibilities Committee Chair (or their designee). The CIRC is also advised by several ex officio members who provide expertise from colleges, General Counsel, NUtech Ventures, and the Office of Sponsored Programs. The committee meets approximately once per month.
COI/COC training completion is required at the time of award for anyone with an issued management plan and/or sponsored researchers who receive funding from the Public Health Service (which includes NIH, FDA, CDC and more). Training must be completed every four years.
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.
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:
- Service as an expert witness must not infringe upon an employee’s duties and responsibilities at UNL.
- Service as an expert witness, whether paid or unpaid, for an outside entity while simultaneously receiving separate work and/or funds (e.g., sponsored research) from that same entity or related to the expert witness work may create a conflict that requires management.
- Service as an expert witness should not conflict with or compromise the interests of the University of Nebraska.
- Understand your obligations if a non-disclosure or confidentiality agreement (NDA/CDA) is involved.
- Be cautious of serving on retainer as this type of engagement/agreement could violate Board of Regents policies and/or create other commitment issues.
- Disclosure, pre-approval, and transparency are key.
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 National Institutes of Health released new requirements and templates for Other Support and the Biographical Sketch. One change requires attaching a copy of related agreements and translated copies if the agreements are not in English. For more information on whether an activity should be included in these documents, please visit NIH’s website, “Protecting U.S. Biomedical Intellectual Innovation,” which provides a useful chart of “Examples of What to Disclose to NIH about Senior/Key Personnel on Applications and Awards.”
- The National Science Foundation updated its guidance for what should be included in Current and Pending documentation and released a related series of FAQs. The NSF also has helpful guidance on Research Security here.
- The Department of Energy has issued revised contract terms for any work performed on-site at a National Laboratory as well as new requirements regarding foreign national involvement in DOE-funded work.
- The Department of Defense has updated instructions for what information should be included in Previous/Current/Pending Support documentation, aligning with a 2019 Memorandum (e.g. CDMRP FY21 General Application Instructions; pp.15-16).
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 Economic Development 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:
- Disclosure of the University’s related financial interests to research study team members and collaborators.
- Disclosure of the University’s related financial interests to human research participants in the informed consent document.
- Disclosure of the University’s related financial interest in all manuscripts, presentations, publications, websites, dissemination of knowledge, and press releases arising from/related to the research.
- Use of an external IRB to review the human subjects study protocol.
- Independent data analysis
- External data safety monitoring board (DSMB).
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
Individual personnel may not always be aware of related institutional financial interests in each separate intellectual property and/or institutional interests in an external entity that wishes to engage with the University. The Conflict of Interest staff, NUtech Ventures, the Office of Sponsored Programs, and others communicate and collaborate closely when an ICOI is present. When COI staff becomes aware of proposed research involving potential or actual related institutional interests, a process for managing, mitigating, or eliminating the effects of the conflict will begin – but the earlier in the proposal/design 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:
- Notify UNL’s COI staff that there is a proposed study that may involve an ICOI; and
- Be prepared to provide, at minimum, the following information:
- A statement of work, study abstract, protocol (preliminary drafts are fine), including study phase, aims, methodology, study team members, anticipated enrollment (if applicable), anticipated risk level to human research participants and potential Adverse Events (AEs), information about the drug/device/biologic/therapeutic/method under evaluation in the proposed research; and
- An explanation outlining any compelling circumstances (if any) as to why this work must be conducted at UNL (e.g. unique equipment, participant populations, PI expertise, etc.).
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:
- The extent to which the research will benefit society in accordance with the University’s mission.
- The extent to which UNL (by virtue of qualifications and/or specialized expertise, space, equipment, and/or subject population) is positioned to best carry out the work.
- The extent of the university’s and/or any conflicted Senior Administrator’s authority over the research/activity and/or the involvement in the conduct of the research/activity.
- The extent to which research objectivity and integrity can be adequately assured through research study structure and design and/or COI management strategies.
- Whether or not human research participants can be adequately protected from potential risk or bias through research study structure and design and/or COI management strategies.
- The risk to the reputation of UNL and the researchers (actual, perceived, or potential) should the ICOI impact the research/activity.
Management Plans & Oversight Agreements
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 as in order to properly manage, mitigate, or eliminate the underlying COI.
Common management plan clauses and/or directives include:
- Recusal from decisions involving the outside entity that the faculty/staff has a significant financial interest in or relationship with.
- Parameters around using UNL resources for activities with an outside entity.
- Restrictions on using UNL employees and students in activities or research involving the conflicted entity. Permission to utilize such individuals typically requires full disclosure of the COI, disclosure of any imposed modifications to the affected employee’s research and/or institutional responsibilities, instructions on contacting unconflicted personnel to discuss any issues, and a signed memorandum acknowledging these obligated disclosures.
Common management strategies for affected research projects include:
- Disclosure to collaborators and team members,
- Disclosure in publications, presentations, press releases, and other dissemination of knowledge
- Disclosure in informed consent documents (as applicable for human subjects research)
- Issuing an oversight agreement that removes the conflicted employee as PI and replaces them with another unconflicted employee
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 related to research is completed by the CIRC. The purpose of the CIRC 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 informed 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 CIRC 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 CIRC also extends meeting invitations to any individual going through a full board CIRC 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.
In addition, if the committee identifies any additional requirements, such as student notifications and/or oversight agreements (e.g., requirements to replace the affected employee as PI with an unconflicted person), an oversight agreement or student notification template will also be provided as attachments to the management plan.
The Committee may find that additional documents are required beyond the management plan, including but not limited to oversight agreements and/or student notification templates. The management plan will reference these documents with copies attached as appendices to the management plan. 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 and oversight agreement (if applicable) 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.
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:
- Unequal access to information: an unfair competitive advantage resulting from obtaining information not generally available to others seeking federal funding.
- Impaired objectivity: assessing performance or evaluating products of someone within your own organization or a direct competitor seeking federal funding.
- Biased ground rules: having provided engineering or technical assistance or written the work requirements for a funding opportunity where someone within your own organization is an applicant.
- A faculty member in the School of Computer Science provides the Defense Advanced Research Projects Agency (DARPA) with technical direction for the development of a Broad Agency Announcement (BAA). If anyone from UNL submits a proposal pursuant to that DARPA BAA an organizational conflict of interest exists. This potential organizational conflict may need to be disclosed to DARPA. There may be exceptions; for example, participating in collective discussion at a workshop related to developing the BAA may not create as much potential for organizational conflict as advising DARPA as an individual.
- UNL develops a detailed model plan for the scientific and technical training of staff at an Air Force Research Laboratory. The Lab adopts the curriculum and incorporates it into a request for proposal to conduct the training. If anyone from UNL responds to the proposal, an organizational conflict of interest exists. This potential organizational conflict may need to be disclosed to the Air Force.
- A non-software engineering researcher collaborates on a project for Homeland Security and has access to confidential government information. Another researcher at UNL submits a proposal for funding to Homeland Security related to the same scientific area. Homeland Security may consider this to be an organizational conflict of interest.
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:
- Contracts to provide scientific, engineering and technical direction;
- Serving as an advisor and providing analysis, assistance or evaluation services;
- Preparing specifications and work statements for funding opportunities; or
- Having access to proprietary, confidential, or sensitive data.
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 CIRC, and others as necessary to manage, reduce, or eliminate the OCI.
Outside Collaborator Disclosures (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/COC Annual Disclosure Form.
Outside Collaborators/Affiliates must complete a disclosure if any of the following apply:
- They are responsible for the design, conduct, administration, or reporting of Public Health Service (PHS) and/or Department of Energy (DOE) Funded Research and their Home Institution does not have a PHS/DOE complaint COI Program; and/or
- They are a member of a UNL Research Oversight Committee (e.g., the IRB, CIRC, SROC, IACUC, or IBC)
Additional Information on PHS rules and regulations:
- 42 CFR 50 Subpart F requires that PHS investigators comply with specific disclosure and COI management requirements. Investigator “means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding.”
- Similarly, the DOE COI Interim Policy requires DOE investigators to comply with specific disclosure and COI management requirements. Investigator means “the principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. DOE program offices have the discretion to expand the definition to include also any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. Such expansion will be specified in the applicable funding opportunity announcement and/or terms and conditions of the financial assistance award.”
- Outside Collaborators/Affiliates may be considered an Investigator for purposes of determining whether they need to complete a UNL disclosure (in addition to determining whether their Home Institution has a PHS/DOE compliant COI program)
- PHS/DOE CITI COI Training is also required for any investigators on PHS/DOE funded projects and/or anyone with a management plan (funded or unfunded)
This information is intended to provide supplemental guidance to employees when their CIRC-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 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.
- Examples of public presentations include conferences, lectures, lab/professional website statements, and any other speaking engagements, journal articles, including review articles, and letters to the editor, without limitation.
- Research or other activities related to the employee’s financial interests includes, without limitation:
- The project is fully or partially sponsored by the company in which the employee has a significant financial interest.
- The project involves technology licensed to or owned by the entity in which the employee has a significant financial interest (including manufacturers of the item or product used in the work).
- Any other projects not covered above where the design, conduct, administration, or outcome of the work may appear to affect (positively or negatively) the entity in which the employee has a significant financial interest (including financial interests in companies that are direct competitors with the sponsor of the work or the manufacturer of the item or product or subsidiaries).
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:
- Who the conflicted party is;
- The nature of the conflict; and
- That the conflict has been reviewed and that disclosure is required. The affected faculty/UNL employee should include the disclosure in journal articles, presentations, posters, conference discussions, or any other work/professional activity related to the conflict.
Generally, employees should follow the journal or scientific organization’s policy for submission of financial disclosure information.
- If the journal or meeting host does not have a policy, the employee should include a disclosure of their interests in a letter to the editor or meeting organizer informing the applicable third party of the identified conflict and of UNL’s requirement of including a statement acknowledging the interests in any affected publications or presentations. It is the employee’s responsibility to assure that the statement is included in the final publication.
- For journals that have preferred disclosure language or format, it is appropriate to use the journal’s preferred language rather than the specific statement provided in the management plan. The journal-specific language does not need to be submitted for review again by the Committee.
- The affected employee must use the template statement from the management plan if the journal does not have a preferred or standard disclosure template.
- The affected employee can place the statement in any location in the article, slide, or poster presentation. It only needs to be included in one location (e.g., not on every slide or every article page).
- When applicable, the CIRC and the IRB, working in conjunction, will provide the affected employee with specific language for inclusion in any affected human research informed consent process. This language must be approved by the CIRC and the IRB.
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 CIRC will request verification that the managed UNL employee has been abiding 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 CIRC 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:
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 (firstname.lastname@example.org or 402-472-6965).
How should this be communicated?
- In research team lab or other meeting, and via email
When should this disclosure be made?
- At study initiation or when a management plan is implemented
- As new team members and/or collaborators join the project
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):
- National Institutes of Health (NIH)
- National Cancer Center Institute (NCI)
- National Eye Institute (NEI)
- National Heart, Lung and Blood Institute (NHLBI)
- National Genome Research Institute (NHGRI)
- National Institute on Aging (NIA)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Arthritis & Musculoskeletal and Skin Diseases (NIAMS)
- National Institute of Biomedical Imaging and Bioengineering (NBIB)
- National Institute of Child Health and Human Development (NICHD)
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- National Institute of Dental and Craniofacial Research (NIDCR)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute on Drug Abuse (NIDA)
- National Institute of Environmental Health Sciences (NIEHS)
- National Institute of General Medical Sciences (NIGMS)
- National Institute of Mental Health (NIMH)
- National Institute on Minority Health and Health Disparities (NIMHD)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institute of Nursing Research (NINR)
- National Library of Medicine (NLM)
- Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention (CDC)
- Indian Health Services (HIS)
- Health Resources and Services Administration (HRSA)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Agency for Healthcare Research and Quality (AHRQ)
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.
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.
- SBIR (Small Business Innovation Research Program) awards
- SBIRs do not require research institution (RI) involvement, but SBCs often collaborate with RIs on SBIRs even though it is not required.
- If the SBC sub-contracts with another party, or with multiple parties:
- SBC must do two-thirds of research during Phase I
- SBC must do at least one-half of research during Phase II
- The PI must be primarily employed by the SBC.
- If the SBC sub-contracts with RI:
- RI may conduct up to one-third of research during Phase I
- RI may do up to one-half of research during Phase II
- STTR (Small Business Technology Transfer Program) awards
- STTRs require that the SBC collaborate with a research institution (“RI”) for a certain portion of the award.
- Not less than 40% of the research/development must be performed by the SBC.
- The PI must be primarily employed by the SBC or RI.
- The RI is required to conduct at least 30% of the research and development but may conduct up to 60% of research and development.
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:
- Department of Agriculture
- Department of Commerce – National Institute of Standards and Technology
- Department of Commerce – National Oceanic and Atmospheric Administration
- Department of Defense
- Department of Education
- Department of Energy
- Department of Health and Human Services
- Department of Homeland Security
- Department of Transportation
- Environmental Protection Agency
- National Aeronautics and Space Administration
- National Science Foundation
STTR participating agencies:
- Department of Defense
- Department of Energy
- Department of Health and Human Services
- National Aeronautics and Space Administration
- National Science Foundation
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 ICorps projects
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 ICorps 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 ICorps 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 ICorps 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:
- Financial Interest: any ownership/equity interest must be reported, regardless of amount, and potential or actual licensing of IP/patents may also come into play and require disclosure.
- Outside Activities: any activities that are completed outside of your UNL responsibilities but have the possibility of overlapping or conflicting with them, must be reported.
A few examples of issues, and the possible conflicts associated with them, are detailed in the table below:
|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
At UNL, an employee 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:
Student/Postdoctoral/Trainee 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:
- Will these activities interfere with the student’s progress towards degree, graduation timeline or the postdoctoral fellows training timeline?
- Will these activities negatively impact the student’s requirements for graduation?
- Will these activities have restrictions on publishing or presentation that could negatively impact publication of a student’s thesis, dissertation, publication work, oral presentations or other requirements for degree completion?
- Is the student/post-doc/trainee supported by a fellowship, training grant or other funding mechanism that restricts work on for-profit enterprises?
- Will these activities and the joint external relationship negatively impact the UNL advisor/advisee relationship?
- Would the student’s ability to maintain full-time enrollment (whether in coursework or research registrations) be impacted? Students may not receive academic credit for efforts related to the external start-up activities.
- Relative to students that receive University assistance, graduate students are generally expected to be full-time students conducting their studies and research. However, on occasion another funding opportunity may arise. When that situation occurs permission to receive remuneration must be requested through the department.
- Are there possible restrictions around engagement in/payment for external activities related to their visa status?
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.
- NIH Guidance
- NSF Guidance
- DOD Guidance
- DOE Guidance
- NASA Guidance
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 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:
- Use of university core facilities may be allowed under documented agreement and payment of external rates as well as in accordance with university core facility procedures (sign-up, scheduled time, etc.)
- Use of university equipment or space may be allowed under documented agreement and payment for use (unless otherwise specified) as well as in accordance with university procedures for use (sign-up, scheduled time, etc.) Please note, in general, the university owns its equipment and employees are not allowed to use or take equipment for non-University purposes without clear agreement/purchase.
The university takes the following factors into consideration when making decisions regarding company requests for lease of university space:
- There should be a specific reason that relates to an aspect of the university mission that the company has to lease university space and not non-University space (e.g., specific collaboration where close access to university space/specialized equipment being used via documented research/use agreement, etc. is needed).
- Employees must avoid using University email, computers, and contact information on behalf of an outside entity or purpose. In other words, it is important to delineate and keep University work and outside entity work separate and distinct.
- The agreement should include a specific and limited duration consistent with the outside need.
- Any conflicted university employee cannot be involved in negotiations or any financial or other transactions on behalf of the outside entity (or university) with respect to the arrangement.
- The agreement terms, cost, etc. should be consistent with market considerations and rates.
- Any agreements between companies and the University should specify terms for intellectual property ownership for any intellectual property developed while using University resources, space, or equipment.
- Licensed electronic information resources, including Library databases and other online tools and services, must be used in accordance with UNL’s license terms and conditions.
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:
- All full-time faculty, including those with nine-month appointments;
- Managerial/professional staff and administrators;
- Anyone who is responsible for the design, conduct, administration, or reporting of research;
- Anyone with an outside professional activity involving a foreign government, quasi-government, institution, or other foreign entity (including businesses);
- All employees who have been issued a University purchasing card;
- All employees with delegated signature authority; and
- Anyone who is otherwise directed to complete the disclosure form
|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, CIRC, SROC, IACUC, or IBC)
|International Scholars |
(J-1 & H-1B Visa Holders)
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)
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)
(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, CIRC, SROC, IACUC, or IBC)
|Other||The 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.|