The public looks to university research as an independent, unbiased source of information. Because some university researchers also have private interests in entities that contribute to research, the federal government, the state of Nebraska, and UNL require disclosure of financial interests.
UNL requires disclosure of interests that appear to be related to your institutional responsibilities. The following FAQs help to address any questions that you may have about the COI process at UNL:
What is a conflict of interest?
Broadly speaking, a conflict of interest is a situation in which a secondary interest may improperly influence or bias a primary interest. In the sponsored research setting, we are focused on ways in which personal financial interests may improperly influence the design, conduct, or reporting of research.
It is important to note that a conflict of interest is a situation. It does not mean an individual’s behavior is necessarily biased. Even a perceived conflict of interest, if unmanaged, can compromise the public’s trust in research results.
Who must disclose financial interests?
A UNL Interest and Outside Activity Reporting Form must be completed annually through NUgrant by all UNL faculty, staff, students and affiliates involved in research.
Why must I disclose?
Federal regulations require institutions that receive federal funding to establish policies and guidelines for the management of potential conflicts of interest. The purpose of these policies and procedures is to protect the credibility and integrity of UNL and to foster public trust and confidence.
The disclosure process is not intended to discourage participation in activities outside of UNL.
What financial interests must be disclosed?
Financial interests that reasonably appear to be related to your institutional responsibilities must be disclosed on an annual basis by filing an Interest and Outside Activity Reporting Form (IOARF) on NUgrant. Financial interests include, but are not limited to:
- Consulting income, royalties, salary or other payments you receive outside the University of Nebraska system
- Equity interests (e.g., stocks, stock options, bonds or other ownership interests) in entities related to your institutional responsibilities
- Intellectual property rights and interests (e.g., patents, copyrights, licenses) upon receipt of income to such rights and interests
- If you are receiving funds from a Public Health Service awarding agency, sponsored or reimbursed travel must be disclosed
Such financial interests include interests related to a covered person’s immediate family, business relationships, fiduciary relationships, or investments.
What constitutes a significant financial interest that may require management?
Per the federal guidelines for Promoting Objectivity in Research (42 CFR 50 Subpart F), a significant financial interest (SFI) is defined as “A financial interest consisting of one or more of the following…that reasonably appears to be related to the Investigator’s institutional responsibilities”:
- Publicly traded entity: if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
- Non-publicly traded entity: if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest)
- Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests. NOTE: this does not include intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights via NUtech ventures
To apply the criteria to your own situation, visit the FCOI Assessment Flowchart found HERE.
Are there exceptions to what must be disclosed?
The following interests are not considered significant financial interests and do not need to be disclosed:
- Interests that do not reasonably appear to be related to your institutional responsibilities
- Salary, royalties, or other remuneration paid by UNL
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, medical center, or a research institute that is affiliated with a U.S. institution of higher education
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control the investment decisions made in these vehicles
What are “institutional responsibilities”?
“Institutional responsibilities” are activities such as procurement, research, teaching, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Who is included in the definition of “immediate family”?
Immediate family is defined as your spouse, child, parent, brother, sister, grandchild, or grandparent, by blood, marriage, or adoption, or an individual who is your Adult Designee for purposes of employment benefits. Therefore, interests held by the parents of your spouse would be considered financial interests that would need to be disclosed if they are related to your institutional responsibilities.
Would I need to disclose income received from international universities or non-profit agencies?
Yes. Payments received from entities that are not exempt from the disclosure requirement (see above) must be disclosed.
If part of my salary is funded by a grant, would I need to disclose such a payment?
Funding that is routed through the appropriate University channels (such as the Office of Sponsored Programs) does not need to be reported. All payments you receive directly from an outside entity must be disclosed if they appear to be related to your institutional responsibilities.
What is the disclosure process?
Complete an Interest and Outside Activity Reporting Form (IOARF) prior to engaging in research. Disclose all interests and outside activities related to your institutional responsibilities at least annually.
How do I complete the Interest and Outside Activity Reporting Form?
Login to NUgrant using your UNL Blackboard credentials. On the homepage, click on [add new] under the heading Interest and Activity Management to start a new form.
If you still have a question about completing the form, contact the COI Coordinator (2-6907, or, unlcoi@unledu) in Research Compliance Services.
What is the review process?
Your IOARF will be routed to your department chair/director and dean. It will then go to the Conflict of Interest Coordinator for review of financial interests and to your appropriate vice chancellor-level reviewer for review of outside activities. Often, disclosure of financial interests is sufficient. In situations where potential conflicts of interest must be managed beyond disclosure, Research Compliance Services will work with you to present your conflict to the Conflict of Interest in Research Committee to develop a custom management plan.
How are conflicts of interest managed?
Dependent on information disclosed, management plans can include, but are not limited to, disclosure in publications and presentations, internal peer review, or safeguards for students.
What should I do if my financial interests change prior to the expiration of my Interest and Outside Activity Reporting Form?
Your IOARF is valid for one year from the approval date. If your financial interests or circumstances change during the annual reporting period, a new IOARF should be completed to update your disclosure within 30 days of a change in your outside interests. The information from your previous form will be pre-populated so that you may quickly and easily make changes.
Can a conflict of interest delay or prevent me from doing research?
When conflicts of interest are properly disclosed and managed, it generally does not prevent you from conducting research. Delays in the ability to conduct research may occur, however, if you do not complete the IOARF and/or training in a timely manner or if you omit relevant interests from the form.
Do I need to complete an Interest and Outside Activity Reporting Form even if I do not have any outside interests related to my research activities?
Yes. An IOARF must be completed by each individual meeting the description of a covered person (above), even if they do not have any outside interests to disclose.
How should individuals that are not affiliated with UNL disclose outside interests?
Contact the COI Coordinator (2-6907, or firstname.lastname@example.org)in Research Compliance Services to first ensure that you need to file a disclosure with UNL.
If you collaborate on a PHS funded UNL sponsored research project, but your institution does not maintain and enforce a conflict of interest policy in compliance with federal regulations, UNL may request that you complete the UNL Collaborator Interest Reporting Form and CITI conflict of interest training.
Are there penalties for not updating my Interest and Outside Activity Reporting Form within 30 days of a change in financial interests?
Maintaining an accurate and up-to-date IOARF is crucial in ensuring that UNL complies with state and federal reporting regulations. Failure to update your IOARF may result in loss of sponsored research funds and may require the University to conduct a retrospective review of the research to ensure no bias has been introduced into research activities.
Public Health Service Regulations
What are the Public Health Service regulations?
The Public Health Service has strict regulations regarding financial conflicts of interest in research funded by their awarding agencies. These regulations went into effect August 24, 2012. At UNL, researchers seeking or receiving PHS funding have additional requirements for maintaining compliance with these regulations.
What are PHS awarding agencies?
The Public Health Service (PHS) is the primary division of the U.S. Department of Health and Human Services. It administers the following agencies:
- 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)
What additional conflict of interest requirements exist for PHS-funded research?
- Expanded definition of investigator – PHS now defines an investigator as ‘the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.’
- Timeframe for disclosure – To comply with the new regulation, all investigators must complete the IOARF by the time of submitting proposals for all PHS-funded research. It is the principal investigator’s responsibility to identify all investigators on the grant prior to submission and submit that list to their grant coordinator. Should an award be made, it is the principal investigator’s responsibility to ensure that the list is kept current during the life of the grant. Any changes must be sent to their post award coordinator.
- Required conflict of interest training – All PHS investigators must complete mandatory training on conflict of interest prior to engaging in PHS-funded research. The IOARF will prompt investigators to take the CITI training at: citiprogram.org They will then attach their completion report to the IOARF. Training must be completed every 4 years.
- Disclosure of sponsored/reimbursed travel – PHS now requires that some sponsored or reimbursed travel be disclosed on the IOARF no later than 30 days after the travel has occurred. Some exceptions apply. Investigators do not need to disclose:
- Travel sponsored by:
- A federal, state, or local government agency
- US institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a US institution of higher learning
- Travel that is included in a grant/project proposal that is administered by UNL’s Office of Sponsored Programs
- Travel sponsored by:
- Public accessibility requirement
According to the United States Department of Health and Human Services regulations, the public has the right to obtain information regarding conflicts of interest for any Public Health Services (PHS) funded Investigators or Key Personnel. The University of Nebraska-Lincoln will supply this information, within five business days, upon receipt of a written request.