Research Ethics & Compliance

Disclosure of outside professional activities and financial interests that relate to your role(s) and responsibilities at The University of Alabama is required by UA’s Policy on Conflict of Interest and Conflict of Commitment.

• Log in to COI Cayuse (Instructions for Statement of Financial Interest Form)
• Follow system prompts, answering any questions

What to Disclose

Tips for what to disclose or not disclose include:

• Is the activity related to what you do at UA? If so, it should be disclosed. If not, it likely does not need to be disclosed.
• Mutual funds or holdings in a retirement account do not need to be disclosed.
• The disclosure asks about outside activities and financial interests that relate to your role at UA, not just self-identified conflicts of interest. While self-identified conflicts should definitely be disclosed, responding honestly and completely is an important best practice that allows UA to demonstrate that UA work is free from even the perception that decisions were biased by personal gain.

When to Disclose

Other times disclosure is required: 

• New SFI. faculty and staff who are involved in sponsored research are subject to research disclosure requirements, which require updates on a rolling basis within 30 days of acquiring (or becoming aware of) a new significant interest. 
• New outside activity. If faculty or staff initiate a new outside activity that is related to their UA responsibilities (e.g., a new freelance business that works with / is seeking to work with UA) it is prudent to update your disclosure. 

Tip! This is also an opportunity to provide documentation or a summary of the conversation you had with your supervisor/chair/dean’s office obtaining prior approval for the activity or discussing how the activity will be handled so that it does not detract from your UA responsibilities. 

Note: if updates are submitted outside of the annual process, that information will be saved and pre-populated for you during the annual process. It will not be necessary to enter the information twice. 

Examples of when researchers need to update their disclosure: 

• Cumulative payments for the past 12 months from an entity exceeding $5,000. The FCOI policy, which is based on federal regulations, requires faculty and staff who are involved in research to update their disclosures if they receive more than $5,000 in cumulative payments from a single company over the previous 12 months. 
• A start-up company is formed. If a faculty or staff member is a founder or co-founder of a start-up company, and consequently is a part owner of the company, that relationship needs to be disclosed within 30 days of creating a legal entity. While we understand that often companies exist “only on paper,” because that paperwork creates a legal entity, legally, those companies exist. Ownership (including being co-founder of a company, having options in a company, or any other equity holding) in a non-publicly traded entity is considered to be an SFI and disclosure is required within 30 days of acquiring that interest. If may be decided, after discussion with the faculty or staff member, that the nascent company does not create a COI given its early stage, but the policy and regulations require disclosure of SFIs, not only COIs. 

What happens if disclosures are not submitted when required by policy? 

Annual Disclosure

If your annual disclosure is not completed during the annual disclosure period in September, the following repercussions may occur: 

• If you are involved in research, and you have not updated in the last 365 days, you may not be able to submit new proposals, and new projects may not receive chartstrings until a disclosure is completed. 
• If you are on active research projects from federal sponsors, UA may not be able to invoice the sponsor for work performed on grants until a disclosure is completed. 

We understand that faculty and staff at the University are busy and balancing many tasks at any given time. For most individuals, disclosure only takes a few minutes and we appreciate the cooperation of the university community in completing their disclosure during the month of September. 

New interest that requires an update.

If a person who is involved in research does not submit an updated disclosure when they have a new SFI, there is a risk that the University will need to conduct a retrospective review. In the instance where someone involved in research has a new SFI that is not disclosed in a timely manner, and it is determined that that SFI is a COI with a research project, the University must review all research activity on that project (methods, data, results, publications – all research activity). 

Significant Financial Interest

Federal regulations and the COI in research policy require disclosure of Significant Financial Interests (SFIs) prior to submitting a proposal and within 30 days of receiving a new interest.

Significant Financial Interests (SFIs) are defined as:

UA’s FCOI Policy requires Investigators (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, whether externally or internally funded) to receive FCOI training from the University. Investigators must receive training related to FCOIs in research:

• Prior to engaging in sponsored research at the University;
• At least every 4 years; and
• Immediately under the following circumstances:
  • University FCOI policies change in a manner that affects Investigator requirements;
  • An investigator is new to the University; or
  • The University finds an Investigator non-compliant with the University’s FCOI policy or management plan.

The Research Integrity and Conflict of Interest Program has streamlined the training process to create a better experience for Investigators and will notify you as soon as your training becomes due.

Investigators must take financial conflict of interest training every four years in CITI. UA applies the same disclosure and management principles to all sponsored research, regardless of sponsor. Therefore, the training requirement applies to all investigators on sponsored research projects.

The FCOI in research training course is available through the CITI link: CITI – Collaborative Institutional Training Initiative (citiprogram.org).

Investigators should save a copy of the Certificate of Completion for their records (available in the Completed Courses section in CITI).

CITI FCOI Training Instructions

The mission of the University Conflict of Interest Committee (UCIC) is to oversee and implement the University’s Conflict of Interest policies to preserve integrity and objectivity in the University’s research, academic, and business activities, while observing the entrepreneurial spirit and mission of the University.

When the assistance of the UCIC is needed, one will be appointed by the VPRED. The UCIC shall be chaired by the CPRED or designee. It shall also include not less than five additional appointed members with broad representation across UA, a member of the University System’s Office of Counsel and a member of the Office of Compliance, Ethics, and Regulatory Affairs will serve as liaison (non-voting members).

Members shall serve three-year staggered terms.

Upon referral from UA’s IIO, the UCIC shall review all material related to a potential or apparent conflict of interest. If the UCIC identifies a conflict, they will work with the IIO and the Investigator(s) to resolve the conflict by management, mitigation, or elimination.

• The VPRED will appoint a UCIC composed of employees who are experienced with the preparation, submission, and administration of sponsored grants and contracts, and all matters relating to the identification and management of actual or apparent conflicts. The appointed members of the committee shall serve three-year, staggered terms. A member of the University’s Office of Counsel and a member of the Office of Compliance, Ethics, and Regulatory Affairs will serve as a liaison (non-voting) members.
  • UCIC serves as an advisory committee for identified conflicts of interest by the RCO. The UCIC shall:
  • Review COI Management Plans outlining and implementing measures to actively reduce, mitigate or eliminate an apparent conflict, potential conflict, or perceived conflict of interest help by an employee.
  • Review amendments to a management plan or make recommendations on a different course of action to be taken in the management, reduction, or elimination of the conflict.
  • Provide assistance in the implementation of the Conflict of Interest Financial Disclosure in Research and other Sponsored Programs Policy.
  • Maintain an ongoing awareness of procedures, practices, and standards with regard to conflicts of interest with a view to assuring consistency with the terms of this policy.
  • Carry on dialogue as necessary with deans and directors or administrative officers to ensure that their knowledge is sufficiently current and complete.
  • Ensure that a proper balance is maintained between confidentiality and UCIC operations and standards.
  • Disclose any potential conflict of interest posed by serving on the UCIC or reviewing Statements of Interests brought before the UCIC to the RCO. If the RCO has any reservations about proceeding with the conflict disclosed, the VPRED will make a final decision on abstention from participation.
  • Oversee the ongoing review of all existing Statements of Interest and COI Management Plans to ensure compliance with this policy.

• The VPRED may accept the COI Management Plan and recommendations of the UCIC or return the plan to the UCIC with stated concerns. The VPRED or delegate shall be responsible for deciding whether to grant final approval of the plan and sign the plan. The RCO shall notify the employee Investigator and the dean, department head or director, as appropriate.

Committee meetings are scheduled on a bimonthly basis and may be scheduled more frequently as the need arises. Issues that come to a vote require a simple majority of voting members to pass. A quorum must be present for any votes, and a quorum consists of voting UCIC members minus one at the time of the vote.

The UCIC is supported by The University of Alabama’s Office for Research and Economic Development.

COI Management Plans are implemented when there appears to be overlap between individuals outside relationships and/or interests and their UA responsibilities. 

The purpose of a COI Management Plan is to enhance transparency and create separation between UA work and the work an individual may be doing outside the university in order to avoid even the appearance that decision making was biased or influenced by that outside interest. 

COI Management plan strategies can vary depending on the circumstance. This page provides a response to some common questions we receive. If you have questions that are not answered here, please always feel free to reach out to us at eahooper@ua.edu or your supervisor or dean’s office for guidance. 

FAQs 

What are common management strategies? 

General strategies for management include: 

• Recusal from decisions involving the outside company the person has a relationship with 
• Parameters around using UA resources for activities with an outside entity 
• Restrictions on using direct reports or trainees in those outside activities without proper agreements and/or reporting line changes in place. 

For research projects, the most common management strategies are: 

• Disclosure to collaborators and team members, 
• Disclosure in publications, presentations, and press releases 
• Disclosure in informed consent documents (as applicable) 

Reporting – General

Why do I need to submit a COI disclosure form?

UA’s FCOI policy requires certain members of the UA faculty and senior/key personnel to complete a FCOI reporting form annually. The COI reporting form collects information related to SFIs, COC, supervisory conflicts, and gifts.

Under the PHS regulations, an Investigator means the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (e.g., NIH). It is the role, rather than the title, of the individuals work that should form the basis of a decision for whether someone qualifies as an “Investigator.” When the definition of Investigator is limited to titles or designations (e.g., to PI’s, key personnel, faculty), the risk is that an unidentified FCOI may compromise the research enterprise, particularly if it results in late reporting and a subsequent retrospective review.

What do I need to report on my Annual COI Disclosure form?

On the University’s annual COI Disclosure form, you will be asked to report SFIs that you or your spouse or dependent child held during the past calendar year that are related to your University responsibilities and professional expertise. You will also be asked additional questions about academic appointments, COC, gifts, non-US support, and supervisory conflicts. Please read the questions carefully. Some people will also have to report travel.

I do not have any interests or conflicts. Why do I still need to submit a COI disclosure form?

The determination regarding whether or not you have conflicts is not a self-determination, but is instead made by the institution. In many instances, the perception of conflict if a critical factor to consider. Perception, however, is seldom considered when one evaluates one’s own potential conflicts. Therefore, the institution does not ask whether you have “a conflict,” but rather, asks you to provide a list of your financial and other outside interests and then evaluates these against your University responsibilities (e.g., research, teaching) to determine if these interests. If you have no interests, the annual COI disclosure form serves as an affirmation that you do not have any reportable interests.

Reportable Interests

What do I have to disclose?

On the University’s annual COI disclosure form, you will be asked to report SFIs that you or your spouse or dependent children held during the past calendar year that are related to your University responsibilities and professional expertise. You will also be asked additional questions about academic appointments, COC, gifts, and supervising relatives. If you need specific advise, email eahoooper@ua.edu

What is a SFI?

A SFI is the receipt by you, your spouse, or your dependent children of any of the following, if related to your University responsibilities or professional expertise:

• Income that exceeds $5,000 from any outside entity, measured on a rolling 12-month basis. This may be one payment from a particular company of more than $5,000, or multiple payments from the same company that, in the aggregate, exceed $5,000.
• Acquisition of equity in a public company that exceeds $5,000 in value;
• Aggregated income and equity/ownership interest from a public company that exceeds $5,000, as measured on a rolling 12-month basis;
• ANY equity/ownership interest in a privately-held company, including start-ups and LLC’s;
• Income received directly from a company/organization (not through UA) from rights in IP and interests (e.g., patents, copyrights), as measured on a rolling 12-month basis.

For purposes of the Annual COI Disclosure Period, consider “rolling 12 months basis” to mean “in the past calendar year. The following interests are excluded from this definition:

• Payments (including salary, travel, and IP royalties) received from your employer, i.e., UA;
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control individual investment decisions (i.e., the purchase of specific stock; or
• Income from seminars, lectures, or teaching engagements from a U.S. government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

What does “related to my University responsibilities or professional expertise” mean?

The term “University responsibilities” refers to any professional responsibilities that you undertake on behalf of UA, which may include, for example, research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Purchasing Committees. Professional expertise refers to anything in your area of expertise with the caveat that it shouldn’t be applied too narrowly. This does not mean that this term broadly captures the entirety of one’s field, such as engineering, biology or political science. When evaluating what is related, instead consider aligning your analysis with the appropriate sub-field, such as electrical engineering, molecular biology or political theory.

Do I really need to report my spouse’s interests?

Yes, the interests of a spouse are reportable if they meet the reporting criteria and threshold. That is, if they are related to your (not his/her) University responsibilities and professional expertise, and if they are >$5,000 for the calendar year or 12 month period (whichever is being asked). For example, if you are a faculty member in the Department of Molecular Microbiology and Immunology and your spouse works for Thermo Fisher with salary and stock options, it may be reportable because it seems related to your University responsibilities and professional expertise. However, if you are a faculty member in the Department of Music and your spouse works for Thermo Fisher with salary and stock options, it would be unrelated to your University responsibilities and thus would not be reportable.

I hold stock in mutual funds. Do these need to be reported?

No, these do not need to be reported because they are excluded from the definition of SFI. In general, any investment vehicle where you have no control over the acquisition of individual stock, are excluded from reporting.

I hold stock as part of an investment portfolio. Do i need to report these stock holdings?

It depends. If the investment portfolio is such that you have control over individual stock purchases – even if you rarely or never exercise it – then the stock holdings are reportable if they meet the reporting criteria and threshold: >$5,000 in value during the calendar year or 12 month period (whichever is being asked) and related to your University responsibilities and professional expertise.

I provide expert legal testimony and services. Do i need to report these?

Yes, expert legal testimony is reportable if it meets the reporting criteria and threshold: >$5,000 in value during the calendar year or 12 month period (whichever is being asked) and related to your University responsibilities and professional expertise. When reporting expert legal testimony, you should report it as income from the law firm or legal entity that paid or retained you. If you know that you provided this testimony on behalf of another company (e.g., a pharmaceutical company), please include this withiin your disclosure form.

I am an Editor of a journal that is published by a professional organization. I receive more than $5,000 per year. Do i have to report that?

Yes, any income from journals and professional organizations that meets the reporting criteria and threshold (>$5,000 in value during the calendar year or 12 month period, whichever is being asked) is reportable because it is not excluded from the definition of SFI.

Last year, I founded a company. At this point in time, it is very much a paper company. It has no products, no employees and not even a website. It’s worth nothing. Is this reportable interest?

Yes, the definition of SFI includes ANY equity/ownership interest in a privately-held company. Therefore, any ownership interest in a legal entity (whether it’s a corporation or an LLC) is reportable even if, at this point, the entity exists mainly on paper and has no assets.

I have written several books. Do i need to report royalties I receive for these publications?

Faculty are generally not required to report royalties that are related to an academic publication. However, if the royalty payments you receive are either significant (e.g., related to a textbook)  or are related to a non-academic publication, they should be reported. If you have reportable royalties, you can report them on the COI disclosure form in 2 ways. You can either report them as income from a particular publisher, if greater than $5,000. Alternatively, you can report them as “income related to IP rights and interests”.

Do I need to report spousal travel?

Yes, spousal travel is reportable if it meets the following criteria:

• The aggregate value of the travel is greater than $5,000 from a single entity over a 12-month period; and
• The travel is related to your University responsibilities and professional expertise.
• The same is true of travel of any dependent children.

What information is required for travel reporting?

When reporting travel, you will need to provide:

• The name of the company or organization that sponsored or reimbursed the travel;
• The destination;
• Travel dates (departure and return dates);
• The approximately dollar value of the sponsored or reimbursed travel; and
• The purpose of the trip (business purpose).

Conflict of Commitment

What is a conflict of commitment?

UA defines a COC as occurring when outside activities interfere with an individual’s ability to meet University Responsibilities. On the COI disclosure form, disclosure of certain information about your outside activities and relationships is required to assess and manage potential COC.

What constitutes “use” of UA facilities or personal for the benefit of a non-UA entity, interest or activity?

Use of UA facilities or personnel by an outside entity is governed by the Conflict of Interest and Commitment Policy. Per the policy, personal use of UA computers and telephones must be infrequent and cannot incur additional incur additional expenses for the University. Similarly, UA offices, email, printers, copiers, or research equipment should not be used for personal consulting or business activities. Likewise, UA personnel should not be engaged in personal consulting or business activities. This applies, regardless of whether the consulting or business activities are for a for-profit or non-profit organization.

Is you or a third, non-UA party wants to use campus space, equipment, or personnel, you must contact your University Representative, in advance, to discuss the implementation of a facilities use agreements.

Submitting Disclosure Updates

Am I required to submit disclosure updates for newly acquired SFIs?

The 30-day updating requirement only applies to Investigators on research projects funded by PHS or foundations that follow the PHS COI regulations. If you are the PI on a research project funded by NIH, for example, then this requirement will apply to you. Likewise, if you are the PI on a research grant awarded by a foundation that follows the PHS COI regulations, this requirement will apply to you. If you are a co-investigator or a mentor/sponsor on an NIH funded research project then this requirement will likely apply to you.

What is a “new” SFI?

An SFI is considered “new” if you have never previously reported it to the University. An SFI is also considered “new” if it is a different type of SFI (e.g., royalty payment vs. Consulting fees) than what has previously been disclosed from the same source, OR is the same type or nature of SFI (e.g., royalty payment) but from a different source (e.g., company A versus company B).

What happens if I forget to submit my disclosure update late?

A new SFI must be reported to the institution within 30 days of acquiring or discovering the interest. If you report a new SFI late, after the 30 days have passed, per the federal COI regulations, the institution may need to conduct a “retrospective review” if the SFI is determined to create a FCOI with your PHS-funded research. The purpose of the retrospective review is to determine whether any of your PHS-funded research, or portions thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such research.

If I have a COI, does it mean I cannot work on certain research or other scholarly activities?

No, having a COI does not prohibit you from engaging in research or other scholarly activities. In most instances, a COI can be appropriately managed so that you can, for example, continue to participate in a research activity while keeping your financial or outside interest. In some rare instances the conflict may be such that it cannot be appropriately managed. In such case, you may be asked to consider reducing or eliminating the financial interest rather than discontinue your participation in the research activity. In general, your outside activities and interests should not prevent you from carrying out your research activities, teaching, and other University duties and responsibilities.

Covered Individual: an individual who (a) contributes in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award from a federal research agency; and (b) is designated as a covered individual by the federal research agency concerned. For the purposes of the UA FCOI policy, PI’s and senior/key personnel will always be considered covered individuals.

Entity: an entity is an external business, company, or other such organization, and includes (but is not limited to) any partnership, corporation, limited liability corporation, unincorporated association, or other institution or organization, whether for-profit, non-profit, academic, or professional.

Financial COI: a FCOI exists when UA, through its designated official(s), reasonably determines that an Investigator’s SFI is related to a funded research project and could directly and significantly affect the design, conduct, or reporting of the funded research, or present the appearance thereof.

Immediate Family Member: immediate family member includes an Investigator’s spouse, domestic or civil union partner, and dependent children.

Institutional Responsibilities: Institutional responsibilities include professional activities that relate to an Investigator’s responsibilities on behalf of UA, such as research, teaching, institutional committee memberships, professional practice, and administrative activities and responsibilities for UA.

Investigator: Investigator includes the project director or principal investigator and any other person responsible for the design, conduct, or reporting of research, regardless of title or position, and their immediate family members.

Significant Financial Interest (SFI): a SFI includes an external financial interest consisting of one or more of the following interests of an Investigator (and those of the Investigator’s immediate family members) that is related to their institutional responsibilities:

• For a publicly traded entity, when the value of remuneration received in the 12 months preceding the disclosure and the value of and equity interest as of the date of the disclosure, when aggregated, exceeds $5,000.
• For a non-publicly traded entity (e.g., a start-up company), when the value of remuneration received in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest regardless of whether that interest’s value can be defined.
• IP rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests (e.g., royalty payments)
• Occurrence of any sponsored or reimbursed travel.

Conflict of Commitment (COC): exists when a University Member’s external relationships or activities have, or will have, a reasonable potential to interfere or compete with the University’s educational, research, or service mission or with that individual’s ability or willingness to perform the full range of responsibilities associated with his/her position.

Conflict of Interest (COI): exists whenever personal, professional, commercial, or financial interests or activities outside of the University are, or have a reasonable potential of, (1) compromising a University Member’s judgement; (2) biasing the nature or direction of scholarly research; or (3) influencing a faculty or staff member’s decision or behavior with respect to teaching and student affairs, appointments and promotions, uses of University resources, interactions with human subjects, or other matters of interest to the University; or (4) resulting in personal or immediate family member’s gain or advancement to the detriment of the University or in ways prohibited by University policy.

COI Management Plan (CMP): is a document that describes how COIs and conflicts of commitment will be managed, monitored, or avoided.

Disclosure: means the reporting of outside interests, activity, or relationship related to an individual’s University responsibilities. The information disclosed includes, but is not limited to, “SFIs” as described in the Public Health Science (PHS) Financial Conflict of Interest (FCOI) regulation.

Financial Conflict of Interest (FCOI): means a SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Intellectual Property (IP): refers to property created or developed by a University Member, including but not limited to, patents and inventions, copyrightable work, software, and trademarks.

Management of COI: means taking action to address an actual, potential, or perceived COI or conflict of commitment, to ensure, to the extent possible, that the design, conduct, or reporting of the research will be free from bias. Examples of management mechanisms include, but are not limited to:

• Institutional disclosure of the COI or COC;
• Monitoring of the research or research management by non-conflicted individuals;
• Limiting participation in some or all of the research;
• Divestiture of the interest; or
• Severance of the relationship that creates the COI or COC.

Outside interest, activity or relationship: refers to an interest with an outside organization that relates to a University Member’s institutional responsibilities. This also applies both to the individual and members of his/her immediate family.

Public Health Service (PHS): refers to the agencies of the PHS of the U.S. Department of Health and Human Services, and any of their components. The NIH, FDA, and CDC are three components that are often involved in academic research.