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Augusta University Conflict of Interest Program

The Conflict of Interest (COI) program at Augusta University (AU) serves to maintain the integrity of the teaching, discovery, and clinical care missions of AU by encouraging transparent reporting and management of external interests and activities.

Conflict of Interest

A conflict of interest may occur when an individual’s personal interests and/or outside activities – family, friendships, financial, or social factors – could compromise their judgment, decisions, or actions in the workplace. For faculty, staff, and affiliates of AU, a potential conflict of interest could create the appearance that an individual’s ability to protect AU’s interest, or perform AU duties, could be compromised by a personal, financial, or business interest. Individuals engaged in research have the additional responsibility to avoid a financial conflict of interest (FCOI) that could affect, or appear to affect, the design, conduct, or reporting of research activities.

There may be times when conflicts of interest, or apparent conflicts, are unavoidable. Indeed, in certain situation, such activities may benefit AU. For example, consulting or entrepreneurial activities may lead to external research funding. The disclosure and management of potential conflicts of interest serve to maintain the integrity of AU’s teaching, discovery, and clinical care missions. AU’s faculty, staff and affiliates have an obligation to disclose external relationships and activities that create potential conflicts of interest.

AU's Individual Conflict of Interest Policy

Conflict Disclosure

All AU faculty, staff, and affiliates are required to complete a COI disclosure within 30 days of hire and thereafter on an annual basis, even if they have no potential conflict to disclose. Individuals must update their annual disclosure within 30 calendar days of establishing any new interests/relationships or when there are substantive changes in any existing interests/relationships that might reasonably be related to their AU responsibilities.

Submit or Modify COI disclosure

Researchers will be asked to disclose any potential conflict of interest created by a new project to the Institutional Review Board (IRB) Office and/or Division of Sponsored Programs (DSPA) via a Project COI Disclosure. The IRB Office and/or DSPA will then communicate with the COI team to verify that the appropriate disclosure has been reviewed and a management plan developed (if appropriate).

It is important to note that many activities that create a potential conflict of interest also have the potential to create a conflict of commitment and thus also fall under the Outside Professional Activities and Off Campus Duty policy. All faculty and staff are expected to obtain supervisory approval before engaging in an outside activity that relates to their role at AU and to submit an annual report of all outside activities at the end of each fiscal year. This approval and reporting process is in addition to, and does not replace, the COI disclosure process.

Outside Activity policy and forms

Conflict Review and Management

Your disclosure will be reviewed, either administratively by the Office of Research Ethics and Compliance, and/or by the COI Committee, and one of the following determinations will be made:

No conflict identified
Potential conflict identified, no management plan required
Potential conflict identified, management plan required
Potential conflict identified, outside activity/interest or AU role/activity must be adjusted.

Results of the review and any management plan requirements will be communicated to the disclosing individual, their supervisor, and Dean or Vice President.

Monitoring of Compliance with Management Plan Requirements

If a management plan is required, plan requirements will be communicated to the disclosing individual’s supervisor, who will be responsible for routine monitoring of compliance with those requirements. Management plan compliance is subject to additional monitoring by the Office of Research, Ethics and Compliance.

Contact Us

Ryan Sconyers, Coordinator, Research Compliance Programs

706-721-8643

COI@augusta.edu

1120 15th Street CJ-1022 Augusta, GA 30912

Best Practices for Potential Conflicts

Do not try to evaluate your own potential conflict. If an outside interest or activity may create even the appearance of a conflict, you should disclose that relationship. It is the responsibility of AU’s Conflict of Interest committee and its designee(s) to evaluate potential conflicts.
When in doubt, make the disclosure. Not sure if a new interest or activity creates a potential conflict? Go ahead and make the disclosure, or contact the COI Office [who’s the COI office?] for guidance.
Obtain prior approval for use of AU resources. AU resources include buildings, equipment, IT networks, libraries, personnel, students, branding (name, logos), etc. Use of AU resources for an outside activity requires prior explicit disclosure and approval. A management plan, if required, will provide additional guidance.
Disclose your potential conflict of interest to other entities. Disclosure may be required in publications, presentations, grant applications, Informed Consent Documents, etc. A management plan, if required, will provide additional guidance.
Avoid creating a conflict of commitment. Limit time commitments to any outside entity to the maximum allowed by the Outside Professional Activities and Off Campus Duty policy.
Recuse yourself from decision making. If the outside entity with which you have a relationship intends to enter into a business relationship with AU, you must recuse yourself from being involved in making any of those business decisions on behalf of AU at the outset or during the relationship. A management plan, if required, will provide additional guidance.
Do not negotiate or sign agreements on behalf of AU. You are encouraged to seek the advice of independent legal counsel for personal agreements (i.e., not related to your work as an AU employee) between you and the outside entity, and you may sign those agreements on your own behalf. Agreements between any outside entity and AU as a named party must be signed by an authorized signatory for AU.
Protect intellectual property (IP) rights. Before you sign an agreement with an outside entity, you should ensure that the agreement acknowledges that the entity’s IP rights are subject to the university’s rights as your employer.
Make the appropriate disclosures to federal funding agencies. Certain conflict of interest, conflict of commitment, and paid or reimbursed travel must be disclosed to federal funding agencies in Biosketch, Other Support, and Foreign Component
Report potential conflicts of immediate family members. If an immediate family member has an interest or activity that may be related to your role at AU, you must report that as a potential conflict.

Frequently Asked Questions

Who must disclose?

All AU employees (including faculty and staff) must complete an annual COI disclosure and must disclose potential conflicts on a project-specific basis.

Do post-docs and graduate students need to disclose?

Post docs and graduate students that are employees of AU are required to disclose.

What needs to be disclosed?

All employees are required to disclose any outside interest (including financial interest), relationship or activity.

What is a Financial Conflict of Interest (FCOI)?

For the purposes of AU’s annual disclosure, a financial interest includes, but is not limited to, one or more of the following:

Remuneration (salary, consulting fees, honoraria, paid authorship) by a publicly or privately traded entity
Equity interest (stock, stock options, ownership interest) in a publicly traded entity
Intellectual property and royalty interests (e.g., patents, copyrights)
Reimbursed or sponsored travel related to their institutional responsibilities including that which is paid on behalf of the traveler (this does not include travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education)
Any fiduciary position held by an individual or a covered family member in a for-profit or nonprofit entity in the preceding 12 months, including a position as a member of the board of directors, an officer, or other executive or management position, for which the individual or covered family member received any form of remuneration or reimbursement for expenses.

What activities and interests are NOT subject to disclosure under AU policy(ies)?

The following activities and interests do not need to be disclosed to AU:

Income from investment vehicles, such as mutual funds and retirement accounts, as long as the individual does not directly control the investment decisions made in these vehicles.
Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Travel reimbursed or sponsored by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

How do I know if my potential conflict is related to my institutional responsibilities?

Per AU policy, every employee has an ongoing responsibility to report and fully disclose any personal, professional, or financial interest, relationship, or activity that has the potential to create an actual or apparent conflict of interest. Employees should raise any concerns about conflicts of interest or outside activities with their supervisor or the SVP for Research or designee as soon as possible.

If I do not have any potential conflicts of interest, do I still need to submit anything?

Yes. Even if you do not have any potential conflicts to disclose, you must still submit an Annual COI disclosure.

If I receive an honorarium or other payment from another university, does that need to be disclosed to AU?

That depends. Income from a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, does not need to be disclosed.

However, honoraria or payments from foreign institutions MUST be disclosed, regardless of the nature of those institutions.

Does income from a government agency need to be disclosed to AU?

It depends. Income from a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, does not need to be disclosed.

However, honoraria or payments from foreign agencies or institutions MUST be disclosed, regardless of the nature of those institutions.

Do honoraria or travel from a professional society need to be disclosed to AU?

Yes. Funds (including travel reimbursement and honoraria) received from professional societies (including non-profits) must be disclosed.

I sit on an editorial board for a journal. Does my income from that need to be disclosed to AU?

This depends on whether the journal is a private organization or if it is published by a U.S. government agency or a U.S. institution of higher education. Follow the same guidelines as for other income.

I receive royalties or licensing income from a patent, do I need to disclose that to AU?

Yes. Your income from a patent could create the appearance of a conflict of interest for any further activities with that intellectual property. This includes patents which are owned wholly or in part by AU.

Does income from service as an expert witness need to be disclosed to AU?

Income from service as an expert witness should be disclosed.

When do I need to disclose or update my disclosure to AU?

Investigators are required to disclose their COI:

(a) within 30 days of your initial employment date

(b) annually, not later than August 31

(c) within 30 days after acquiring a new potential conflict requiring disclosure; and

(d) not later than the submission date for a funded research proposal or human subjects research protocol (or the addition to either, if employed/added after the initial submission date).

What if I inadvertently fail to disclose my potential conflict of interest?

You must disclose the potential conflict immediately. The disclosure will be reviewed to determine if a conflict of interest exists, and if so, a management plan may be implemented.

Will the COI review process delay my research project(s)?

It is important to submit your disclosure and any updates in a timely manner. If your disclosure requires review by the COI Committee, it can take one or more months due to the committee's docket and the complexity of information, as well as any follow-up meetings or information collection required. In addition, if you will be using human participants in your research, please note that the Institutional Review Board (IRB) will not complete its review of your application until the COI review has been completed. Finally, AU will not release funds for a project until all compliance reviews, including COI, have been completed.

Does sponsored travel need to be disclosed to AU?

It depends. The occurrence of any reimbursed or sponsored travel (including meals and per diem) must be disclosed, UNLESS the reimbursed or sponsored travel is by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. It is recognized that the exact cost might not be available, in which case the cost should be estimated.

What types of sponsored or reimbursed travel do NOT need to be disclosed to AU?

You do not need to disclose travel that is sponsored or reimbursed by AU or by a federal, state, or local government agency, or an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

What should I do if I have a potential conflict with my clinical care provided in WellStar facilities?

You should disclose in InfoEd and contact the WellStar representatives, Roshunda Drummond Roshunda.Drummond-Dye@wellstar.org and Beth Kost, Beth.kost@wellstar.org and cc Allison Luke ALLLuke@augusta.edu

How do I add an entity to my COI disclosure in InfoEd?

Type the name of the entity in the search box. The search results will display as you type.
Click on the entity you want to add from the search results and then click "ADD ENTITY."
If the entity does not appear in the drop-down list, enter "Not Found 1" in the search box and select it. Click "ADD ENTITY."
If you entered a "Not Found" entity you will be asked for the entity name in the Entity Names section. Otherwise, the entity's name you selected will be displayed in the Entity Names section.
Repeat the above steps to add all entities associated with your reportable external interests (summarized at the top of this page).
Click "Expand/Collapse" to hide or display the questions you must answer for each entity.
Note: Many of the questions are logic based and you will only see certain fields depending on how you answer previous questions.
Please add one entity and complete all information at a time, you will be asked if you have additional entities at the end. If you have multiple entities that do not appear in the drop-down list, please select Not Found 2, 3, 4 etc.

How do I edit entities on my COI disclosure in InfoEd?

Click "Expand/Collapse" to display and then update any entity details.
Use the "DELETE ENTITY" button to remove any entities that no longer apply. Please note that this will not delete the entities listed on your prior year’s disclosure.