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