Conflict of Interest in Research Disclosure Instructions
What do I need to disclose in my Annual Conflict of Interest Disclosure Form?
New conflict of interest regulations require some changes to the information that you must disclose in your annual Disclosure of Interest in Research (DOIR) form. Unless otherwise specified, the changes outlined below will apply to all West Virginia University investigators, regardless of funding. However, certain requirements will apply only to those who receive NIH or other PHS funding ,or who plan to apply for such funding. This reference guide can help as you prepare to file your DOIR form.
One important change is a new requirement that you disclose financial interests that reasonably appear to be related to your Institutional Responsibilities, not just those financial interests that are related to your research. The phrase institutional responsibilities is understood to mean all of the activities that you are required to perform in fulfilling your obligations to West Virginia University (WVU), including your sponsored activities(such as sponsored research or service projects), teaching, University administrative duties, clinical practice, and other University activities.
To understand what is meant by “related to your institutional responsibilities,” you should think about your outside activities that are associated with your area of professional expertise, or that are related to your role at the University. Ask yourself, “Am I being asked to participate in this outside activity because I am a professional in my field at West Virginia University?” If the answer is “Yes,” then it may reasonably appear that the requested activity is “related to your institutional responsibilities.” By this measure, any consultation in your area of professional expertise should be disclosed. However, if, for example, you are an orthopedist with a family business that imports rugs, that would not need to be disclosed. Keep in mind that “relatedness” is not always a bright-line determination. You should use your judgment when deciding what needs to be disclosed; but when in doubt, err on the side of transparency.
As before, you must disclose Financial Interests of any amount that are held or received by you or your Family (see below). However, the new requirements mandate broader disclosures than before. For example, Financial Interests now include remuneration from, and other relationships with, not-for-profit as well as for-profit entities. Financial Interests fall into several categories:
Compensation/Remuneration – You must disclose all non-WVU salary and payments for services (such as consulting
fees, honoraria, etc.) received by you or your family from outside entities,
including not-for-profit as well as for-profit entities, that reasonably appear
to be related to your institutional responsibilities.
You should NOT include:
salary or other remuneration from the University (other than royalty payments);
income from seminars, lectures or teaching sponsored by a Federal, state or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education;
income from service on advisory committees or review panels for a Federal, state or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education.
– You must disclose any stock, stock option, or other ownership interest in any
outside entities, held by you or your family, that reasonably appear to be related
to your institutional responsibilities.
You should NOT include:
equity held in diversified financial holdings that you or your family do not directly control, influence or manage, such as mutual funds and retirement accounts.
– You must disclose any payments to you or your family from intellectual property
rights that reasonably appear to be related to your institutional responsibilities,
such as royalties, license fees, or similar payments. Be sureto include payments
received either directly from an outside entity, which includes not-for-profit
as well as for-profit entities, or through the University (such as through a
University license agreement).
PHS researchers must also include royalties or other income received from an independent publishing company arising out of authoring, editing or reviewing publications (print or electronic).
- Special Relationships – You must disclose if you or your family hold any directorship, management role, or other special relationship(s) with an outside entity, including not-for-profit as well as for-profit entities, having the potential for personal material gain, if the role or relationship reasonably appears to be related to your institutional responsibilities.
– Some travel disclosures are required for all investigators. In addition, if
you are funded by the PHS or plan to apply for such funding, you must
disclose more broadly all reimbursed or sponsored travel that reasonably appears
to be related to your institutional responsibilities. Your disclosure must include:
the purpose of the travel, the identity of the sponsor or organizer, the duration
of travel and approximate value.
You should NOT include:
travel funded through the University and charged to a sponsored project or departmental account, or
travel that is reimbursed or sponsored by a Federal, state or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education.
- Other – You must disclose any other financial interests held by you or your family that reasonably appear to be related to your institutional responsibilities (e.g., certain intellectual property rights).
Collaborative Institutional Training Initiative (CITI) COIR Training Requirements and Instructions.
Any investigator/key personnel engaged in a research study, whether funded by the University, externally sponsored from federal sources, state sources, or foundation, industry, or other private sources; or unfunded and unsponsored, who wishes to be eligible to engage in research shall have an ongoing duty to complete CITI COIR training prior to engaging in research, and at least every four years afterward. This training will be monitored by the COIR Officer and must be completed prior to the release of research funding.
To access the required training, go to the CITI Website.
- Choose “Add a course or update your learner groups for West Virginia University”
- Answer Yes to Question 2, “Would you like to take the Conflicts of Interest course?”
- Click on “Continue” at the bottom and complete the required modules.