COIR FAQ

Conflict of Interest in Research Disclosure FAQ

Q: What is the purpose of the WVU Conflict of Interest in Research disclosure requirements?

A: Disclosure is required whenever there is an actual conflict of interest so that a management strategy can be developed to assure that the actual conflict does not interfere with the employee's performance of his/her University responsibilities. Disclosure may also be required when there is an appearance of a conflict even though, in fact, there is no actual conflict. In this case, disclosure can be beneficial to both the University and the employee in order to protect them against unfounded claims of impropriety. Disclosure does not necessarily mean that the employee may not engage in the disclosed activity.

Q: I am an employee with a consulting business and want to hire a graduate student I am advising to do some research for this outside activity. Is this ok?

A: This represents a conflict of interest that probably can be managed. It is important that both you and the student understand that engaging (or even a decision to not engage) in this outside activity can in no way influence the student's academic relationship with the advisor and the University. In order to insure this, any arrangement should be disclosed and reviewed periodically for a continuing relationship.

Q: I am an employee with a consulting business and wish to use University facilities (including personnel) to test some samples for a company for which I am consulting. How can I do this?

A: This represents a conflict of interest that may be manageable through a contract with the University. You may submit a proposal through the Office of Sponsored Programs and use the appropriate forms to disclose your relationship to the consulting business. In this case it appears that there are no intellectual property issues and so the primary issue is deciding on a fair value for the services to be performed. This may be suggested by the unit's chair, and the Research Office as part of the disclosure review process.

Q: I am an employee with a small research business and we wish to submit a "small business innovative research (SBIR)" project to the federal government (the University is not eligible to apply directly to these programs) in which we would subcontract the experimental work to the University. How can this be done?

A: This may be possible, as in the previous question, with the addition of the need to negotiate an intellectual property agreement with the University.

Q: I am an employee who, with my spouse and children, owns ten percent interest in a small biotechnology company. The combined value of the stock we hold in this company is $25,000. I am writing a research proposal that I plan to submit to the National Institutes of Health to support a project that is related to the business interests of the company. Can I do this?

A: You may be able to do so. To comply with University Guidelines and National Institutes of Health rules, you will need to disclose your involvement in the company by acknowledging the presence of a potential conflict of interest by completing the Certifications, Disclosures, and Assurances section of the proposal routing form at the time you are submitting your proposal. Your involvement in the company and project will be reviewed at that time. If you receive funding from NIH, agency rules and University Guidelines may require further review and restrictions or conditions may be imposed to manage, reduce, or eliminate the possibility that your research project could be influenced by your business interests. The NIH rule requires that the University certify that such issues have been resolved before you start spending any funds for your research project. Any intellectual property resulting from such research will, as usual, need to be processed through the Office of Technology Transfer.

Q: I have a consulting arrangement with Pharmaceutical Company X, which markets drugs related to my medical specialty. I do not have an active research program and do not receive any research funding from Company X or any of its competitors. Is this a conflict of interest?

A: It could be, especially if you prescribe Company X's products to your patients, evaluate the results and report those results to Company X.

Q: I am a participant in a national protocol developed by Pharmaceutical Company Q. They provide the medication in a blinded protocol and patients are selected at random for the medication. I collect the designated patient data and forward it to the company and they reimburse me for each completed patient. This includes a physician's fee, which I receive through my PPP. Do I have a conflict of interest?

A: If you administer the medication blinded and to random patients and forward the patient data to the company, there is no conflict. However if the study is not blinded and you select the patients, gather the patient data and forward the information to the company, there could be a conflict in that a bias could be used in selecting the patients, especially if you provide any evaluation of the patient data.

Q: I have a business arrangement (i.e., a consulting or executive position) with a biotech company and they pay me to review research data and provide them with my evaluation. They do not support any of my research. I do have support from other sources for my research, which is related to the area of the biotech. Is this a conflict?

A: Yes, this is a potential conflict of interest as it may bias your research evaluations or otherwise affect your research results.

Q: My spouse is a member of the Board of Directors of a company that competes with a company for which I do research. Is there a conflict in this situation?

A: Yes, this situation represents a potential conflict of interest. Due to relationships within families, there could exist the potential of a bias in the research you conduct.

Q: I am doing research funded by a pharmaceutical company in which I have not purchased stock. My father-in-law recently died and left in his estate to my wife stock in this company. Am I in violation of the WVU Conflict of Interest in Research Guidelines?

A: If the value of the stock is at least $5,000 there is a conflict of interest that must be reported. It is for circumstances such as these that NSF and NIH require an annual evaluation since conflicts may not be present at the beginning of funded research but may surface sometime during the research period.

Example Situations

Creating a Possible Conflict of Interest in Research

The examples are by no means exhaustive, and are provided only as samples of commonly encountered situations.

Entering into consulting agreements that purport to transfer to a private entity intellectual property that belongs to the University. (See the University's Policy on Patents and Copyrights for further detail.)
Undertaking basic or clinical research when the investigator or the investigator’s immediate family has financial, managerial, or ownership interest in the sponsoring company or in the company producing the drug/device under evaluation
Accepting gratuities or special favors from research sponsors
Entering into a consultantship arrangement with an organization or individual having an economic interest in related research
Using students or employees of the University to perform services for a company in which an employee has an ownership interest or from which he/she receives any type of remuneration
Unreimbursed or unauthorized use of University resources, such as equipment, supplies, and facilities, for personal research or to support the research activities of an independent entity in which an investigator holds a financial or other interest
Unauthorized use of privileged information acquired in connection with one’s professional responsibilities
Accepting support for basic or clinical research under terms and conditions that results be held confidential, unpublished, or significantly delayed in publication
Providing privileged access to information, developed with University resources or supported by independent sponsors, to an entity in which the employee has a financial interest
Purchasing equipment, instruments or supplies for research or teaching from a firm in which the employee has a financial or other interest
Consulting to a federal agency when one is conducting federally-sponsored research (the federal conflict of interest statutes 18 U.S.C. § 202-209 should be consulted)

Conflicts of Interest, Defined by Policy and Law

Detailed disclosure, review, and approval are also required prior to submission of the research proposal to the research sponsor(s) when the Investigator will be engaged in any of the following: (not an exclusive list). Depending on the facts, management plans may be possible for some after disclosure and review.

A proposal to a research sponsor, including a start-up company
1. From which the Investigator receives or anticipates receiving compensation in excess of $5,000 during a calendar year; or
2. In which an Investigator has an equity or profits interest greater than five percent (5%) of all equity or profits interests or worth more than $5,000; or
3. From which an Investigator is entitled to receive royalties under a license or assignment of the University’s intellectual property rights to such proposed sponsor.
A proposal to evaluate technology that is owned by a business
1. From which the Investigator receives or anticipates receiving compensation in excess of $5,000 during a calendar year; or
2. In which an Investigator has an equity or profits interest greater than five percent (5%) or worth more than $5,000.
A proposal to a research sponsor involving a waiver or preferential reduction of University direct or indirect costs to benefit the sponsor
1. From which the Investigator receives or anticipates receiving compensation in excess of $5,000 during a calendar year; or
2. In which an Investigator has an equity interest greater than five percent (5%) or worth more than $5,000.
A proposal involving the purchase of equipment or other materials from a vendor or supplier
1. From which the Investigator receives or anticipates receiving compensation in excess of $5,000 during a calendar year; or
2. In which an Investigator has an equity or profits interest greater than five percent (5%) or worth more than $5,000.
Doing research involving a technology that has been licensed or offered under an option to the sponsor or other commercial entity under an arrangement that will result in the Investigator(s) receiving royalties or other compensation from the commercial exploitation of the technology.
Consulting for a fee with the research sponsor.
Speaking for a fee with the research sponsor.
Serving on a scientific advisory board of the research sponsor for a fee. The conflicted investigator would be required to recuse himself or herself from matters involving the conflict.
Receiving honoraria from the research sponsor.
Receiving nominal gifts and gratuities from a research sponsor
Receiving research support from or doing research for a sponsor in which the Investigator holds an equity or profits interest, including stock options or expectations of receiving equity interests, in excess of five percent (5 %) or $5,000.
Receiving research support from or doing research for a sponsor in which an Investigator’s immediate supervisor, co-investigator on that project, or any laboratory staff or students who are directly supervised by that Investigator and who would be engaged in the proposed project or their immediate family individually or collectively hold equity in excess of five percent (5 %) or $5,000.
Receiving external research support involving non-investigators employees or students to whom the circumstances described above apply.
Serving on Board of Directors of the sponsor.
Serving as an officer of the sponsor.
Using students, fellows, and staff to perform services for a company in which the investigator has a financial interest, imposing confidentiality restrictions on them, or allowing the conflict to interfere with their academic freedom or ability to publish data.
A University investigator shall not ordinarily participate in any clinical trial of a therapeutic strategy or product if the investigator (or immediate family member) is in a position to receive royalties or other compensation as a result of the commercial success of such strategy or product or has an equity interest (except in publicly-held entities on terms generally available to the public) in the producer of that product. An exception may be made upon a written finding by the COIR Director that the investigator is uniquely qualified to perform the research and no other person who is unbiased can be substituted because of unique technology or other applications. In such a case, the investigator may be allowed to conduct certain aspects of the research under a strict management plan. For example, if the technology is such that the investigator is the only individual who can perform it, the performance might be allowed, but the investigator could not recruit human subjects, administer the informed consent, analyze the data (except in an appropriately blinded study), etc. By definition, a multisite clinical trial would not qualify for the exception.