Research Conflict of Interest and Financial Disclosure

FAQs
Why did the University revise the Conflict of Interest Policy?
Who has to file a Financial Interest Disclosure form?
How do I file my Financial Interest Disclosure form?
When do I have to file my new Financial Interest Disclosure?
When do I have to update my Financial Interest Disclosure?
What types of activities do I have to report?
What is meant by “financial interest” and “significant financial interest”?
Are there financial interests that I don’t have to disclose? 
Who determines if I have a conflict of interest?
What happens if I do have a conflict of interest?
Are there other WSU policies that address outside activities and financial interests?

Why did the University revise the Conflict of Interest Policy?

The COI policy was revised for two reasons.  First, the previous policy had not been updated since 1995.   It needed revision to reflect current interpretations of federal requirements so that WSU would be collecting and reviewing disclosures in a manner that was both compliant and that would meet the expectations of the greater research community. 
Second, the policy was revised to reflect proposed changes to the federal regulations that are expected to be enacted in 2011 so that WSU would save resources and avoid making multiple revisions in a short period of time.  You can find more information on NIH’s proposed rule change here.
Who has to file a Financial Interest Disclosure form?
Federal regulations and university policy require that all persons who are involved in the design, conduct, or reporting of research, hereafter, referred to as the “Investigator,” must complete an annual COI disclosure. The following list of individuals would be considered “investigators”:

• All regular faculty engaged in any research activities;
• All part-time, clinical, research, auxiliary or emeritus faculty who have a role in the design, conduct, or reporting of research – including research with animals and human subjects;
• Clinical and research staff members and students who have a role in the design, conduct, or reporting of research with animals or human subjects. Examples of such roles include the following:
1. Staff or students who are formally listed on, or their salary or effort is associated with, a specific sponsored project or award;
2. Staff and students who are included as a co-investigator or key personnel on an Institutional Review Board (IRB) or Laboratory Animal Care and Use Committee (LACUC) application;
3. Clinical or research staff or students who collect or analyze data, or consent research subjects; and
4. Staff or students who plan to participate as authors on publications or presentations resulting from research.
• Principal administrative officials designated by the Vice President for Research and Graduate Studies as having a significant role in the supervision of research.

If you have questions as to whether you are required to file an annual COI disclosure, please contact Ellen Reinsch Friese, Assistant Vice President for Research, Office of Research and Sponsored Programs (RSP), ext. 2709 or Ellen.Friese@wright.edu.

How do I file my Financial Interest Disclosure form?
The current disclosure process is evolving as a result of the revised policy.  Currently, Investigators, as described above, must use the forms and directions located on the Disclosure and Management page.   All appropriate disclosures should be made at or before the time a proposal for external funding is submitted to RSP or when a protocol is submitted for human subjects or animal research. 
An annual disclosure process will be implemented in 2012 – eliminating the need for repeated disclosures during the year, unless there have been reportable changes to your financial interests.

 
When do I have to file my new Financial Interest Disclosure?
Current federal regulations and university policy require faculty, research staff, and students to update their current financial interest disclosure annually or whenever a new significant (i.e., income greater than $5,000 in the preceding 12 months) financial interest is received.  
If you are planning to be involved in the following activities that are related or appear to be related to your research you should contact RSP as soon as possible for a confidential consultation:

• Submitting a patent application;
• Receiving royalties from a license agreement not managed by the University;
• Starting your own company or working for a company in a fiduciary role; or
• Entering into an independent consulting agreement.

Doing so will save you considerable time and effort as your research cannot begin until an appropriate Management Plan is in place or the interest is determined to be not significant or related.
Research that commences without proper management and approval may be suspended until proper measures have been put into place.  This will likely cause significant delays in the conduct of the research, therefore, it is important to disclose financial interests as soon as possible.

When do I have to update my Financial Interest Disclosure?

What types of activities do I have to report?
You must report any financial interests that might reasonably appear to be related or are related to your institutional responsibilities.  Institutional responsibilities include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. This would include any financial interests in any company or business that:

• funds your research through sponsored research agreements, gifts, or any other funding arrangement;
• provides materials or other in kind support (e.g., drugs, devices, other tangible items) for your research;
• holds an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) for the research being performed;
• owns, licenses, or has any financial interest in your research; or
• acts for on behalf of another company. This may include some medical education companies or other similar entities.

Additionally, you must report any other financial interests that could reasonably appear to be affected by your research including any patents or property held by you or an immediate family member.
Example: A faculty member’s spouse formed a Limited Liability Company (LLC) six months ago. The faculty member does not work for the company.  However, the consulting services provided by the company appear to be related to the faculty member’s research interests.  The faculty member must disclose this financial interest to WSU because it is related to his “institutional responsibilities.”
The company has requested information from RSP on how to fund research conducted by the faculty member’s students at WSU.  Such funding would represent a “conflict of interest” and would require formal review to determine if it could be managed appropriately.
Generally, these types of funding relationships are discouraged unless it can be demonstrated that the research cannot be conducted without the involvement of the conflicted person or persons, that the goal of the research is consistent with the WSU’s mission and that potential benefits of the research are not limited to the sponsoring company or individual.

What is meant by “financial interest” and “significant financial interest”?
A “financial interest” means anything of monetary value or potential monetary value held by the Investigator, the Investigator’s spouse and/or dependent children.
Examples of financial interests include but are not limited to:

• salary or other compensation for services including: consulting fees, honoraria, speaking fees, serving on advisory boards/panels, directorships, executive roles, or other special relationships;
• equity interests including stocks, stock options, or other ownership interests (LLCs, sole proprietorships, corporations);
• intellectual property (IP) rights including patents and copyrights; or
• royalties, licensing fees, or other similar payments deriving from IP rights that are related to the research at issue.

Under the current federal regulations and university policy and procedures, a financial interest is considered significant when it reasonably appears to be related to your institutional responsibilities and:

• the value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of the disclosure, when aggregated, exceeds $5,000.  Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel reimbursement). Equity Interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

• An Investigator received $3,000 in consulting fees from Company A in the past 12 months.  Her husband owns $2,500 worth of stock in Company A.  This would be a significant financial interest ($3,000 + $2,500 > $5,000) that must be reported.

• the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest;

•  An Investigator has an equity stake in Start-Up Company B, a private biotechnology firm whose only products are in the early research and development stage.  Even if the Company B has zero net worth at the time this would be a significant financial interest that must be reported.

• intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.

•  An Investigator’s spouse receives royalties via licensing agreement for a new electronic sensor and electronic sensors appear to be related to the Investigator’s institutional responsibilities. This would be a significant financial interest that must be reported.

These examples include commonly encountered significant financial interest situations, but are by no means exhaustive.  If you have questions about financial interests, please contact Ellen Reinsch Friese, Assistant Vice President for Research, Office of Research and Sponsored Programs, ext. 2709 or Ellen.Friese@wright.edu.

Are there financial interests that I don’t have to disclose?
The university does not require you to disclose the following types of financial interests:

• Any salary or other payments for services that Wright State University pays to you as long as you remain employed or otherwise appointed by Wright State University.
• For example, royalties from Wright State University licensing agreements are not considered reportable financial interests, but royalties from licensing agreements from your previous academic employer would be considered reportable financial interests. 
• Income from service on advisory committees, review panels, seminars, lectures, or teaching engagements sponsored by federal, state or local government agencies or institutions of higher education.
• Note that income from non-profits (e.g., hospitals) would require disclosure under NIH’s proposed rule change.

Who determines if I have a conflict of interest?
In accordance with the new policy, your financial disclosure is reviewed by your supervisor in conjunction with designated members of the Office of the Vice President for Research and Graduate Studies (and the Outside Interest Committee, if applicable).

What happens if I do have a financial conflict of interest?
If it is determined that a significant financial conflict of interest exists, a Management Plan is created in order to manage, reduce, or eliminate the conflict. All Management Plans are reviewed, approved, and annually monitored by WSU’s Office of the Vice President for Research and Graduate Studies and the Outside Interest Committee as required by the new policy. Conflict Management Plans are effective as long as the conflict is present.

Are there other WSU policies that address outside activities and financial interests?
Yes, please link to the following policies and guidance documents to obtain more information:

• WSU Ethics Policy – (Faculty and Staff)
• Policy and Procedure for Intellectual Property – (All University Employees)
• Soliciting and Administering Financial Support from External Sources– (Faculty)
• Guidelines for Outside Consulting Agreements – (Faculty)
• Outside Employment Policy – (Faculty)
• Purchasing from External Vendors – (All University Employees)
• Pharmaceutical/Medical Device Industry Conflict of Interest (Boonshoft SOM Faculty)