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Statement on Conflict of Interest in Research
by the Vice President of Research (Institutional Official)
The Office of Research & Compliance's statement can be downloaded and viewed here: Conflict of Interest in Research - WVU Statement (PDF)
Conflict of Interest in Research Guidelines
- Guiding Principles
- To Whom Do These Guidelines Apply
- Investigator Responsibilities and Disclosure Requirements
- Disclosure Review and Administration
- Management Plans
- Regulatory Requirements
West Virginia University (“the University” or “WVU”) is a public institution committed to the mission of teaching, research, and community service. These Guidelines serve to educate the WVU academic community about Federal and institutional requirements concerning conflicts of interest in research with the following objectives:
- Provide information for identifying and addressing perceived, potential, and actual Conflict of Interest in Research (COIR);
- Maintain the highest standards of objectivity, freedom from bias, and integrity of research data;
- Protect human subjects who participate in research from risks and provide them with information they can use in reaching decisions about entering or remaining in research protocols;
- Provide clear guidance on responsibilities and procedures to investigators and employees to assist them in reaching decisions about the activities in which they engage, in view of their research and commitment to the University;
- Assist employees and agents with the management of potential COIR in a way that facilitates and encourages the full professional and personal development of investigators through their research, as long as their relationships with industry and their personal financial and other rewards do not adversely affect their objectivity, integrity, or professional commitment; and
- Reduce or eliminate COIR wherever possible.
2.0 Guiding Principles
External research sponsors, and the University, seek to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research, including that supported by grants, cooperative agreements and contracts, will be free from bias resulting from Investigator Financial Conflicts of Interest. In particular, the Public Health Service (PHS) has promulgated regulations on “Promoting Objectivity in Research.” These Guidelines are premised on the PHS regulations.
WVU personnel who submit applications for funding to more than one external sponsor will be held to the most stringent standards of the various sponsors to which they apply. To the extent that such standards are more stringent than these Guidelines, the sponsor’s requirements will take precedence.
3.0 To Whom Do These Guidelines Apply
Any individual acting as a “project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research” is an Investigator and must satisfy the disclosure requirements of these Guidelines . For purposes of these Guidelines, the definition of “Investigator” includes:
Faculty who function or are designated as project director, principal investigator or as key personnel on an application for research support (or any other report) submitted to an external source. Faculty who assume independent responsibility for portions of another Investigator’s proposed or funded project will also be required to meet the disclosure requirements of these Guidelines, whether that other Investigator is at WVU or another institution. This may include Adjunct Faculty.
Staff members who assume independent responsibility for portions of an Investigator’s proposed or funded project. In addition, Staff who are to be paid from funding obtained by a Faculty member and who receive compensation from an outside entity owned or controlled by the Faculty member will be required to meet the disclosure requirements of these Guidelines.
3.3 Postdoctoral and Clinical Fellows
This includes Postdoctoral and clinical fellows who assume independent responsibility for portions of an Investigator’s proposed or funded project and fellows who seek independent funding for themselves from external sources. In addition, fellows who are to be paid from funding obtained by a Faculty member and who receive compensation from an outside entity owned or controlled by the Faculty member will be required to meet the disclosure requirements of these Guidelines.
3.4 Graduate Students
While it is anticipated that most graduate students will not be subject to the disclosure requirements of this Policy, graduate students with independent responsibility for portions of an Investigator’s proposed or funded project are covered by this Policy. In addition, graduate students who are to be paid from funding obtained by a Faculty member and who receive compensation from an outside entity owned or controlled by the Faculty member will be required to meet the disclosure requirements of these Guidelines.
3.5 Non-WVU Affiliated Investigators
This may include grant sub-recipients, collaborators and consultants who assume independent responsibility for portions of an Investigator’s proposed or funded project.
4.0 Investigator Responsibilities and Disclosure Requirements
Investigators are required to disclose any Significant Financial Interest (SFI) to the University. A SFI is any Financial Interest that meets the following criteria:
- A Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s Immediate Family Member) that reasonably appears to be related to the Investigator’s University responsibilities (i.e., an Investigator’s responsibilities on behalf of the University, such as research, teaching and institutional committee memberships):
- With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated for the Investigator and members of his or her Immediate Family, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
- With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated for the Investigator and members of his or her Immediate Family, exceeds $5,000, or when the Investigator (or the Investigator’s Immediate Family Member) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. SFI does not include intellectual property rights assigned to the University or agreements to share in the royalties related to such rights.
- For PHS funded Investigators, SFI also includes the occurrence of reimbursed or
sponsored travel related to their University responsibilities received in the
twelve months preceding the disclosure, if when aggregated for the Investigator
(or Members of his or her Immediate Family) from a single entity, exceeds $5,000.
This includes that which is paid on behalf of the Investigator (or members of
his or her immediate family) but not reimbursed directly, so that the exact monetary
value may not be known. In such circumstances, an estimate of the sponsored travel
must be disclosed.
This disclosure requirement, however, does not apply to travel that is reimbursed or sponsored by a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
SFI does NOT include:
- Salary, royalties or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University;
- Intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator 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, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education; or
- Income from service on advisory committees or review panels for a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education.
4.1 When is Disclosure Required
Each Investigator is required to report SFI’s on an ongoing basis within 30 days of discovery or acquisition of a new SFI and at least annually by filing a DOIR form. Investigators must review and make any necessary revisions to their annual DOIR form:
- With each new, continuation, or revised grant or contract application submitted to the Office of Sponsored Programs,
- With each new protocol involving animal or human subjects, and;
- When there is a new or previously unrecognized financial interest not reported on the annual disclosure.
If there is no additional information to report and the annual DOIR form is current, the Investigator is not required to take further action.
5.0 Disclosure Review and Administration
- Screening forms and documentation of plans to minimize or manage possible COIRs shall be maintained in the office of the COIR Officer who is designated by the Institutional Official.
- The COIR Officer will review all COIR forms and determine whether disclosure is a sufficient COIR management step or a full committee opinion is warranted; if so, the COIR Officer will forward the disclosure to the Conflict of Interest in Research Committee (CIRC) for resolution.
- The CIRC will make the following determinations:
- No significant conflict of interest,
- Disclosure of conflict of interest is sufficient,
- Significant conflict of interest that can be managed (a management plan must be presented), or
- Impermissible conflict of interest.
- In the case of research involving human subjects, the financial disclosure form and the management plan will be reviewed by a convened IRB. The convened IRB has the final authority to determine whether, given the financial interest and management plan, the research will be approved. The COIR Officer will serve as liaison to the IRB.
- Detailed information concerning the appeals process and administration of COIR review can be found on a supporting document titled “CIRC Procedural Guidelines”.
6.0 Management Plans
A plan to eliminate or manage a conflict shall be developed and documented in writing by the CIRC and shall be signed by the investigator/filing party, the COIR Officer, and the Chair of the CIRC. A copy of the plan will also be provided to the Department Chair of the principal investigator for oversight of compliance therewith. Distinction between the management plans for basic science research and clinical research involving human subjects will be made by the CIRC.
The following are examples of noncompliance with these Guidelines:
- Failure to submit a disclosure report;
- Submission of an incomplete, erroneous or misleading initial, updated or annual disclosure report;
- Failure to disclose information as required by this Policy; or
- Failure to comply with prescribed management plans.
Instances of noncompliance will be decided in accordance with applicable University disciplinary policies and procedures. For instances of noncompliance involving PHS proposals and awards, whenever a FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a SFI, or failure to comply with the management plan, the University must complete a retrospective review of the Investigator’s activities on the project to determine if there is bias in the design, conduct or reporting of the research resulting from the FCOI. The University must also promptly notify PHS and submit a mitigation report when bias is found.
8.0 Regulatory Requirements
As per PHS requirement, public requests for access to individuals' reportable FCOI's will be made available within five (5) business days of the request and should be submitted to the COIR Officer.
Federal Law and Regulation Relevant to this set of Guidelines:
8 U.S.C. § 201-209 (or 18 U.S.C. § 208), 5 C.F.R. § 2635.201-205, 26 U.S.C. § 501©(3), 42 C.F.R. § 601-607, 45 C.F.R. § 94.1-94.6, 42 C.F.R. § 50(F), 21 C.F.R. § 54.
West Virginia Law and Regulation Relevant to this set of Guidelines: W.Va. Code
§ 6B-2-5 through §6B-2-8, 158 C.S.R. § 4,158 C.S.R. § 6 through 8,128 C.S.R. 36.
West Virginia University Policies and Forms Relevant to this set of Guidelines:
Office of Technology Transfer Policies, West Virginia University IRB SOPs, WVU-HR-18 (Hiring of Relatives), Disclosure of Interest in Research Form.
Other Relevant Resources
AAMC Guidelines,Form FDA 3455 (10/09).