08-2 Investigator Disclosure (Second Release)
1.1 Wayne State University is required to have a policy for the disclosure of information by faculty and staff engaged in sponsored research and procedures for institutional review of the relevance of personal outside interests to the integrity of proposed sponsored research.
1.2 This University Policy is intended to fulfill these external obligations while minimizing the personal privacy concerns of researchers and their families. The disclosure and review process also protects researchers from misplaced charges of conflict of interest by providing a mechanism for objective review and approval of outside financial interests.
2.1 A Conflict of Interest arises when a staff or faculty member, in relationship to an outside organization, is in a position to influence the University¢‚¬„¢s business, research, or other decisions in ways that could lead directly or indirectly to financial gain for the staff or faculty member or his/her immediate family, or give improper advantage to others to the detriment of the University, as provided in the disclosure form attached.
2.2 Immediate Family means the investigator¢‚¬„¢s spouse or domestic partner and dependent children.
2.3 Institutional Responsibilities means an Investigator¢‚¬„¢s professional duties performed on behalf of he Institution which may include the following activities for example: research; research consultation; teaching; professional practice; institutional committee memberships; and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
2.4 Investigator means the principal investigator and study personnel who are responsible for the design, conduct, or reporting of externally funded research or research proposed for such funding. For purposes of the requirements of this subpart relating to financial interests, "Investigator" includes the Investigator's immediate family. "Investigator" also includes Investigators employed by subcontractors, subgrantees, or collaborators.
2.5 Research means a systematic investigation designed to develop or contribute to general knowledge. The term encompasses basic and applied research and product development.
2.6 Significant Financial Interest means: An economic benefit consisting of one or more of the following interests of the Investigator (and those of the Investigator¢‚¬„¢s spouse and dependent children) that reasonably appear to be related to the investigator¢‚¬„¢s institutional responsibilities.
2.6.1 (i) with regard to any publicly traded entity
220.127.116.11 a significant financial interest 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, exceeds $5,000. For the 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 measure of fair market value;
2.6.2 (ii) with regard to any non-publicly traded entity
18.104.22.168 A significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the Investigator¢‚¬„¢s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
2.6.3 (iii) intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2.6.4 Public Health Service (PHS)-funded investigators must also disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, State, or local government agency, an Institution of Higher Education (as defined at 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.
2.6.5 The term Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the Institution to the investigator if the investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
- Any ownership interest in the Institution held by the investigator, if the Institution is a commercial or for profit organization
- 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, an Institution of Higher Education as defined at 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
- Or income from service on advisory committees or review panels for a Federal, State, or local government agency, an Institution of Higher Education as defined at 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
2.7 Small Business Innovation Research (SBIR) Program means the extramural research program for small business that is established by the Award Components of the Public health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.
3.1 Each Investigator who plans to participate in externally funded research shall submit a disclosure form listing his/her known Significant Financial Interests and those of his/her spouse and dependent children, when the interests (1) would reasonably appear to be affected by the research for which funding is sought, or (2) are in entities whose financial interests would reasonably appear to be affected by the research.
3.2 All financial disclosures must use the form that is currently approved by the University¢‚¬„¢s Financial Conflict of Interest (FCOI) Committee before the initiation of the project. The form (available at http://www.research.wayne.edu/coi/) should be submitted to the FCOI Committee, resubmitted annually, and resubmitted within 30 days of such time as new reportable Significant Financial Interests are obtained.
3.3 A Conflict of Interest under this part of this University Policy shall be deemed to exist when the Vice President for Research or the FCOI Committee reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of externally funded research.
3.4 If the Vice President for Research or FCOI Committee reasonably determines that a Conflict of Interest exists, he/she/they shall take appropriate steps to manage the conflict. These steps may include but are not limited to requiring the following:
- Public disclosure of Significant Financial Interests;
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification from participation in all or a portion of the research;
- Divestiture of significant financial interests;
- Severance of relationships that create actual or potential conflicts.
4.1 This University Policy is revocable by the President at any time and without notice.
5.0 Effective Date
5.1 This University Policy is effective upon issuance.
5.2 Executive Order 96-2 is hereby revoked, effective immediately.
Signed by President Allan Gilmour, August 24, 2012