2.10 Objectivity in Research and Investigator Financial Disclosure
Scope
This policy applies to Gallaudet University employees who serve as investigators and who apply for funding through Gallaudet from the Public Health Service (PHS), which includes the National Institutes of Health (NIH), and the National Science Foundation (NSF). This policy may also be extended to any federal sponsor that has similar requirements with regard to investigator financial disclosure. The term "investigator" includes the principal investigator, co-principal investigator, and any other person at Gallaudet University who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by PHS and NSF.
Policy
The University complies with Federal (DHHS, NSF) disclosure regulations in order to maintain eligibility to submit applications for grant, cooperative agreement or contract funding to the Public Health Service and National Science Foundation. The regulations are designed to promote objectivity in research and to ensure that the design, conduct and reporting of research funded under PHS or NSF agreements are not biased by any conflicting financial interest of an investigator.
Before a proposal is submitted for funding, each investigator must disclose, to an authorized Gallaudet representative, any significant financial interests (including those of the investigator's spouse and dependent children):
- that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by PHS and NSF; and
- in entities whose financial interests would reasonably appear to be directly and significantly affected by such activities.
The term "significant financial interest" does not include:
- salary, royalties or other remuneration from Gallaudet University;
- income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
- income from service on advisory committees or review panels for public or non-profit entities;
- salary, royalties or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next 12 months are not expected to exceed $10,000; or
- an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both of the following tests:
- does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value; and
- does not represent more than a five percent (5%) ownership interest in any single entity.
Procedures
- The Director, Office of Sponsored Programs, is the primary University representative for matters related to financial disclosures and this policy.
- A financial disclosure form must be completed and filed by each person to whom the policy applies at the time a proposal is submitted. The financial disclosure must be updated during the award period, either on an annual basis, or as new reportable significant financial interests are obtained. The Office of Sponsored Programs is responsible for distributing and processing the forms.
- If a principal investigator refuses to submit the required information, the sponsored project proposal will not receive institutional approval and certification and will not be submitted to the agency. In the case of ongoing projects, the funding agency may be notified and the project may be suspended. Similar actions may be taken if others associated with the project refuse to submit the needed information.
- The Office of Sponsored Programs reviews each financial disclosure form and makes an initial determination as to the existence of an actual or potential problem. Should a problem be identified, the Office of Sponsored Programs reviews the disclosure with the person filing the financial disclosure form, his/her chairperson and dean, and the Dean of the Graduate School and Professional Programs. Should the results of this review reasonably indicate that a significant financial interest could directly affect the design, conduct, or reporting of the proposed sponsored project, the disclosure information is referred to the University Conflict of Interest Committee. This Committee determines what conditions or restrictions, if any, should be imposed by the University to manage, reduce, or eliminate the actual or potential financial conflict. These may include, but are not limited to:
- public disclosure of significant financial interests;
- monitoring of the research by independent reviewers;
- modification of the research plan;
- disqualification from participation in all or a portion of the research that would be affected by the interests;
- divestiture of the significant financial interests;
- severance of relationships that create the actual or potential conflicts; or
- other actions as appropriate to the circumstances.
- The Committee transmits proposed conditions to the person filing the financial disclosure form and to the Office of Sponsored Programs. The Office of Sponsored Programs incorporates the Committee's plan of resolution into a Memorandum of Understanding between Gallaudet University and the investigator which is signed by the investigator, the department chair/unit administrator, the appropriate University administrator, and, on behalf of the University, the certifying official for Federal proposal submissions (usually the Dean of the Graduate School and Professional Programs or the Director, Office of Sponsored Programs).
- If the matter is not resolved to the satisfaction of the University, the appropriate persons at the PHS/NSF are notified in accordance with agency regulations. Prior to the University's expenditure of any funds under the award, the University reports to the sponsoring agency the existence of a conflicting interest (but not the nature of the interest or other details) and assures that the conflict has been managed, reduced, or eliminated in accordance with the regulations.
- The Office of Sponsored Programs keeps a complete record of each case and of all actions proposed and taken. All records are retained until at least three years beyond the termination or completion of the award to which they relate, or until the resolution of any Government action involving those records, whichever is longer.
- To the extent permitted by law, the Office of Sponsored Programs exercises due diligence not to disclose information gained in the course of its duties except to the person filing the financial disclosure form or to the individuals who are involved in the analysis of the potential financial conflict of interest or in its management or to individuals who, by virtue of their position at the University, have a need to know the outcome of the process.
- If Gallaudet conducts funded research through subgrantees or subcontractors, reasonable steps are taken to ensure that investigators working for such entities comply with the regulations, either by requiring those investigators to comply with Gallaudet policy or by requiring the entities to provide assurances to Gallaudet that enable the University to comply with the regulations.




