UNIVERSITY POLICY ON FINANCIAL CONFLICT OF INTEREST PERTAINING TO PUBLIC HEALTH SERVICE AND THE NATIONAL INSTITUTES OF HEALTH SPONSORED PROJECTS
Last Revised: 5/8/2012
The teaching, research, and service mission of SIUE must be conducted in an objective manner, free from undue influence arising from private or other special interests. The purpose of this policy is to establish guidelines for recognizing, disclosing, and managing significant financial conflicts of interest in relation to Public Health Service and the National Institutes of Health sponsored research. The policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from financial conflicts of interest. This policy operates in conjunction with other University policies governing conflicts of interest.
This policy sets forth procedures and guidelines that are to be followed in resolving actual and potential conflicts of financial interest related to research sponsored by the Public Health Service and the National Institutes of Health.
The University, its employees, and the public often benefit from the employee's participation in both public and private outside activities. The University has no interest in setting forth detailed rules that may interfere with the employee's legitimate outside interests.
Employees, however, must ensure that their outside obligations, financial interests, and activities do not conflict or interfere with their commitment to the integrity of the research, the Public Health Service, the NIH, and the University. This obligation pertains to both full-time and part-time employees.
The following are excluded from the definition of significant financial interests:
SIUE must report promptly to the PHS/NIH any conflicts of interest SIUE has identified, including those of its subrecipients and subcontractors, and provide assurance that the interests have been managed prior to expending any funds under a PHS/NIH award if:
· bias is found with the design, conduct or reporting of PHS/NIH-funded research
· an Investigator fails to comply with SIUE’s FCOI policy or a FCOI management plan
· a FCOI management plan appears to have biased the design, conduct, or reporting of the funded research.
Any conflicts of interest identified in the disclosure process must be resolved before the University can approve the individual's activity with PHS/NIH. The University must complete and document retrospective reviews within 120 days of the University’s determination of noncompliance for SFIs not disclosed in a timely manner or previously reviewed or whenever a FCOI is not identified or managed in a timely manner. In addition, the public must have access to the investigator’s Financial Disclosure form.
Procedures for this policy will be managed by The Graduate School in compliance with all state and federal rules and regulations. These procedures may be revised by The Graduate School as necessary.
Each investigator must complete FCOI training prior to engaging in research related to any PHS/NIH funded project. Investigators must complete training every four years and immediately when any of the following occurs:
· SIUE finds the investigator noncompliant with its policy or a management plan
· the investigator is new to SIUE
· the SIUE policy changes in a manner that significantly affects requirements.
The University must maintain FCOI-related records for at least three years after the termination of the activity (date of the final financial report and progress report to the funding agency).
Charges of violations of this policy shall be carefully examined. Charges shall be processed in the normal reporting channels. Disciplinary sanctions may range from reprimands to dismissal.
When the Department of Health and Human Services determines that a PHS/NIH-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by SIUE as required by regulation, the Investigator shall:
· disclose the FCOI in each public presentation of the results of the research
· request an addendum to previously published presentations.
Approved by Graduate Council May 4, 2012