consultation, teaching, professional practice, institutional committee memberships, and service on panels such as the Institutional Review Board or a Data and Safety Monitoring Board.
Procedures for Financial Disclosure and For Addressing Conflict
Prior to the submission of a grant application to the Public Health Service (most commonly to the National Institutes of Health), each investigator named on the grant must have filed, within the preceding 12 months, a Significant Financial Interest Disclosure Form and an interim update, if and as needed (see below).4 Completed forms will be reviewed by the administrative office for the Faculty Conflict of Interest Committee ("FCIC"). No federal funds awarded can be expended until all financial conflicts of interest related to a grant have been eliminated, reduced or managed.
The Faculty Conflict of Interest Committee manages implementation of ADARC's financial conflict of interest policy. The FCIC, appointed by the Scientific Director is composed of three senior faculty members who serve staggered three-year term and the Chief Operating Officer.
Each Significant Financial Interest Disclosure Form will be reviewed to determine whether reported SFI reasonably appear to be related to the investigator's research and other institutional responsibilities and, if so, whether a financial conflict of interest exists. The FCIC will work with an investigator who has a conflict to secure his or her agreement to eliminate, reduce or manage the conflict.
In addition to reporting Significant Financial Interests at least annually, investigators must update SFI disclosures within thirty (30) days of acquiring new SFI or discovering previously unreported SFI. If new SFI creates a conflict of interest, a plan to eliminate, reduce or manage the conflict must be put in place. If previously unreported SFI is discovered during the course of federally-funded research, ADARC must undertake a documented audit to determine whether conflict of interest is present and, if so, whether the research has been affected by bias. If there is evidence of bias, a report of this activity, and steps taken to address the findings must be submitted to the National Institutes of Health or other Public Health Service granting agency.
Within five (5) business days of receiving a written request from the public for information about federally-funded research involving a conflicted investigator the ADARC will respond to the request in writing, providing the name of the conflicted investigator, the entity in which the investigator holds SFI, the nature of the SFI and the approximate dollar value of the SFI, in dollar ranges, if known.
Federal regulations further provide that when a financial conflict of interest is not timely identified or managed due to an investigator's disclosure failure or to the ADARC's conflict management failure, a documented institutional audit of the investigator's activities must be undertaken by ADARC to identify any bias in the design, conduct, analysis or reporting of the investigator's research. ADARC must notify the federal granting agency of any bias found in the funded research and submit a mitigation report. Additional corrective and disclosure measures may be required.
|4||Financial Disclosure Forms and Updated Financial Disclosure Forms will be available on the ADARC’s Shared Drive. These Forms will be accessible on line and can be completed and submitted electronically.|