5.6.4 Disclosure of Real or Potential Conflict of Interest5.6.4 Disclosure of Real or Potential Conflict of Interest abruneau3 Thu, 06/26/2014 - 18:10
Disclosure to the State of Georgia
Except as provided in subsection (b) of the Official Code of Georgia Annotated Section 45-10-26, any Public Official or Employee whether for himself or herself, or on behalf of any Business, or any Business in which such Public Official or Employee or any member of his Family has a Substantial Interest who transacts business with the state or any agency thereof, shall disclose such transactions. Such disclosure shall be submitted prior to January 31 each year to the Secretary of State on such forms as he or she shall prescribe and shall include an itemized list of the previous year's transactions with the dollar amount of each transaction reported and totaled. Such disclosure statements shall be public records. [Official Code of Georgia 45-10-26]
Disclosure to the Institution
Every Employee of the Institute, including all who participate in outside professional activities and/or sponsored research must complete an annual disclosure using the online Conflict of Interest system. In answering the questions, if an Employee has indicated an actual or potential conflict, the system will notify the COI Office for review. Employees must update their disclosures on an ongoing basis when circumstances change.
Disclosure to Sponsors
Any person involved in the design, conduct, or reporting of research (technical and financial) or educational activities proposed for funding by a sponsor must complete the Investigator Financial Interest In Research Report via the online Conflict of Interest System disclosing any potential or actual Significant or Substantial Financial interests of the Employee (including those of the Employee’s Family). (See https://ecoi.research.gatech.edu for this system.) Disclosures should include, but is not limited to:
- Performance or business transactions related to the sponsored activity;
- Equity interests in or fees from either the sponsor of the research or a subcontractor;
- Intellectual property rights.
Each such Disclosure needs to be updated via the online system by the Employee during the life of any award, as new Significant or Substantial Financial Interests are recognized.
In completing a disclosure on the Conflict of Interest Online System, the Employee is certifying to the following:
"In submitting this form I affirm that the above information is true to the best of my knowledge and I certify that I have read and understood the Conflict of Interest and Outside Professional Activity Policy as set forth in the Georgia Institute of Technology Faculty Handbook, that I have made all required disclosures, and that I will comply with any conditions or restrictions imposed by the Institute to manage, reduce or eliminate conflicts of interest."
In any proposal submitted to a potential sponsor, the Office of Sponsored Programs is responsible for certifying that the Institute has implemented a written and enforced conflict of interest policy that is consistent with the provisions of Grant Policy Manual Section 510 of the National Science Foundation, the National Institutes of Health Guide for Objectivity in Research, and other applicable sponsor regulations. In submitting the proposal, the Office of Sponsored Programs certifies that to the best of their knowledge all financial disclosures required by such conflict of interest policy have been made and that all identified conflicts of interest will have been satisfactorily managed, reduced or eliminated prior to the Institute’s expenditure of any funds under the award, in accordance with the Institute’s Conflict of Interest and Outside Professional Activity Policy.
Disclosure to the Institutional Review Board
Investigators submitting protocols to the Institutional Review Board (IRB) for the use of human subjects in research or other activities shall disclose any and all Significant Financial Interests that may appear to affect the design, conduct or reporting of such research. It is imperative that Investigators fully disclose to the IRB an ownership interest in any Business proposing to test any drug, device or other technology with human subjects or any potential financial interest in such technology that the Investigators, or the Investigators' Families might have. The IRB, in collaboration with the COI Office, shall conduct an independent review and may or may not impose restrictions, including denial of approval for the protocol, as it deems is in the best interest of the subjects and the Institute.
Disclosure to Students
Special care needs to be taken when dealing with students involved in research so that a potential or actual Conflict of Interest does not adversely affect their education, i.e. their ability to graduate or publish. Prior to retaining students on research projects that may involve a potential or actual Conflict of Interest, the Investigator and senior personnel will disclose to the student as well as to the COI Office and Responsible Unit Official, any interests in outside companies that may be perceived to benefit from the student’s research. Should a conflict of interest exist, the COI Office, the Responsible Unit Official, the conflicted Investigator, and the Conflict of Interest Review Committee, will design a conflict management plan to manage, reduce or eliminate the conflict prior to the student’s involvement in the project pursuant to the procedure provided for below.
Review of Financial Disclosures and Resolution of Conflicts of Interest
When a financial disclosure or report of a conflict of interest is made via the online Conflict of Interest module and forwarded to the COI Office, the COI Office reviews the disclosure per the COI Office Procedures.
Should an actual or apparent conflict of interest exist, the COI Office and the Conflict of Interest Review Committee will design a conflict management plan to manage, reduce or eliminate the conflict prior to the Institute's expenditure of any such funds.
In developing a management plan, the COI Office and the Conflict of Interest Review Committee will work with the conflicted Employee and with the Responsible Unit Official and will consider the relationships between the Employee and the Institute to ensure adequate conditions or restrictions are in place to manage, reduce or eliminate the conflict(s).
Such conditions may include, without limitation:
- Public disclosure of significant financial interests;
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification from participation in the portion of the sponsor funded research that would be affected by the Significant or
Substantial Financial Interests;
- Divestiture of Significant or Substantial Financial Interests; and/or
- Severance of relationships that create actual or potential conflicts.
Conflict management plans and/or restrictions must be in writing and forwarded to the conflicted Employee and the Responsible Unit Official(s). The COI Office and the Responsible Unit Official(s) will monitor compliance with the plan. A copy of the plan and relevant documentation will be maintained in the COI Office.
Upon recommendation by a Responsible Unit Official, the Conflict of Interest Review Committee may determine a) that imposing conditions or restrictions would be ineffective or b) that any potential negative impacts which may arise from a Significant or Substantial Financial Interest is outweighed by interests of scientific progress, technology transfer, or the public health and welfare. In such cases, the Responsible Unit Official and the Conflict of Interest Review Committee may recommend to the Provost that the Institute allow research to go forward provided that any conflict management plan includes ongoing monthly review by the Responsible Unit Official and the Conflict of Interest Review Committee.
Notwithstanding the foregoing, nothing herein shall permit the Institute to authorize an activity that is contrary to the laws of the State of Georgia, federal regulations, or other restrictions imposed by regulation or contract by research sponsors. Furthermore, no activity involving human subjects may be authorized that has not been approved by the Institutional Review Board which in compliance with 45CFR46 may, in its sole discretion, deny such approval.
Should the Responsible Representative of the Institution find that the Institute is unable to satisfactorily manage a conflict of interest prior to the Institute's expenditure of any such funds, the Responsible Representative of the Institution shall immediately notify the COI Office and the Office of Sponsored Programs.
All determinations made or actions taken by the COI Office, and/or the Conflict of Interest Review Committee shall be in writing and together with all financial disclosures made hereunder, be maintained until at least three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records. If the Investigator is engaged in any research or other sponsored activity supported by the Department of Health and Human Services including but not limited to the National Institutes of Health, the Responsible Representative of the Institution shall forward this information to the sponsor in compliance with regulation.
Written management plans must be reviewed annually or upon a change in circumstances affecting the plan and appropriate disclosures should continue during the ongoing management of any conflict.
Conflict of Interest Training Requirements
Conflict of interest training is required for all Investigators before engaging in funded research and every four years thereafter.