OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

RESEARCH INTEGRITY AND COMPLIANCE

Conflict of Interest Policy

I. Policy Statement

 

Consistent with the missions of the State University of New York Health Science Center at Brooklyn, all faculty and staff are encouraged to pursue free and open inquiry and the unrestricted dissemination of knowledge independent of personal interests. Open exchange of scholarly knowledge is integral to the Center's goals of teaching, research, clinical care and public service. As members of a public university, the Center's faculty and staff have a responsibility to ensure integrity in all aspects of the performance of their responsibilities and activities. In keeping with this obligation, they are also required to avoid conflicts of interest. In instances where potential or actual conflicts exist, faculty and staff are expected to consult with appropriate Center officers and abide by this policy. It is the responsibility of Center officials charged with implementing this policy to identify potential or actual conflicts of interest and take appropriate steps to manage, reduce or eliminate them.

 

To meet these objectives and to ensure compliance with federal regulations, the State University of New York Board of Trustees Policy on Conflict of Interest and the New York State Public Officers Law, the Health Science Center at Brooklyn requires each Investigator to comply with the disclosure requirements set forth in this policy.

 

II. Guiding Principles

 

Faculty and staff may not engage in other employment or activities which interfere with the performance of their professional obligations to the Health Science Center.

 

The Health Science Center will not accept sponsored research funding from a faculty-owned company for work to be carried out under his/her direction.

 

Products of research (i.e., publications, materials, etc.) are to be made available on a timely basis and on an at-cost basis.

 

Selection of speakers, course materials and "enduring materials" for CME and other programs should be entirely the responsibility of the Health Science Center and not subject to the review and approval of the organization providing financial support for the program.

 

Disclosure of affiliations, sponsorships, monetary support and other potential biasing factors should routinely be made to the individuals attending CME or other programs by the Health Science Center.

 

III. Definitions

 

Conflict of interest: any interest, financial or otherwise, direct or indirect; participation in any business, transaction or professional activity; or incurring of any obligation of any nature, which is or appears to be in substantial conflict with the proper discharge of an employee's duties in the public interest. A conflict of interest is also any financial interest that could, or may be reasonably expected to, bias the design, conduct or reporting of sponsored research.

 

The potential for conflicts of interest may arise from specific actions taken by Investigators, or by the nature of positions they hold at the Center and outside the Center, or by the financial interests they or their immediate family hold. For example, a conflict on interest can result when:

• consulting arrangements exist between an Investigator and a business enterprise that supports or is supported by Center programs involving the Investigator;
• consulting arrangements exist between an Investigator and a business enterprise that is licensed to commercialize Center technologies invented by the Investigator;
• significant financial interests of an Investigator at the Center exist in a business enterprise that supports or is supported by the Investigator's Center research;
• an Investigator at the Center holds a position as consultant, officer, director, trustee or owner of a non-Center business enterprise that supports or is supported by the Investigator's Center research;
• significant financial interests of an Investigator at the Center exist in a business enterprise that owns or has applied for the patent, manufacturing or marketing rights to a drug, device or procedure that is a subject of, or will predictably result from, the Investigator's Center research; or
• significant financial interests of a Investigator at the Center exist in a business enterprise that is known by the Investigator to own or have applied for patent, manufacturing or marketing rights that can reasonably be expected to compete with a device, product or procedure that will predictably result from the Investigator's Center research.

 

Investigator: the principal investigator or co-principal investigator (or project director or co-project director) of a sponsored research proposal to the National Science Foundation or the Public Health Service. For the purposes of this policy, "Investigator" shall include the Investigator's spouse and, as required, all dependent children.

 

IV. Review Procedure

 

The Senior Vice President for Biomedical Education and Research shall appoint an ad hoc faculty committee to review financial disclosure information and relevant sponsored research applications and to make recommendations regarding the resolution of actual or potential conflicts of interest. The Assistant Vice President for Scientific Affairs (the financial disclosure designee) shall be responsible for ensuring that all reporting requirements are met, that records are maintained, that any sanctions imposed by the Center are recorded, that appropriate persons at the University, State and Federal levels are notified of the disposition of alleged policy violations and that copies of all current rules and law governing conflict of interest are maintained on file.

 

The SUNY II financial disclosure form (see attached) shall be initially filed and updated annually, or more frequently if new reportable significant financial interests are obtained, by SUNY faculty and staff who apply for funds to external sponsors under the following conditions:

• faculty/staff who apply to any external sponsor and whose salary are above the threshold established by the State Ethics Commission ($58,198 in FY95/96); and
• faculty/staff, regardless of salary level, who submit applications for funds as Investigators to the National Science Foundation or the U.S. Public Health Service report only those interests 1) that would reasonably appear to affect or be affected by the research or educational activities funded or proposed for funding by NSF or PHS and 2) which are valued at greater than $10,000.

 

Research Foundation employees at the Health Science Center who are applying as Investigators to the NSF or PHS for sponsored research support and who represent or act on behalf of the Foundation or are in a significant decision making capacity with respect to the professional, technical or scientific aspects of a program or project conducted or administered by the Foundation must complete and file the Research Foundation's Conflict of Interest Disclosure Statement (see attached).

 

The financial disclosure designee and the ad hoc faculty committee will review the financial disclosure statements, determine whether an actual or potential conflict of interest exists, and recommend to the Senior Vice President for Biomedical Education and Research and/or the Research Foundation's Operations Manager at the Health Science Center what conditions or restrictions, if any, should be imposed by the Center to manage, reduce or eliminate such conflict of interest. The Senior Vice President for Biomedical Education and Research will make the final decision regarding the conditions or restrictions to be imposed.

 

An Investigator or employee who disagrees with the determination of the Senior Vice President may appeal to the President of the Health Science Center (to the President of the Research Foundation in the case of Foundation employees) for reconsideration of such determination. The determination of the President shall be final and binding.

 

Faculty and staff of the Health Science Center are encouraged to seek assistance in reviewing potential relationships with outside organizations prior to their execution in order to minimize or eliminate any potential conflicts of interest.

 

V. Resolution of Conflict of Interest

 

When a conflict of interest, as defined by this policy, is discovered, actions must be taken to manage, reduce or eliminate such conflict of interest. These actions can include, but are not limited to:

• public disclosure of significant financial interests;
• monitoring of research by independent reviewers;
• with respect to NSF or PHS funded research, disqualification from participation in the portion of the NSF or PHS funded research that would be affected by any significant financial interests;
• severance of relationships that create actual or potential conflicts; or
• with respect to NSF funded research only, if the Center determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from significant financial interests are outweighed by interests of scientific progress, technology transfer or the public health and welfare, then the Center may allow the research to go forward without imposing such conditions or restrictions.

 

For PHS funded research programs, where any such conflict is found, the Center will report to the sponsor prior to the Center's expenditure of funds under the award the existence of a conflicting interest (but not the nature of the interest or other details) found by the Center and assure that the conflict of interest has been managed, reduced or eliminated in accordance with PHS policy; and, for any interest that the Center identifies conflicting subsequent to the Center's initial report under the award, the report will be made and the conflicting interest managed, reduced or eliminated, at least on an interim basis, within sixty days of that identification. For NSF funded research programs, conflicts of interest must be managed, reduced or eliminated prior to the Center's expenditure of any funds under the award. Both NSF and PHS will be notified if the Center is unable to satisfactorily manage a conflict of interest situation or upon completion of disciplinary proceedings as provided for in this policy.

 

For PHS funded clinical research programs, whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment and which has been designed, conducted or reported by an Investigator with a conflicting interest that was not disclosed or managed as required under this policy, the Investigator must disclose the conflicting interest in each public presentation/publication of the results of the research.

 

Where any such conflict is found with respect to the Investigator or the Investigator's spouse (in contrast to those with respect to the Investigator's dependent children), which would also violate the NYS Public Officers Law, corrective steps must be taken to render the activities in conformance with such law.

 

VI. Compliance

 

The Senior Vice President for Biomedical Education and Research shall report promptly to the President all cases in which Investigators have failed to comply with the Center's Conflict of Interest Policy or the means determined to resolve a conflict of interest. In such cases where disciplinary action is contemplated, the President, or his/her designee, shall:

• institute disciplinary proceedings against an Investigator who has failed to comply with the conflict of interest policy. Article 19 of the UUP Agreement shall be the sole source of Center discipline for members of the UUP-represented unit.
• disciplinary sanctions may include termination or alteration of the employment or academic status of persons against whom charges have been substantiated, and must be consistent with established SUNY Board of Trustees policies and applicable collective bargaining agreements.

 

For Research Foundation employees, in addition to any penalty contained in any provision of law or federal policy, officers or employees who knowingly and intentionally violate any of these provisions may be suspended from employment with the Research Foundation or their relationship with the Foundation may be terminated.

 

VII. References

 

• State University of New York Board of Trustees Policy on Conflict of Interest (approved 6/27/95)
• New York State Public Officers Law (Sections 73-a, 73 and 74)
• Research Foundation Board of Directors Conflict of Interest Policy (approved 5/10/95)
• National Science Foundation Investigator Financial Disclosure Policy (revised 7/11/95)
• Public Health Service Objectivity in Research Policy (revised 7/11/95)