Policy on Conflicts of Interest in Public Health Service Sponsored Programs
August 24, 2012
This policy item applies to:
This Policy provides for the disclosure, management and reporting of financial conflicts of interest of investigators who apply for, receive or participate in research sponsored by the Public Health Service of the U.S. Department of Health and Human Services and its component agencies, including the National Institutes of Health.
Policy on Conflicts of Interest in Public Health Service Sponsored Programs
State University of New York and The Research Foundation for The State University of New York
I. Reason for Policy
The State University of New York (“SUNY”) and The Research Foundation for The State University of New York (“RF”) have an agreement providing that applications made by faculty or staff at SUNY who are seeking support for sponsored programs shall be made by SUNY through RF, and all funds awarded by sponsors in support of such sponsored programs shall be paid to and administered by RF in accordance with the terms and conditions of the grants.
As institutions that receive U.S. Public Health Services (“PHS”) funding, SUNY and RF and their faculty, research staff and administrators are committed to meeting the highest ethical standards and to preserving the public trust by promoting objectivity in their teaching, research and public service missions. As part of this commitment, SUNY and RF share an obligation to protect their missions and reputations from being compromised by private interests and to operate in compliance with policies of various federal funding agencies.
This policy addresses the requirements under the revised regulation on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, published in Federal Register, vol. 76, No. 165, on August 25, 2011. This policy does not replace or supersede disclosure requirements under NY Public Officers Law, §73-a, or ethical standards under NY Public Officers Law, §§ 73 and 74.
II. Statement of Policy
SUNY and RF Investigators may not have any interest or engage in any outside activity which results in unmanaged Financial Conflict of Interest. To this end, SUNY and RF Investigators must disclose their interests and outside activities, and those of a Related Party, which may affect their independent and objective performance of their PHS-funded project(s). Financial Conflict of Interest shall be subject to management plans, and compliance with such management plans shall be monitored.
This policy applies to all Investigators who apply for, receive, plan to participate in or are participating in PHS grants or cooperative agreements for research. This includes SBIR/STTR Phase II applicants/awardees (but not Phase I SBIR/STTRs, which are exempt from this policy).
A Campus may promulgate a policy and procedure that is more stringent than this policy or applies to conflicts in addition to FCOIs in PHS-sponsored programs, provided that such policy and procedure complies with the requirements of this policy, the PHS Regulations, and collective bargaining requirements, as determined and approved by the SUNY Vice Chancellor for Research. Until a Campus policy and procedure is so approved, this policy shall apply.
 Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
 Equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
There is no related information relevant to this policy.
A. Disclosure and Management Plans
(1) Investigators shall disclose all SFIs to the DIO (see Appendix E for PHS Significant Financial Interest Disclosure Form):
(2) Upon receipt of a PHS proposal for processing, the DIO will confirm that updated disclosures for all Investigators have been made.
(3) Awards involving subrecipients must comply with the PHS Regulations by incorporating, as part of the written agreement with the subrecipient, terms establishing whether this policy or that of the subrecipient will apply to the subrecipient’s investigators. If the subrecipient’s policy applies, the subrecipient shall certify in the written agreement that its policy complies with PHS Regulations. If subrecipient cannot make such certification, then the written agreement shall provide that this policy will apply for disclosing investigator SFIs that are directly related to subrecipient’s work for SUNY or RF. The written agreement shall also include time periods for subrecipient to provide to the DIO all necessary information for evaluation of subrecipient investigator disclosures and reporting of FCOI to the sponsor.
(4) The DIO will review the disclosures of SFIs and determine if a FCOI exists. In determining whether a FCOI exists, the DIO will determine if the SFI is related to the PHS-funded research, and, if so, could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
(5) For all identified FCOIs, the DIO will develop and implement a management plan (which may include the reduction or elimination of the SFI). Examples of conditions or restrictions that a management plan might include are:
(6) The Investigator must agree to comply with the management plan in written or recorded form.
(7) The FCOI and the management plan will be reported to PHS (see Appendix A for content of report):
In addition, for any FCOI previously reported with respect to an ongoing PHS-funded research project, the DIO shall annually report on the status of the FCOI and any material changes in the management plan.
(8) For all identified FCOI’s, the DIO will monitor compliance with the applicable management plan. Such monitoring will be documented and maintained in accordance with the PHS Regulations.
(9) In any case in which PHS determines that a PHS-funded 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 whose FCOI was not managed or reported as required by this policy or the PHS regulations, the Investigator involved will disclose the FCOI in each public presentation of the results of the research and will request an addendum to previously published presentations.
B. Required Investigator Training
Each Investigator must complete FCOI training:
C. Public Disclosure of FCOI’s
The DIO will make information concerning FCOIs held by Senior/Key personnel available via a written response to any requestor within five business days of a request, and update such information as specified in the PHS Regulations. In response to such request, the Institution will provide, at a minimum, the information outlined in Appendix B. Requests for information concerning FCOIs held by Investigators other than Senior/Key personnel will be governed by the provisions of the New York’s Freedom of Information Law (NY Public Officers Law, Art. 6).
D. Retrospective Review
When a FCOI is not identified or managed in a timely manner or when an Investigator fails to comply with a management plan, the DIO, within 120 days of a determination of non-compliance, must complete a retrospective review of the Investigator’s activities and the PHS Award to determine if there was bias in the design, conduct, or reporting of such research. The information that must be documented in the retrospective review is outlined in Appendix C.
If bias is found through a retrospective review, the DIO will notify the PHS Awarding Component promptly and submit a mitigation report containing the information outlined in Appendix D.
Thereafter, the DIO will submit FCOI reports annually as described in Appendix A.
The DIO will maintain records of all Investigator disclosures of financial interests and the DIO’s review of, and response to, such disclosures (whether or not a disclosure resulted in the DIO’s determination of FCOI) and all actions under this policy, including retrospective review, if applicable, for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR §74.53(b) and §92.42 (b) for different situations.
F. Other Requirements
1. RF and SUNY will maintain this policy and make it publicly available on their respective websites.
2. Violators of this policy are subject to the respective disciplinary policies of RF and SUNY.
See linked form in Appendix section.
Resolution 95-138, adopted June 27, 1995.
There is no history relevant to this policy.
FCOI Reports to PHS will consist of:
The following information regarding an SFI will be made publicly available prior to expenditure of any PHS Award funds if it is determined that an Investigator still holds the SFI and that the SFI is a FCOI and is related to the PHS Award.
The following must be documented in the retrospective review:
The following will be documented in mitigation report: