Conflicts of Interest in Research/Sponsored Programs
Updated October 1, 2021
The purpose of this policy is to promote objectivity in Research/Sponsored Programs by establishing standards and procedures to ensure that there is no reasonable expectation that the design, conduct, or reporting of such Research/Sponsored Programs will be biased by any conflicting financial interest of the investigator.
This policy is intended to comply with the requirements of federal regulations, including the following:
|42 CFR Part 50, Subpart F||Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought|
|45 CFR Part 75||Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments|
|45 CFR Part 94||Responsible Prospective Contractors|
|34 CFR Part 74||U.S. Department of Education Administration of Grants and Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations|
|NSF Grants Policy Manual||Chapter V, Section 510 Conflict of Interest Policies|
|21 CFR Part 54||FDA Financial Disclosure by Clinical Investigators|
|NIH Grants Policy Statement 4.1.10||Financial conflict of interest, responsibility of applicants for promoting objectivity in research, free from bias, FCOI, FCOIs, and FCOI report|
II. Applicability and Prohibition
- This policy applies to all Research/Sponsored Programs at New York Institute of Technology (New York Tech) whether supported by external or internal funding, sponsored or unsponsored, and to all research to be carried out at other sites in the name of New York Tech.
- No Investigator, faculty member, key grant staff member, or administrator at New York Tech may participate in Research/Sponsored Programs in which they or their family have a Conflict of Interest unless approved in advance in writing in accordance with this policy.
- No Investigator, faculty member, or administrator at New York Tech shall assign any student, post-doctoral fellow or other trainee or subordinate to any Research/Sponsored Programs project in which that person has a Conflict of Interest unless approved in advance in writing in accordance with this policy.
A. "Conflict of Interest" means a Significant Financial Interest or an Outside Activity that could directly and significantly affect the design, conduct, or reporting of Research/Sponsored Programs.
B. "Equity Interest" includes stocks, stock options and other ownership interests, but does not include income from investment vehicles, such as mutual funds and retirement accounts, provided the Investigator does not control the investment decisions made in these vehicles.
C. "Institutional Responsibilities" means an Investigator's professional responsibilities on behalf of New York Tech, including teaching, Research/Sponsored Programs, administrative functions and committee memberships.
D. "Investigator" means the principal investigator and any other person who is responsible for the design, conduct or reporting of Research/Sponsored Programs, including faculty, the attending physicians, interns and residents sponsored by New York Tech, research scientists, clinical fellows, nurses, technicians and others engaged in Research/Sponsored Programs, whether as employees or volunteers. "Investigator" does not include advisors, persons who provide technical support or clinical trial participants, who have no responsibility for design, conduct or reporting of the Research/Sponsored Programs.
E. "Family" means spouse and/or dependent children.
F.1 "Integral Staff Members" means other staff members who are specifically named and listed on grants which may be research or non-research programmatic grants.
F.2 "Key Personnel" means the Principal Investigator or Project Director and any other person identified as senior or key personnel in the grant application or in other institutional reports to the grantor.
G. "New York Tech" means New York Institute of Technology and all of its schools, departments, centers, and affiliates.
H. "Remuneration" means salary or any other payment for services, including consulting fees, honoraria and paid authorship.
I. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge, including behavioral and social science research. It encompasses both basic and applied research and product development.
J. "Significant Financial Interest" means:
- Any interest of monetary value of the Investigator or the Investigator's Family that reasonably appears to be related to the Investigator's Institutional Responsibilities, consisting, in the aggregate, of one or more of the following:
- In the case of a publicly traded entity, Remuneration and/or the value of any Equity Interest together totaling in excess of $5,000 during the preceding twelve months;
- Remuneration from any non-publicly traded entity in excess of $5,000 during the preceding twelve months, or any Equity Interest in a non-publicly traded entity;
- Intellectual property rights and interests in excess of $5,000 in the Research/Sponsored Program (e.g. patents and copyrights) and the right to receive royalties therefrom;
- Remuneration affected by the outcome of the Research/Sponsored Program—for example, compensation that is higher for a favorable outcome than for an unfavorable outcome;
- Remuneration from the sponsor of the Research/Sponsored Program to the Investigator, or payments to New York Tech to support activities of the Investigator, which remuneration or payments are over and above the costs of conducting the current Research project;
- Position as a director, officer, manager, employee or consultant to an entity with a Significant Financial Interest in the Research/Sponsored Program.
"Significant Financial Interest" does not include the following:
- Remuneration paid to the Investigator by New York Tech, including any share in royalties related to intellectual property rights assigned by the Investigator to New York Tech, provided that the Investigator is currently employed or otherwise appointed by New York Tech;
- Income from seminars, lectures or teaching engagements sponsored by a government agency, institution of higher education or affiliated research institute, academic teaching hospital, or medical center;
- Income from service on advisory committees or review panels for a government agency, institution of higher education or affiliated research institute, academic teaching hospital, or medical center.
K. "Sponsored Program" includes but is not limited to any externally funded research, programmatic (ie: STEP, CARES HEERF, etc.), or scholarly activity that gets processed through OSPAR.
L. "Outside Activity" includes but is not limited to:
- Service on boards
- Business activities including managerial positions with domestic or foreign entities, whether or not remuneration is received
- Financial interests, including but not limited to, stock, cash, and LLC interests in an entity that does business with New York Tech
IV. Disclosure Requirements
A. Investigators, Key Personnel, and Integral Staff Members on grants are required to disclose, in accordance with the procedures set forth in Section IV–B below, the following:
- Any Significant Financial Interest.
- Any Outside Activity which reasonably appears to be related to the Investigator's Institutional Responsibilities.
- Any Travel sponsored or reimbursed by a foreign organization, regardless of the type of organization sponsoring the travel, and all other travel sponsored or reimbursed by any person or entity other than the following:
- New York Institute of Technology
- U.S. Federal, state or local governmental agencies
- U.S. Institutes of higher education
- U.S. Research institutes affiliated with Institutes of higher education
- U.S. Academic teaching hospitals and medical centers
B. Investigators are required to submit to the Institutional Official, in accordance with Sections VI–B and VI–C below, a completed and signed New York Tech Financial Interest Disclosure Form (Please contact OSPAR at email@example.com to initiate a new COI form).
If you actively submit Research/Sponsored Programs grant proposals, you will be asked to complete the Financial Interest Disclosure Form annually so that OSPAR has it on file for compliance purposes. You will then be asked to update it if anything has changed upon submission/award of a new grant or contract.
The Financial Interest Disclosure Form must be submitted as follows:
- The Financial Interest Disclosure Form (if one isn't already on file) must be submitted with any Research/Sponsored Programs proposal, and prior to the submission of any proposal to the sponsor, any Institutional Review Board, or any other outside entity.
- A new Form must be submitted annually thereafter during the pendency of the Research/Sponsored Programs project.
- A new Financial Interest Disclosure Form must be submitted within 30 days of the Investigator's discovering or acquiring a new Significant Financial Interest during the pendency of the Research/Sponsored Programs project.
C. It is the responsibility of the Principal Investigator on any Research/Sponsored Program to ensure that all Investigators, Key Personnel, and Integral Staff Members involved with the Research/Sponsored Program submit the required Financial Disclosure Forms.
D. Human Subjects Research Investigator Conflict of Interest: In addition to the annual and amended disclosures set forth in this Conflict of Interest in Research/Sponsored Programs, all investigators submitting protocols to the Institutional Review Board (IRB) for review must submit a conflict of interest disclosure statement. An investigator must disclose potential conflicts as outlined in this policy. Investigators must also update the protocol and/or disclosure anytime there is a significant change.
E. IRB Member Conflict of Interest: IRB Members must submit an annual conflict of interest disclosure and must also notify the IRB Administrator should any conflicts of interest arise when they are reviewing a protocol.
F. Organizational Conflict of Interest: In addition to the disclosure requirements set forth for Conflict of Interest in Research/Sponsored Programs, the Senior Director of Sponsored Programs and Research who is the designated Institutional Official will work with the Office of General Counsel to ensure disclosure to the IRB of potential Institutional conflicts.
A. New York Tech requires that all Investigators, Key Personnel, and Integral Staff Members complete a Conflicts of Interest training program through Citiprogram.org which is labeled the Conflict of Interest Module. This module is selected from by the Institutional Official. The Institutional Official may in their discretion require that training be completed or renewed in certain circumstances, including for example, if an Investigator, Key Personnel, and Integral Staff Members is found to be non-compliant with the Policy, or for Investigators, Key Personnel, and Integral Staff Members who are new to New York Tech.
B. Investigators conducting PHS-Funded Research must comply with the training requirements set forth in Appendix A, Section 1, below.
VI. Institutional Responsibilities and Procedures
A. New York Tech shall designate an institutional official (the "Institutional Official") who shall be responsible for identifying Conflicts of Interest and taking action to manage, reduce or eliminate such Conflicts. The currently-designated Institutional Official is the Senior Director of Sponsored Programs and Research.
B. Each proposal for external funding shall be submitted for review, together with a Financial Interest Disclosure Form (if one isn't already on file), to the Institutional Official. The Institutional Official in consultation with the Assistant Controller will determine if a Conflict of Interest exists. If a Conflict of Interest exists the Institutional Official will consult with the Office of the General Counsel in order to comply with the regulations of the funding agency with regard to reporting, creating a conflict of interest management plan and managing any continued conflicts. (See Appendix A hereto for specific policies applicable to PHS-funded research.)
C. Review of Research/Sponsor Programs that is funded internally shall be carried out by the Institutional Official in consultation with the Assistant Controller and applicable Dean. The Investigator will complete and sign a Financial Interest Disclosure Form and submit it to the Institutional Official for review and action in accordance with this policy.
D. In the event that the Institutional Official determines that a Conflict of Interest exists for any Investigator, Key Personnel, and Integral Staff Members involved in proposed Research/Sponsored Programs, they shall advise the Investigator or Key Personnel on mechanisms designed to manage, reduce, or eliminate the Conflict of Interest. These may include, but are not limited to, the following:
- Public disclosure of the Significant Financial Interest whenever and as often as reasonably necessary to ensure objectivity of the Research/Sponsored Program.
- Monitoring of research by independent reviewers, such as independent peer review or audits of data.
- Modification of the research plan, such as using a double-blinded protocol where appropriate, ensuring that subjects are randomly selected or excluding the Investigator (Key Personnel or Integral Staff Members) from the portion of the research that may be affected by the Significant Financial Interest.
- Divestiture of the Significant Financial Interest.
- Severance of the relationships that create actual or potential Conflicts of Interest as a result of the Significant Financial Interest.
E. The Institutional Official shall sign the Financial Interest Disclosure Form when the official is satisfied that there is no Conflict of Interest or that the Conflict of Interest has been appropriately managed, reduced, or eliminated.
F. New York Tech OSPAR shall establish an ad hoc Committee on Objectivity in Research (if necessary) which may be advised by the Office of the General Counsel. In the event that the Institutional Official and the Investigator (or Key Personnel) do not agree on either the existence of a Conflict of Interest or on procedures that will insure that a Conflict of Interest is managed, reduced, or eliminated, the Institutional Official shall refer the matter to the Committee on Objectivity in Research. The Committee shall make a decision after reviewing the research proposal and the Financial Interest Disclosure Form, and, if the Committee sees fit, after meeting with the Investigator (or Key Personnel). In the event that the Committee determines that a Conflict of Interest does not exist or has been appropriately managed, reduced, or eliminated, the Chair of the Committee shall indicate so in writing to the Institutional Official and Investigator (or Key Personnel).
A. The Institutional Official shall make and maintain records of the steps to which the Investigator has agreed to ensure that Conflicts of Interest are managed, reduced, or eliminated.
B. The Institutional Official shall maintain Financial Interest Disclosure Forms and all records of action taken for not less than seven (7) years after the latest of:
- Conclusion of the Research/Sponsored Program
- Submission of the final expenditure report to a sponsor
- Disposition of property and equipment provided by a sponsor
- Final resolution of any litigation, claim, or audit arising out of the research
VIII. Violations of this Policy
The Committee on Objectivity in Research shall have authority to take any of the following actions upon a determination that any Investigator, faculty member, or administrator has violated this policy:
- Issue a written reprimand that may be placed in the offender's employment file.
- Recommend that the offender be disciplined, up to and including termination.
- Terminate the Research/Sponsored Program that is associated with the Conflict of Interest.
- Bar the offender from Research/Sponsored Program activities for a specific period of time.
- Report the violation to any sponsors, bodies, or individuals as may be required by federal regulations, laws or contracts.
Appendix A: Special Rules Applicable to PHS-Funded Research
Any Research/Sponsored Program for which an Investigator is applying for Public Health Service funding ("PHS-Funded Research") must comply with the New York Tech Policy on Conflicts of Interest in Research (the "Policy"), and must additionally comply with the Special Rules set forth in this Appendix A.
Each Investigator (and Key Personnel) engaged in or applying for PHS-Funded Research must complete the Conflict of Interest training requirements specified by the Institutional Official as follows:
- The Investigator and Key Personnel must complete the Citiprogram Conflict of Interest training before commencing the Research/Sponsored Program and the training must be repeated every four (4) years during the pendency of the Research/Sponsored Program.
- Any Investigator and Key Personnel who is found to be non-compliant with the Policy will be required to immediately complete the designated training again.
- The Institutional Official may direct that Investigators and Key Personnel complete the designated training in other instances, including in the case of changes to the Policy or for Investigator new to New York Tech.
2. Management and Reporting of Conflicts of Interest
A. "Public Disclosure of Policy": The New York Tech Policy on Conflicts of Interest in Research/Sponsored Programs, including this Appendix A, is publicly available on the website, at nyit.edu/ospar.
B. "Public Disclosure of Conflicts of Interest": New York Tech will disclose any FCOI to all staff working on the grant. New York Tech will also respond within five (5) calendar days to any request for information regarding Conflicts of Interest held by Key Personnel associated with any PHS-Funded Research. For any Conflict of Interest which has been disclosed and determined to exist in accordance with this Policy, New York Tech's response will include the following information: the Key Personnel's name, title and role in the research project, name of the entity in which the Significant Financial Interest is held, the nature of the Significant Financial Interest, and the approximate dollar value of the Significant Financial Interest or a statement that the value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. The response will note that the information provided is current as of the date of the correspondence and is subject to updates on an annual basis and within 60 days of New York Tech's identification of a new Conflict of Interest, which should be requested subsequently by the requestor.
C. "Reporting to NIH":
- Prior to New York Tech's expenditure of funds in connection with any PHS-Funded Research, New York Tech will provide a report to the PHS Awarding Component regarding any Conflict of Interest of an Investigator which has been determined to exist in accordance with this policy (and has not been eliminated). The report will include information regarding the management plan which New York Tech has implemented.
- In the event that during the course of an ongoing PHS-Funded Research project, a new or newly-discovered Significant Financial Interest is disclosed, the Institutional Official shall within 60 days determine whether a Conflict of Interest exists, and if so, the Institutional Official shall implement an interim management plan, subject to further institutional review. The new Conflict of Interest and management plan will be reported to the PHS Awarding Component.
- Any report under (i) or (ii) above will provide sufficient information for the PHS Awarding Component to understand the nature and extent of the financial conflict and to assess the appropriateness of New York Tech's management plan, including:
- Project number and contact information;
- The Investigator's name, title and role in the research project, name of the entity in which the Significant Financial Interest is held, the nature of the Significant Financial Interest, and the approximate dollar value of the Significant Financial Interest or a statement that the value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
- A description of how the financial interest relates to the Research and the basis for New York Tech's finding of a Conflict of Interest; and
- A description of the key elements of the management plan, how it will safeguard objectivity, confirmation of the Investigator's agreement to the management plan, and how the plan will be monitored to ensure Investigator compliance.
- In the event that New York Tech makes any report as provided above, New York Tech will provide the PHS Awarding Component annual update reports throughout the period of the project, addressing the status of the Conflict of Interest, including whether it still exists and is being managed, and any changes to the management plan.
D. "Retrospective Review": In the event that a Conflict of Interest in connection with any PHS-Funded Research is not identified or managed in a timely manner including failure by the Investigator to disclose a Significant Financial Interest which is determined to be a Conflict of Interest, failure of the institution to review or manage the Conflict of Interest, or failure by the Investigator or Key Personnel to comply with a Conflict of Interest management plan, then the Institutional Official shall, within 120 days of the institution's determination of non-compliance, complete a retrospective review of the Investigator's activities to determine whether any PHS-Funded Research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct or reporting of such research.
The Institutional Official shall document the retrospective review, including:
- Project number and contact information;
- The Investigator's or Key Personnel's name(s), title and role in the project, and name of the entity in which the Significant Financial Interest is held;
- Reasons for the retrospective review and detailed methodology of the review process; and
- Findings and conclusions of the review.
Based upon the results of the retrospective review, if appropriate, New York Tech will update the previously submitted Conflicts of Interest report, specifying the actions which will be taken to manage the Conflict of Interest going forward. If bias is found, New York Tech will promptly notify the PHS Awarding Component and submit a mitigation report, including the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and New York Tech's plan of action or actions taken to eliminate or mitigate the effect of the bias. New York Tech will update this report at least annually.
3. Subrecipient Awards
In the event that a portion of any New York Tech PHS-Funded Research is carried out by a subrecipient, then the agreement between New York Tech and the subrecipient institution must include the following provisions:
- The subrecipient Investigators and Key Personnel must comply with this policy or the subrecipient must certify that its own research conflicts policy complies with all legal requirements.
- The subrecipient Investigators and Key Personnel must report any Significant Financial Interests to New York Tech so that New York Tech may make any required disclosures and reports.
4. Enforcement Mechanisms and Remedies and Noncompliance
Failure to properly disclose relevant financial interests or to adhere to conditions or restrictions imposed by the designated Institutional Official will be considered a violation of this policy.
Alleged violations of this policy will be reported to the Office of General Counsel and Compliance Office. The alleged violation will be investigated by the designated Institutional Official, who will make recommendations for action to the Provost and/or Executive Vice President and Chief Operating Officer. Breaches of policy include failure to file the necessary disclosure statements; knowingly filing incomplete, erroneous, or misleading disclosure forms; or failure to comply with procedures prescribed by the designated Institutional Official.
If the Provost and/or Executive Vice President and Chief Operating Officer determines that this policy has been violated; he/she may impose a range of sanctions including but not limited to: notification of sponsor and possible termination of award; formal admonition; a letter to the Investigator's personnel file; suspension of the privilege to apply for external funding and/or to seek IRB/IACUC approval; and other remedies necessary to eliminate or mitigate the impact of any potential bias. A concurrent report will be made to the Office of General Counsel, which may involve the department of Human Resources in further disciplinary action.
In any case in which the Department of Health and Human Services determines that a PHS-funded research project involving clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, that has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required by the regulations, the Institution shall require the Investigator involved to:
- Disclose the FCOI in each public presentation of the results of the research, and
- Request an addendum to previously published presentations.
Please contact OSPAR at firstname.lastname@example.org to initiate a new COI form.