Conflict of Interest and Commitment for Principal Investigators and Senior Personnel on Sponsored Programs - Policies

Scope

Principal investigators and senior personnel on sponsored programs

Policy Statement
(Faculty Manual 3.44)

Syracuse University’s mission is to promote learning through teaching, research, scholarship, creative accomplishment, and service. As a natural outgrowth of the University’s mission, it may be appropriate and desirable that University Members be professionally involved in outside activities such as lecturing at other institutions, practicing their profession, consulting for businesses, engaging in travel sponsored by businesses or foundations, or serving in community organizations. These outside activities can enrich teaching, extend professional expertise, and contribute to the advancement of knowledge; however, in some circumstances they can give rise to real or apparent conflicts of interest.

For the purposes of this policy,

A Conflict of Interest exists when an Investigator’s financial interests may reasonably be affected by research, scholarship, educational or other externally funded activity.

To minimize the potential for financial interests to influence federally funded research, in 1995, the Federal government implemented regulations which were updated in 2011[1] requiring institutions to develop a way for their investigators to disclose the existence of financial interests that may reasonably be affected by the research.

Purpose and Applicability

The purpose of these guidelines is to ensure that any financial interest(s) of Investigator’s responsible for the sponsored activity, funded or proposed, do not bias the credibility and objectivity of the activities and its findings. Syracuse University has established the following written standards and procedures to be followed by all Investigator(s) applying for or receiving external funding, regardless of source or funding mechanism to comply with federal regulations. These procedures do not replace the Member’s obligation to obtain University approval prior to beginning outside activities (The Faculty Manual – paragraph 3.30 edition 18 January 1995 and Administrative Policy Manual – section labeled Office of Human Resources).

The University will obtain assurance that other institutions collaborating with University Investigators on sponsored projects have comparable policies that comply with Federal regulations or are willing to comply with the University’s FCOI policy.

Definitions

Disclosure of Significant Financial Interests means an Investigator’s disclosure of significant financial interests to the University.
FCOI Report means the University’s report of a financial conflict of interest to a PHS Awarding Component.
Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.
HHS– the United States Department of Health and Human Services, and any components of the Department to which authority may be delegated.
Institution – any domestic or foreign, public or private entity or organization (excluding a Federal agency), that proposes to carry out activities in support of a project, proposed or funded, and assumes all associated legal obligations.
Institutional Responsibilities-means an Investigator’s professional responsibilities on behalf of the University.
Investigator – the principal investigator, project director or any other person at the institution who is responsible for the design, conduct, or reporting of a research project, proposed or funded.
Manage-Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.
PHS-Means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
Significant Financial Interest – Anything of monetary value – aggregated for the Investigator and the Investigator’s spouse, domestic partner, and dependent children – that reasonably appears to be related to the Investigator’s institutional responsibilities including but not limited to the following:
1. Salary or other payment for services (e.g. consulting fees) that exceeded in the previous twelve months or is reasonably expected to exceed in the next twelve months $5,000
2. Equity interests (e.g. stocks, stock options or other ownership interests) that meet the following tests:
  1. exceeds $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value (e.g. most recent sales price recognized by the company), or
  2. constitutes more than a 5% ownership interest in any single entity.
3. Intellectual property rights (e.g. patents, copyrights and royalties from such rights) upon receipt of income related to such rights and interests.
4. Services as an officer, director, or in any other executive position in an outside business, whether or not remuneration is received for such service.
5. Reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and is not reimbursed)
If compensation or equity interests may be influenced by a particular outcome in sponsor- funded research, such interests are significant financial interests even if the identified thresholds are not met or if the monetary value of interests is not immediately ascertainable.The definition of Significant Financial Interest may change from time to time depending on changes in federal and state statute(s) or regulation(s).

Significant Financial Interests do NOT include:
1. Salary, royalties or other remuneration from Syracuse University.
2. Ownership interests in a commercial entity, if the University is an applicant under the SBIR (or STTR) Phase I Program.
3. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
4. Income from seminars, lectures, or teaching engagements sponsored by Federal, state or local government agencies, an Institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.
5. Income from service on advisory committees or review panels for Federal, state or local government agencies, Institutions of higher education, academic teaching hospitals, medical centers or research institutes that are affiliated with an institution of higher education.
Public Health Service (PHS) awarding component – organizational unit of the PHS that funds activities subject to these guidelines and procedures.
Research – a systematic investigation, study or experiment designed to contribute to generalizable knowledge relating to natural and physical sciences, social and behavioral sciences, education and engineering. The term encompasses basic and applied research, product development, or any such activity for which funding is available from an awarding component through a grant or cooperative agreement such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant or research resources award.
Small Business Innovation Research (SBIR) – the extramural research program for small business that is established by the awarding components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended.

Responsibilities

Syracuse University’s responsibilities as required by federal regulations include the following:

To maintain an up-to-date, written, enforceable institutional policy which will be publicly accessible on a website.
To inform each Investigator via regular required training sessions of the institutional policy, Investigators’ disclosure responsibilities, and applicable federal regulations. To inform Investigators of any changes to this policy through immediate FCOI retraining.
To provide annually and on an ad-hoc basis Financial Disclosure Forms to all faculty members and any other SU employees or students who are involved in the design, conduct or reporting of results on any sponsored project.
To appoint an individual or committee to review disclosures of significant financial interests; to determine when conflicts exist and develop appropriate management plans; and to monitor implementation of plans.
To provide Sponsors with annual FCOI reports and other required information, as well as any incidents of non-compliance and corrective actions taken, in accordance with Sponsor policies.
To maintain records as confidential, to the extent allowable by law.
To ensure that institutions participating as subgrantees/subawardees on University proposals have policies compliant with Federal guidelines or are willing to comply with the University’s FCOI policy.
To maintain records of all financial disclosures (whether or not a disclosure resulted in a determination of an FCOI) and all actions taken by the University with respect to conflicting interests. To make disclosures related to publicly-funded projects available to the public within 5 days of receipt of a request.

Investigators’ responsibilities include complying with this policy and procedures including:

Complete annual financial disclosure forms.
Complete ad-hoc disclosure forms immediately in the following circumstances:
- When the Investigator is new to the University
- When the Investigator is found to be not in compliance with this policy
Complete ad-hoc disclosure forms within 30 days of acquiring (e.g., through purchase, marriage or inheritance) a new significant financial interest
Certify prior to submission of an application for external support or expenditure of funds that the annual disclosure has been filed, current and complete or has been recently updated, if necessary, to reflect current information.
Complete mandated FCOI training in the following circumstances:
- Prior to the Investigator’s commencement of involvement with a funded project.
- Every four years thereafter.
- After being found to be in noncompliance with this policy.
Present certification of training with grant applications.
Comply with any management or mitigation plan or retrospective review, if applicable.

Conflict of Interest Committee

The Vice President for Research will appoint a Conflict of Interest Committee (COIC), consisting of five full-time faculty members. Members will be appointed to three-year terms and will undergo at least the same levels of in FCOI policies as Investigators. The Vice President for Research will chair the Committee. The Executive/Director of the Office of Sponsored Programs, the Director of Regulatory Compliance, the Director of Technology Transfer, and Director of the Office of Audit and Management Advisory Services will serve as ex officio members without vote.

The COIC will review all significant financial disclosures and supporting documentation to determine whether a significant conflict of interest exists that requires management to preserve objectivity in the design, conduct or reporting of the research and if that research is from a sponsor requiring reporting (such as the PHS). This determination will be made when an investigator, or the investigator’s spouse, domestic partner or dependent children have significant financial interest(s) that may compromise, or have the appearance of compromising, an investigator’s professional judgment that could directly and significantly affect the design, conduct, or reporting of the research, proposed or funded.

If the COIC determines that there is a conflict that can be managed, a management plan will be developed in the best interest of the University, in consultation with the Investigator and an assigned Conflict Manager. An interim management plan may be developed for time critical situations and approved by the chair of the committee. The plan should be updated as more information becomes available. This management plan will be instituted before a new Investigator joins a research project or within 60 days from when the University discovers an undisclosed SFI or one no previously reviewed for whatever reason.

The COIC will review managed conflicts annually (or as relevant information arises) to monitor the conduct of the activity (including use of students and postdoctoral scholars), and to ensure scientific objectivity and timely dissemination of the research results.

Any appeal of the COIC’s decision can be made through the appropriate chairperson, dean, director, or Vice President for Research, with final appeal to the Vice Chancellor for Academic Affairs.

Reporting

In addition to the annual FOIC Reports required by Federal Agencies, the Vice President for Research will submit an annual report that has been approved by the COIC to the Audit Committee of the Board of Trustees that will include summaries of disclosure activity, nature of significant conflicts of interest, summaries of respective management plans, the estimated financial or potential value of the conflict, and summaries of any significant outcomes or issues.

Compliance

Whenever the University identifies a significant financial interest that was not disclosed within the allotted time requirements by an Investigator, the Investigator will be referred to the Vice President for Research, the COIC and the Department for non-compliance management and mitigation. The COIC shall, within 60 days, review the significant financial interest and determined whether a financial conflict of interest exists. If the FCOI exists, the COIC shall implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI going forward. At this time the COIC shall also determine if the FCOI is related to PHS-funded research, if so, the Vice President for Research will notify the NIH promptly regarding the nature of the FCOI and including the Management report. Within 120 days of the Institution’s determination of noncompliance, the COIC shall complete a retrospective review of the Investigator’s activities to determine whether any research was biased in design, conduct or reporting. Based upon the retrospective review, the COIC shall, if appropriate, update the previously submitted FCOI report, and, if bias was found, submit a mitigation report to the PHS Awarding Component.

If an Investigator operating under a management plan is non-compliant with the plan, the Conflict Manager must report non-compliance to the Vice President for Research, who alerts the COIC which must meet within 60 days to determine if continued non-compliance has occurred. If continued non-compliance has occurred, and the COIC determines that the research is funded through the PHS, the Vice President for Research is to promptly notify the PHS Awarding Component.

Non-compliance to either disclosure policies or to management plans may cause administrative actions in accordance with University policies found in The Faculty Manual, and the Administrative Policy Manual, in addition to any legal penalty(ies) under state and federal laws that may be appropriate (e.g., oral admonishment; written reprimand; reassignment; demotion; suspension, or separation; denial of eligibility to engage in research funded through the university; or other appropriate penalties.). Appeals by investigators are to follow University procedures found in The Faculty Manual or the Administrative Policy Manual.

In any 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 with a conflicting interest that was not disclosed or managed as required, Syracuse University must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research and to request an addendum to all previously published presentations.

Procedures

Disclosure Procedure
1. Annual disclosures
  1. All Investigators must complete the Annual Disclosure of Significant Financial Interests for the previous university fiscal year and submit it to the Vice President for Research by the University’s deadline. New faculty must submit the form within 60 days of appointment or before they conduct a sponsored research project, whichever occurs first.
  2. The Vice President for Research will review all disclosures and forward all significant conflicts of interest to the Conflict of Interest Committee.
2. Ad hoc disclosures
  An Investigator is to update the Annual Disclosure and submit it to the Vice President for Research when such interests become reportable within 30 days of the acquisition of the new financial interest.
3. Disclosure Forms
  Disclosure forms (both annual and ad-hoc) will include the following information:
  1. Name of Investigator
  2. Project Name and title and project PD/PI (or contact PD/PI for projects with multiple PD/PIs) name and title for each sponsored research project.
  3. Investigator’s title and role within each sponsored research projects.
  4. Reason for disclosure (Annual or description of event that triggered Ad-Hoc disclosure)
  5. Details of each Investigator significant financial interests in the preceding 12 months including:
    1. Name of entities with which the Investigator has significant financial interests.
    2. Nature of the significant financial interests (i.e., stock, non-stock equity, honorarium, consulting fee, payment for services, paid authorship, tenure on advisory panels, intellectual property, fee-splitting agreements for referrals or other investment/payment)
    3. Amount of significant financial interests or a statement that value cannot be readily determined through reference to public prices or other reasonable measures of fair market value
  6. Details of sponsored or reimbursed travel including:
    1. Purpose of trip
    2. Identity of sponsor/organizer
    3. Destination of trip
    4. Duration of trip
    5. Value (actual for reimbursed travel or estimated in cases of sponsored travel).
    6. In cases where value is not immediately ascertainable, Investigator will provide information on the covered services including but not limited to class and carrier of air travel, type and location of accommodation and number and type of meals provided.
  7. Details of other, potentially non-quantifiable interests including but not limited to:
    1. Gifts of goods or services.
    2. Outstanding agreements that contain provisos restricting the Investigator’s ability to speak, publish or otherwise undertake activities contrary to a company’s commercial interest.
4. Review by the Conflict of Interest Committee
  The committee will meet at least annually to review disclosures of significant financial interests and determine if a plan is warranted to eliminate, reduce, or manage any conflict.The Committee Chair will send the COIC’s determination of whether a plan is required or not, in writing, to the Investigator (or other relevant party) and the appointed conflict manager.The written decision must include a rationale for the decision.Managed conflicts will be reviewed by the COIC annually or as new information arises.
5. Review in Cases of Noncompliance
  If the Vice President or the COIC is alerted of cases of suspected non-compliance (i.e., interested not disclosed within set time constraints), the Vice President for Research, within 60 days, review the significant financial interest and determine whether a financial conflict of interest exists. If so, the COIC shall, on an interim basis, implement a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward.In addition, the COIC shall, within 120 days of the University’s determination of noncompliance, complete a retrospective review of the Investigator’s activities to determine whether any research was biased in design, conduct or reporting.Based on the results of the retrospective review, the COIC will prepare a mitigation report within 30 days of completion of the retrospective review.Retrospective Review Reports will include the following information:
  1. Project Title and Number (if applicable)
  2. PD/PI (or contact PD/PI if multiple PD/PI model is used)
  3. Project Funding sources and amounts
  4. Name of Investigator with the FCOI(s)
  5. Name of entity(ies) with which the Investigator has the FCOI(s)
  6. Reason(s) for the retrospective review
  7. Detailed methodology used for the retrospective review including:
    1. Methodology of the review process
    2. Composition of the review panel
    3. Documents reviewed
  8. Findings of the review
  9. Conclusions of the review
  Mitigation Reports will include the following information:
  1. A cover sheet including:
    1. Project Title and Number (if applicable)
    2. Name of Investigator with the FCOI
    3. PD/PI (or contact PD/PI if multiple PD/PI model is used)
  2. A copy of the retrospective review report (above)
  3. Description of the impact of the bias on the research project
  4. Institutional plan of action to eliminate or mitigate effects of bias
Management of conflicts
1. Delegation of Management
  The conflict of interest committee will delegate management of the conflict to a Conflict Manager, who will be an appropriately qualified individual (e.g., dean or chair) and who will undergo training in FCOI policies to at least the same levels as Investigators.
2. Development of Management Plan
  The Conflict Manager in collaboration with the Investigator will develop a plan utilizing the Management Plan Form (see below), which must be approved by the COIC, to manage, eliminate or reduce the conflict.
  Some examples of possible conflict management are:
  1. Public disclosure of significant financial interests
  2. Monitoring of research by independent reviewers
  3. Modification of the research plan
  4. Disqualification from participation in all or a portion of the funded research
  5. Divestiture of significant financial interests
  6. Severance of relationships that create actual or potential conflicts
  7. Oversight by the Conflict Manager of any financial transactions in which the conflict may be relevant
  Management Plan Forms will include the following information:
  1. Investigator’s Name
  2. Title and Number (if applicable) of research project
  3. PD/PI (or Contact PD/PI if multiple PD/PI model is used)
  4. Conflict Manager’s name and title
  5. Role and principle duties of the conflicted Investigator in the research project.
  6. Conditions of the Management (see above)
  7. How the management plan is designed to safeguard objectivity in the research project.
  8. Confirmation of the Investigator’s agreement to the management plan
  9. Confirmation of the COIC’s agreement to the management plan
  10. How the management plan will be monitored to ensure Investigator compliance
3. Correspondence
  The Conflict Manager will put forward to the COIC in writing the proposed strategies to manage the conflict for their review and approval, or revision.
  The COIC will approve or revise the plan in consultation with the Conflict Manager; a copy of the approval memo will be sent to the Investigator, Office of Sponsored Programs, Department Chair or Dean if the conflict does not involve them.
4. The assigned manager will provide a semi-annual report on the status of managed activities to the COIC.
5. Final Authority In any instance in which the COIC, the Conflict Manager, or the individual in conflict do not agree regarding the management of the conflict, the matter will be referred to the Vice Chancellor for Academic Affairs, who will have the final authority.
Reporting to Sponsors
1. Prior to expenditure of PHS funds under an award, Syracuse University’s Office of Sponsored Programs will report to the PHS awarding component the existence of any conflicting interest found and assure that the interest has been managed, reduced or eliminated in accordance with regulations. Syracuse University will make available upon Sponsor’s request how those interests have been managed, reduced, or eliminated to protect the research from bias.
2. FCOI reports will be sent to the PHS in the following circumstances:
  1. Prior to the expenditure of funds.
  2. Within 60 days of the identification for an Investigator who is newly participating in the project.
  3. Within 60 days for new, or newly identified, FCOIs for existing investigators
  4. Annually along with the required progress reports.
  5. Following a retrospective review to update a previously submitted report.
3. Syracuse University’s Office of Sponsored Programs will report the existence of any actual or potential conflicting interest influencing National Science Foundation awards that the University has been unable to manage prior to expenditure of funds.
4. Syracuse University’s Office of Sponsored Programs will report on the existence of any actual or potential conflicting interest influencing external sponsor awards as required by sponsors.
5. For any interests that are identified subsequent to the initial annual report under the award, a report will be made and the conflicting interest will be managed, reduced or eliminated, at least on an interim basis, within sixty days of that identification.
6. Unless otherwise required by sponsors, the FCOI report will include the following information:
  1. Project Number
  2. PD/PI (or contact PD/PI if multiple PD/PI model is used)
  3. Name of the Investigator with the FCOI
  4. Name of the entity with which the Investigator has a FCOI
  5. Nature of the financial interest (i.e., stock, non-stock equity, honorarium, consulting fee, payment for services, paid authorship, tenure on advisory panels, intellectual property, fee-splitting agreements for referrals or other investment/payment)
  6. The approximate dollar value of the significant financial interest within the following ranges:
    1. $0 – $4,999
    2. $5,000 – $9,999
    3. $10,000 – $19,999
    4. $20,000 – $100,000 by increments of $20,000
    5. Amounts above $100,000 by increments of $50,000
    OR
7. A description of how the financial interest relates to the funded research and the basis for the Institution’s determination that the financial interest conflicts with such research.
8. A copy of the Management Plan (see above)
Public Reporting
In the event of a formal request from the public for information of FCOIs the Office of Sponsored Programs will provide a Public FCOI Report in writing within 5 working days provided the FCOI meets the following criteria:
1. The significant financial interest is related to publicly funded research
2. The significant financial interest was disclosed and is still held
3. The Institution determines that the significant financial interest is a financial conflict of interest.
The Public FCOI Report will include the following information:
1. Investigator’s Name
2. Investigator’s Title and Role with respect to the research project
3. The name of the entity in which the significant financial interest is held
4. The nature of the significant financial interest (i.e., stock, non-stock equity, honorarium, consulting fee, payment for services, paid authorship, tenure on advisory panels, intellectual property, fee-splitting agreements for referrals or other investment/payment)
5. The approximate dollar value of the significant financial interest within the following ranges:
  1. $0 – $4,999
  2. $5,000 – $9,999
  3. $10,000 – $19,999
  4. $20,000 – $100,000 by increments of $20,000
  5. Amounts above $100,000 by increments of $50,000
Records Retention
The Office of the Vice President for Research will retain all disclosure forms, conflict management plans and related documents for a period of five years[2] after the completion of the relevant research (submission of final expenditure reports) or five years after the conflict has ended, whichever is longer.
Remedies and Sanctions
1. Failure to submit the required Financial Disclosure Form will delay submission of the proposal to the funding agency or sponsor until after the Form is submitted to the Office of the Vice President for Research and may trigger sanctions described under the above discussion of noncompliance.
2. Failure of an investigator to comply with the conflict of interest policy at Syracuse University or to comply with conditions or restrictions determined by the COIC will be referred to the Vice President for Research, the COIC and the Department Chair for non-compliance review, as detailed above. This failure to comply must promptly be reported to the awarding component and corrective action must be taken which may affect the award process.
Education, Training and Information
1. The Office of Sponsored Programs will be responsible for providing formal and information education on federal regulations and requirements required by these guidelines. Training for new faculty will occur before they submit their first disclosure forms (i.e. within 60 days of appointment or before they join a sponsored research project, whichever occurs first). Refresher courses must be taken every four years thereafter and automatically in cases of noncompliance. Researchers with lapsed or revoked status must complete courses before engaging or continuing sponsored research.
2. The University will supply Investigators with training certification upon completion of required training which may be provided to sponsors.
3. Questions involving regulations, guidelines, precedents, and practice in this context, and particularly as they may relate to sponsored programs, may be directed to the Office of Sponsored Programs.

[1] 42 CFR 50.610-607 and 45 CFR 94.1-6.
[2] Six years for New York State Contracts

Policy Administration

Office of Sponsored Programs

Links to Procedures and Related Information

Conflict of Interest and Commitment for Faculty and Staff Not on Sponsored Programs

Date: August 2006
Amended: August 2012