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Scope

Principal investigators and senior personnel on sponsored programs

Policy Statement
(Faculty Manual 3.08)

All faculty and research staff are expected to (i) abide by the conflict of interest policies and standards set forth herein. (ii) fully disclose professional and relevant personal activities when required by the University, or when there is potential for a conflict situation, (iii) remedy conflict situations or comply with any management or monitoring plan prescribed by the University, (iv) remain aware of the potential for conflict, and (v) take initiative to manage, disclose or resolve conflicting situations as appropriate.

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, 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 influenced 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 (42 CFR 50.610-607 and 45 CFR 94.1-6) 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 (Faculty Manual Policy #3.03 and University Policy [name/link]).

The University will obtain assurance that other institutions collaborating with University Investigators on sponsored projects have comparable policies that comply with Federal regulations.

Definitions

1. 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.

2. Investigator - the principal investigator or any other person at the institution who is responsible for the design, conduct, or reporting of a research project, proposed or funded.

3. Significant Financial Interest - Anything of monetary value - aggregated for the Investigator and the Investigator's spouse, domestic partner, and dependent children - including but not limited to the following:
   1. Salary or other payment for services (e.g. consulting fees) that exceeds or over the next twelve months is reasonably expected to exceed $10,000;
   2. Equity interests (e.g. stocks, stock options or other ownership interests) that meet the following tests:
      
      1. exceeds $10,000 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).
   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.

   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.

   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 seminars, lectures, or teaching engagements sponsored by public sector or non-profit entities.
   4. Income from service on advisory committees or review panels for public sector or nonprofit entities.

4. Public Health Service (PHS) awarding component - organizational unit of the PHS that funds activities subject to these guidelines and procedures.

5. Research - a systematic investigation 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.

6. 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 inform each Investigator of the institutional policy, Investigators' reporting responsibilities, and applicable federal regulations through formal and informal educational approaches.
• To provide annually 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 report conflicts of interests 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.
• To maintain records of all financial disclosures and all actions taken by the University with respect to conflicting interests.

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

• Complete the annual financial disclosure form by the institutional deadline.
• 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.
• Disclose new reportable interests within 60 days during the period of an award.
• Comply with any management plan, 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. The Vice President for Research will chair the Committee. The Associate Vice President for Research, , 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. 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.

The COIC will review managed conflicts semiannually (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

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, and summaries of any significant outcomes or issues.

Compliance

Failure of an Investigator to comply with any aspect of the conflict of interest policy will be referred to the Vice President for Research, the COIC and the Department Chair for non-compliance review.

Non-compliance may cause administrative actions in accordance with University policies found in The Faculty Manual, and the Syracuse University 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 Syracuse University 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.

Procedures

1. 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.
      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
   3. Review by the Conflict of Interest Committee
      1. The committee will meet or communicate at least semi-annually to review disclosures of significant financial interests and determine if a plan is warranted to eliminate, reduce, or manage any conflict.
      2. The Vice President for Research will communicate the determinations of the committee to the principal investigator and to the administrative superviser of the principal investigator.
      3. Managed conflicts will be reviewed by the COIC semi-annually or as new information arises.

2. 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).
   2. Development of Management Plan
      1. The Conflict Manager in collaboration with the Investigator and the Vice President for Research will develop a plan, to manage, eliminate or reduce the conflict.
      2. Some examples of possible conflict management are: " Public disclosure of significant financial interests " Monitoring of research by independent reviewers " Modification of the research plan " Disqualification from participation in all or a portion of the funded research " Divestiture of significant financial interests " Severance of relationships that create actual or potential conflicts " Oversight by the Conflict Manager of any financial transactions in which the conflict may be relevant
   3. Correspondence
      1. The Conflict Manager will develop a management plan in consultation with the Vice President for Research, who will communicate the outcome to the COIC. .
      2. The assigned manager will provide a semi-annual report on the status of managed activities to the COIC.
   4. 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.

3. 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 (but not the nature of the interest or other details) 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. 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.
   3. 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.
   4. 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.

4. 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 (six years for New York State contracts) after the completion of the relevant research (submission of final expenditure reports) or five years after the conflict has ended, whichever is longer.

5. 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.
   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. This failure to comply must promptly be reported to the awarding component and corrective action must be taken which may affect the award process.

6. 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.
   2. 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.

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