INVESTIGATOR FINANCIAL DISCLOSURE POLICY (Conflict of Interest) - P209

Issued by: Office of the Vice President for Research

CONTENTS

1. Background and Objectives
2. Statement of Policy
3. Definitions
1. Conflict of Interest
2. Investigator
3. Stony Brook University
4. Significant Financial Interest
5. Exclusions
6. Significant Obligations
4. Review of Disclosure
5. Remedies
6. Appeal
7. Compliance
8. Program to Inform the University Community
9. Review and Evaluation

I. Background and Objectives:

The Stony Brook University as a community and as a public institution of higher learning is committed to promoting the highest quality research and creative activity. In meeting this commitment, the University encourages interaction of its members (faculty, administrators, students, staff and fellows) with the public and private sectors as an important component of its educational, research and public service missions. External support through grants, contracts and gifts from public and private sources is necessary to provide significant assistance and direction for University activities. Professional interactions with public agencies, private businesses, non-profit organizations and individuals advance the University's ability to provide research and educational experience for our students, contribute to the economic well being of our community, and add to our store of knowledge and understanding. Similarly, technology transfer in the form of patents, licensing agreements, and consulting opportunities for University members are important means of meeting the needs of society and fostering the welfare of the citizens of the State of New York.

The University and its members in pursuing their teaching, research and public service missions, are committed to meeting the highest ethical standards and to minimizing the risks of conflict of interest or the appearance of conflict of interest between the private and the public interests the University serves. As part of this commitment, the University and its members share an obligation to protect the University's mission and reputation from being compromised by private interests. Furthermore, the University must operate with policies consistent with various federal funding agencies.

To this end, disclosure by Investigators at the University of outside personal interests and obligations, and effective management of actual or apparent conflicts of interest are essential.

II. Statement of Policy:

The responsibilities and obligations of Investigators to the University must be clearly separated from personal financial interests or other obligations. Prudent stewardship of public funds requires protecting University research, education and public service from being compromised by the private interests or obligations of any Investigator.

To meet these objectives and to ensure compliance with federal regulations, Stony Brook University requires each Investigator named on a grant or contract to submit, and keep current, a disclosure of all significant financial interests and significant obligations (as defined in Section III. D, E and F). This requirement is designed to avoid or manage actual or potential conflicts of interest, or even the appearance of a conflict of interest.

This policy sets forth requirements and guidelines for:

• disclosure of outside interests by all Investigators at the Stony Brook University who engage in University activities funded by specified internal and external entities;
• review of Investigator disclosures by University officials; and
• identifying, reporting and managing conflicts of interest.

This policy applies to all forms of internal and external support for University programs, projects, activities and services, solicited and unsolicited, including gifts and donations with the exceptions noted below:

• Internal Support - The only internal programs to which this policy applies are those which require formal application in response to a request for proposals (for example, Center for Biotechnology Programs, Carol Baldwin Foundation Awards, Targeted Research Opportunity Grants, etc.)
• Gifts and Donations - This policy applies to all gifts and donations made to support the activities of identified individuals..

III. Definitions:

A. Conflict of Interest : Conflicts of interest in the conduct of externally and applicable internally supported activities, may take various forms, but typically arise when an Investigator at the University is, or may be, in a position to influence activities or University decisions in ways that could lead to personal gain for the Investigator or the Investigator's family, or give an improper advantage to third parties in their dealings with the University. Conflicts may also arise when Investigators have outside obligations of any kind which are in substantial conflict with the Investigator's University responsibilities or the public interest.

The potential for conflicts of interest may arise from specific actions taken by Investigators, or by the nature of positions they hold at the University and outside the University, or by the financial interests they or their immediate family hold.

A conflict can result when:

1. A University Investigator's design, conduct, or reporting of a research, educational or public service activity could directly affect the significant financial interest of that investigator,
2. An Investigator at the University has a significant non-University obligation to an individual or a private organization that provides support for a University research, educational or public service activity; or
3. An Investigator at the University has a non-University obligation to an Investigator or an organization to which the University provides support through an agreement to perform a program project, activity or service supervised by the Investigator.
1. Consulting arrangements between an Investigator at the University and a business enterprise that supports or is supported by University programs involving the Investigator;
2. Consulting arrangements between an Investigator at the University and a business enterprise that is licensed to commercialize University technologies invented by the Investigator;
3. Significant financial interests of an Investigator at the University in a business enterprise that supports or is supported by the Investigator's University research;
4. A position held by an Investigator at the University as consultant, officer, director, trustee or owner of a non-University business enterprise that supports or is supported by the Investigator's University research;
5. Significant financial interests of an Investigator at the University 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 University research;
6. Significant financial interests of an Investigator at the University 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 University research.

B. Investigator: The principal Investigator, co-principal Investigators and all other person(s) who are responsible for the design, conduct, or reporting of University programs, projects, activities or services described in an application or prospective application made through the Stony Brook University for external and selected internal support, or in an award made to the University without application. For the purposes of this policy, "Investigator" shall include the Investigator's spouse and all dependent children.

C. Stony Brook University: In this policy, the term Stony Brook University includes the State University of New York at Stony Brook, the Research Foundation of State University of New York as it relates to the Stony Brook University, the Stony Brook Foundation, the University Medical Center and University Hospital, and the Long Island State Veterans Home.

D. Vice President for Research (VPR) shall be taken to include his/her appointed designee.

E. Significant Financial Interest: Anything of monetary value to the Investigator that would reasonably appear to be directly and significantly affected by work externally funded or proposed for external funding or selected internal funding, including but not limited to: salary or other payments or services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, warrants or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). Examples include ownership of stock, stock options, or any equity, debt, security, capital holding, salary or other remuneration, or financial consideration, or thing of value for services as an employee, consultant, officer, or board member in:

1. the entity to which the application will be submitted;
2. any entity that owns or has applied for the patent manufacturing or marketing rights to product or procedure involved in, or will predictably result from, the work described in the application;
3. any entity that is known by the Investigator to own or have applied for such rights in any product that can reasonably be expected to compete with the product or procedure that will predictably result from the work described in the application; or
4. any entity that will be a sub-recipient from the University of funding resulting from the application.
5. any entity where the value of financial interests exceeds $10,000 and represents more than a 5% ownership interest for any one enterprise or entity when aggregated for the Investigator and the Investigator's spouse and all dependent children.
6. any entity from which the investigator consults or receives other remuneration where the value is greater than $10,000 annually.

F. Exclusions:

1. salary, royalties or other remuneration paid to an Investigator by the University;
2. income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
3. income from service on advisory committees or review panels for public or nonprofit entities;
4. financial interests in business enterprises or entities if the value of such interests do not exceed $10,000 and do not represent more than a 5% ownership interest for any one enterprise or entity when aggregated for the Investigator and the Investigator's spouse and all dependent children.
5. consulting or other remuneration from business enterprises or entities if the value does not exceed $10,000 annually.

G. Significant Obligations: Significant obligations include positions held as an officer, trustee, director, employee or consultant of an entity whether the entity is for profit or not-for-profit and whether the position is paid or unpaid, that would reasonably appear to be directly and significantly affected by the work funded or proposed by the University for external and selected internal funding.

IV. Review of Disclosures:

1. To satisfy this requirement, the Conflict of Interest Declaration (CID) and Investigator Disclosure Form (IDF) forms will serve as the mechanisms for declaring and reporting significant financial interests and obligations by all Investigators at the University.
2. The current version of the CID form is available at http://www.stonybrook.edu/research/forms/campus/cid.pdf and the Investigator Disclosure Form is available at http://www.stonybrook.edu/research/forms/campus/idf.pdf .
3. Each investigator must append a completed, endorsed CID to the Proposal Processing and Approval Form (SBU-299, i.e., '4-page form'). The cognizant Chair and Dean/VP (or designee) reviews and signs the CIDs and the Proposal Processing and Approval form. If Chair or Dean/VP assesses missing or incomplete CID's, then the Chair or Dean/VP must notify Principal Investigator for appropriate corrective action. Complete and endorsed CIDs are forwarded by the Dean/VP to the Office of Research Compliance. Complete and endorsed Proposal Processing and Approval Forms are forwarded by the Dean/VP to the Office of Sponsored Programs for review and endorsement by that office for subsequent, applicable processing (e.g., submission to sponsor etc.)
4. For investigators answering 'yes' to any question on the CID, filing by the investigator of an IDF with the COI committee is required within 7 business days of submission deadline.
5. CID's on which all questions are answered 'no', are either accepted or questioned by the Chair and by the Dean. If accepted, no further action is required by the investigator. If questioned, or clarification is sought, the Chair and/or Dean must file a request for clarification within 7 business days with the COI committee. The COI committee may either request that the Investigator file an IDF within 7 business days, or may determine that no further action is required by the investigator.
6. Steps A-E above must be followed :
• at the time of submission of each application for external or selected internal support made by an investigator, or
• prior to establishment of an account in instances where proposal submissions are not required to precede awarding of funds.

Submission of grant proposals to the sponsor will be delayed if CIDs for all investigators are not submitted.

7. It is the investigator's responsibility to ensure CID's and IDF's are updated and kept current during the pendency period of the proposal and the performance period of the award, or whenever significant financial interests or obligations change.
8. To ensure compliance with the Investigator Disclosure Policy each Investigator named on a submission to a sponsor must submit a CID .
9. At the outset of every case considered by the COI Committee, it will advise the Investigator of the matter under consideration and invite the Investigator to comment on the case. In any such case where human subjects research is involved, it will additionally advise the Director of Research Compliance of the matter under consideration, and consult with him/her as needed. The COI Committee will determine if the COI can be managed, and if so, what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflicts.
10. The COI Committee may meet with the Investigator to draft a management plan at either party's request. Recommendations of the COI Committee (e.g., management plans etc) will be conveyed in writing by the COI Committee to the Vice President for Research. Pending approval by the VPR, the COI Committee will convey the recommendations etc. in writing to the Investigator, with copy to the cognizant dean/VP. Investigator's written concurrence and certification for compliance with the management plan will be required in order for the award in question to be established.
11. The cognizant dean/VP will be responsible for monitoring investigator compliance with any management plan imposed, and will report on a semi-annual basis to the VPR regarding ongoing compliance with said plan(s).
12. The Office of Research Compliance will be the repository for all original IDF's and COI Committee correspondence in case of audit (e.g., federal, etc).
13. Every award of a University program, project, activity or service received from an outside party and every instance of unsolicited support accepted by the University, except as specifically waived in section III.E above, must have associated with it completed CIDs for all investigators and, where conflicts are declared, applicable IDFs that have been reviewed by the COI committee and assessed as either absent of conflict of interest, or accompanied by a suitable management plan recommended by the COI Committee.
14. In instances where a cognizant dean or vice president is an Investigator on an application for external or selected internal support, or is otherwise conflicted with the proposed activity, the Vice President for Research (VPR) shall assume the dean/VP role as outlined in this policy.
15. The VPR shall report to the appropriate external funding agency/agencies:
• Any instances in which the institution finds it is unable to satisfactorily manage an actual or potential conflict of interest
• Any instances where an Investigator participating in externally or selected internally funded research has not complied with this policy, and the specific corrective measures taken by the University.
16. The review of financial disclosure forms requires the exercise of the utmost discretion by all participants. To the maximum extent permitted by federal and state law, and by University policy, all elements of this process are to be treated as strictly confidential. The purpose of confidentiality is to assure that the integrity of the research and the Investigator, as well as the interests of the University, are protected at all times.
17. The University will maintain all disclosures and records of all actions taken to resolve actual or potential conflicts of interest until at least three (3) years after the termination or completion of the award to which they relate, or the resolution of any audit involving those records. These materials will be the maintained in the Office of Research Compliance.

V. Remedies

Any or all of the following conditions or restrictions might be imposed to resolve actual or potential conflicts of interest:

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 the portion of the externally funded research that would be affected by the significant financial interests;
5. Divesture of significant financial interests;
6. Severance of relationships that create actual or potential conflicts
7. Removal of investigator as Principal Investigator/Project Director.
8. Additional remedies specific to the conduct of research involving human subjects, including but not limited to, the removal of ability to recruit and/or consent research subjects.

If the University is unable to resolve a real or potential conflict of interest or the appearance of same, it will decline to perform the activity in question.


VI. Appeal

Should an Investigator fail to concur with the management plan recommended by the COI committee, he/she may transmit comments to the VPR within ten working days from receipt of the committee's recommendation. In such a case, the VPR will review the case (which may include seeking the advice of appropriate impartial experts and holding discussions with the investigator and/or the COI committee) and will render a judgment within twenty working days of the time that the committee's initial recommendation is made known to the investigator. Awards for external and selected internal support of a program, project, activity or service may not be activated by the University unless a management plan is in place.

When the Vice President for Research serves as the reviewer of a disclosure statement (see III B), the appeal shall be to the President.

VII. Compliance

In addition to reporting requirements outlined in Section IV.M above, if an investigator is found to have failed to comply with the University's Investigator Disclosure Policy or the means determined to resolve a conflict of interest, the VPR shall:

- report promptly in writing to the President, to initiate disciplinary proceedings against said investigator. and

- report promptly in writing to the Director of Research Compliance, where the activity in question involved human subjects, to initiate investigation into matters concerning subject safety and welfare, and potential regulatory violations, in accordance with federal law governing human subject protections

and, if appropriate

- initiate the processes associated the University's Scholarly Misconduct policy, if applicable.

And, if appropriate

- initiate procedures associated with other relevant University policies, as applicable.

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 University and Board of Trustees policies, and applicable collective bargaining agreements. Article 19 of the UUP Agreement shall be the sole source of University discipline for members of the UUP-represented unit.

Additional sanctions may be rendered in accordance with applicable University policies (e.g., governing human subject protections, University scholarly misconduct etc).

Upon completion of disciplinary proceedings, the President shall report to the appropriate University officers or bodies, to cognizant federal agencies when federal funds are involved, and to all other parties as necessary.

VIII. Program to Inform the University Community

One of the best means to avoid disclosure issues is to educate all members of the University community in recognizing actual and potential conflicts of interest, or the appearance of such. It is essential that all persons subject to this policy be informed of its contents as well as understand the meaning of conflict of interest. Therefore, the Vice President for Research will ensure that all unit heads receive a copy of this policy with instructions that the unit make copies available to all its members (faculty, administrators, students, staff and fellows). Each unit head shall make its members aware of the Investigator Disclosure Policy on an annual basis and provide a copy of the Policy to every new member as soon as possible after the start of their association with the unit. Any failure of this distribution process should not be construed as relieving any individual member of the University of obligations under this Policy for Investigator Disclosure.

IX. Review and Evaluation

This policy shall be periodically reviewed by the University to determine if it is working as intended and whether any modifications are needed. This review and evaluation as well as any changes in the Policy will be made available to the University community.

INQUIRIES/REQUESTS:

Office of the Vice-President of Research

S5421 Frank J. Melville, Jr. Library
Zip=3365
Phone: (631) 632-7006 Fax: 631-632-5704

RELATED FORMS:

Conflict of Interest Declaration Form (CID)

Investigator Disclosure Form (IDF)

RELATED DOCUMENTS:

Compliance Web site at: http://www.sunysb.edu/research/policies/coihome.html

RELATED LINKS:

SCHOLARLY MISCONDUCT

VIOLATIONS OF CORIHS POLICY