Integrated CSU Administrative Manual

CSU POLICY

Section:  SPONSORED PROGRAMS ADMINISTRATION

Section 11000 Policies

Policy Number:  11000.010.002

Policy Title: Financial Conflict of Interest

Policy Effective Date:

Last Revision Date:  
(see revision history)

POLICY OBJECTIVE

It is the policy of the California State University (CSU) that each campus shall have procedures to comply with conflict of interest regulations related to investigators, students and research staff engaged in sponsored research activities.

 

POLICY STATEMENT

It is the responsibility of the campus president or designee to ensure compliance with federal, state and CSU regulations regarding the disclosure, filing and resolution of financial conflicts of interest related to sponsored research. 
Each campus will, at minimum:

  • Assist investigators, students and research staff in determining whether and to what extent outside financial relationships and interests may conflict with their primary research and academic activities or other institutional responsibilities. 
  • Maintain procedures for:
    • Managing and resolving individual financial conflicts of interest. 
    • Complying with the regulations applicable to grants and contracts received from sponsors, as summarized below.

Federally Funded Grants and Contracts
Applicant institutions must certify with NSF, DHHS and other federal grant sponsors for each proposal that they have formal procedures for managing any conflict of interest that could bias a funded project.  Disclosure requirements are applicable to any person who will work on the proposed federal grant or contract, and who is responsible for the design, conduct, or reporting of work performed on the project. This includes the principal investigator, co-principal investigators, and other individuals with independent responsibility for accomplishing project objectives, including investigators working for subgrantees.

  • If the faculty member states on the form that there are no reportable financial interests, the form should be filed with the appropriate campus office in conformance with campus standard procedures, and no further action need be taken.
  • If a significant financial interest is reported on the form, the disclosure must be reviewed by the applicable campus review committee to determine whether such a financial interest could directly and significantly affect the project and if a conflict of interest appears to exist. The committee must be composed in accordance with applicable CSU guidelines.
  • If a conflict of interest appears to be present, the committee shall determine what conditions or restrictions, if any, should be imposed on the research or investigator in order to manage, reduce, or eliminate the conflicts. The committee may consult with the investigator and others to develop a plan to resolve any real or apparent conflict of interest issues. The committee shall then recommend that the University take one of the following actions: (1) acceptance of the project award, (2) withdrawal of the proposal or disapprove acceptance of the award, or (3) acceptance of the award subject to modifications in either the proposal or in the external affiliations or economic interests of the investigator. Recommended actions to resolve conflicts may include:
  • public disclosure of significant financial interests,
  • monitoring of research by independent reviewers,
  • modification of the research plan (with sponsor approval),
  • disqualification from participation in all or a portion of the research funded by the sponsor,
  • divestiture of significant financial interests, or
  • severance of relationships that create actual or potential conflicts.
  • If required by the sponsoring agency, prior to the expenditure of any funds under the award, the campus shall report to the sponsoring agency the existence of any conflict of interest (but not the nature of the interest) and provide assurance that the conflict has been managed, reduced, or eliminated.

Privately Funded Grants and Contracts
There is no “annual” filing requirement for Principal Investigators (PIs); however, the Fair Political Practices Commission (FPPC) requires PIs to file a statement of economic interest before the final acceptance of a contract, grant or gift, and when funding for such a contract or grant is renewed. In addition to FPPC requirements and consistent with CSU policy: 

  • Principal Investigators are required to file a project completion statement within 90 days after the expiration of the grant/contract, or after the funds have been completely expended in the case of a gift
  • Principal Investigators who are employed by the University must complete the CSU Ethics and Conflict of Interest Training within 6 months of receiving the grant. Subsequent training is required at least once each consecutive period of two calendar years that the grant is in place.

Benjamin F. Quillian
Executive Vice-Chancellor/Chief Financial Officer

Date: October 31, 2011




APPLICABILITY AND AREAS OF RESPONSIBILITY

 

REVISION HISTORY

 

RESOURCES AND REFERENCE MATERIALS

Useful Guidelines:

Definitions
Research:  From 45 CFR 46.102, “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  The term encompasses both basic and applied research.  Basic research is defined as systematic study directed toward fuller knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.  Applied research is defined as systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met.
Investigator:  The Principal Investigator, Co-principal investigator(s), and any other person who is responsible for the design, conduct, or reporting of research or educational activities conducted under the auspices of the University, including investigators working for sub-grantees or contractors.
Significant Financial Interest:  Anything of monetary value, including but not limited to salary or other payments for service (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options); being an owner, partner, director or officer in a non-publicly held company or entity; and, intellectual property rights (e.g., patents, copyrights) and royalties from such rights.

 

Related Principles:

Sound Business Practices:

Summary of Disclosure Requirements


Type of Agreement

Sponsor

Who Must Disclose

Exempt from Disclosure

Disclosure Form*

When to Submit

Grant or Contract

PHS, NSF or other federal sponsors with similar requirements

PI, Co-PI, and others with independent responsibility for accomplishing project objectives

Fellowships & Institutional Training Grants

Federally Compliant Institution Disclosure Form for PIs

  • At time of proposal submission

  • As new reportable financial interests are obtained

Grant or Contract

Non-governmental agencies

PI

If sponsor is on the exemption list

700-U

  • Before final acceptance of contract, grant or gift

  • When funding is renewed

  • Within 90 days after expiration  of grant/contract or after gift funds have been fully expended

Fellowship

Non-profit

 

 

None required

Fellowship

For-profit

Fellow

 

700-U

Subcontract

Prime = PHS, NSF or other federal sponsor with similar requirements

PI, Co-PI, and others with independent responsibility for accomplishing project objectives

 

Federally Compliant Institution Disclosure Form for PIs

  • At time of proposal submission

  • As new reportable financial interests are obtained

Prime = Non-governmental agencies

PI

If sponsor is on the exemption list

700-U

  • Before final acceptance of contract, grant or gift

  • When funding is renewed

  • Within 90 days after expiration  of grant/contract or after gift funds have been fully expended

* The federal disclosure form, which may be a campus-developed form, must be filled out at the time of proposal submission. 
It is important for campuses to facilitate the coordination efforts of their sponsored programs office and campus filing officer, in order to manage compliance with the applicable regulations, including 700-U filings and CSU Ethics & Conflict of Interest Training.  To gain access to the Ethics & Conflict of Interest Training, the sponsored programs office must provide the PI’s, name, email address and role (PI) to the campus filing officer or designee – who will forward a request to the Chancellor’s Office training coordinator.  The PI will receive an email notification when they have been granted access to the training module.  Campuses should also define whether the campus filing officer or the sponsored programs office retains ownership of the various completed COI forms, in accordance with applicable regulations. 

 

Laws, State Codes, Regulations and Mandates:

Research Sponsor

Applicable Regulations and Links

Public Health Service (e.g., NIH); American Heart Association; American Cancer Society

42 CFR Part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." 
http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm
http://grants.nih.gov/grants/policy/coi/index.htm

Note:  New regulations have been issued by DHHS (US Department of Health & Human Services) related to conflict of interest.  This policy will be revised to incorporate the changes.  Until then, the updated NIH policy on Conflict of Interest may be found at:

http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf  
For a  table summarizing the significant changes between the 1995 and new 2011 regulations, visit: http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc

National Science Foundation

NSF Award and Administration Guide – NSF April 2009; Chapter IV - Grantee Standards
http://www.nsf.gov/pubs/policydocs/pappguide/nsf09_29/aag_4.jsp#IVA

Non-Governmental agencies
(for-profit and non-profit)

Regulations of the Fair Political Practices Commission (FPPC), Title 2, Division 6, California Code of Regulations; §18755. Statements of Economic Interests: Person or Persons at an Institution of Higher Education with Principal Responsibility for a Research Project
http://www.fppc.ca.gov/legal/regs/current/18755.pdf
Exempt Organization List:  http://www.ucop.edu/research/policies/exempt.html
California State University, Office of the Chancellor

 

COGNIZANT OFFICE(S)

CO Manager:

Ms. Sue DeRosa 
Director, Sponsored Programs
CSU Office of the Chancellor
sderosa@calstate.edu

Subject Expert:

 

Affinity Group:

RAC, CCRO, FOA, CABO

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