Legislative History

At its meeting of May 3, 1999, the Academic Senate passed S99-8 presented by Annette Nellen for the Professional Standards Committee resolving that the following policy be issued as a new policy.

ACTION BY THE UNIVERSITY PRESIDENT:
"Approved" signed Robert Caret, May 4, 1999

POLICY RECOMMENDATION
CONFLICT OF INTEREST POLICY FOR PRINCIPAL INVESTIGATORS

Background

San José State University actively encourages increased involvement of academic researchers and educators with industry and with private entrepreneurial ventures. However, such involvements create an increased risk of conflict between the private interests of individuals, the companies with which they are involved, and the public interest that Federal funding serves. SJSU has adopted policies to regulate potential conflicts of interest among its grantees and its investigators in order to protect the funded research from bias.

The National Science Foundation and the Department of Health and Human Services (NIH-PHS-HHS) are adopting parallel policies on Investigator Financial Disclosure that are relatively consistent. The CSU has had a policy related to Conflict of Interest in effect since 1985. The SJSU Conflict of Interest Policy incorporates requirements from the federal funding agencies and the CSU into its policy.

Investigator Disclosure

Investigators must disclose significant financial interests at the time of proposal submission and update this information annually or as new interests are obtained during the life of the award.

- Investigator

Investigator is defined as principal investigator, co-principal investigator, and any other person who is responsible for the design, conduct, or reporting of the sponsored project. In addition, disclosure must be made for each investigator's spouse and dependent children.

- Significant Financial Interest

Significant financial interest is defined as any financial interest that a principal investigator would have that would reasonably appear to be directly and significantly affected by the sponsored activities or any interest that a principal investigator would have in entities whose financial interest would reasonably appear to be directly and significantly affected by the sponsored activities. Financial interest includes salary or payment for services outside the parameters of the award, interests in business enterprises more than $1,000 or 5 percent ownership interest, and intellectual property rights.

Institutional Certification

Certification will be performed by the Associate Vice President for Graduate Studies and Research (AVP GS&R) and will be based on information provided by the Investigator on the Conflict of Interest Disclosure Form (Attachment A). The AVP GS&R will review disclosures, assess their potential for

conflicts of interest, confer with the Board of Academic Freedom and Professional Responsibility (as needed) if a potential conflict is identified, and develop resolution strategies with the investigator to manage, reduce or eliminate such conflicts.

- Resolution Plan

A Resolution Plan must be implemented prior to award. The Resolution Plan must be in writing and approved by the AVP GS&R and the College Dean.

Resolution Options may include but are not limited to:

- public disclosure of significant financial interests

- monitoring of research by independent reviewers

- modification of the research plan if necessary to avoid conflict of interest

- disqualification from participation in the portion of the project that is affected by the significant financial interest

- divestiture of significant financial interests

- severance of relationships that create actual or potential conflicts

- Enforcement Mechanisms and Sanctions

Potential violations of the Conflict of Interest Resolution Plan shall be handled by the Board of Academic Freedom and Professional Responsibility which monitors the state of academic freedom and professional responsibility at SJSU. The Board of Academic Freedom in conjunction with the AVP GS&R will establish and enforce appropriate sanctions based on the specific conduct of an investigator failing to follow the approved Resolution Plan.

Documentation and Record Maintenance

The SJSU Foundation will maintain records related to all disclosures and ensure that follow-up reporting is conducted in a timely manner.

History

This policy was originally created by S95-9 and was added as an appendix to S93-12, Academic Freedom and Professional Responsibility. In Spring 1999, it was removed from S93-12 to stand as a separate policy because it does not apply only to faculty.