CONFLICT OF INTEREST IN RESEARCH

Conflict of interest has become a national concern as universities engage in increasingly complex relationships with other institutions, including corporations, nonprofit organizations, and agencies of the state and federal governments. As a public entity, the University of California falls under particular scrutiny.

Conflict of Interest Defined

A conflict of interest exists when a researcher's outside financial interests or obligations have the potential to bias a research project. The University of California recognizes that faculty and other investigators have a range of relationships with entities outside of the University. These relationships often provide useful components to the research effort. Sometimes, however, they can give rise to conflicts of interest. These conflicts most often relate to receiving funding for research projects while also having other sources of income from the same entity, such as salary, loans, or gifts, or ownership, investments, or positions held by the individual.

Conflict of interest situations can compromise the scientific integrity of a research project. They can be associated with a range of difficulties, including improper direction of a student or University employee's work, inappropriate delays or restrictions on publications, and the appearance of impropriety.

Disclosure of Conflict of Interest

Investigators at the University of California are subject to both State of California law and federal regulations on disclosure of financial conflicts of interest. Under these regulations, investigators must file disclosure forms when receiving gifts and with proposals to non-governmental agencies, federal Public Health Services agencies and the National Science Foundation, UC Discovery Grants programs, the American Heart Association, and the American Cancer Society.

In addition, the UC Berkeley Office for Protection of Human Subjects (OPHS) requires that when human subjects are used in research, individuals who have independent roles in projects and who are responsible for the design, analysis, conduct, or reporting of the results of research performed (or to be performed) under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying the materials, drugs, or devices for the project. If any individual has a conflict, the OPHS staff will forward the materials to the Conflict of Interest Committee (COI) for separate review.

The state, federal, and OPHS disclosure requirements differ as below. See http://researchcoi.berkeley.edu for details.

State of California Financial Disclosure: State of California law requires disclosure of financial interest in the sponsor if the proposal is for a research project to be funded by a non-governmental source, including research gifts. For contracts and grants, the disclosure form (Statement of Economic Interests for Principal Investigators: Form 700-U) should accompany the proposal and Proposal Review Form to the Sponsored Projects Office.

Federal Financial Disclosure: Federal regulations require investigators to disclose interests in outside entities that are "significant" and "related" to the research described in the proposal. Applicants to the National Science Foundation and Public Health Service agencies (including the National Institutes of Health) must disclose project-related financial interests for themselves and coordinate the disclosures of all other project investigators at the proposal submission stage. This requirement also applies to subcontracts from PHS/NIH or NSF or other agencies that have adopted the federal requirements (UC Discovery Grants, the American Heart Association, and the American Cancer Society).

OPHS Disclosures: required with all protocols submitted to CPHS in which there is a declaration of a conflict on the CPHS application form.

Filing Disclosures 

Federal policy requires disclosure:

1. at the time of proposal submission,

2. as new investigators are added to the project, and

3. as investigator's financial interests change.

California State requires disclosure:

1. at the proposal submission stage,

2. when new funding is sought for the same project,

3. at the project close out, and

4. as investigator's financial interests change.

OPHS policy requires disclosure:

1. when submitting the application for human subjects CPHS Review, and

2. as investigator's financial interests change.

The Conflict of Interest Review Process

The faculty Conflict of Interest Committee (COI), which operates in conjunction with the Office of Research Administration and Compliance, is responsible for the review and assessment of financial disclosures related to research projects. The Committee seeks first to "manage" conflict of interest. Remedies may include modification of the research or project plan and monitoring of the project by independent reviewers. If the conflict is deemed "unmanageable," the Committee can require that the proposal be withdrawn or that the relationships that created the conflict be severed. For detailed information see http://researchcoi.berkeley.edu/coiguidelines.html.

Office of Research Administration and Compliance
2150 Shattuck Avenue, Suite 313, Mail Code 5940
Telephone: (510) 642-8117
Fax: (510) 642-8236
Web site: http://researchcoi.berkeley.edu