August 2005

What is conflict of interest?

Conflict of interest – is a set of conditions in which an investigator’s judgment concerning a primary interest (e.g., subject’s welfare, integrity of research, reporting of results, etc.) may be biased by a secondary interest (e.g., personal gain). In other words one outcome is preferred to another due to a financial association that would cause preferential decision-making. Conflict of interest may be found at the institutional as well as the individual level.

What are some of the key issues with regard to individual versus institutional conflict of interest?

Individual Level

• Investigator closely tied to area of research under review
• Investigator holds significant financial interest in the sponsor of the research
• Investigator may receive monetary or non-monetary bonuses for meeting recruitment/enrollment goals (e.g., token gifts, authorship, future participation, post study incentives)

Institutional Level

• Desire for institution to protect it’s reputation or prestige
• Desire to promote research versus protecting subjects
• Protection of the institution from liability
• Pressure for speedy turn-around-time from compliance units and contractual units
• Objectivity and integrity of the research, itself
• Appropriate use of sponsor or University funds
• Integrity of academic and administrative decision making
• Open publication and sharing of research results

What is financial conflict of interest?

Financial conflict of interest is a financial association or relationship that would cause an individual to prefer one outcome over another based on these financial associations.

What is the reporting threshold for an individual at the University of Arizona?

$10,000 in annual income or 5% equity ownership in a company as defined in the UA Conflict of Interest and Commitment Policy. More information regarding the guidelines at the University of Arizona can be found at http://vpr2.admin.arizona.edu/rie/COIwebs/COICPolicy.1198.pdf .

If I find that I exceed the threshold for disclosure, what do I do next?

Go to the Vice President for Research website at www.vpr2.admin.arizona.edu and click on Conflict of Interest (http://vpr2.admin.arizona.edu/rie/conflict_of_interest.htm) for the forms and the instructions for filing a disclosure.

What do the regulations say about financial conflict of interest?

The Food and Drug Administration (FDA) issued a final rule in 1998 that requires sponsors to certify the absence of financial interests of investigators who conducted their studies or to disclose those interests. Such interests include patents, equity or significant payments of other sorts of $25,000 or more to support investigator activities outside of conducting the clinical study (e.g., equipment, honoraria, or consulting fees). This disclosure is tied to the submission of a marketing application to the FDA, and the intent is to protect the integrity of supporting data.

According to “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection” (2004), institutions and individuals involved in human subjects research may establish financial relationships related to a particular research project. Those financial relationships may create financial interests of monetary value, such as payments for services, equity interests, or intellectual property rights and may create a financial conflict of interest that may affect the rights and welfare of human subjects.

Where can I get information related to NIH’s financial conflict of interest policy?

The NIH has had a longstanding interest in objectivity in research and financial conflict of interest. They have initiated a web site to provide information on this important topic at http://grants1.nih.gov/grants/policy/coi/index.htm .

In essence, the problem with conflict of interest is one of bias in judgment…where the potential for bias is such that decisions may be called into question. The educational and research activities of a University should be, and should appear to be, motivated primarily by a concern for the advancement of knowledge and the pursuit of truth, not by the pursuit of reward whether financial or otherwise. Although the attention nationally is towards financial conflict of interest, any association that would cause an Investigator or research personnel to prefer one outcome to another is problematic.

*Nelson, D. (2002). Conflict of interest: Researchers.. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 197-203). Sudbury , MA : Jones and Bartlett.