October 27, 2003

New Form Makes It Easier For Researchers
To Declare Possible Conflict Of Interest

The University is trying to make it easier for faculty and professional staff working on grants to disclose information, as required by the federal government, when they have significant financial interests that might affect their research.

A new form, the Significant Financial Interest Disclosure Form, is required from all principal investigators for Storrs-based programs when they submit a grant application. The form is available on-line here or it can be requested from the Office of Grants and Contracts.

A similar form is required annually from all investigators at the Health Center. It is available on-line here.

Federal regulations require this disclosure for federal grants, but University policy extends the requirement to research grants from any source.

Faculty must disclose the information regarding financial interest, and leave it to the University to determine if there is a conflict of interest.

"A conflict of interest does not mean there is a problem. It just means a situation exists that merits review. For most cases, disclosure

is all that is necessary," says Janet Greger, vice provost for graduate education and research.

The forms must be filled out by all researchers participating in any grant, and they must notify the University if a change occurs during the year. The form asks faculty to spell out whether they or any member of their immediate family (including spouse, children, or other persons living in the same household) are receiving salaries or other payments for services, such as consulting or honoraria; have equity interests such as stocks, stock options, or ownership in a private company; or have a significant financial interest that could affect - or be perceived to affect - the results of the research they are doing, the education of their graduate students, or service activities that are funded through the federal government.

The forms are an important first step in making sure the University is in compliance with federal requirements.

Greger says the federal government requires every faculty member who has a grant to disclose potential conflicts of interest, as defined by Board of Trustees' policy, not only when they fill out the form but throughout the year.

Checking "yes" on the form does not mean the investigator cannot be given federal funds. It does mean, however, that the Conflict of Interest Committee in Storrs, or the Conflict of Interest in Research Management Committee at the Health Center, will review what, if anything, should be done to manage a potential conflict.

"Our goal is to manage the program in a way in which we foster both the conduct of scholarly activities and ensure compliance with federal and state regulations," says Greger.

The Board of Trustees adopted University-wide conflict of interest provisions in 1995. Generally, federal standards consider fees or income of $10,000 or more, or serving on the board of a company doing business in the area of your research, might create a potential conflict. According to state conflict of interest regulations, an equity interest in a company of five percent or more may create such a conflict. Both Greger and Leonard Paplauskas, associate vice president for research and administration at the Health Center, recommend disclosure if there is any question at all.

"Once you disclose a financial interest, the responsibility for determining whether a conflict of interest exists and how to manage it becomes the University's responsibility," says Greger. The University is held responsible by the federal government, which audits the University periodically for compliance.

When a faculty member checks the form indicating he or she has consulting, equity interests, intellectual property rights, or other significant financial interest that could possibly affect or be perceived to affect the results of the research, or educational or service activities, the form is reviewed by the appropriate committee. Often additional information is sought.

In the event of a potential conflict, the committee either at Storrs or the Health Center appoints a management committee of researchers to ensure that the principal investigator's consulting or ownership activity does not interfere with the research or the activities of graduate students, who are supposed to focus on their thesis and not on faculty consulting responsibilities.

"Eighty percent of disclosures of significant financial interests we look at are unnecessary. Often someone reports that they sit on a not-for-profit board such as the American Heart Association, or that they have more than $10,000 in mutual funds which have some stocks in pharmaceutical companies," says Paplauskas.

But sometimes, there may be a potential conflict. In such cases, he says, the management committee might require a researcher to disclose ownership of stock in, say, a pharmaceutical company to all participants in a study and in any papers that result from the study. Or the management committee might speak with graduate students working in the principal investigator's lab. Sometimes the management committee feels no action is warranted.

"Problems do not arise from disclosing information but rather from non-disclosure," Greger said. "Federal regulations say that if there is a conflict of interest, then federal funds cannot be spent until the conflict is managed, reduced, or eliminated."