U.S. universities lack clear, consistent standards to ensure that financial conflicts of interest do not sully the integrity of research projects sponsored by industry. That's the conclusion of a pair of studies published in the 1 November issue of the Journal of the American Medical Association (JAMA).
Stock options, corporate titles, and lucrative consulting contracts are a fact of life for many scientists today. Recognizing the potential conflicts of interest in studies that could lead to financially lucrative outcomes, the federal government--by way of the Department of Health and Human Services (DHHS) and the National Science Foundation (NSF)--in 1995 suggested some preliminary standards for universities. A $10,000 stake or 5% equity in a company represents a "significant financial interest," they said, leaving to universities the challenge of figuring out how to deal with such potential conflicts.
A study by bioethicist Mildred Cho of Stanford University and colleagues finds that most institutions responded with vague, inconsistent, and unevenly interpreted policies. The review is based on 89 policies at biomedical institutions in the top 100 for funding from the National Institutes of Health (NIH). Just over half required researchers to disclose their financial interest to administrators or oversight committees. But only 19% of the policies set a ceiling for the size of a faculty member's financial stake in the corporate sponsor of their research, and a scant 12% limit what companies may say about the publication of research results.
Cho concedes that official policies don't always reflect actual practice, noting the possibility of exemptions or unwritten rules. In a study of the University of California, San Francisco, UCSF pharmacologist Lisa Bero found that the university's conflict of interest advisory panel that she chairs suggested that faculty members cut some financial ties in 26% of the cases it reviewed. Its recommendations included selling company stock, refusing additional payment for talks, or stepping down from a management position or the role of principal investigator.
"It's important to talk about policies and conflict of interest at the university level, but we need to go much further," says internist Thomas Bodenheimer, an unpaid clinical teaching faculty member at UCSF. JAMA editor Catherine DeAngelis echoes this concern: "As the amount and proportion of funding from private corporations for research increase, it is vital that all institutions that accept these funds develop methods for disclosure and oversight."
Answers to FAQ about investigator financial disclosure policy, from DHHS and NSF