Two new reports on industry-sponsored medical research raise questions about how academic medical centers track such sponsorship and, for the first time, raise the issue of institutional conflicts of interest.

A study of five sample universities by the US General Accounting Office (GAO) found that although all had conflict policies in place, there were serious problems with campus record keeping. Data on industry sponsorship was stored “in multiple offices, files and formats...making it a challenge to ensure that conflicts of interest were appropriately managed and not overlooked.” (http://www.gao.gov/new.items/d0289.pdf)

Although attention to conflicts of interest has, in the past, been focused on individual scientists who might benefit financially from their work, the GAO report also looked at situations in which a university owns stock in a pharmaceutical company or invests in a faculty member's start-up company. It found that each school had, or was developing, policies to deal with such conflicts but that these differed considerably. For example, one restricted equity holdings to 2% while another set the threshold at 49%. The report recommends that the Department of Health and Human Services (HHS) “develop specific guidance” for schools on how to identify and manage institutional conflicts, and labeled pending HHS guidelines as “limited.”

The report “underscores the gaping hole in federal policy in addressing institutional conflicts of interest,” said Sheldon Krimsky, a Tufts University professor who is working on a book on commercial interests on campus. “Should universities with equity ownership in a company receive federal funds to do research that is in the company R&D profile?” he asks.

The concept of an institutional conflict is a relatively new one at medical schools, says Russel Kaufman, vice dean for education and academic affairs at the Duke University School of Medicine. Kaufman served on an American Association of Medical College (AAMC) panel that issued new guidelines on dealing with conflict of interest for individual researchers. The group is now working on institutional conflicts. In the meantime, a new AAMC guideline calls for universities to bar investigators from doing research involving human subjects if they have a financial interest in the research such as equity interests, royalty payments, consulting fees, honoraria, company sponsored travel or other such payments of more than $10,000 per year.