Research Institutions May Need Guidelines to Prevent Conflicts of Interest

The federal government and the clinical trials industry are discussing the possibility of drafting guidelines, or even formal regulations, to ensure universities and clinical research institutions are not engaging in detrimental activities that create conflicts of interest.

Because of the shortage of financial resources available to many universities, some institutions are developing baseline strategies more akin to businesses than educational institutions, some critics say. This trend could result in more conflict-of-interest problems, according to observers.

Universities were afforded the option to profit from their discoveries after the passage of the Bayh-Dole Act in 1980, which allows for the transfer of exclusive control of government-funded inventions to universities and businesses operating with federal contracts for the purpose of further development or commercialization. The technology transfer standard has created conflict-of-interest problems within universities and research institutions, leading to some research being compromised.

"The tension is likely to get worse before it gets better," said Bernard Schwetz, director of the HHS' Office of Human Research Protections.

Schwetz, who spoke at the recent "The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects" conference in Houston, said some sort of guidance is needed to help dictate what constitutes professional conflicts of interest regarding product development at the university level.