Greater oversight of trials urged

Experts say financial interests may impact safety of participants in human subjects research.

By Andis Robeznieks, AMNews staff. Jan. 21, 2002.

Medical research was put under the microscope by both government and academia last year, resulting in calls for reforming scientific trials with human test subjects.

This scrutiny also resulted in two major studies released last month, one from the Assn. of American Medical Colleges and the other from the U.S. General Accounting Office. The GAO study was called for by Sen. Bill Frist, MD, (R, Tenn.) who is also a heart and lung transplant surgeon.

Based upon the GAO findings, Dr. Frist indicated that new laws may be needed to protect the health and safety of individuals participating in human subject research.

"While the report acknowledges that some steps have been taken to address these concerns, the report clearly indicates that additional measures are needed," Dr. Frist said. "Chief among them is the need to develop enhanced conflict-of-interest guidelines and harmonize differences between competing federal regulations."

The GAO report detailed how collaborations between government-funded researchers and private industry has increased since the passage of the Bayh-Dole Act of 1980. The act amended patent and trademark laws, giving universities the ability to retain patents to facilitate commercialization of new technologies.

The financial impact of this legislation has been significant.

The budget of the National Institutes of Health, the main federal agency funding biomedical research, has grown from about $3 billion in fiscal year 1980 to more than $20 billion in fiscal year 2001, the report stated. [...]