Originally created 05/24/00

Research rules get tougher



WASHINGTON - Federal health officials are proposing fines of up to $250,000 for scientists who violate medical research rules - and fines of $1 million for rule-breaking universities or hospitals - amid criticism that the government hasn't done enough to protect thousands of patients involved in clinical trials.

"This is a clear message that we intend to get serious," Health and Human Services Secretary Donna Shalala said Tuesday, stressing that the government will hold responsible not just the scientist at fault but the entire research institution.

Scientists' wallets will be safe for a while - Ms. Shalala still must ask Congress to pass legislation allowing the Food and Drug Administration to fine researchers who break the rules.

But Ms. Shalala announced additional steps Tuesday that will start immediately: better training of the local medical boards primarily responsible for overseeing patient safety and tougher requirements that patients be fully informed of research risks.

In the wake of a research fraud scheme uncovered three years ago, Medical College of Georgia already is providing additional training of investigators and research assistants and has created the Office of Clinical Trials Compliance to more closely monitor studies, said Barry Goldstein, senior vice president for academic affairs.

"What we found is it has actually enhanced what we do on campus in terms of research, as far as clinical investigation," Dr. Goldstein said. "Most institutions are now moving in that direction. The federal government is adding on top of that, saying, `These are the right things to do, and you're going to do them.'ƒ"

But with the power to step in and halt all research at an institution when there are widespread violations, the FDA already has powerful enforcement tools, Dr. Goldstein said.

"The loss of moneys and revenues and income is devastating to those programs," Dr. Goldstein said. "That in and of itself is a deterrent, so I'm not sure how much more these types of fines will improve the research subject safety."

Still, the move to shore up public confidence in research is very necessary, Dr. Goldstein said.

"Not only is it important for the federal government to come out and say, `We're on top of this,' but it's important for the whole clinical research enterprise, otherwise we're not going to get the subjects we need to come up with the better drugs and the better medical devices and procedures and treatments and so forth," Dr. Goldstein said.

Associated Press reports were used in this article.

Reach Tom Corwin at (706) 823-3213 or tomc@augustachronicle.com.