WEDNESDAY, May 24 (HealthSCOUT) — Researchers who cross the line in ethics or safety regarding patients they’re studying may each find themselves facing a $250,000 fine, if the government has its way.

And institutions are looking at fines of up to $1 million each, said Donna E. Shalala, Health and Human Services secretary, yesterday.

This stance comes in the wake of serious questions on how clinical trials are conducted. The debate was brought to a head last year when an 18-year-old man died while taking part in a gene transfer study done by the University of Pennsylvania.

The government announced several steps it plans to take to improve the safety of patients involved in biomedical clinical trials.

“Today’s actions are designed to further strengthen government oversight of all biomedical research, including gene transfer research, and to reinforce institutions’ and researchers’ responsibility to follow internationally accepted ethical standards and federal guidelines,” said Shalala in a written statement.

The HHS plans to pursue legislation that would let the FDA slap the massive fines on researchers and institutions who violate such accepted research practices as informed consent. The FDA can now only issue warning letters or force the research to stop until the problems are corrected.

The new plan also includes measures to beef up bioethics education and training for researchers and to tighten monitoring of the smaller research studies that come before large-scale clinical trials.

Stronger federal guidance on informed consent and conflict of interest is also promised as part of the government’s action.

“It’s important for patients to feel that they’re well protected and well informed,” says Larry Bachorik of the FDA. “If people lose trust in the nation’s biomedical researchers then the pool of possible research subjects may dry up.”

Better late than never

“It’s about time the government held researchers and institutions accountable,” says Dr. Michael Grodin. He is director of the law, medicine and ethics program and professor of health law at the Boston University Schools of Medicine and Public Health.

Grodin says that up until now, researchers only had to fear a scolding from the government or the withdrawal of financial support if federal funding was involved.

“When people violate the regulations, there should be personal and institutional accountability, not just a pull back on funding,” says Grodin.

Grodin says the proposed fines won’t put a damper on future biomedical research efforts.

“For people who don’t know how to do research, this should be a warning,” says Grodin. “But good researchers, those who understand the regulations, are committed to research and to human safety, won’t have to worry.”

Bachorik says there’s already a strong system of safeguards in place, but it’s still important for researchers to follow the rules. “Conscientious investigators should not be concerned [by the government’s proposed plan] because they won’t find themselves in violation of accepted practice,” he says.

The ability to fine each researcher in the study is key to the government’s plan because it would spare institutions that by and large do an excellent job.

“Civil money penalties would not necessarily affect an entire institution, but could be aimed at specific researchers or their sponsors,” says Bachorik.

Grodin agrees and adds the government’s actions will only affect scientists who are the exception, not the rule.

What To Do: For information about clinical trials along with worldwide clinical trial listings and new drug therapies approved by the FDA visit CenterWatch.