Citing lapses in gene therapy tests, U.S. health officials Tuesday announced steps that aim to better protect patients and boost public confidence in the safety of medical research.
As part of the effort, the Food and Drug Administration will ask Congress for power to impose civil fines of up to $250,000 for researchers and up to $1 million for universities that violate federal rules.
Health and Human Services Secretary Donna Shalala said the new measures would bolster existing requirements to make sure patients in experimental trials are fully informed of risks and that researchers disclose financial conflicts of interest.
Officials have acknowledged that many gene therapy researchers have been lax in following federal rules on how to conduct clinical trials.
The new steps, which apply to all types of medical research trials including gene therapy, are intended to protect patients as well as improve public confidence, Shalala said.
"This golden age of biomedical research and of clinical trials will continue only if the public has full confidence in the researchers and the institutions that sponsor them," Shalala told reporters.
Gene therapy is a relatively new field of medicine that seeks to treat or cure a range of diseases by using healthy genes to override faulty ones.
The field was shaken last September by the death of 18-year-old Jesse Gelsinger, who died during a University of Pennsylvania trial that was testing a treatment for a rare liver disorder.
A probe of Penn's gene therapy program found several violations of federal rules. All of Penn's gene therapy trials have been put on hold while the federal investigation continues.
Meanwhile, officials acknowledged widespread lapses by other researchers in the field.
Shalala said the new efforts aim to give notice to researchers, and the institutions they work for, that they need to meet their responsibilities.
"We're making it very clear who is responsible, and it starts with the investigator," she said.
Specifically, regulators will try to improve education and training of clinical investigators, issue new guidelines on informed consent and require closer monitoring of investigators' research plans.
Also, officials will seek better ways to handle possible conflicts of interest for researchers who might profit from their work.
