Apr 23, 2002
Lawmakers on Tuesday threw their support behind new federal safeguards--including the formation of a new national research oversight agency--to protect people who volunteer to participate in medical studies.
Democratic and Republican senators both declared that they will move to increase the government's role in monitoring institutions' oversight of clinical trials and in making sure that patients are adequately informed about risks of research. Some lawmakers also want a law guaranteeing subjects the right to know about researchers' financial ties to industry.
"I believe its going to take legislation...to accomplish that goal," said Sen. William Frist (R-TN), the senior Republican on the Health, Education, Labor, and Pensions (HELP) public health subcommittee.
Congress began targeting human subjects research in early 2000 after the death of 17-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania. Several other incidents since, including the death of a woman participating in a Johns Hopkins University allergy medication experiment, have helped galvanize public demands for greater oversight of research and the boards that oversee experimental protocols at universities.
Witnesses testifying on Capitol Hill Monday told lawmakers that rules currently governing human trials are confusing and often crisscross different agencies at both the state and local level. The system has left many researchers confused about their ethical responsibilities to subjects, they said.
Cherlynn Mathias, a clinical trials manager at Harris Methodist Fort Worth Hospital in Texas, told the committee that the National Institute of Health, the country's largest supporter of human-based research, does a poor job of monitoring the ethical quality of studies it funds.
"I've been doing an NIH study for four-and-a-half years and they've never sent around a monitor," she said.
The National Bioethics Advisory Council issued a report last year calling for the formation of a single federal agency responsible for writing and enforcing a single set of research regulations.
The council also recommended that the agency oversee a national accreditation system for academic institutions, companies, and university-based institutional review boards (IRB's). Lawmakers said they support passing a law implementing both recommendations.
But despite bipartisan enthusiasm, several hurdles remain before lawmakers agree on the form of any new laws. Lawmakers and experts are still at odds over whether new federally-monitored accreditation should be voluntary or mandatory.
"Accreditation works best when organizations will make the commitment to change their culture and behavior in the direction we wish," said Marjorie Speers, executive director of the Association for the Accreditation of Human Research Protection Programs.
Mathias disagreed, saying that medium- and small-sized hospital and institutions will ignore federal ethical standards unless they are forced to comply. "Most places just simply won't do them," she said.
Frist, a former researcher at Vanderbilt University, said in an interview that new federal standards would be easier to implement if they are voluntary. "I don't think you could make it mandatory and fully enforce it for years," he said.
A GOP aide told Reuters Health that the issue is a key sticking point standing in the way of a human subjects protection bill in the Senate.
Lawmakers will also have to decide how broad to make their bill. A law covering research performed through the Department of Health and Human Services (HHS) would cover important agencies including the NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). But it would leave out other human-based research funded by the US Departments of Defense, Education and Veterans' Affairs.
Researchers told lawmakers that while unified and simpler oversight was needed, any new regulations would only serve to slow important research on human diseases.
"Are the current protections adequate? Yes," said Dr. P. David Charles,
a Vanderbilt University Parkinson's disease researcher.
© 2002 Reuters Ltd