By Kim Coghill

Washington Editor

WASHINGTON - Although physicians and researchers realize that participation in a clinical trial doesn't mean a patient is putting his life at risk, many potential and past research subjects may disagree and fear for their lives if they volunteer for a trial.

That perception is most evident in the black community, said Annette Dula, a research associate in women's studies at the University of Colorado at Boulder, during her address at the Medical Research Summit held here Monday.

And if blacks fear participation in such trials, they have understandable reasons. Particularly, she said, as a result of the much-publicized Tuskeegee Syphilis Study back in the 1930s. The study involved hundreds of black men with syphilis who remained untreated in order to track the course of the disease even after penicillin became readily available.

"Research is extremely important in making health care better," Dula said. "But to many people it makes no sense at all to be involved in a trial - especially to blacks and other minorities. We don't participate for a number of reasons. For one thing, we may not know what a clinical trial is or we may be getting health care in urban hospitals and trials are being held in academic settings.

"But what I hear the most is that blacks are afraid that they will be used as guinea pigs or that doctors will unnecessarily harm them," Dula said. "Our goal has to be to transform the legacy of the Tuskeegee research so that blacks and minorities will participate in research in order to reduce the disparities between blacks and whites."

And the federal government is taking steps to ensure that human subjects are protected once they submit to participate in research trials.

Last summer, then-secretary of Health and Human Services Donna Shalala set up the Office for Human Research Protections to lead efforts in protecting human subjects in biomedical and behavioral research. The OHRP replaced the former Office for Protection from Research Risks at the National Institutes of Health.

Greg Koski, who was tapped to serve as director of the office, followed Dula's address Monday by saying he has been on a campaign since last summer to build a new system for protection of human subjects.

"Even in illnesses like cancer, only about 3 percent of people affected by the illness take part in trials, and this is a growing concern," Koski said. "People are concerned about safety and privacy, and the foundation of the trial has got to be trust. If you look at abuse over the years, most polls taken show that people think much of it was done by the government."

The OHRP was organized to work with the NIH and FDA to carry out patient-protection initiatives, including clarification of existing policies on potential conflicts of interest and new efforts to educate and train clinical investigators and members of institutional review boards (IRBs).

"We are engaged in what amounts to a two-year program of remodeling; it's a huge job. We have to think beyond the concept that the IRB is doing the job," he said. "We have to imagine how we can move from the system that we have that is so totally focused on the IRB."

As the first part of organizing the new agency, Koski said the Institute of Medicine in October agreed to produce fast-track accreditation standards for human research programs, which are expected to be complete next month.

"The IOM also is looking at the human research protection process, the way it is, the way it ought to be - and trying to make sure we address issues in a comprehensive manner."

Last summer, around the time that the OHRP was forming, a bipartisan group of House members introduced legislation to enhance protection of human subjects volunteering for biomedical research. (See BioWorld Today, June 9, 2000.)

One of the bill's measures include a beefed-up informed-consent process for the disclosure to research participants of any conflicts of interest of the investigator. Also, the bill calls for stronger institutional IRB oversight. Because IRBs are responsible for approving trials at the local level, the bill calls for more education and resources for IRBs to ensure they have the support necessary to review and oversee human subjects research. n