Tougher laws urged for medical research

The Institute of Medicine, part of the National Academy of Sciences, called yesterday for tougher laws and policies to protect people enrolled in medical research.

The federal Department of Health and Human Services had asked the institute to evaluate protections for human subjects after Jesse Gelsinger, 18, a healthy volunteer, died during a gene-therapy trial at the University of Pennsylvania in 1999.

"In the past few years a number of tragic events involving research participants have shaken public confidence" in the safety of research trials, said Dr. Daniel Federman, a senior dean at Harvard Medical School and chairman of the committee that studied the issue. "Media publicity of these cases and the weaknesses in the protection system that have been exposed have heightened concerns."

Among the news accounts cited in the institute's report was The Seattle Times' series "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died." The series highlighted two clinical trials at the Fred Hutchinson Cancer Research Center in which patients weren't told all the risks and in which at least 20 patients died prematurely.

The new report cites failures in patient protection across the research spectrum. Federal oversight is so weak that no one even knows how many people are enrolled in research trials, Federman said.

"There does not appear to be a single cause for these failures but rather a confluence of factors — a combination of stresses, weaknesses, vagaries and lack of accountability — that has pushed the system to the point where change must occur," the report concluded.

Among the recommendations:

• Federal oversight should extend to all medical research, not just to research that is federally funded.

• All research centers should have boards to evaluate the scientific merits of an experiment and potential financial conflicts of interest. All experiments should be previewed by an ethics board.

• Everyone involved in research should be taught ethics.

• Participants should be clearly told all the risks of research.

• Consent documents should be designed to inform participants in research, not protect research centers from liability.

• People injured in experiments should be compensated for injuries.

• Managers at research centers should foster a culture of protection.

Sen. Edward Kennedy, D-Mass., introduced a bill yesterday to enact many of the institute's recommendations, but it appears to lack the bipartisan support to pass this session.

David Heath: 206-464-2136; dheath@seattletimes.com.