Stronger safeguards for human studies urged

Central registry to track all tests recommended

October 04, 2002|By Jonathan Bor | Jonathan Bor,SUN STAFF

An expert panel yesterday urged stronger safeguards for people participating in medical experiments, saying the public's confidence has been shaken by several highly publicized deaths in recent years.

The group, which was convened by the Institute of Medicine, recommended that federal oversight be extended to studies done by drug companies and foundations, and that a central registry be created to track all human studies.

It also recommended that institutions compensate people for injuries they suffer in research, even if negligence is not involved. The group also called for a revamping of the review boards that oversee trials at medical centers so they can focus primarily on ethics and safety.

"It is understandable that the public has come to perceive that research institutions put more emphasis on insulating themselves from liability than on protecting people from harm," said Dr. Daniel Federman, a Harvard Medical School dean who headed the committee that produced the report.

"There is no single cause for the errors and mishaps that have resulted in the deaths of some research participants in recent years," Federman said yesterday at a briefing in Washington. Instead, he blamed "a combination of stresses, weaknesses and lack of accountability."

The Institute of Medicine is a private organization that advises the federal government. It began its study at the request of the Department of Health and Human Services after the death in 1999 of 18-year-old Jesse Gelsinger, a participant in a gene therapy trial at the University of Pennsylvania.

The committee was already at work when Ellen Roche, a 24-year-old lab technician from Reisterstown, died in June 2001 after inhaling a chemical in an asthma experiment at the Johns Hopkins School of Medicine.

Finding widespread safety lapses at both institutions, the federal government closed the gene therapy program at Penn and briefly shut down research at Hopkins. It also forced Hopkins to overhaul its system of protecting volunteers.

Two months ago, the federal Office for Human Research Protection released Hopkins from all remaining restrictions, saying it had made vast improvements.

Yesterday, Federman said that nobody knows how many human studies are performed annually in the United States or how many deaths or illnesses occur in the course of research. Nor does anybody have a clear idea of how many people participate in such studies, saying estimates range from 2 million to 20 million.

In part, the confusion arises from the fact that many privately-funded studies fall outside federal jurisdiction. Studies receiving federal funding and clinical trials of experimental drugs - many of which are conducted at academic centers and community hospitals - are regulated by different agencies.

The group recommended the creation of a central registry of all trials being conducted in the United States. Also, safety regulations that govern federally funded research would be extended to all studies, regardless of who runs or pays for them.

Timothy Jost, a panel member who is a law professor at Washington and Lee University, said the group did not decide whether researchers funded by private concerns should be required to report unexpected illnesses to the federal government. At minimum, he said, they should be required to set up the same type of review boards that are required of academic centers.

Noting the growing burden facing review boards, the panel suggested they focus primarily on ethical questions such as whether people have properly been advised of risks and whether the risks are worth the potential benefits. Separate committees would advise the review boards on scientific questions and potential financial conflicts of researchers doing the research.

Dr. Michael Klag, Hopkins' vice dean of clinical investigation, said the school has long had a separate committee that weighs financial ties. But the review boards consider both scientific and ethical issues, tapping the varied expertise of its members.

Since Roche's death, Hopkins expanded the number of review boards from two to seven - including one operated by a private firm. This, he said, has helped the institution cope with pressures of monitoring nearly 3,000 experiments annually.

Though Hopkins reached a confidential settlement with the Roche family, Klag said the school advises volunteers that it will not automatically compensate them for health care should they get sick during a study.

Jost said compensating victims should be considered part of "the cost of doing research."

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