Tests bill toned down

Delegate will soften proposal to restrict medical experiments

New version still opposed

Revised draft would protect trade secrets such as drug contents

January 31, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

After meeting yesterday with leaders of Maryland's academic medical centers, a state delegate said he would soften his proposal to require more public scrutiny of medical experiments, but the plan still faces opposition.

Del. James W. Hubbard told representatives from the Johns Hopkins medical school and the University of Maryland in a closed-door session yesterday that he would revise his proposal to require university review boards to open their records to the public.

House Speaker Casper R. Taylor Jr. said he opposes even that watered-down proposal. He said he doesn't want any additional state regulations that would make Maryland more restrictive than other states, because it might scare away research grants.

"I think this would have such a chilling effect on medical research, it would be foolish," Taylor said.

Hubbard, a Democrat from Prince George's County, said the goal of his proposed legislation is to restore public confidence in volunteering for medical experiments, which was shaken after scandals last summer at Johns Hopkins and the affiliated Kennedy Krieger Institute.

A healthy volunteer died in a Hopkins asthma experiment in June, and in August, the state's highest court criticized the ethics of a Kennedy Krieger lead paint study in which two families said their children were poisoned.

Hubbard, a 10-year member of the House Environmental Matters Committee, said he was inspired to draft his proposal after hearing that a Hopkins review board approved the 1993-1995 Kennedy Krieger lead-paint study without having a lead-paint expert present.

An early draft of Hubbard's bill would require university review boards that approve experiments on humans to include experts with knowledge in the areas of studies under review.

His proposal would allow the Maryland attorney general's office to seek court injunctions to halt dangerous experiments. And it would require that federal safety regulations be applied to experiments on humans, whether funded by the government or private companies.

After meeting with Hopkins and University of Maryland representatives yesterday, Hubbard said he is determined to move ahead with some form of his bill, which he plans to introduce to the General Assembly by next week.

He said he would revise his proposal to require public access to review board minutes.

Before releasing the records, universities would be allowed to remove information that they thought would include trade secrets such as contents of drugs being developed, Hubbard said. That would allow greater scrutiny of the review process without hurting researchers by releasing proprietary information, he said.

"We can still do good research and create more protections to enhance the public's safety," Hubbard said.

No other state requires the review board records of even private universities to be made public. But some advocates for safety in research say more openness would provide another layer of scrutiny to protect against conflicts of interest and dangerous experiments.

Del. John Adams Hurson, chairman of the Environmental Matters Committee, said he expects to schedule a hearing on some form of the bill next month. The proposal is evolving, he said.

Johns Hopkins officials did not speak against Hubbard's proposal yesterday and declined to comment on most aspects of his draft.

In the past, Hopkins has strongly opposed additional state restrictions that could drive away research grants by making Maryland's rules tighter than federal laws. University of Maryland officials opposed yesterday the release of review board minutes without first allowing administrators to cut out trade secrets.

Dr. Howard B. Dickler, associate dean for research and graduate studies at the University of Maryland, said opening up records would be a good idea "as long as confidential information isn't disclosed."

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