Delegates approve bill on human medical tests

Measure would force even private colleges to disclose research

March 26, 2002|By Tom Pelton | Tom Pelton,SUN STAFF

The House of Delegates overwhelmingly approved last night a bill designed to increase the safety and public scrutiny of medical experiments on humans.

If approved by the Senate, review boards that approve experiments even at private universities would for the first time be required to open most of their meeting minutes to the public.

The bill also would empower the Maryland attorney general's office to seek court injunctions to halt privately funded research by companies that do not follow safety regulations.

The bill, approved 133-2, was weakened last week by the House Environmental Matters Committee to win the support of the University System of Maryland and Johns Hopkins Medicine, which had lobbied against the measure.

The bill was introduced by Del. James W. Hubbard, a Prince George's County Democrat, to increase public confidence in the wake of a pair of scandals last summer at Johns Hopkins -- one involving the death of a volunteer in an asthma experiment, another involving a lead paint study that sparked lawsuits.

"This bill is a little step in the correct direction, and everything done down here in Annapolis is done in small steps," Hubbard said. "I am pleased that we are laying out some more safety measures for private industry research."

Both Johns Hopkins and the University of Maryland supported Hubbard's bill after they persuaded the House committee to make changes that reduced the bill's public-disclosure requirements.

The amended measure would require review boards to make their final minutes available within 30 days of a request. But the bill would also allow the boards to cut "confidential or privileged information."

The compromise also eliminated language that specified types of information that must be released, including the names of board members present and summaries of discussion about risks to volunteers. The changes could permit review boards to release bare-bones minutes with much information eliminated.

But Joanne E. Pollak, general counsel of Johns Hopkins Medicine, said that is not the school's intention. Hopkins plans to make complete, detailed review board minutes available to the public, excluding only information about new drugs that companies might need to keep secret for competitive reasons.

"Our hope would be that this bill would help the public have more confidence in the research community," Pollak said.

T. Sue Gladhill, vice president for external affairs at the University of Maryland in Baltimore, said the university system has dropped its opposition to the bill, in part because the disclosure requirements are now weaker than those imposed on state universities as part of the Maryland Public Information Act.

Hubbard's bill would close a loophole in existing regulation of human studies. Now, pharmaceutical companies that want to run privately funded experiments in Maryland are not compelled to follow the same federal safety laws that apply to universities receiving federal funding.

Those laws require, for example, informed consent by all volunteers. Hubbard's bill would duplicate the federal regulations in state law.

Sun staff writer Howard Libit contributed to this article.

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