Draft focuses on subjects in experiments

Legislator wants to protect volunteers in medical tests

Fueled by lead paint study

Measure would open institutions' records to public scrutiny

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

A state delegate is proposing to introduce legislation that would strengthen protections for volunteers in medical experiments and open up the records of university review boards to public scrutiny.

Del. James W. Hubbard, a Democrat from Prince George's County, said he plans to introduce the bill Feb. 4 because he was disturbed by the process by which a much-criticized Kennedy Krieger Institute lead paint study was approved.

"We don't want to cut off research, but we do want to improve the protection of human research subjects and make sure it's done in everybody's best interests," said Hubbard, a 10-year veteran of the House Environmental Matters committee.

Hubbard's proposed bill is still in the drafting stage and it was not immediately clear yesterday how much support it had among other legislators.

Del. John Hurson, chairman of the environmental matters committee, said he has scheduled a meeting Wednesday with representatives from Johns Hopkins Medical Institutions and the University of Maryland to discuss Hubbard's ideas.

Hurson said he will need to hear all opinions before he decides whether to endorse the proposal. But he added that some privately funded drug research might need more scrutiny and regulation to protect volunteers.

The protection of volunteers in medical research has been discussed by the committee since the Maryland Court of Appeals criticized on Aug. 16 the ethics of a 1993-1995 study of partial lead paint abatement in Baltimore rowhouses that two families claim poisoned their children.

Hubbard, who has long taken an interest in lead paint issues, said he was upset to hear that a Hopkins institutional review board approved the Kennedy Krieger study without having an independent lead paint expert present for the discussion.

Hubbard's bill would require institutional review boards to include medical specialists in the fields of research they are reviewing, according to a draft of the proposal obtained by The Sun yesterday.

The measure would also extend federal safety regulations to privately funded studies run by corporations, some of which are not required to follow federal safety guidelines.

The proposed bill would also require university institutional review boards to open up the minutes of their meetings to public scrutiny. And it would allow the Maryland attorney general's office to seek court injunctions to halt research that it finds in violation of safety regulations, according to the draft legislation.

Gary Stephenson, a spokesman for Hopkins, said university officials have made several improvements to their system for reviewing experiments in recent months and look forward to studying Hubbard's proposal.

"Hopkins certainly understands the interest of the members of the General Assembly in [review boards]," said Stephenson.

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