Originally created 05/27/01

New group will approve, monitor human research



WASHINGTON -- As Congress considers ways to protect people who volunteer as subjects in medical experiments, a new organization is announcing plans to monitor researchers and offer them ways to accredit their programs.

The Association for the Accreditation of Human Research Protection Programs, based in Rockville, Md., said Wednesday it will issue standards on how researchers should choose their subjects and monitor their progress as they test everything from new medicine to behavioral therapy.

The process will be voluntary, but research institutions praised it as a way to improve public confidence in research in light of recently publicized mistakes that killed or harmed human research subjects.

"The participation of patient volunteers is vital to the discoveries that will lead to effective treatments and possible cures for millions of patients," said Myrl Weinberg, president of the National Health Council, which includes the American Cancer Society and the American Heart Association, among other groups. "Voluntary accreditation of programs is another logical measure to ensure patient safety."

Some members of Congress are looking for standards and reviews that could be required to conduct research or receive federal funding. Senators plan a hearing in coming days to gather testimony from researchers and families of research victims on how to address the problem.

The issue drew new scrutiny last year after an Arizona teen-ager, Jesse Gelsinger, died at the University of Pennsylvania four days after being injected with a genetic drug designed to correct a liver disorder.

A federal investigation found researchers had enrolled patients such as Gelsinger who were ineligible for the study and had failed to warn human patients that two monkeys used in the same experiment had to be put to death because they developed serious side effects.