Privacy Rule Creates Bottleneck For U.S. Biomedical Researchers

摘要

University of Pittsburgh epidemiologist Roberta Ness wants to identify risk factors for preeclampsia, a rise in blood pressure that can kill pregnant women and their fetuses. But last year, thanks to a new federal patient rights' law, her search for subjects suddenly got a lot harder. Instead of just screening medical records for potential enrollees, her team had to spend months compiling a registry of women who have given their doctors permission to share their medical records with researchers. Even worse than the time lost, she says, is the increased possibility that her study may be biased toward a particular type of patient: those savvy enough about medical research to extend their consent. "We can no longer address the question of selection bias," she says. Ness isn't the only researcher whose studies have been compromised by the new law, called the Privacy Rule. The rule, which was implemented in April 2003, imposes new restrictions on the use of patient health records―the raw material for much clinical and epidemiological research. It has made "fundamental alterations to the way in which some research is conducted and even in the ability to carry out some kinds of research on human subjects," says recent testi- mony from the Association of American Medical Colleges (AAMC). "It's a mess," says pathologist William Grizzle of the University of Alabama, Birmingham.