By Andrew Pollack
The government is proposing sweeping changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies.
The officials said the changes were needed to deal with a vastly altered research climate, whose new features include genomics studies using patients’ DNA samples, the use of the Internet and a growing reliance on studies that take place at many sites at once.
“These are the first substantial changes that have been made to the rules governing human subjects in decades, so this is really quite a historic moment,” Kathy Hudson, a deputy director of the National Institutes of Health, said in a telephone news conference on Friday.
The changes would be in the rules that cover topics like the informed consent that research participants must provide and the institutional review boards that oversee research at universities and hospitals. Initially drawn up by the Department of Health and Human Services in the 1970s and ’80s, the system was adopted by 14 other federal agencies and departments in 1991 and became known as the Common Rule.