Report Criticizes Proposed Rules on Human Subjects

A new report from the National Academies of Sciences, Engineering and Medicine urges the creation of an independent commission to examine federal regulations on research involving human subjects, and the rejection of proposed changes in those rules. The report says the proposed rule extends regulations involving human subjects beyond reasonable protections. For example, the report says the new proposed regulations cover biospecimens, such as tissue, blood, saliva and urine, among others. Current rules allow research to be performed using previously collected biospecimens without informed consent as long as the specimens are not linked to an individual, and the report says that changing that rule would be disruptive to much important research.