US agencies plan research-ethics overhaul
Long-awaited revision proposed for regulations governing studies of human subjects.
03 September
After years of uncertainty, the US government has revived an effort to update regulations that govern human-subjects research. The revision would be the most significant change to the rules since they were introduced in 1991.
On 2 September, the US Department of Health and Human Services (HHS) announced a proposal to address concerns that have emerged since the regulations — known collectively as the 'Common Rule' — took effect more than two decades ago. These issues include the need for overlapping ethics reviews of studies conducted at multiple sites, and the rise of genomic technologies that can identify the donors of anonymized samples.
The HHS will begin a 90-day public comment period on the proposal next week and will decide how to proceed once that concludes, says Kathy Hudson, deputy director for science, outreach and policy at the US National Institutes of Health (NIH) in Bethesda, Maryland.
https://www.nature.com/news/us-agencies-plan-research-ethics-overhaul-1.18309