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New Rule Dropped

A proposed change to the so-called Common Rule has been dropped, Stat News reports.

As part of its bid to modernize the rules that protect human research subjects, the Obama Administration had suggested changing the informed consent requirement for using leftover biospecimens, such as blood samples, for research. The change would've required researchers to only use samples from patients who'd explicitly agreed to secondary research.

This prompted pushback from many in the research community who argued that anonymous samples would have become unusable as the donors would not be able to be re-contacted for consent and that precious tissue and other samples would become even harder to come by. The National Academies of Sciences, Engineering, and Medicine even urged the administration to scrap its proposal and start anew.

"There was concern," Jerry Menikoff, the head of the Health and Human Services Office of Human Research Protections, tells NPR, "that by implementing this new rule it would be harmful to the research enterprise, because it would make it harder to do research that is very, very useful."

This proposal was eliminated in the final version of the Common Rule published in the Federal Register yesterday, it adds. Stat News notes that other changes such as allowing multi-site studies to rely on one institutional review board and requiring clearer consent forms have been left intact.