Acting under a mandate from President Obama to weed out unnecessary regulations, government officials have come up with a new set of rules governing federally-financed research involving humans. These new regulations tinker with the "Common Rule," a set of guidelines on consent, oversight and the protection of human subjects which have been in place for more than 20 years. And while some of the proposals could simplify drug studies, others would extend the reach of government involvement.
The New York Times' Andrew Pollack focuses on one key change as an example of how these new rules could facilitate human drug studies. A single institutional review board would be allowed to supervise drug studies which occur at multiple sites, simplifying a process that now requires a board review at each of the sites. The Washington Post reports that the newly revised "Common Rule" would allow researchers to use a single website to report adverse events, rather than be held responsible for reporting the same event to multiple agencies.
But the Times also notes that the new rules, which are now being made available for public comment ahead of final approval, would extend the reach of these regulations to all studies conducted by an institution which gets federal money. That way all studies at a university receiving NIH grants, for example, would be subjected to the federal rules, including studies solely funded by a drug company. And researchers would need to get the consent of volunteers before they could use tissue specimens in future studies, a rule driven by sequencing technology which makes it impossible to make any tissue truly anonymous these days.
"I think this will really have quite a significant response from the research community," Heather Pierce, from the Association of American Medical Colleges, tells the Post. "I think it will be seen as moving human-research oversight into the 21st century."
"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, deputy director of the National Institutes of Health, told reporters.