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Safety and Oversight Improvements Needed at NIH

A task force has made a series of recommendations aimed at reinforcing safety and quality at the US National Institutes of Health.

The task force, chaired by former Lockheed Martin CEO Norman Augustine, recommends that NIH create a research support and compliance office as well as systems to monitor and enforce safety and quality standards, while also bolstering clinical research leadership authority and responsibility, among other suggestions.

The review was sparked after two vials of albumin manufactured by the NIH's Clinical Center's Pharmaceutical Development Service were found last year to contain fungal contaminants and an inspection by the Food and Drug Administration unearthed a number of deficiencies. In addition, work at two NIH facilities was also halted over safety concerns earlier this week.

"The emphasis on research is so great, and on trying to save people's lives, that there became a cultural attitude that overshadowed handling some of the details that are important details," Augustine tells NPR.

He and the task force found that some of the issues had been around for quite some time and that workers did bring them up. "People at the bottom were aware of problems and they didn't get up to where the people who could really solve them had a chance," Augustine adds.

NIH Director Francis Collins appears to be acting on a number of the task force recommendations. In a statement, he has announced the creation of a hospital board and appointed Laura Forese from New York-Presbyterian as its chair; the establishment of an Office of Research Support and Compliance with Kathryn Zoon as its interim director; and the hiring of Working Buildings and Clinical IQ, two companies that specialize in quality assurance for manufacturing and compounding.

He adds at NPR that learning about these safety issues was "for me, the darkest moment since I've been NIH director, which is now going on seven years."

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