Federal Overhaul of Rules for Human Research Hits Impasse

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Massachusetts General Hospital

E. Greg Koski, a former director of the Office for Human Research Protections, says the government should ask basic questions about what exactly it is trying to achieve, rather than "tinkering around the edges" of the current rules.

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Massachusetts General Hospital

E. Greg Koski, a former director of the Office for Human Research Protections, says the government should ask basic questions about what exactly it is trying to achieve, rather than "tinkering around the edges" of the current rules.

After nearly two years of effort, a bid to rewrite the federal rules governing research involving human subjects appears to be stuck, with little optimism for a way forward.

Universities and researchers pressing for changes in the Common Rule, which governs the ethics of biomedical and behavioral human-subjects research, gained an apparent breakthrough in July 2011, when the federal government's Office for Human