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The US government’s proposed overhaul of regulations that govern research with human subjects is flawed and should be withdrawn, an independent advisory panel said today.

The regulations, which are known collectively as the ‘Common Rule’, address ethical issues such as informed consent and storage of study participants’ biological specimens. In its report on 29 June1, the US National Academies of Sciences, Engineering and Medicine said that the government’s proposed changes are “marred by omissions and a lack of clarity”, and would slow research while doing little to improve protections for patients enrolled in studies. Instead, the panel recommends that the government appoint an independent commission to craft new rules for such research.

The Common Rule, which was introduced in 1991, is based on the Belmont Report, a 1978 document that lays out principles for ethical research with humans, such as minimizing patient harm and maximizing the benefit of such research to society. Over time, achieving such goals has become more complex because of technological advances — such as the rise of DNA identification and shared databases, which can make it harder to maintain patient privacy.

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Report: Optimizing the Nation’s Investment in Academic Research, National Academies of Science, Engineering, Medicine

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