Health Policy Update

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Jan. 26, 2017

On Jan. 19, 16 federal departments and agencies updated the Federal Policy for the Protection of Human Subjects, known as the Common Rule. The final rule comes after an Advanced Notice of Proposed Rulemaking in 2011 and a Notice of Proposed Rulemaking (NPRM) in 2015.

In line with comments submitted by ASTHO in response to the NPRM, the Common Rule does not expand the definition of “human subject” to include non-identified bio-specimens, such as newborn dried bloodspots. As a result, state health agency newborn screening activities, including secondary research and developing and implementing new tests, are outside the scope of the rule. However, the Common Rule does not supplant state laws and regulations, meaning state-level requirements or restrictions still apply. To learn more about state approaches to informed consent for newborn screening and how state health agencies are saving and improving the lives of over 12,000 newborns each year, visit ASTHO’s Newborn Screening webpage.

In addition, the final rule excludes certain “public health surveillance activities” from the definition of research. The rule limits the exclusion to activities “necessary to allow the public health authority to monitor, assess, or investigate public health signals, onsets of disease outbreaks, or conditions of public health importance.” For purposes of this exclusion, public health authority is defined as “an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government…that is responsible for public health matters as a part of its official mandate.”

ASTHO will provide updates in the coming weeks about how other changes to the Common Rule, such as informed consent requirements and new standards for institutional review boards, may impact state and territorial public health agencies.