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There are separate definitions for the protection of children in the HHS regulations and for the inclusion of children in the NIH policy, as follows:

1.  From the HHS regulations (46.402, Subpart D) – persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted

2.  From NIH Policy (NIH Policy and Guidelines on the Inclusion of Children as Participants in Research) – an individual under the age of 21 years

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