See the Glossary for more terms.
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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
To increase participation of children in human subjects research so investigators can gather data to support treatments that may affect children.
You must include children in all human subjects research conducted or supported by NIH unless you have scientific or ethical reasons for excluding them.
NIH developed its inclusion of children policy because medical treatments used in children are frequently based on tests performed only on adults, and children have less access to scientifically evaluated treatments because of barriers that exclude them from research studies.
NIH policy defines a child as a person under the age of 21.* It applies to all human subjects research, including research that is exempt from other human subjects requirements according to Sections 101 (b) and 401 (b) of 45 CFR 46—Federal Policy for the Protection of Human Subjects.
*NIH changed the definition of a child from under 21 to under 18 years of age. Applications with due dates on or after January 25, 2016, must reflect the new definition. See Inclusion of Children—Policy Implementation.
Studies may use a specific age range of children. Investigators must provide a rationale for including or excluding an age group. For more details, see NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects and Office for Human Research Protections, Research Involving Children Frequently Asked Questions.
To learn more, see Human Subjects—Warning, If Reviewers Have Concerns, and the Bars to Grant Awards SOP.
After award, you must request prior approval to change human subjects involvement. If applicable, include documentation of new or revised inclusion plans for children in your written request.
See the GMP Assignments by Geographic Region and Program Code for the appropriate specialist.
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45 CFR 46, Protection of Human Subjects, HHS
NIAID's Application portal
Human Subjects Research Requirements SOP and other Human Subjects SOPs
NIAID Human Subjects Resources portal
OER Inclusion of Children Policy Implementation
OER Inclusion of Children Policy Implementation Page
Office for Human Research Protections, HHS
Trans NIAID Clinical Research Toolkit
Last Updated November 12, 2015
Last Reviewed March 16, 2015