Inclusion of Children in Clinical Research: Change in NIH Definition

Notice Number: NOT-OD-16-010

Key Dates
Release Date:   October 13, 2015

Related Announcements
NOT-OD-16-058
NOT98-024
NOT-OD-16-004

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to notify NIH applicants/offerors and grantees/contractors about a change related to the NIH policy on the inclusion of children in clinical research.  NIH’s long-standing policy has been that children must be included in all human subjects’ research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.  The policy was developed because medical treatments applied to children are often based upon testing done only in adults, and scientifically evaluated treatments are less available to children due to barriers to their inclusion in research studies.  Therefore, applicants/offerors conducting human subjects’ research must include a description of plans for including children.  If children (or a subset of children) will be excluded from the research, the application or proposal must present an acceptable justification.   

What’s Changing:  Starting with applications/proposals submitted for due dates on or after January 25, 2016, for the purposes of inclusion policy, the age of a child will be defined as individuals under 18 years old instead of under 21 years old, the current NIH definition of a child for inclusion policy considerations.  Applicants/offerors for NIH funding will still be expected to justify the age range of the proposed participants in their clinical research, with particular attention paid to addressing the inclusion (or exclusion) of children (or subsets of children).  However, now that threshold applies to individuals under the age of 18 rather than under the age of 21.     

Reason for Change: Consideration of children as a vulnerable population for human protections from research risk and the NIH child inclusion policy are often conflated.  While these are distinct policies, many think of children as under 18 years of age, typically the age of consent.  This has sometimes led to confusion on the part of applicants/offerors, peer reviewers, grantees/contractors, and even NIH staff about how to ensure compliance with the child inclusion policy. By aligning the NIH definition for the age of a child with the typical age of consent and the common perception of the age of adulthood, the NIH can continue to implement this policy in a manner that focuses on the group of children that need particular attention.

The NIH recognizes that development continues well beyond 18 (and even 21, the current age); however, there is particular concern about ensuring the appropriate inclusion of individuals under 18 while also safeguarding this vulnerable group.  NIH policies on inclusion are aimed at ensuring that appropriate individuals are included in clinical research and clinical trials.  Results need to be generalizable to individuals that comprise the population under study.  This includes consideration of age as a factor in the scientific design.

For more information on the child inclusion policy:  https://grants.nih.gov/grants/funding/children/children.htm

Inquiries

Please direct all inquiries to:

NIH Inclusion Policy Officer
Office of Extramural Research (OER)
Telephone: 301-435-7124
Email: inclusion@od.nih.gov

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.