Inclusion of Children - Policy Implementation

NIH Inclusion of Children as Participants in Research Involving Human Subjects

This covers the NIH policies and procedures on the inclusion of children as participants in research involving human subjects.

NIH policy requires that applicants and grantees include children when conducting clinical research, unless there is a strong justification for their exclusion.

For information about the protection of children as human subjects: go here.

Latest Updates on the Inclusion of Children

There are no new updates at this time. Please check back periodically for updates.


Sections:


Policy References

Title Description Link Original Posting Date
NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects NIH Guide Notice. The goal of this policy is to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. Website 03/06/1998
Decision Tree for Participation of Children in Research This is a tool for deciding if the inclusion of children is appropriate for a specific study. It is an attachment to the 03/06/98 NIH Guide shown above. Website 03/06/1998
FAQ on the Inclusion of Children as Participants in Research Involving Human Subjects Questions and Answers about the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research involving Human Subjects. Website 03/17/1999
 

FAQs and Other Resources

Title Description Link Original Posting Date
Inclusion of Children Case Studies (SCIENTIFIC)
 
Case Studies have been developed to assist Investigators in evaluating when children should be included in research studies supported by the NIH. Website


Word
03/26/99