In the March 6, 1998, issue of the NIH Guide for Grants and Contracts, NIH published guidelines for including children in research involving human subjects, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. The goal of the policy is to increase the participation of children in research to obtain appropriate data. This policy applies to all initial (Type 1) applications/proposals and intramural projects submitted to NIH for receipt dates after October 1, 1998.
Investigator responsibilities are:
- Include section in the application on "Participation of Children"
- Assess and justify the scientific/ethical rationale for inclusion/exclusion of children
Background materials are available on the web by accessing:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
For more information call your program official or the Office of Extramural Program Review, NIDA.