In 1998, the National Institutes of Health (NIH) implemented a policy requiring scientists to include children in their clinical studies, unless there was justification to not include them. This study examined the implementation of the NIH Policy on the Inclusion of Children in Clinical Research. The study determined the participation rate of children and how much research scientists considered examining differences in disease and treatment for children. Reviews were conducted of grant applications that NICHD did and did not fund.
The majority of grantees were including children as research subjects, and peer review study sections identified only a very small number of compliance issues. However, the percentage of grants that included only children over 18, and the apparent confusion of reviewers and applicants about the definition of children, suggested that further education of the applicant and review communities about the NIH policy might be appropriate.
Report Title: NIH Policy on the Inclusion of Children in Clinical Research: Evaluation of Policy Implementation at the NICHD
Agency Sponsor: NIH, National Institutes of Health
Federal Contact: Sarah Glavin, 301-496-7898
Performer: MasiMax Resources Inc
Record ID: 9182 (Report issued July 1, 2010)