Regulatory considerations when children are involved as subjects in research

Investigators planning research projects face a myriad of considerations including careful review of the literature, study design, selection of subject population, analysis of data, financial and administrative support, and publishing the data. One area for careful thought by those contemplating research in educational settings is the regulatory requirements that may apply when human subjects--children or students in particular--are involved in the research. This article describes the applicability and some basic provisions of US Dept. of Health and Human Services (DHHS) regulations for the protection of human subjects, requirements for informed consent, and some additional protections for children involved in research. Suggestions for preparing a grant application for DHHS support and sources of additional information also are included.