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FINAL DRAFT WHITE PAPER: THE ETHICAL CHALLENGES OF RECRUITING MINOR ADOLESCENTS FOR THE NATIONAL CHILDREN'S STUDY
Citation:
LOBDELL, D. T., L. COURTNEY, AND E. MARKS. FINAL DRAFT WHITE PAPER: THE ETHICAL CHALLENGES OF RECRUITING MINOR ADOLESCENTS FOR THE NATIONAL CHILDREN'S STUDY. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/027, 2005.
Impact/Purpose:
research results
Description:
The federal government is designing the National Children's Study (NCS), a congressionally mandated longitudinal study that will examine the effects of environmental exposures among children, from before birth until age 21. The goal of the NCS is to improve the
health and well-being of children. Current plans for the NCS include the following design components:
(About 100,000 children will be enrolled in the study, which is a sample sufficiently large to study the effects of low levels of exposure to environmental agents.
( Data collection (i.e., measurements and observations) will begin as early as possible in a woman's pregnancy. Some participants will be enrolled preconception.
(Data will be collected on the participant's environment and outcomes until the subject is at least 21 years old.
( Study findings will be combined into a database whose elements can be used to assess the impact of environmental and other factors on children and families. NCS planners have noted that including sexually active or pregnant minors in the National Children's Study may pose unique risks and benefits to the individual and to adolescents as a group. The National Institutes of Health (NIH) and other agencies require children to be appropriately included in research studies. Before deciding whether and how to
recruit minors into the NCS, the NCS planners identified eight questions to be addressed. This paper responds to those questions by synthesizing literature from the medical, behavioral, research, bioethical, and legal fields.