Excerpt

The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21.

NICHD requested the Committee on National Statistics of the National Research Council (NRC), in collaboration with the Board on Children, Youth, and Families of the NRC and the Institute of Medicine (IOM) and the IOM Board on Population Health and Public Health Practice, to conduct a review of the research plan for the NCS. The purpose of the review is to assess the scientific rigor of the NCS and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. Topics to be addressed include proposed outcomes and hypotheses; proposed measures of environmental exposure, genetic makeup, family and community environment, and personal characteristics; proposed data collection and analysis methods; and other aspects of the study's research plan.

Contents

• The National Academies
• Panel to Review the National Children’s Study Research Plan
• Committee on National Statistics
• Board on Children, Youth and Families
• Board on Population Health and Public Health Practice
• Acknowledgments
• Executive Summary
  • STRENGTHS
  • WEAKNESSES AND SHORTCOMINGS
  • CONCLUDING OBSERVATION
  • RECOMMENDATIONS
• 1. Introduction
  • BACKGROUND
  • THE PANEL’S REVIEW
  • ORGANIZATION OF THIS REPORT
• 2. NCS Goals, Conceptual Framework, and Core Hypotheses
  • DESIGN IN BRIEF
  • STUDY GOALS
  • CONCEPTUAL FRAMEWORK
  • CORE HYPOTHESES
  • USING THE VANGUARD CENTERS AS PILOTS
• 3. Priority Outcome and Exposure Measures
  • PRIORITY OUTCOMES
  • EXPOSURE MEASURES
• 4. Study Design, Data Collection, and Analysis
  • DESIGN SUMMARY
  • SAMPLING DESIGN
  • DATA COLLECTION
  • DATA ANALYSIS AND DISSEMINATION
• 5. Ethical Procedures and Community Engagement
  • APPROACH TO REVIEW
  • CRITERIA FOR GIVING INFORMATION TO PARTICIPANTS
  • PROTECTION AND RELEASE OF INFORMATION
  • IRB REVIEW AUTHORITY
  • INFORMED CONSENT
  • COMMUNITY ENGAGEMENT
  • CONCLUSION
• 6. Conclusions and Recommendations
  • CHAPTER 2: NCS GOALS, CONCEPTUAL FRAMEWORK, AND CORE HYPOTHESES
  • CHAPTER 3: PRIORITY OUTCOME AND EXPOSURE MEASURES
  • CHAPTER 4: STUDY DESIGN, DATA COLLECTION, AND ANALYSIS
  • CHAPTER 5: ETHICAL PROCEDURES AND COMMUNITY ENGAGEMENT
• Biographical Sketches of Panel Members
• References

This study was supported by Contract No. NO1-OD-4-2139 between the National Academy of Sciences and the National Institute of Child Health and Human Development. Support of the work of the Committee on National Statistics is provided by a consortium of federal agencies through a grant from the National Science Foundation (Number SBR-0453930). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.

Suggested citation:

National Research Council and Institute of Medicine. (2008). The National Children’s Study Research Plan: A Review. Panel to Review the National Children’s Study Research Plan. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Board on Children, Youth, and Families and Board on Population Health and Public Health Practice, Institute of Medicine. Washington, DC: The National Academies Press.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.