The National Children’s Study works with many different partners, advisory groups and oversight bodies that provide guidance and oversight to the Study.
Data Access and Confidentiality in the National Children’s Study: The Data Access and Confidentiality team oversees the development of policies guiding data sharing and the protection of privacy for participants.
Federal Consortium: The Federal Consortium is a forum for representatives of more than 20 federal agencies to come together to share ideas, plan and discuss implementation of the Study.
Independent Study Monitoring and Oversight Committee (ISMOC): The ISMOC monitors National Children’s Study data and the safety of Study participants. Formerly referred to as the Data and Safety Monitoring Board, the name of this committee was changed to more accurately reflect its charge. The ISMOC performs an essential oversight role that helps ensure participant safety and data integrity.
National Children’s Study Federal Advisory Committee (NCSAC): The National Children’s Study Federal Advisory Committee (NCSAC), constituted under the Federal Advisory Committee Act, provides advice and recommendations to the Director of the National Institutes of Health, the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Director of the National Children’s Study regarding critical strategic aspects of the Study.
Organization Chart: A diagram of how the various different groups make up the National Children’s Study.
Program Office: The National Children's Study Program Office directs the implementation of the day-to-day operations of the Study. The Program Office houses scientists, staff on detail assignment from other organizations, program analysts, and contractors.
Publications Committee: The National Children’s Study encourages publication and presentation of National Children’s Study results throughout all stages of Study progress. A Publications Committee was established to oversee the identification, prioritizing, writing, and review of primary Study publications (publications based on analysis of centrally collected Vanguard or Main Study data across Study Centers). There are many established Writing Teams with representatives from groups and universities across the nation.
Vanguard Study Locations and Regional Operations Centers: The Vanguard Study locations are the 40 locations across the United States where participants were recruited. These locations are still active and for any participant that moved out of the area. The Regional Operations Centers (ROCs) manage data collection and field activities in the NCS Study Locations. Each of four ROCs manages 10 Vanguard Study locations.
Office of Management and Budget, Office of Information and Regulatory Affairs: The National Children’s Study works closely with the Office of Management and Budget, Office of Information and Regulatory Affairs (OMB/OIRA) to ensure the NCS is compliant with the requirements of the Paperwork Reduction Act. The Paperwork Reduction Act requires that is a federal law enacted in 1980 designed to reduce the total amount of paperwork burden the federal government imposes on private businesses and citizens. All submissions to OMB/OIRA are public and can be found on their website.
NICHD Institutional Review Board: The National Children’s Study relies on the NICHD IRB to approve all study protocols with regards to human subjects protection. Human subjects protection refers to the protection of the rights, welfare, and wellbeing of people involved in research.
More information on many of these groups can be found at the links below.
The NCS has multiple avenues available for researchers and the public to provide comments on the Study’s design and content, outside of the groups listed above. More information on these opportunities can be found in the Study Questions and Answers.