Announcements 

The National Children’s Study has reframed the Vanguard Study scope of activity to focus on feasibility, acceptability, and cost of the elements that will form the Main Study. This is the second in a planned series of announcements for Letters of Intent to augment Vanguard Study activities with efforts that will accelerate development and deployment of the Main Study.

The National Children’s Study Program Office received a robust response to the Letter of Intent (LOI) announcement that was issued on December 24, 2009 for evaluating alternate recruitment strategies for the National Children’s Study Vanguard Study. The LOIs were impressive both scientifically and technically. The LOI responses were evaluated by the Program Office in a systematic and thorough manner and the 10 Study Centers selected for each of the 3 recruitment strategies are listed.

The National Children’s Study is planning to expand the scope of activity of the Vanguard Study in order to accelerate development and deployment of the Main Study. The goals are to evaluate (1) alternative strategies for recruitment, (2) Study visit assessments (those events and assessments that are scheduled during Study visits), and (3) Study logistics and operations.

In the October 2009 issue of Environmental Health Perspectives, researchers identify a tiered data collection approach for extant data. This approach, used by the Queens Vanguard Center, is presented as general guidance for the data needs of other Study locations.

The NCS Program Office has analyzed the Vanguard Study experience to date and based on this analysis, several changes will be implemented to ensure that the NCS will accomplish its scientific and public health goals aligned with the highest scientific, ethical and fiscally responsible standards. The Vanguard Study will focus entirely on assuring the feasibility, acceptability and determining the cost of the procedures and data collections being considered for the Main Study. The Vanguard Study will continue for the same length of time as the Main Study, but always by a time interval, currently estimated as about two and a half years, ahead of the Main Study with the purpose of developing and refining the operations and assessments that will be in the Main Study.

Capt. Steven Hirschfeld, MD, PhD, NICHD’s Associate Director for Clinical Research, has been appointed Acting Director of the National Children’s Study. Peter Scheidt, MD, MPH, led the Study through its inception and planning phases, into the current pilot phase. Dr. Scheidt will now provide guidance to the NICHD Director and program directors on activities in perinatal and pediatric epidemiology and medicine. Under Dr. Hirschfeld’s direction, the Study will continue all the activities needed to make this Study scientifically, programmatically, and administratively strong.

In the August 2009 issue of Exceptional Parent magazine, Dr. Marion Balsam, Director of Partnerships and Adjunct Studies for the National Children’s Study, provides a follow-up to her 2005 article about a day in the life of the Study, highlighting the recruiting that has started at the seven Vanguard Centers. This article is posted with the expressed consent and approval of Exceptional Parent, a monthly magazine for parents and families of children with disabilities and special healthcare needs. For more information visit http://www.eparent.com.

In the January 2009 issue of Environmental Health Perspectives, Dr. Peter Scheidt, Director of the National Children’s Study, and other lead Study investigators, highlight the opportunities, challenges, and potential health benefits of this national longitudinal cohort Study of 100,000 children, as enrollment and data collection begin at the first of the Vanguard locations.

Tour the home page and the site design for details on the Web site’s features.

The National Academy of Sciences (NAS) panel identified a number of concerns and recommendations for realizing the Study’s optimum potential. The Study has carefully considered all of the identified concerns and the 33 recommendations in the NAS report and has responded accordingly. The Study is very pleased with the NAS review of the Research Plan and feels that it clearly met the objectives for performing it. Although, as noted in more detail in the Study’s response, some of the concerns and recommendations are either already being addressed or would require substantial additional resources to implement. Additionally, a number of the recommendations point to ways that the Study can be improved. We welcome these recommendations and where possible will be incorporating them into the Study.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), has issued a Request for Proposals (RFP) to award a contract to an organization to serve as a Repository for biospecimens and environmental samples for the National Children’s Study. The Repository will be responsible for receipt, secure storage, preparation, and distribution of all biological specimens that will be collected from participants periodically throughout the Study. The Repository will also store all environmental samples that will be collected from households and perhaps other locations periodically throughout the length of the Study.

In preparation for the start of recruitment, the National Children’s Study has launched a new national Web site with enhanced content, new sections, and an updated look and feel. The national Web site uses the same address as the old Web site and can be accessed at www.nationalchildrensstudy.gov. The Study redesigned its Web site to communicate new and updated information to its numerous key stakeholders, the largest of which will be its participants, and to better represent the Study’s progress to date.

The National Children’s Study announces another major step toward the Study’s full implementation with the issuing of a new Request for Proposals (RFP) for additional Study Centers. The Study plans to establish another wave of new Study locations and Centers across the country. Fifty-eight previously identified Study locations that have not been included in past awards are included in this solicitation.

The National Children’s Study announces that it will move forward with plans to fund 10–15 additional Study Centers to manage Study operations in communities across the country. This increased pace of Study activity is possible because of the Congressional appropriation of funds for fiscal year 2008. With this funding, NICHD is planning to award contracts to expand the active locations (counties) in the Study and to increase the number of organizations that can serve as Study Centers.

This telebriefing announces approximately 24 new Study Centers that will manage operations in approximately 30 locations of the National Children’s Study. It also provides an opportunity to hear the latest Study news firsthand, as well as to ask questions of Study leaders.

The National Children’s Study has completed the Research Plan for the first phase of the Study (from birth to 24 months of age), and is making it available to the public for comment. The Research Plan builds on the initial Study Plan, and provides a broad overview of how researchers will conduct the Study and how the data will be collected.

The National Children’s Study announces a Request for Proposals (RFP) to award contracts to interested organizations with the capability to serve as Study Centers. The Study plans to establish up to 20 new Study Centers in as many as 30 previously designated Study locations across the country.

The National Children’s Study is moving forward and broadening its reach to a number of new communities across the United States. In September 2005, the Study opened seven initial Vanguard Centers. With the 2007 expansion, the Study plans to establish up to 20 new Study Centers in previously designated Study locations across the country.

If additional funds are provided in the fiscal year 2007 federal budget for the Study, NICHD is planning to award contracts to more organizations having the ability to serve as Study Centers. Study Centers will manage Study operations at one or more previously designated Study locations (counties).

Although the FY 2007 Presidential budget did not include funds for the Study, the seven Vanguard Centers and the Coordinating Center will engage in start-up activities across the country. Congress authorized the Study through the Children’s Health Act of 2000 and has demonstrated ongoing interest in its being continued. While action on FY 2007 appropriation is in process, Study planners will continue to work with the Centers to establish infrastructure to support the Study, while simultaneously preparing for cessation of Study activities in 2007, as directed in the President’s budget.

The National Children’s Study welcomes South Dakota State University (SDSU), with the Children’s Medical Center of Cincinnati and the University of Cincinnati, to the National Children’s Study as the seventh Vanguard Center. SDSU will implement the Study in one location composed of four adjacent counties—Brookings County in South Dakota and Yellow Medicine, Pipestone, and Lincoln Counties in Minnesota.