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 December 2002 Federal Consortium Meeting

December 17, 2002
Baltimore Marriott Waterfront
Baltimore, MD

Summary Minutes

This meeting was held in conjunction with the National Children’s Study, which is led by a consortium of federal agency partners: the U.S. Department of Health and Human Services (including the National Institute of Child Health and Human Development [NICHD] and the National Institute of Environmental Health Sciences [NIEHS] , two parts of the National Institutes of Health , and the Centers for Disease Control and Prevention [CDC] ) and the U.S. Environmental Protection Agency (EPA).

Overview and Details on the Status of the National Children’s Study

Duane Alexander, M.D., NICHD Director and Federal Consortium Chair, welcomed members to the third Federal Consortium (Consortium) meeting for the National Children’s Study. The meeting was held during the Study Assembly, a convocation of the primary structures set up to plan the Study (the Interagency Coordinating Committee [ICC], the Advisory Committee [NCSAC], the Program Office, the 22 Working Groups, and the Consortium).

This meeting was held to update Consortium members on Study issues generally, provide more depth on certain issues covered in the plenary, and give Consortium members an opportunity to ask questions of interest to them and the agencies they represent. While considerable progress has been made in setting the broad operational focus of the Study, Dr. Alexander assured Consortium members that decisions taken thus far have set the context for Consortium members to actively participate in the planning process. They were encouraged not only to take the Study message back to their respective agencies, but to bring their own agendas directly to the Consortium, and to actively pursue them by participating in whichever of the more than 20 Working Groups best represented their concerns. Dr. Alexander encouraged Consortium members to contact the Study Program Office with any questions or concerns, and use the Working Groups as forums to pursue their agency’s issues.

The Study has begun to take a more specific form since the Consortium last met, and Dr. Alexander provided a thumbnail sketch of what he believes will be perhaps the largest cohort of children ever studied, and certainly the best-characterized study of such a size, on the order of 100,000 children born over the course of 3 to 5 years. At a minimum, the Study will collect extensive information on both parents, their medical histories, environmental exposures, specific exposures, and other events during the course of pregnancy including any complications, labor, and delivery, as well as DNA from both parents and the child. After birth, the child and family will be followed for 21 years. It is likely that formal exams will occur twice during the first year of life, once at around age 2, once before beginning school, then twice during elementary school, once each in middle school and high school, with the exit interview at age 21. These medical examinations will be augmented by ongoing assessments of family, community, environment (air and water quality, household exposures, etc.), school, and specific testing of various aspects of the child’s behavior and development.

Dr. Alexander pointed out that such a dataset will not only be historic, but will keep paying dividends on the initial investment. Only a fraction of the potential studies likely to be undertaken based on these data will rely on the core federal support and address the core hypotheses. A much greater number of studies will certainly be conducted by other investigators, supported by the four initiating agencies (National Institute of Child Health and Human Development [NICHD], Centers for Disease Control and Prevention [CDC], Environmental Protection Agency [EPA], and the National Institute of Environmental Health Sciences [NIEHS]) and many others, public and private, testing hypotheses that arise as the data accrue and medical science evolves.

Peter Scheidt, M.D., Director of the Program Office and Co-chair of the ICC, reviewed the general outlines of the Study and its progress to date. He described one component of the Study Assembly meetings, sponsored by the EPA, in which there occurred a wide-ranging discussion of international activities that have three parallels tracks with the Study. Over the past 18 months, Program Staff have corresponded with some 15 to 20 investigators from abroad, who expressed interest in developing possible longitudinal studies in their own countries, or who simply want to learn what the Study will do. To facilitate this ongoing dialogue, an active Listserv has been established, and the Web-based portal system will be used. Dr. Scheidt believes that the possibility of parallel but coordinated longitudinal studies in other countries is a very real one.

As to the timeline, the Study is currently and actively engaged in planning and development. Pilot studies are being discussed to analyze the methods and the targets. By 2005, Study expects the first enrollment of subjects at vanguard centers. By 2007-08, early results on the outcomes of pregnancy should be available. This will be an important milestone to illustrate that Study payoffs will be continuous, notwithstanding that final outcomes of this longitudinal study are several decades away. During the course of the Study, Dr. Scheidt expects numerous targeted analyses addressing hypotheses to be posed, based on a series of public-use datasets and RFAs that will allow investigators all over the world to analyze the data almost as soon as it is collected.

Budget and Funding

As to the budget, Dr. Scheidt noted that the planners have consulted a variety of sources and experiences to get a handle on the magnitude of the projected costs. Embedded in these projections are many assumptions and caveats; for example, that no final decisions have been made about explicit measures, the frequency of followup visits, etc.

​FY ​Budget/Status
​’02 ​$6M  (just finishing) operations budget and the cost of planning and pilot studies
​’03 ​$10M  (proposed) to expand the pilot study effort
​’04 ​$26M  (estimated need) assuming field startup in 2005
​’05 ​$80M  (rough estimates) once the Study is operational
​’07 ​$200M  (estimate) this would be the peak cost if enrollment is three years; a bit less than that if the enrollment is stretched to five years.

Dr. Alexander reiterated that the costs in the project’s first four years have been borne by four organizations-NICHD, NIEHS, CDC, and EPA. No other agencies have been asked to contribute, on the theory that the magnitude of this Study far surpasses what existing agencies or even alliances of agencies could muster the resources to fund. NIH Director Elias Zerhouni, M.D., DHHS Secretary Thompson, and EPA Administrator Whitman are firmly committed, but thus far the Study program has not made a direct appeal to the Office of Management and Budget (OMB). Until they do-and that may be 18 months, according to Dr. Alexander-he would be unable to report to the Consortium precisely how the Study is going to be funded. Since the payoffs are so general-transportation, education, many others-planners are taking the position that the most basic support of the Federal Government is justified.

Funds are earmarked in the fiscal year 2004 request to continue the planning effort, but they fall short of the $26 million needed to do all of the planning, piloting, and other advance work required to launch the Study the following year. Whether the advocacy organizations will be successful in making up that ’04 shortfall remains to be seen. Planning staff are proceeding with certain assumptions:

  • There will be a Study of this magnitude (or nearly this magnitude).
  • The core Study will be federally funded.
  • Add-on studies based on the anticipated dataset are feasible, and might be funded in part by foundations and other interested organizations
  • Additional data beyond current requirements could also be collected, without undue burden on the subjects, also funded perhaps by non-federal funds.

In the meantime, Dr. Alexander reiterated that he was not soliciting funds from any of the Consortium members, and hoped he would not ever have to. He did, however, request that members to stay alert to any opportunities:

  • to get their agencies and agency heads on record in support of the value of this Study to the mission of their particular organization and constituency
  • that arise at congressional appropriation hearings to endorse the project and get testimony on the record
  • to make the case in direct interactions with OMB.

There should be a consistent and key message to OMB, to Congress, and to advocacy organizations helping to raise funding: "This is a very important study for our agency. The resources it requires go beyond our budget; new money must be identified and made available."

Issues Raised by Consortium Members

Dr. Alexander and Dr. Scheidt were both eager to take questions:

Q: What is the bang for this $80 million buck?

Precisely the question Dr. Zerhouni, the NIH Director, asked us. If we’re going to sell this project successfully, we have to demonstrate how the information yielded from the Study will provide broad benefits. First, the data should help to identify risk and prevention factors for a number of these conditions (e.g., pesticides, toxins, and foods). Second, the Study should shed light on practices associated with progress that a particular child makes or fails to make. These might include experiences during labor and delivery, something in the home or school environment-factors we can associate scientifically with their likelihood of suffering an injury, or developing asthma, diabetes, or obesity-a wide range of possible associations. We will be able to address with a combined breadth and depth questions about the interaction of genetic and behavioral characteristics. In simpler terms, we hope to get at things such as the relationships among parenting/abuse/neglect, and may develop a novel understanding of the mechanisms that underlie them. The potential benefit to parents and our children is incalculable. There’s your potential "bang"-if from what we learned in this Study, we were able to reduce the total societal burden from childhood obesity by just 1 percent, the effort would pay for itself many times over, in just one year.

Q: It might be helpful for us to see the analysis you’ve provided Dr. Zerhouni. Can you provide budget justification statements to use in the bureaucratic process, an endorsement that we could sign on to?

Good point. We’ll look at that, and try to do what we can. A sort of "Friends of the Study" coalition is building to organize outside advocacy groups and interests as well.

Q: What help can the Consortium provide?

Help us support the concept and quest for funding the Study. Pick an issue that your agency wants to explore and consider funding your own add-on studies.

Q: Is this an "all-or-nothing" effort?

If forced to cut corners or tighten our belts, we would focus on shoring up the integrity of the large longitudinal study (e.g., subject retention, preserving the sample, maintaining a wide range of exposures to be tested). If resources were limited, we might have to reduce the number or the scope of visits and observations.

Q: What is the justification for such an enormous and expensive undertaking?

This is the main question Dr. Zerhouni and all of us must be able to answer with a compelling rationale, and the answer is implicit in the very size of the Study. Not only is it perhaps the largest such study ever undertaken in children, but it will be by far the richest of large studies, in terms of data. Thus, economies of scale will actually make the numerous datasets very efficiently funded compared with smaller studies. Rich enormous datasets will be made available for countless studies not yet even envisioned. This richness comes from combining and tracking multiple classes of exposures in the same study. Not only can you answer parallel questions at the same time, but you can look at interactions that you couldn’t possibly hope to look at by doing separate unrelated studies in separate cohort populations. Yes, it’s much more expensive to do a broad, enormous, and comprehensive study like this, but it’s less expensive than to do three or four separate studies of this size concurrently.

Q: Think of the possibilities for looking at gene/environment interactions. You’re building a resource that goes far beyond the core questions, something that individual studies could not provide.

People frequently ask us, "Is this a hypothesis-driven study or a data mining study?" The answer is both. Hypotheses are necessary to frame decisions about how we design the study-whom do we sample and how do we do it-and what measures we collect. At the same time, we see the enormous value of the Study as a national resource for many other future analyses. As planners of this Study, we feel obligated to plan it and to collect data in ways that optimize that future potential.

Q: What will be the earliest products and output from the Study?

First will be a set of papers (agreed upon by a steering committee and produced from within the Study structure) that address the core hypotheses. As soon as feasible, we will make these data available to the scientific community and the public in a usable format. This information will, of course, be only the raw material for subsequent analyses, without the resources to analyze them, but others nationally and worldwide will have access, since so many other questions can be answered by this dataset.

Q: How will these additional opportunities be funded?

We’ve always anticipated that there would be a number of adjunct studies beyond the core, although we haven’t yet formalized any process for planning, prioritizing, and accommodating such studies. But it’s a given that has to happen. An Assistant Secretary at HHS is interested in developing that opportunity, and so we’re motivated.

Q: How broad and comprehensive can your conceptual framework be?

The final decisions will require a balancing act that we haven’t tried yet to perform. We believe that the Study will yield a resource of rich data that should not be wasted. From the outset, issues have been raised about which disciplines and questions would be included-the scope. This issue has scientific, political, organizational, and fiscal concerns. Study organizers welcome that healthy debate, and the Study Assembly and meetings like this one represent our attempt to be responsive to those concerns. We’ve heard much more than what is reflected in this meeting. The organization has sorted some issues in order to frame this meeting, but the wiser range of issues has not been selected yet. I think that the next iteration will reflect that.

Q: Some of the issues that have been raised in discussion don’t seem to be still on the table.

We need to emphasize that what you see thus far is only the starting point. These are the just the issues that made it through the first hurdle. Many other hypotheses on other topics remain to be incorporated into this Study. Some are being actively considered; others are being developed; some haven’t even surfaced yet are probably going to wind up in the Study. Those already in-asthma, growth and obesity, pregnancy outcomes, injury, learning, behavior, and mental health-are the obvious first ones over the hurdle, but infectious disease, autism, and many other areas remain to be incorporated. So don’t be discouraged, please.

Q: How do you preserve scientific integrity in such a large, collaborative project?

With so many people involved (various federal agencies, the Working Groups, federal and non-federal scientists, academicians, and committees), you can’t sit down and write a protocol. That must be done by a small core of fully dedicated scientific staff, with iterations passing back and forth, internal and external reviews and feedback, and constant collaboration with the structures that we’ve developed. With NIIH input and help, we are recruiting at least three additional scientific staff to work with the ICC and the Working Groups to sit down and write protocol. We hope to add more scientific staff later on, in addition to the support staff in the Program Office. This additions would occur incrementally, as the program grows.

Q: Traditionally, it’s been hard to overcome societal barriers that undermine participation by such populations in health studies. How can you recruit such people?

The answer is we’re doing everything we possibly can, and we believe it is possible. We feel strongly that it is our mission as a federal agency to study and speak for the underserved and minorities. From the initial planning stages, such hard-to-reach populations have been a priority in the Study. We have been surveying previous people involved with this issue, and find there are lots of experiences around the country working with hard-to-reach, -recruit, and -retain populations. Funders, including EPA and NIEHS, have had a lot of experience in this area, and people all over the country working in pediatric environmental health centers face the challenge every day. We conducted a workshop that focused on the ways a study like this can interact with communities to take advantage of that experience. The Women’s Health Initiative, for example, made hard-to-reach minority populations a priority, and struggled mightily with the difficulties. Ultimately, they succeeded in recruiting and retaining the people they needed to make the study work, and these are the people who can benefit enormously from the Study results. The techniques are there, but you have to learn them, and do them, and commit to making them work.

Q: How can you ensure that those most in need won’t be overlooked in such a large effort? Can you use U.S. Census data on poverty and disability, for example?

We have two Working Groups driven especially by that concern. The Working Group on Health Disparities and Environmental Justice is testing hypotheses about the mechanisms entailed and that may place certain populations at increased risk of the biologic effects from various environmental exposures. We may need to oversample or target certain populations to test the ways in which certain subgroups are placed at increased risk.

Q: How are communities with a special interest represented, such as women focused on childbearing issues?

Well, it’s certainly a prominent part of the Study, with our focus on immediate pregnancy outcomes. But where do you go from there? Congress has reflected the concerns of some advocacy organizations by showing interest that we follow mothers for at least two years after delivery, which seems quite reasonable. It would be great to follow some outcomes in these women for the full duration of the Study, and likely would yield rich insights into a lot of health conditions that are less-directly related, such as long-term diabetes. But you see the cost involved just for the kids. We exist to carry out this longitudinal study in children, as a response to the Children’s Health Act of 2000. The structure we are creating to do that will have the power and potential to embrace a much wider range of exposures and outcomes, and it would seem a shame to pass up the opportunity. But that’s another issue that may only be addressed comprehensively by a national debate over the required resources. There remain, however, at least two Working Groups focused on pregnancy.

Q: How would you do that?

One possibility under consideration is to recruit a substantial portion of the sample before pregnancy. This would yield information about infertility, difficulty becoming pregnant, and pregnancy losses that might occur before a woman is enrolled in this Study (if we waited to recruit only those who are pregnant at some gestational age and seeking care through one of the mechanisms we will use to accrue patients). We would be quintupling the size of our sample at enrollment if we took the "earlier" route. A different sampling strategy would come into play, for example, defining a representative, population-based probability sample of households with women of childbearing age, whom you follow prospectively. Before a woman became pregnant, the information we would collect would be very minimal. However, it’s a matter of not being able to afford to do that much information collection, but you can begin to get at some of those pregnancy issues.

Q: Will the family be considered as context?

Once the child is born, the family will definitely be followed. That also provides a fundamental part of the environment we’re assessing, which we’re conceptualizing very broadly. From both mother and father, we will get detailed medical histories, environmental exposure histories, DNA, and probably other information, as well. We won’t focus on just the physical or chemical exposures; it’s the family in which the child grows and develops; it’s the community; it’s also the school and other influences on this child.

Q: How are people motivated to participate; will you pay them?

We probably will. We’re consulting a wide range of advice, experiences, and contacts about this question. If the Women’s Health Initiative is an example, we also believe a major motivation will be the information it generates for participating families. But we expect to learn a great deal that can benefit individual subjects as we go. For example, there is immediate value in the diagnostic studies and developmental assessments that will be done on these children, and we will share those data with them. And there are specific problems to solve. For example, we’ll be collecting blood lead measures to avoid confounding our results. If we uncover blood lead levels that put a child at risk, we are mandated to share that with subjects.

Q: How will you respond to existing health problems you uncover, such as cancer in children?

When any other conditions or disorders are discovered in the child, we expect to have procedures in place to respond. Often, that will be notification of a primary care physician of record. In other cases, it may become the duty of the investigators to help the family locate the resources to deal with the child’s problem that was identified in the course of the research activity. Traditionally, the research community has responded to that challenge.

Q: What about injuries from auto accidents?

Injury has made the first cut as one of the five primary topics being considered right now under hypothesis development and testing. But none of the hypotheses currently focuses on motor vehicle injuries, per se. We are looking more broadly for generic factors that relate to multiple injuries. If there are specific hypotheses and questions that you think might be amenable to this kind of study and methodology, by all means we’re interested in those.

Meeting Attendees

Robert W. Amler, M.D., M.S.
Agency for Toxic Substances
 and Disease Registry
Centers for Disease Control and Prevention

John Anderson
National Center for Health Statistics
Centers for Disease Control and Prevention

Bob Axelrad
Indoor Environments Division
U.S. Environmental Protection Agency

Lisa Begg, Dr. P.H.
Office of Research on Women’s Health
National Institutes of Health

Cheryl Boyce, Ph.D.
National Institute of Mental Health
National Institutes of Health

Coleen Boyle, Ph.D.
National Center for Birth Defects
 and Developmental Disabilities
Centers for Disease Control and Prevention

Yvonne E. Bryan, Ph.D., R.N.
National Institute of Nursing Research
National Institutes of Health

Virginia S. Cain, Ph.D.
Office of Behavioral and Social Sciences
National Institutes of Health

Denise Dougherty, Ph.D.
Office of Priority Populations Research
Agency for Healthcare Research and Quality

Vivian B. Faden, Ph.D.
National Institute on Alcohol Abuse
 and Alcoholism
National Institutes of Health

Jean L. Flagg-Newton, Ph.D.
National Center on Minority Health
 and Health Disparities
National Institutes of Health

Martin S. Gould, Ed.D.
National Council on Disability

Alan E. Guttmacher, M.D.
Deputy Director
National Human Genome Research Institute
National Institutes of Health

Evan C. Hadley, M.D.
National Institute on Aging
National Institutes of Health

Deborah G. Hirtz, M.D.
National Institute of Neurological
 Disorders and Stroke
National Institutes of Health

Shelly L. Jackson, Ph.D.
National Institute of Justice
U.S. Department of Justice

Tamara Jackson
Office of Science and Technology Policy
Executive Office of the President

Christine L. Johnson, M.D., LCDR, USN
Department of Pediatrics
Uniformed Services University
 of the Health Services

Judith Katz-Leavy, M.Ed.
Center for Mental Health Services
Substance Abuse and Mental Health
 Services Administration

Peter G. Kaufmann, Ph.D.
National Heart, Lung, and Blood Institute
National Institutes of Health

Donald W. King, M.D.
National Library of Medicine
National Institutes of Health

Woodie Kessel, M.D., M.P.H.
Office of Disease Prevention
 and Health Promotion
Office of the Secretary of Health
 and Human Services

Marguerite A. Klein, M.S., R.D.
National Center for Complementary
 and Alternative Medicine
National Institutes of Health

Doreen S. Koretz, Ph.D.
National Institute of Mental Health
National Institutes of Health

Danuta Krotoski, Ph.D.
National Institute of Child Health
 and Human Development
National Institutes of Health

Amal M. Mahfouz, Ph.D.
Office of Water
U.S. Environmental Protection Agency

Susan J. Marsiglia Gray, M.P.H.
Center for Substance Abuse Prevention
Substance Abuse and Mental Health
Services Administration

J. Ricardo Martinez, M.D., M.P.H.
National Institute of Dental
 and Craniofacial Research
National Institutes of Health

Michelle McConnell, M.D.
Division of HIV/AIDS
Centers for Disease Control and Prevention

Joseph J. Merenda, M.S.
Office of Prevention, Pesticides,
 and Toxic Substances
U.S. Environmental Protection Agency

Margaret Ann Miller, Ph.D., D.A.B.T.
Office of Women’s Health
U.S. Food and Drug Administration

Alan N. Moshell, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health

Sheila A. Newton, Ph.D.
National Institute of Environmental
Health Sciences
National Institutes of Health

Donna L. Rickert, Dr.P.H.
Immunization Services Division
Centers for Disease Control and Prevention

Roger R. Rosa, Ph.D.
National Insititute for Occupational Safety
 and Health
Centers for Disease Control and Prevention

Peter C. Scheidt, M.D., M.P.H.
National Institute of Child Health
 and Human Development
National Institutes of Health

Lone Simonsen, Ph.D.
National Institute of Allergy
 and Infectious Diseases
National Institutes of Health

Vincent L. Smeriglio, Ph.D.
National Institute on Drug Abuse
National Institutes of Health

Karyl Thomas, M.D., M.S.
Office of Disease Prevention and Promotion
U.S. Department of Health and Human Services

David G. Thomassen, Ph.D.
Office of Biological and Environmental Research
U.S. Department of Energy

Jennifer Tschantz, Ph.D.
Office of Special Education Programs
U.S. Department of Education

Dennis E. Utter, M.A.
National Highway Traffic Safety Administration
U.S. Department of Transportation

Kishena C. Wadhwani, Ph.D.
Maternal and Child Health Bureau
Health Resources and Services Administration

Mary Bruce Webb, Ph.D.
Administration for Children and Families
U.S. Department of Health and Human Services

Deborah Winn, Ph.D.
National Cancer Institute
National Institutes of Health