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 December 2002 NCSAC Meeting Summary Minutes

The 4th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)

December 17–18, 2002
Baltimore Marriott Waterfront
Baltimore, MD

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) .

Donald R. Mattison, M.D., NCSAC Chair
National Institute of Child Health and Human Development, NIH, HHS

Meeting Goals

  1. Review and discuss sampling strategies.
  2. Action item: Review and discuss recruitment prior to conception.
  3. Review and discuss life-course timeline proposed by the Health Services and Social Environment Working Groups.
  4. Action item: Review, discuss, and prioritize pilot studies.
  5. Review and discuss ethics issues in thematic areas, community outreach, and communications issues in thematic areas.

Tuesday, December 17, 2002

Welcome

Review Meeting Goals, Agenda, and Action Items

Donald Mattison, M.D., Chair, convened the meeting of the National Children’s Study Advisory Committee (NCSAC) shortly after 8:00 a.m. Dr. Mattison reviewed the agenda and briefly reviewed the five themes for the working core hypotheses for the Study that were drafted by the Interagency Coordinating Committee (ICC):

  1. Pregnancy outcomes
  2. Altered neurobehavioral development, developmental disabilities, psychiatric outcomes
  3. Injury
  4. Asthma
  5. Obesity and altered physical development.

These core thematic areas for National Children’s Study (Study) hypotheses were to be discussed further during the Plenary Session later that morning.

Dr. Mattison introduced the first presentation noting that Dr. Christine Bachrach would speak about a broad conceptual framework for the Study that was developed by the Co-chairs of two Working Groups. Dr. Mattison explained that such a framework would be needed because of the diverse disciplines that underpin the Study, and that the framework will be helpful as a timeline is developed with specifics regarding exposures and outcomes.

Health Services and Social Environment Working Group Presentation:
An Integrative Framework for the National Children’s Study Concept Paper

Neal Halfon, M.D., Ph.D., University of California, Los Angeles
William Lawrence, M.D., M.S., Agency for Healthcare Research and Quality
Linda Burton, Ph.D., Pennsylvania State University
Christine Bachrach, Ph.D., National Institute of Child Health and Human Development

Dr. Bachrach presented the framework, which was a joint effort of the Co-chairs of the Social Environment and the Health Services Working Groups. She explained that the Study has ambitious goals and complex challenges. Dr. Bachrach also discussed the purpose of developing such a framework:

  • To help create a common vision for the Study that different disciplines could relate to and that would help facilitate interdisciplinary collaboration and the integration of related hypotheses
  • To guide the development of Study methods for data collection and analysis
  • To help communicate the Study to multiple audiences.

Dr. Bachrach went on to explain that the starting point for the framework was a Halfon and Hochstein paper published in the Milbank Memorial Fund Quarterly in 2002 on “Life Course Health Development: An Integrated Framework for Developing Health, Policy, and Research.” (The paper can be e-mailed on request.) The Halfon/Hochstein framework was broad and inclusive and addressed the complexity of the development of health over time. The group then simplified the framework for this presentation.

Dr. Bachrach’s presentation included the following points (see the handout for further details):

  • Definition of health: A multidimensional and developmental process that influences physical, psychological, and social functioning. Health incorporates both positive and negative aspects, including disease, disability, and the ability of the organism to function effectively.
  • Three major themes or ideas: Nested environments of health, health development over time, and processes and mechanisms that link environment to health development over time.
    1.) Nested environments of health development: There are multiple internal and external influences on child health development; nested environments span the social to the physical and the external to the internal (e.g., family, neighborhood, health services, cellular, chemicals and pathogens).
    2.) Health development over time in multiple domains: environmental and health development trajectories (physiological, psychological, and behavioral) are shaped by cumulative and programming mechanisms.
    3.) Processes and mechanisms of health development, including the concept of constrained choices: health is constrained by resources and capacities available to the organism.
  • Determinants of health were illustrated in several slides, including a slide from Healthy People 2010 that lists determinants as biology, behavior, social and physical environment, access to health care, and policies and interventions. Another slide depicted the health field model showing multiple determinants of health and illustrating feedback effects and pathways. A third slide presented a model of health determinants as "environtype" as well as genotype and phenotype.

Dr. Bachrach summarized her presentation by saying that the proposed framework is useful because of its broad scope of potential determinants of health, because it encourages looking at health trajectories over time, and because it enhances the potential for useful discovery by underscoring the complexity of causal pathways and potential interactions of determinants. She also noted that the Working Group invites comments and discussion regarding next steps and that development of a common vision and useful tool requires input from all Study Working Groups, the ICC, and the NCSAC.

NCSAC members raised a number of questions, expressed concerns, and made other comments:

While the framework will be helpful, is the implication that the Study must touch all of these bases every time, or is there room for compromise if it is not possible to fit in all the measurements?

Dr. Bachrach responded that the framework’s broad approach would help Study planners focus on specific pathways and issues. Dr. Lawrence commented that it would not be necessary to include all aspects each time. Dr. Burton added that the framework would help to develop a common language about issues and ensure that important factors are not overlooked.

The framework design seems pretty solid, and there are serious issues buried in it.

If there were a pop quiz, I would flunk; the language used was not common with my discipline; yet the slide show was useful. A framework can help provide focus.

This is a broad and abstract way of thinking, and concrete examples of how it would be applied would be helpful.

Dr. Bachrach noted that input from other disciplines from within the other Working Groups is needed to develop the framework further.

An observer asked about the child health trajectory and its implications.

Dr. Lawrence commented that childhood health is a complex issue and that it is difficult to define health for specific ages.

What do we measure when? There is a need for practical guidance for measures to be made at specific points in the life cycle.

Dr. Mattison responded that the Working Groups and the Inter-working Group meetings would address these kinds of issues. He also noted that he hoped that by the next meeting of the NCSAC, there would be specific measures within the framework.

Is the primary outcome of interest "health" as opposed to the absence of various diseases? Must health be included as an outcome?

How do you show variability in health? Health is not easy to measure.

Health is not disease. The Study must look at well children, not just at disease outcomes. We need to ask questions about the healthy children to understand those that do get sick.

The diagnosis of disease is a beginning rather than an endpoint. The issue becomes, "Can health be maintained despite disease," versus keeping healthy people healthy.

Most of the children in the Study will be healthy.

The Study planners do not want to leave out positive outcomes.

Dr. Mattison proposed that the draft framework be referred to the Study Design Working Group for comments and feedback to the two Working Groups that developed the framework. During the afternoon, the chairs of the Study Design Working Group would then present an evaluation of the sampling strategies document.

The committee adjourned to join the Plenary Session.

Sampling Strategy Presentation and Discussion

Moderator: Roderick J. A. Little, Ph.D., University of Michigan

Summary of Westat Report

John Kiely, Ph.D., National Center for Health Statistics, Centers for Disease Control and Prevention

Dr. Kiely, a member of the Study Design Working Group, presented an overview of possible sampling designs for the Study that were included in the Westat report. He noted that the lack of hypotheses made Westat’s task difficult. An Expert Panel reviewed a draft of the report in October 2002, and the draft was revised in November 2002. In their review of the report, members of the Study Design Working Group raised a number of concerns and questions.

The Study Design Working Group had prepared a handout, “Thoughts on Obtaining a Study Population for the National Children’s Study.”

The handout highlighted several key questions, concerns, and issues:

  • Is population representativeness necessary?
  • Would a hybrid design be ideal?
  • Study population selection, as well as several other features of the Study design, must await the framing of core hypotheses.
  • The process of sample selection cannot be separated from issues of sample attrition.
  • Power assumptions must be realistic.
  • Costs of the several sample selection designs should encompass the entire duration of the Study.
  • Consequences of design considerations for Study management and standardization.
  • Ethical consequences of design issues.

The report discussed probability-sampling approaches, the household model (two versions) and the medical-office model, and the center model, which could be probability based. The Expert Panel unanimously recommended against the medical-office model. Probability sampling is needed to generalize findings and is essential for determining prevalence rates.

Dr. Kiely also discussed sources of potential bias, geographical distribution, and other issues. He described the household and center model mechanics and costs. He briefly discussed the possibility of a hybrid model, which the Study Design Working Group feels may be necessary.

Dr. Kiely responded to a number of questions related to why the Expert Panel opposed the medical-office model. He also fielded questions on retention issues, costs, and random digit dialing. Dr. Kiely explained that the Expert Panel felt that the medical-office model would be disastrous because of practitioner noncooperation. Regarding retention, Dr. Kiely noted that Westat was not asked to address that issue. He noted that the panel did not discuss costs at length and added that random digit dialing was not seriously considered.

Comments from the Study Design Working Group

Nigel Paneth, M.D., M.P.H., Michigan State University.
Peter Gergen, M.D., M.P.H., Agency for Healthcare Research and Quality

Dr. Paneth, Co-chair of the Study Design Working Group, explained that the Working Group’s concerns revolved around two major themes, whether Westat was given an impossible task and the lack of information base for many key questions. There was considerable concern about attrition in the household model, and Working Group members agree that a hybrid approach may be needed. The Working Group concluded that population representativeness just would not work, it is an unrealistic“holy grail” and, even with limited attrition, in 20 years the sample would no longer be representative. Some Working Group members felt that the center model would be better in certain respects, while others were concerned about the resulting sample. Other comments of Working Group members related to the difficulty of identifying pregnant women outside medical offices, hybrid design ideas that would allow representativeness on a smaller scale, and ethical issues.

Dr. Gergen, Co-chair of the Study Design Working Group, commented on the issue of preconception sampling. An NCSAC member expressed concern about recruiting women under age 16 and about representativeness in light of the federal commitment to eliminating health disparities. Another member pointed out that pregnant teens are a special population and complicated to deal with. Other comments related to the possibility of getting some preliminary answers in five years as opposed to having to wait 21 years. Still other comments focused on the “nuts and bolts”of how the probability model would actually work.

Critique and Comments

Roderick Little, Ph.D., University of Michigan
Robert Michael, Ph.D., University of Chicago

Dr. Little and Dr. Michael commented about a number of issues, including selection bias in the center model, probability samples versus representative samples, oversampling, retention, preconception sampling (which appears to be more feasible in the household model), degree of clustering, and a hybrid model. Dr. Little summed up by saying that he thought that the Westat report was useful despite its limitations and that a hybrid model was worth considering.

Dr. Kiely commented that the Expert Panel had engaged in a lively discussion about these issues. He also noted that members of the Expert Panel had concluded that the center model would be a better choice if delivery room measures were to be included in the Study.

Dr. Michael noted that the Bureau of the Census and large survey organizations have the capacity and experience to conduct random sampling of households. These entities do this type of sampling routinely. Door-to-door screeners are used to find out who lives in a household.

Comments from the Social Sciences

Angus Deaton, Ph.D., Princeton University

Dr. Deaton, an economist involved in studying medical and nonmedical determinants of health, spoke about “Design Issues in the National Children’s Study.”

He discussed the household versus the center models. Using randomized clinical trials (RCTs) for approval of new drugs as an example, Dr. Deaton made a case that the Study must use a randomized household sample in order to assure representativeness.

Dr. Deaton also discussed problems with the center model, such as selection bias, ownership of data, and the problem of attrition due to high rates of family mobility. He summarized by saying that behavioral scientists were opposed to the center model and to a nonrandomized sample, that birth cohorts were preferred, and that alternatives need careful assessment. Dr. Deaton acknowledged that these are difficult issues, and everyone in the Study wants to know about the hypotheses and what the Study intends to measure.

There was considerable discussion after Dr. Deaton’s presentation. Dr. Kiely commented that while the RCT example is useful, environmental exposures do not occur at random, and the Study planners must use their prior knowledge of exposure distribution. He also noted that selection bias is tied to representativeness. Dr. Deaton responded that selection bias in the center model was a serious concern. Dr. Kiely pointed out that survey research centers within the medical centers could manage sampling for the area served.

Dr. Goldman commented that data quality is another important issue while it would be a burden to get prenatal data, this information also must be of high quality.

Dr. Michael offered that identifying and recruiting the sample population are two separate issues. The first list should be drawn using a probabilistic approach.

Another participant argued that no sample will still be representative in 20 years and that it is extremely important to understand the realities of sample selection.

Dr. Kiely mentioned that defining a birth cohort by using birth certificates was not considered because previous attempts using this approach had failed.

Dr. Little observed that it is possible to do random sampling within center-based clusters.

Dr. Dudley expressed the view that the Study will not really be a survey. Rather, it will be interventional in nature, and the Study will need to obtain sufficient data to determine causality. Without prenatal data, causality cannot be shown. Dr. Little responded that while prenatal measures may be necessary, in his view the Study will not be interventional, but observational in nature.

Dr. Goldman asked for clarification regarding ownership of Study data. Dr. Mattison referred the question to Dr. Scheidt. According to Dr. Scheidt, the ICC has begun to draft a policy on use of Study data (including ownership). The ICC wants to assure that there will be maximal and optimal use of the data, no matter who does the analysis. The ICC is also considering proposing to fund targeted analyses to ensure that certain hypotheses are analyzed and questions are answered.

Regarding drawing a sample using birth certificates, Dr. Scheidt noted that Westat’s instructions were to assume prenatal data collection, which ruled out the use of birth certificates. Dr. Little suggested that it might be useful to have a sample of births as part of a hybrid design. Dr. Deaton agreed and added that understanding how a sample is selected is essential when analyzing data.

Pre-Conception Recruitment: Presentation and Discussion

Moderator: Donald Dudley, M.D., University of Texas

Presentation and Discussion of Fertility and Early Pregnancy White Papers

Germaine Buck, Ph.D., National Institute of Child Health and Human Development, NIH

Dr. Buck, chair of the Fertility and Early Pregnancy Working Group, discussed preconception recruitment issues. She made three points: (1) that human development occurs early in pregnancy, before women know they are pregnant; (2) that it is difficult to reconstruct a pregnancy history after the fact, and such data are often not very reliable; and (3) regarding design utility and feasibility, that it is no harder to enroll women prior to pregnancy than during pregnancy.

Dr. Buck noted that five white papers have been developed. The Working Group is making final edits and hopes to submit these papers for publication in January to Environmental Health Perspectives.

Dr. Buck commented that even if women arrive in prenatal care early, it will be too late to get all desirable data. She emphasized that conception and pregnancy are dynamic, and that the father is important. Dr. Buck noted that when women become pregnant, they often begin to behave differently; yet they may not recognize exposures of interest to the Study. Regarding sampling, Dr. Buck gave examples of methods to recruit couples before pregnancy, noting that investigators have addressed these issues.

Charlotte Hobbs, Ph.D., Co-chair of the Birth Defects Working Group, also spoke. Dr. Hobbs mentioned that the Birth Defects and the Fertility and Early Pregnancy Working Groups have discussed these issues, including the best time to identify and enroll women. The groups concluded that it would be ideal to include some women prior to conception.

Dr. Hobbs pointed out that birth defects affect 250,000 babies each year and are a major cause of mortality. Most studies dealing with this issue are case-control studies. She stressed the importance of understanding early exposures and the difficulties in collecting sound data when women are asked to recall preconception exposures (such as medicines, fevers, and nutrition). Dr. Hobbs urged the NCSAC to recommend that the Study should include the association of preconception and early pregnancy exposures by enrolling women before they conceive.

Kent Thornburg, Ph.D., a member of the Early Origins of Adult Health Working Group, commented about the changes that occur in the early stages of pregnancy and that the mother’s nutritional state prior to implantation determines child size. If the mother is undernourished, the child will have a low growth trajectory. Also, growth-restricted babies at term have a higher risk of cardiovascular disease later in life. He concluded that it is very important to include a pre-pregnancy population to help understand these issues.

Discussion by NCSAC: Should Pre-Conception Recruitment be Included in the Study?

Questions, comments, and responses from Dr. Buck and others included the following:

How extensive would data collection be? Would it be a questionnaire? Blood tests?

The Fertility and Early Pregnancy Working Group is addressing these questions, looking at surveys and biological monitoring.

How often would contact be needed every three months?

That has not yet been determined; however, it would be necessary to capture baseline data for both parents. Dr. Scheidt commented that the Westat household sample model assumed a 15-minute interview, and then telephone contact, followed by a 45-minute interview when pregnancy occurs. Dr. Buck said that it is highly likely that couples could conceive before the Study could contact them, even if they are not trying to do so.

What age group would be enrolled? Would the Study cohort be limited to women age 18 and over?

This has not been decided yet.

Many households do not have traditional “couples,” and women under age 18 often become pregnant. This is a significant population, so how do we resolve this?

Most unplanned pregnancies end in abortion. Not all bias is bad, and there are approaches we can use, please see the white paper.

Dr. Hobbs commented that birth defects occur both to those who plan and those who do not plan pregnancy. She stressed that more information about organogenesis period exposures is needed, and it would be unfortunate to miss this opportunity to obtain important data.

How long would the follow-up be? 10 years or more?

Shorter-term outcomes can be tracked as well as longer-term outcomes.

Contraceptives are poorly used among teens, and many teens desire pregnancy. We do not want to encourage teen pregnancy.

What samples would be needed?

We would need blood samples and semen, if possible.

What happened to the hypothesis relating to ART [assisted reproductive technology]?

There were issues because it is such a small subset. At the September meeting, the NCSAC recommended that it be set aside for the time being.

How will the Study define preconception, and when are measurements needed? This is important in relation to short half-life exposures. Will daily samples be required? It is not clear that these issues have been thoroughly considered.

An NCSAC member responded regarding the number of specimens needed. One study used repeated baselines every six months. If the exposure is known, it is possible to determine when to collect the data.

Would the women have to be trying to conceive to be included in the Study?

No, we hope to capture information from both groups. The key is to reach women of reproductive age.

What specimens would be collected in the home?

His and hers fertility kits would be used; there would be no daily urine specimens. The Study should capture early pregnancy loss.

Are daily tests required to capture the day of conception?

Yes. Fertility monitoring has a short-term burden but a great yield.

This will be expensive and difficult. Is it a goal of the Study to do preconception enrollment and testing? This issue should be placed on a level playing field with all the other hypotheses.

The Study could use a nested exposure stratification strategy. An alternative design could use a cohort of parents of newborns who may get pregnant again.

Yes, but such a design would miss out on those having trouble getting pregnant.

The Study could face serious controversy if teens are involved.

The Study should not focus on teens for this purpose; there is no reason to skew the sample that way.

Additional comments related to the increase in infertility in women aged 20 to 24 (especially nonwhite women), the limitations of census data, and the fact that communities can change rapidly due to population mobility. One member described a study in Pittsburgh that offered recruits four protocols and let them choose. Approximately 74 percent chose the most intensive approach.

It was generally agreed that there are probably many ways that preconception data could be obtained. Study planners should determine the merit and feasibility of several different options.

NCSAC members made a number of positive comments about the presentation. One member noted that it appears that the various ideas for preconception data collection are beginning to crystallize. Another Committee member commented that there is general agreement that obtaining preconception data would be ideal. At this point, the key questions revolve around the costs in time and in resources.

Dr. Dudley suggested that the Assembly provided an opportunity for the Fertility and Early Pregnancy and the Birth Defects Working Groups to work with the Study Design Working Group to flesh out proposals.

Dr. Mattison urged the Working Groups to continue planning.

Issues and Concerns in Thematic Areas

Moderator: Alan Fleischman, M.D., New York Academy of Medicine

Presentation of Ethics Issues and Concerns

Dr. Fleischman noted that there are many viewpoints regarding epidemiological and statistical issues and study design. Yet there is only one ethicist on the NCSAC. The Ethics Working Group does have leading pediatric ethicists involved, and the Working Group has tried to address ethics issues and concerns. A white paper has been drafted regarding relevant regulations and related issues.

Ben Wilfond, M.D., Co-chair of the Ethics Working Group, spoke about the activities of the Working Group. Dr. Wilfond indicated that there will be a workshop on “lessons learned” related to procedural issues, although the exact date has not been set.

Dr. Wilfond also explained that interesting issues regarding the conduct of the Study include how Institutional Review Boards (IRBs) will deal with a study of this magnitude, and whether people will participate. Critical issues include:

  • Recruitment (such as reimbursement questions)
  • Consent (a challenging issue as an ongoing consent process will be needed)
  • Standards
  • Risks
  • Return to the communities and individuals
  • Responsibility for remediation if environmental hazards are found.

There will need to be a mechanism to cope with these kinds of issues.

The Ethics Working Group recommended a three-pronged approach: (1) that dedicated Study staff with ethics experience be hired; (2) that the consent process be centralized and coordinated through some kind of office of communication; and (3) that the Ethics Working Group could act as an independent advisory committee to help identify and study issues and provide input. A diagram was displayed.

Dr. Fleischman commented that he shared Dr. Wilfond’s concerns and said that there is a controversy regarding IRBs because of local versus central review. He mentioned that the National Cancer Institute is experimenting with central review and raised the question of what a central IRB would look like. Dr. Fleischman explained that local IRBs cannot be omitted, but that they should be provided with incentives. If many IRBs were involved, it would be a problem. He added that there are some interesting ideas about liability issues. Another issue is the need for continual communication with the cohort, which will be critical for informing them as well as for retention. With young people, there are assent as well as consent issues. He summarized that there is a need for an ethics advisory group of some kind to make recommendations to the Study on these kinds of issues.

Other comments related to returning the results of the Study to participants and teen consent issues. In response to a question about whether ethicists could both conduct the research on ethics and guide the Study, Dr. Wilfond said that separate groups would be needed, and, in fact, there are three separate functions related to ethics.

Dr. Dudley suggested that the Ethics Working Group be elevated to a sub-committee of the NCSAC and that a representative of the Working Group could become an NCSAC member.

A member mentioned the significant issue of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations and the effects they will have.

Further discussion touched on genetic data, the upcoming workshop, possible conflict between individuals and their communities, and the sophistication of communities with regard to the questions they need to ask. Other comments related to involving people in target communities early to promote cooperation, taking necessary precautions to ensure that communities are protected, barriers to including mental health outcomes, and the need for assistance in exploring liability issues.

Dr. Scheidt stated that Dr. Alexander, the Study Program Office, and the ICC are aware that more Study staff are needed, and that the recommendations of the NCSAC will be heeded.

Dr. Mattison noted that the NCSAC would need to review the proposed structure from the Ethics Working Group. He also introduced two new staff members, Candice Jalonen, M.P.H. (CDC) and Frank Holloman, M.S.W., M.A. (NIH). Dr. Mattison reminded the NCSAC of the discussion forum that evening and mentioned that ICC and investigators from the NIEHS/CDC/EPA Children’s Environmental Health Centers would meet on Wednesday. The NCSAC meeting was adjourned until Wednesday.

Wednesday, December 18, 2002

Dr. Mattison reconvened the NCSAC meeting at approximately 8:30 a.m.

Unresolved Issues from Yesterday, Thoughts, or Additional Comments

Dr. Philip Landrigan provided an update about the Children’s Environmental Health Centers. There is a national network of 12 child health research and prevention centers, funded by NIEHS, EPA, and CDC. Much of the work going on in these centers is relevant to the Study and both are intellectual products of the work that resulted in the Children’s Health Act of 2000. According to Dr. Landrigan, there are at least four prospective birth cohorts up and running; the centers have successfully retained children and have had good experience communicating with families. He suggested that “lessons learned” from the centers could be included in the June 5-6, 2003, NCSAC meeting.

Comments were positive, although Dr. Kumanyika commented that there is a need to avoid duplication and excess burden on the centers. Dr. Mattison said that he would take comments to the ICC. Dr. Goldman commented that there are many other studies underway that can also contribute their information and experience. Dr. Graham added that it is important to encourage multidisciplinary crosstalk and that the Working Groups need to link with each other.

Dr. Landrigan suggested obtaining upcoming meeting dates of the Centers to allow an opportunity to attend. Dr. Kumanyika suggested placing ads in journals regarding the interest of the Study in methods to “kick up the dust,” and state-of-the-science articles could be prepared and published in journals such as Environmental Health Perspectives. Dr. Mattison said that people have been asking how to get academic credit for their efforts, and that he would think about the idea of placing ads.

Dan Swartz suggested contacting advocacy groups; Dr. Doswell suggested contacting the NIH National Center for Minority Health and Health Disparities. Dr. Mattison said that a letter was sent from a group of Study advocates to President Bush regarding funding for the Study. Dr. Fleischman added that CDC has funded a group of urban research centers that have much expertise.

Presentation and Discussion of Proposed Pilots

The review of proposed pilot studies, reviews/papers, and workshops began with the presentation of two proposals not included in the Briefing Book that resulted from the Fetal and Neonatal Growth and Development Workshop held on Monday, December 16. Gary Hankins, M.D., and George Saade, M.D., of the University of Texas Medical Branch presented the two proposals.

Gardosi Growth Potential Model Pilot Study

First, the group would like to test the Gardosi growth potential model in a U.S. population. The model appears to be better than the traditionally used population-based norms for identifying intrauterine growth restriction. Many of the proposed core hypotheses relate to fetal growth.

There is an existing large cohort study of 40,000 patients that has ended (the FASTER trial) and the cost would be to analyze the data. The FASTER trial was an NICHD study conducted at 11 centers in the U.S. Pregnancy outcomes from the study would first have to be subcategorized.

There were several questions and comments from members concerning how ethnicity is coded in the Gardosi model. Dr. Saade said that there are several categories but he did not have the specifics. One member indicated that she could not endorse the proposal without having additional information about ethnicity coding.

There was also a question about other variables used in the model, and Dr. Saade explained that the model was tested in Europe in a study of 40,000 normal pregnancies and it found 6 different variables that correlated with growth, then individual growth charts were developed for the babies. We may find that in the U.S., different variables apply. The idea is to use the same methods to develop a set of variables suitable for the U.S. population.

Drs. Hankins and Saade responded to other questions:

What would be the cost and the number of people needed?

We do not have that yet. The cost is to analyze the data.

Must all records be subcategorized?

No, a subset could be used.

Why is this pilot needed for planning?

It is needed because current definitions and methods are not adequate.

Who would be involved in the statistical team?

We hope to work with Jason Gardosi himself.

One member commented that there are disparities in U.S. environments that affect birth weight and growth, and expressed concern that the model might expect a small baby from small parents. The Study needs sensitivity, this is an environmental study, and not everything is genetics. Another member added that it is also possible to misclassify a baby as small that is supposed to be small.

Additional comments included:

It is important that we are able to identify growth restriction very early, we need something better for immediate use.

The Gardosi model can identify children at risk much earlier and 40,000 is a good number. We do not have a handle on good predictors of the link between fetal growth restriction and fetal death.

We need to think about the policy implications of this.

3D Ultrasound Pilot Study

The second proposal presented by Drs. Hankins and Saade concerned the feasibility and acceptance of doing 3D ultrasound. 3D ultrasound produces a huge number of data points and volume data that can be stored, and storage costs are going down. The group would like to evaluate patient acceptance of the procedures. The data would not be used clinically, but archived for later analysis.

Questions, comments, and responses included:

What is the cost of the machine?

The machines cost $400,000 each.

How does 3D differ from 2D ultrasound?

3D ultrasound measures volumes, and data can be stored.

Are there standardized procedures?

Not yet.

Can 3D make precise measurements of organs?

Yes.

Additional questions related to whether 3D would replace 2D over time, the possible use of 3D after birth, the amount currently charged for a 3D ultrasound, and how long it would take to obtain the measures. There was a comment that many of these machines are already in use, and the Study could limit the 3D measures to centers that already have the machines.

Dr. Mattison summarized by emphasizing that there is clearly interest in both pilot proposals, but more detail and justification are needed, as well as clarification of value-added versus cost. He stated that the presenters should take these comments back as feedback for further information that needs to be presented to the NCSAC.

Dr. Landrigan observed that there seemed to be more enthusiasm for the second proposal than the first.

Dr. Scheidt pointed out the potential for conflict of interest if those proposing the pilot propose certain tools or techniques and/or propose to do the analysis. He stressed the need to be cautious about this type of proposal. An NCSAC member asked whether it could be stipulated that someone else do the analysis, and said that perhaps the Program Office could look at alternatives as to who could do the work.

Other comments included a suggestion to do the 3D ultrasound with a relatively small sample, and a comment that the measurement of intrauterine growth will be important and must be workable. Some members expressed skepticism that 3D is significantly better than 2D ultrasound and that it is not clear that 3D will improve pregnancy outcomes; however, it may prove to be a significant advancement in the future. A member pointed out that technology sometimes develops because of the “cute and cool" factor,” which is used for marketing.

Following a short break, Dr. Mattison continued the process of reviewing proposals for pilot studies.

Dr. Mattison explained that these proposals came from various Working Groups; that they include pilot studies, reviews and papers, and workshops; and that Study staff has already reviewed the proposals. Dr. Mattison stated that the NCSAC was to consider whether the proposals made sense, whether more information was needed, and whether the proposals were appropriate or duplicative of other work. He explained that the Working Groups have identified these proposals as high priority and said that it is appropriate to ask for more information if desired, including cost information.

There were questions concerning the roles of the ICC and NCSAC and whether anyone has assured that the proposed studies are not already being done, and a member commented that it would be helpful to group together related proposals. Dr. Mattison explained the concept clearance process that NIH uses to identify important areas for research; the process leads to decisions regarding RFPs or preliminary work that is needed, and so forth. This review is a similar process. Dr. Mattison added that the process could be revised, if necessary.

Dr. Scheidt commented that when the Program Office proposes to fund pilots, it must use the standard funding mechanisms available to NICHD. Dr. Alexander must approve them and the first thing he will want to know is what the NCSAC thinks about these proposals. Dr. Scheidt said that while the proposals generally were not detailed enough yet to allow a full review, the NCSAC could make a rough determination relative importance and that would be helpful to the Program Office in prioritizing pilots. He described varied funding mechanisms that could be used, such as an interagency agreement and existing centers or an umbrella contract vehicle for conducting private studies.

The NCSAC then addressed each of the proposed pilot studies and made comments.
(Note: P = pilot study, R = review or paper, and W = workshop)

P42: The utility of frozen breast milk in accurate assessment of environmental toxicants or their metabolites, and metabolic, nutrition, and genomic endpoints

Source: Early Origins of Adult Health Working Group
Reviewers: Judith Graham, Ph.D. and Daniel Swartz

Regarding this proposed pilot study, Dr. Graham said that the science regarding when and how is open to question. The proposal may need some modification but it is pretty much ready to go.

There were a number of comments about unanswered questions regarding breast milk and about contacts that should be made, particularly the Chemical Exposures Working Group. In response to comments about whether a literature review has been done, Dr. Graham said it appears that the Working Group reviewed the literature and found only a handful of existing publications.

Dan Swartz agreed with Dr. Graham and said it would be good to answer all the breast milk questions at the same time. He mentioned that there was a recent EPA symposium held related to breast milk monitoring and that those findings should be integrated into the study.

The consensus recommendation was that this pilot study should be done, with modifications.

R24: Review of methods for measuring physical activity across different age groups

Source: Early Origins of Adult Health Working Group
Reviewers: Daniel Swartz and Grace LeMasters, Ph.D.

Dan Swartz recommended that this literature review should happen soon, as the Study will need to develop good methods for measuring physical activity if the review shows that they do not yet exist. He said that there is time to develop new methods, as physical activity becomes more important as a child gets older. He added that physical activity is a dependent as well as an independent variable.

Dr. LeMasters had no additional recommendations but commented that physical activity in the pregnant woman is a key variable that should be assessed at different time points. She said that this is a reasonable literature review that is needed.

Dr. Spence commented about nationwide standardization being set up by multiple General Clinical Research Centers (GCRC) regarding physical activity and pulmonary function in autistic children and said this will be a useful resource. She added that the Study will not look at genetics but must consider genetics when relevant. Dr. Kumanyika commented that the concept is not well developed; the technology is changing rapidly to measure physical activity, and more information is needed.

The consensus was that this review is recommended.

W23: The utilization of methods and biomarkers to study childhood asthma

Source: Asthma Working Group
Reviewers: Daniel Swartz and Jonathan Samet, M.D.

Dan Swartz said that this is a controversial area that has been discussed extensively and that the two-day workshop proposed will not help clarify the issues. He did not find the proposal worthwhile. Dr. Samet agreed and said that a pilot study is probably needed instead of a workshop. He added that there is a need to collate instruments and protocols (see also W22, “Questionnaire and diary-based methods for the early assessment of asthma-related health outcomes,” below).

The consensus was that this workshop is not recommended.

W22: Questionnaire and diary-based methods for the early assessment of asthma-related health outcomes

Source: Asthma Working Group
Reviewers: Shiriki Kumanyika, Ph.D., M.P.H. and Jonathan Samet, M.D.

Dr. Samet said that rather than having a workshop, the Study should just move ahead on the design related to the asthma hypotheses. Dr. Kumanyika agreed.

The consensus was that this workshop is not recommended.

P9, R7, and W3: Methods development for successful cohort retention in a longitudinal follow-up of children and families

Source: Study Design Working Group
Reviewers: Jonathan Samet, M.D. and Grace LeMasters, Ph.D.

Dr. Samet said of course this should be done and suggested that emphasis should be placed on sharpening up the proposal and doing a pilot study. He said that a glossary of terminology and methods would be helpful so that everyone could understand what is being discussed, and that the proposal was vague. He stressed that there is no need to review lessons learned from the past 50 years. Dr. LeMasters asked what would the pilot be, it was not clear. The workshop does not sound useful as described, lacks clear, specific goals, and needs a lot more revision. Dr. Samet said he agreed.

There was extensive discussion. Dr. Spence said they should talk to those who did the studies with successful recruiting and retention mentioned in the Plenary. Dr. Dudley said that this was the first mention of HIPAA, and perhaps there should be a workshop on HIPAA. He said that the Study Design and Ethics Working Groups could jointly address ethics policy issues related to HIPAA. Dr. Michael said it may be premature to assemble a group to look at this now and it could be targeted more effectively once it is known what data the Study will actually collect and how. Dr. Kumanyika was supportive of a literature review and said that the Community Outreach and Communications Working Group should be involved in this. Dr. Landrigan suggested tying this to the Children’s Centers and said that the Columbia and Mt. Sinai Children’s Centers have proposed a workshop involving their community partners regarding lessons learned. Dan Swartz noted that the Environmental Justice Working Group is not involved in this and should be.

Dr. Mattison summarized that there is some enthusiasm for the literature review, and it is recommended to be done first, before a pilot or a workshop.

There was some discussion concerning HIPAA and Dr. Dudley’s suggestion of having a workshop. Dr. Fleischman said that HIPAA is worrisome now, but by the time that the Study is recruiting, many issues may have been worked out. He added that there was an NIH advisory group on HIPAA. Dr. Mattison said that he could bring in someone to the next NCSAC meeting to discuss this issue. Dr. Suarez commented about state laws related to HIPAA, and Dr. Goldman said that there is a need to collate information about state laws.

It was agreed that Dr. Mattison would invite someone to speak on HIPAA at the March NCSAC meeting.

P19 and W16: Feasibility of longitudinal assessment of fetal development and environment, and their effect on neonatal function; methods for fetal and newborn assessment

Source: Pregnancy and the Infant Working Group
Reviewers: David Bellinger, Ph.D. and Roderick Little, Ph.D.

This was not discussed, as neither reviewer was present. However, Dr. Dudley said that he would discuss it with Dr. Cathy Spong to see if she was still interested. The NCSAC agreed to proceed with that.

P21: Evaluation and validation of accessible biological samples as surrogates for analyzing molecular and cellular events in inaccessible tissues

Source: Fertility and Early Pregnancy Working Group
Reviewers: Willa Doswell, R.N., Ph.D. and Robert Michael, Ph.D.

Dr. Doswell said she was not sure how to evaluate the proposal with regard to time urgency, but that she thought it should be done with revisions. Dr. Michael was also uncertain what to say about it. Dr. Spence said there were problems with this proposal and that more information was needed; however, it may be useful to go ahead with it with revisions. Dr. Dudley said most of this is being done, and the rest is RO1 potential. Dr. Graham said that, rather than a pilot study, this sounded like a major research program.

Dr. Mattison summarized that this was not to be recommended, but that comments would be given back to the Working Group.

P23: Telomere length as a chromosomal biomarker of growth variation and chronic disease risk in children

Source: Early Origins of Adult Health Working Group
Reviewers: Donald Dudley, M.D. and Ken Sexton, Sc.D.

Dr. Dudley said this is a high-risk proposal. Dr. Spence said that it is good science and methods, but it might be hard to justify doing this as aStudy pilot study; perhaps it should be an RO1 instead. She said others are already doing similar work. Dr. LeMasters asked if the pilot would help to make a decision about measures to be included in the baseline data collection that will be done at all Study Centers. Other members questioned the need for a pilot study on this and suggested that this component of the Study could be designed now. A pilot could be done if they find an unknown along the way to study.

Dr. Mattison summarized that the measures should be integrated into the protocol instead of doing a pilot study first.

P29 and R17: Measuring variables stemming from housing quality and characteristics and how they may be incorporated in the Study

Source: Social Environment Working Group
Reviewers: Alan Fleischman, M.D. and M. Anne Spence, Ph.D.

Dr. Fleischman said that this is important and a literature review would be needed before doing a pilot study. The Study needs to address the implications of finding illegal and dangerous environments that can cause injury to children. Dr. Spence agreed and said it needs some revisions but should be done, and there was a need to coordinate with the Exposure to Chemical Agents Working Group. Dr. Kumanyika said that there is overlap with P43 (“Administrative and other data on individuals and areas”), which also is housing-related. Other members mentioned additional contacts that should be made, including Dave Jacobs at the U.S. Department of Housing and Urban Development (HUD), who has completed data collection for a national survey.

Dr. Scheidt said that Dave Jacobs had recommended a person to co-chair the new Physical Environment Working Group that is being formed.

There was further discussion about ethical issues related to safe housing and it was suggested that the Ethics Working Group be involved.

Dr. Mattison summarized that it is recommended to go forward with this, but in consultation with the Ethics Working Group.

Following the lunch break, the review continued.

P19: Feasibility of longitudinal assessment of fetal development and environment, and their effect on neonatal function; methods for fetal and newborn assessment

Source: Pregnancy and the Infant Working Group/Program Office
Reviewers: David Bellinger, Ph.D. and Roderick Little, Ph.D.

P34: Statistical methods for the life course approach to the development of chronic disease: causal inference, collinearity, interactions, and sample size

Source: Early Origins of Adult Health Working Group
Reviewers: Roderick Little, Ph.D. and Stephen Spielberg, Ph.D., M.D.

Proposals P19 and P34 were not discussed, as the reviewers were not present. Any comments should be given to Dr. Mattison.

P41: Feasibility testing and validation of gross and histologic placental measurement instruments for the National Children’s Study

Source: Early Origins of Adult Health Working Group
Reviewers: Lynn Goldman, M.D. and Lucina Suarez, Ph.D.

Dr. Goldman said that this seems like a reasonable pilot study, it’s a good proposal. Dr. Suarez agreed. Another comment was that it correlates with P29 (“Measuring variables stemming from housing quality and characteristics and how they may be incorporated in the Study”).

The overall response of the NCSAC was favorable but the authors need to link up with others.

R13 and W10: Definition and quantification of effects of maternal stress on pregnancy, labor, and childhood health

Source: Pregnancy and the Infant Working Group
Reviewers: Grace LeMasters, Ph.D. and Willa Doswell, R.N., Ph.D.

Dr. LeMasters said that this should be done as a white paper only. Dr. Doswell said that the proposal was missing the behavioral and cultural aspects of stress.

The NCSAC agreed to recommend that a review be done first, then a white paper.

R14: Review of family effects on child health outcomes

Source: Social Environment Working Group
Reviewers: Robert Michael, Ph.D. and Donald Dudley, M.D.

Dr. Michael said he thought that it was good idea and it is doable at the level of a literature review.

The NCSAC agreed to recommend that the review be done.

R16: Review of research on rurality and child health

Source: Social Environment Working Group
Reviewers: Ken Sexton, Sc.D. and Alan Fleischman, M.D.

Dr. Fleischman said that this was a good subject for a review.

The NCSAC agreed to recommend this but with the caveat that additional expertise may be needed.

R19: Environmental exposures: beyond the usual suspects

Source: Pregnancy and the Infant Working Group
Reviewers: M. Anne Spence, Ph.D. and Philip Landrigan, M.D.

The reviewers were negative on this proposal and said it was unnecessary.

R20: Review and critical assessment of scientific benefits and disadvantages, feasibility, and cost of approaches to sampling environmental exposure specimens during the follow-up of the cohort for the National Children’s Study

Source: Study Design Working Group
Reviewers: Philip Landrigan, M.D., and Lynn Goldman, M.D.

Dr. Landrigan found it a reasonable proposal. Dr. Goldman was more critical and said that we need to bring together people who are doing this work now. Dr. Graham suggested that they get in touch with the Exposures to Chemical Agents Working Group chair.

Dr. Mattison summed up that the committee agreed that there should be a white paper and that the authors should make contacts with others as suggested.

R22: Assessing dietary intakes and patterns in women and young children: methodological issues with implications for the design of the Study

Source: Early Origins of Adult Health Working Group
Reviewers: Stephen Spielberg, Ph.D., M.D., and Judith Graham, Ph.D.

Dr. Graham said it will be important to get dietary exposure measurements right, as they are integral to many of the core hypotheses. Dr. Spence said that a workshop could be done to work out the issues identified by the white paper.

The conclusion was to go forward with this review and to interface with the Exposure to Chemical Agents Working Group.

Dr. Scheidt spoke about staffing issues and the development of a technical research support contract. The Statement of Work will include the development of literature reviews, white papers, etc. This contract will allow the Study to move forward on parallel paths. They are trying to fill three in-house staff positions at the moment. There was some discussion about the need for finding talented authors with good interpretation and judgment and that perhaps the Working Groups could advise about possible authors. Dr. Scheidt reminded the NCSAC about the potential for conflict of interest and that the open contract process will allow the Working Group people to compete for funding.

R23: Measures for evaluating cognitive development

Source: Interagency Coordinating Committee (ICC)
Reviewers: Lucina Suarez, Ph.D. and Shiriki Kumanyika, Ph.D., M.P.H.

Dr. Suarez said that this should be done. There was some discussion about work already being done and Dr. Spence mentioned some things that should be included related to developmental disabilities, autism, and measures of children at different IQ levels.

The committee recommended that this go forward and that the Working Group be referred to others working on this.

R25: Methods for assessing timing of pubertal maturation in a longitudinal cohort study: measures, frequency, and type of contact

Source: Study Design Working Group
Reviewers: David Bellinger, Ph.D. and Robert Michael, Ph.D.

Dr. Michael said the puberty of the children in the NCS is a decade or more off, and clinical techniques may change, thus this one could be postponed.

The committee agreed to recommend postponing this one.

R26 and P34: Statistical methods for the life course approach to the development of chronic disease: causal inference, collinearity, interactions, and sample size

Source: Early Origins of Adult Health Working Group
Reviewers: Roderick Little, Ph.D. and Stephen Spielberg, Ph.D., M.D.

These were not discussed, as the reviewers were not present.

R29: Prioritizing child health outcomes: methods development and application

Source: Study Design Working Group
Reviewers: Roderick Little, Ph.D. and Stephen Spielberg, Ph.D., M.D.

This was not discussed, as the reviewers were not present.

W6: Methods for fetal and newborn assessment

Source: Pregnancy and the Infant Working Group
Reviewers: Donald Dudley, M.D. and Ken Sexton, Sc.D.

Dr. Dudley said this might be worthwhile as the current literature is already obsolete. The NCSAC generally agreed that the workshop should be done, but after further discussion it was decided to wait until the Fertility and Early Pregnancy Working Group returns with additional information as the NCSAC had requested.

Dr. Mattison said that a recommendation would be deferred until after the Working Group reports back.

W13: Workshop on existing studies of the social environment and child health/development

Source: Social Environment Working Group
Reviewers: Lynn Goldman, M.D. and Stephen Spielberg, Ph.D., M.D.

Dr. Goldman said that this could be valuable and should be done early on. Dr. Kumanyika said that it should touch on all relevant social factors at multiple levels.

Dr. Mattison summarized the recommendation that this workshop be done but that it should be broad in scope.

W21: The impact of health care system on childhood health outcomes

Source: Health Services Working Group
Reviewers: Judith Graham, Ph.D., and Lucina Suarez, Ph.D.

Dr. Graham said that while the most vulnerable children do not get good medical care, the Study participants may get better care, and how the Study will deal with this is an issue. Dr. Suarez said she found the proposal vague. Dr. Landrigan said that the questions were important, but that the Study may not be the right venue. However, it will be important to know about the health care that the children in the Study are getting. Dr. Fleischman asked how the Study would deal with children who are entitled to insurance but not getting it. There was some further discussion.

Dr. Mattison summed up that the committee felt that they should think about the sensitivity of the outcome in the context of the NCS and that there are a number of questions that must be answered before a recommendation can be made about a workshop.

What’s Next? (Remaining Issues)

Dr. Spence said that she thought it was time to make a list of what the NCSAC is prepared to recommend at this point regarding issues such as enrolling teen mothers, and whether the Fertility and Early Pregnancy Working Group should be asked to drop ART pregnancies from consideration. There could be another list of topics on which more information and discussion are needed. There was some discussion about this and how to do it, for example, via email or after the minutes are received.

Dr. Mattison said that questions must be answered in this meeting, and if there are clear recommendations, they should be listed; however, a single dissenter is enough to keep these items open for discussion.

Dr. Graham said that the core hypotheses would drive the Study. Dr. Mattison said that by the next meeting, the core hypotheses will have been fleshed out and the Study Design Working Group would have scored them. The NCSAC can study them before the next meeting.

Dr. Dudley said that he expected that there would be detailed results from the Working Groups that would help move things forward. Dr. Michael said it would be good to make some decisions now before new members come on board.

A concern was raised about the architecture of the data structure (including ownership and access issues) will be important to the scientific community and there was some discussion about these issues. Another concern mentioned was the issue of the observational versus the interventional nature of the Study.

The discussion returned to the issue of enrolling teen mothers. Dr. Dudley said they need to be in the Study, and Dr. Goldman said she was against studying teens, except perhaps as a separate study targeted at teens that would have teen-friendly staff and procedures.

Dr. Mattison said several Working Groups would have to weigh in regarding the inclusion or exclusion of teens. He asked about the lower age cutoff and what ethical and health care issues are involved.

Dr. Goldman suggested that selected centers could enroll 16 to 20 year olds, possibly.

The committee recommended that women aged 20 to 44 should be the main group to be included, while those aged 16 to 20 could be handled with special attention in a center.

Dr. Scheidt spoke about data architecture and said that we are done with “phase zero” of the data management component of the Study. We are in the process of using information for the next phase, a detailed scope of the data management system. The NCSAC will need to review this at the next meeting. Also, some Program Office staff visited the Women’s Health Initiative (WHI) to review their data management system, and a report can be made available to the NCSAC as background for the next meeting.

Dr. Spence commented about the use of SNPs (single nucleotide polymorphisms), as described in poster 18, and said there is much dissent about them in the genetic community. Dr. Scheidt said that regarding storing samples for possible future case-control studies, the Study will need a repository of samples (e.g., blood, skin) and that the sooner testing is done, the better. We can store samples for a long time, but there is a question regarding adequacy of the samples. Dr. Spence added that SNPs are not enough.

Dr. Goldman asked whether the hypotheses would be put out for competition or intramural NIH research. Dr. Scheidt said that all options are available but the science should drive the process.

Dr. Mattison clarified the role of the NCSAC as an advisory group; Dr. Alexander and the ICC make the final decisions.

After a few more comments by members, Dr. Mattison said that he would go back through all the NCSAC minutes to identify all agreed-upon items.

The meeting was adjourned at 3:05 p.m.

NCSAC Committee Members

Donald R. Mattison, M.D., NCSAC Chair
National Institute of Child Health and Human Development, NIH

Peter Scheidt, M.D., NCSAC Executive Secretary
National Institute of Child Health and Human Development, NIH

*David C. Bellinger, Ph.D.
Boston Children?s Hospital

Willa M. Doswell, R.N., Ph.D.
University of Pittsburgh School of Nursing

Donald J. Dudley, M.D.
University of Texas Health Sciences Center at San Antonio

Alan R. Fleischman, M.D.
The New York Academy of Medicine

Lynn R. Goldman, M.D.
Johns Hopkins University Bloomberg School of Public Health

Judith A. Graham, Ph.D.
American Chemistry Council

Shiriki Kumanyika, Ph.D., M.P.H.
University of Pennsylvania School of Medicine

Philip J. Landrigan, M.D.
Mount Sinai School of Medicine

Grace LeMasters, Ph.D.
University of Cincinnati

Roderick Joseph Alexander Little, Ph.D.
University of Michigan

Robert T. Michael, Ph.D.
University of Chicago
Jonathan M. Samet, M.D.
Johns Hopkins University Bloomberg School of Public Health

*Ken Sexton, Sc.D.
University of Minnesota School of Public Health

M. Anne Spence, Ph.D.
University of California, Irvine Medical Center

*Stephen P. Spielberg, Ph.D., M.D.
Johnson & Johnson Pharmaceutical

Lucina Suarez, Ph.D.
Texas Department of Health

Daniel J. Swartz
Children’s Environmental Health Network

*Did not attend the December 17-18 meeting in Baltimore

Presenters/Speakers

Christine Bachrach, Ph.D.
National Institute of Child Health and Human Development, NIH

Germaine Buck, Ph.D.
National Institute of Child Health and Human Development, NIH

Angus Deaton, Ph.D.
Princeton University

Peter Gergen, M.D., M.P.H.
Agency for Healthcare Research and Quality

Gary Hankins, M.D.
University of Texas Medical Branch

Charlotte Hobbs, M.D., Ph.D.
University of Arkansas for Medical Sciences

John Kiely, Ph.D.
National Center for Health Statistics, Centers for Disease Control and Prevention

Nigel Paneth, M.D., M.P.H.
Michigan State University

George Saade, M.D.
University of Texas Medical Branch

Kent Thornburg, Ph.D.
Oregon Health and Science University

Ben Wilfond, M.D.
National Human Genome Research Institute, NIH

Observers and Other Participants

R.J. Berry
Linda Burton
Bob Chapin
Adolfo Correa
Denise Dougherty
Dave Erickson
Rebecca Goodman
Chuck Grewe
Frank L. Holloman
Sarah Keim
Carole Kimmel
Mark Klebanoff
William Lawrence
Jan Leahey
Matthew Longnecker
Pauline Mendola
Caitlin O’Brien
Roger Rosa
Lee Salamone
Ken Schoendorf
Sherry Selevan
Angela Sharpe
Karen Studwell
Cristal Thomas
Kent L. Thornburg
Marshalyn Yeargin-Allsopp
Barry Zuckerman

  6/1/2008
  8/19/2005