October 2001 Study Assembly Meeting Plenary Session Summary

 

 

Dr. Kenneth Schoendorf, of the Centers for Disease Control and Prevention (CDC) and co-chair of the Interagency Coordinating Committee (ICC) of the National Children’s Study (NCS), welcomed attendees to the first meeting of the Study Assembly and first in-person convening of the NCS working groups. He noted that the study was the culmination of much planning and the start of substantive, important work. The gathering of such a large group of people concerned with the future health and well-being of children was also an affirmative act in the wake of the events in September that have altered in some unfathomable way the world in which our children will be living.

 

 

Dr. Schoendorf related the genesis of NCS, explaining that the idea for a large-scale, federally sponsored longitudinal study of pregnancy and child health had been germinating for some time. The idea coalesced several years ago under the President’s Task Force on Environmental Health Risks and Safety Risks to Children. The task force is still in existence, with broad Federal representation and the Administrator of the Environmental Protection Agency (EPA) and Secretary of Health and Human Services as co-chairs. The germ for NCS originated with the task force’s subcommittee on developmental disabilities and was followed by organizational work, information dissemination, and efforts to gain congressional support. The study was legislated under the Child Health Act of 2000, which charged the director of the National Institute of Child Health and Human Development (NICHD) to conduct a large-scale, national longitudinal study focusing on a comprehensive examination of environmental influences as they affect child health and well-being. Both environmental influences and health and well-being were broadly defined under the legislation.

A series of meetings and briefings were conducted to gather input on and promote interest in NCS from key stakeholders. In January 2000, a moderately sized, first consultation meeting was held in the Department of Health and Human Services (DHHS) to gather comments from an international group of investigators involved in longitudinal studies and laboratory research as well as people interested in child health. Input received at this meeting served as a reality check on the feasibility and requirements of the study. Participants confirmed that the study could be done but emphasized that it would require a significant amount of hard work, cooperation and collaboration, bold and creative thinking, and financial resources over and above existing research budgets.

The germ planted by the presidential task force also led to formation of ICC, a central planning committee with representatives from EPA and DHHS. ICC convened a meeting of perceived institutional stakeholders and representatives of community and parent groups to obtain an additional reality check and advice about accruing support and cooperation from these groups. A second consultation meeting was held in December 2000. This large, open meeting was designed to promote broad interest in the study, solidify the organizational structure, and begin discussion of substantive study topics. The next briefing was held earlier this year to generate interest and ideas among a broad range of potential Federal agency participants. The ongoing formation of an organizational structure and working groups represents the synthesis of all the information gained from the previous meetings. The current meeting is the start of substantive work that will be pulled together and molded into a coherent study product.

 

 

Although NCS is not yet fully structured, certain underlying concepts are necessary to provide a strong foundation. Dr. Schoendorf described the following study concepts:

• The study will be national in scope. NCS is not necessarily a nationally representative study that will permit real national estimates of disease and exposure. However, it will cover a broad cross-section of the U.S. population, which is diverse in terms of both population and geography.
  
  
• The study defines "environment" broadly. Environment includes not only pollutants and chemical toxins, but also the totality of the surroundings of child, mother, and family.
  
  
• The study will require collaboration between multiple, appropriate Federal agencies.
  
  
• The study will use expertise and support from non-Federal representatives from academia, community groups, and industry.
  
  
• The study will not operate in scientific isolation but will inform subsequent studies, guide policy, and serve as a resource for years to come.
  
  

Potential Study Attributes

In addition to the study concepts, Dr. Schoendorf noted that several broad assumptions can be made about the study. Unlike the study concepts, which must be taken into account, these potential study attributes should not be viewed as constraining issues at this point.

• The study will be very large. The study sample will be approximately 100,000 children and their families.
  
  
• The study sample will be enrolled as early in pregnancy as possible and in multiple sites throughout the country. NCS will allow the incorporation of substudies, which can represent either separate smaller samples (e.g., women of reproductive age before pregnancy or specific exposure groups such as farm workers), or specific indepth studies of particular exposures or outcomes that may not be part of the broader study.
  
  
• The study will try to use state-of-the-art technology in terms of data collection, storage, and management and interview techniques.
  
  

Study Structure

Dr. Schoendorf described the organizational structure of NCS. From the top down, the structure consists of the following components:

• The NICHD director has the ultimate responsibility for NCS as stipulated in the legislation. The director is not involved in the day-to-day operation of the study but is apprised of developments by the Federal Consortium.
  
  
• The Federal Consortium consists of representatives from Federal agencies who have relevant interest and expertise to contribute to NCS. This high-level group communicates directly with the NICHD director and is involved in broad planning and the general issues of the study. The Federal Consortium meets a couple of times of year with the NICHD director.
  
  
• ICC consists of approximately a dozen representatives from EPA and DHHS who have been working on the day-to-day planning and organizational work of the study. ICC communicates through weekly conference calls, monthly in-person meetings, and e-mail. As the more substantive work of the study proceeds, ICC will have the ultimate responsibility for molding working group findings passed through the Federal Advisory Committee into a coherent study project that can be presented to the NICHD director and the Federal Consortium.
  
  
• The Federal Advisory Committee (FAC) is necessitated by adherence to the Federal Advisory Committee Act, which requires that Federal efforts using non-Federal partners operate through an officially chartered Federal Advisory Committee. This committee offers advice to the people running NCS, including ICC. The formation of the NCS FAC had been delayed due to the administration’s freeze on new FACs. This wait was responsible, in part, for the delay in the participation of non-Federal partners.
  
  
• FAC subcommittees do not yet exist but are proposed by ICC. If approved by FAC, the subcommittees will represent three areas of overarching importance in the study: policy and communication, ethics, and science. The subcommittees would comprise members of FAC.
  
  
• Study working groups will perform the bulk of the detailed substantive, scientific work necessary for the creation of NCS. They will provide findings that will be filtered through FAC and fashioned by FAC into the group’s official advice. This advice will then be passed to ICC, which will use it to plan the overall study. Although the working groups are officially the tools of FAC, they are where the important developmental scientific work of the study will take place. Each working group has a liaison from ICC who will work closely with the group. The working groups cover the following four areas:
  
  
  • Specific areas of exposures (e.g., physical, chemical)
  • Specific outcomes (e.g., asthma, birth defects, developmental disabilities or behavior)
  • Broader topic areas (mid and late pregnancy, fertility and early pregnancy, early markers of adult disease), which do not focus on specific outcomes
  • Cross-cutting topics relevant to all working groups (e.g., ethics, community outreach and participation, study design)
    
    
• The Study Assembly comprises all individuals and agencies, whether Federal or non-Federal, that have an interest in planning and participating in NCS.
  
  

Charge to the Working Groups

Ms. Amy Branum of CDC outlined what the working groups should try to accomplish during the day’s breakout sessions. She described the following goals for the day’s activities:

• Working group charge-If the working groups have not yet established their charge, today’s meeting provides the opportunity to do so. Working groups with an established charge can share ideas about relevant hypotheses for their topic area.
  
  
• Pertinent study design issues-One working group is relegated solely to examining overall study design issues. Other working groups should address specific study design issues that are in keeping with their respective hypotheses. Study design issues should include potential methods and measures relevant to the working group’s specific hypotheses.
  
  
• Past and future-The meeting is a good time to consider what has and has not been done in the field related to the working group’s topic area. Each working group should consider what future work will need to be done in terms of pilot studies, research papers, and white papers.
  
  
• Timeline-Each working group should develop a rough estimate of a timeline that outlines some of the deliverables described above.
  
  
• Cohesion-Some of the working groups have been meeting on an ad hoc basis and are fairly loosely based. The breakout session provides a good opportunity for those groups to achieve greater cohesion.
  
  

Ms. Branum advised the working groups to place a high priority on developing a document that is geared to getting the group organized. Each document should lay out the working group’s objectives, timeline, and deliverables and should serve as a communication tool with ICC, other working groups, and stakeholders. The working group documents should be flexible to allow for evolution and change as the groups progress in the planning process. Working groups that have such a document in place should take the time to review their drafts.

Ms. Branum noted that NCS will not be driven by one single hypothesis. She urged working group participants, when developing hypotheses, to think about high priorities for their specific group’s topic. Considerations should include the theoretical rationale for hypotheses generation and the public health significance of a specific outcome. Related technical issues include exposure prevalence, measurability, the need or feasibility for longitudinal assessment, and required sample size. When thinking about hypotheses, the working groups will need to address potential study design issues related to their area of focus as well as constraints, such as limitations involved in the multisite enrollment of pregnant women. In discussing measures and methods, working groups should consider the requirements of hypotheses in terms of the type of measure, frequency, and type of contacts (e.g., types of interviews, sample collection techniques, types of examinations). In considering hypotheses, working groups should think about gaps in knowledge and what it would take to fill those gaps (e.g., what type of workshops, white papers, pilot studies are needed to explore certain issues and have them completed before the ideas can be incorporated into NCS). Working groups also need to formulate a rough estimate of the timeline for deliverables such as work products, a list of potential resource needs for the group, and a membership roster.

Ms. Branum explained that the chairs of the working groups were selected by ICC based on the model of having both Federal and non-Federal representatives as co-chairs. The core membership of the working groups will consist of 10 to 20 Federal and non-Federal representatives who are chosen by the chairs and ICC liaison. Members are expected to devote 10 percent of their time to NCS and participate in frequent meetings and conference calls. At-large members of working groups consist of anyone with expertise and interest in the working group’s area. At-large members will be called on to review documents and share ideas.

Conflict-of-Interest Issues

Dr. Peter Scheidt acquainted participants with conflict-of-interest issues that were raised by working group chairs. He noted that there had been extensive efforts to involve non-Federal as well as Federal scientists in the planning of NCS. Federal guidelines in the Federal Advisory Committee Act and the oversight of a FAC are what allow working groups to operate with non-Federal members. However, concerns have been raised about possible conflict of interest by non-Federal members participating in working groups that will discuss the use of Federal resources to procure studies or products.

Dr. Scheidt defined the basis for conflict of interest as being a working group member’s financial interest (e.g., employment) in an organization, company, or academic institution that becomes a topic of a working group’s deliberations, especially if the deliberations concern the expenditure of Federal resources. When such a situation occurs, it is the responsibility of individuals with possible conflict of interest to excuse themselves from discussions related to their organizations. If a chair or ICC liaison recognizes conflict of interest, those individuals may ask a member to be excused.

Conflict of interest is most commonly seen when a study section undertakes a review of a research proposal submitted by an institution with which a study section member is affiliated. Such a member ordinarily removes himself or herself from discussion of the proposal. Federal guidelines specify how working groups may be formed and conduct work under the auspices of a FAC. These guidelines stipulate that only FACs, not working groups, may advise the Federal Government. Working groups can only develop "findings" that FACs use to formulate advice to the Federal Government. Therefore, working group members need to be aware that their products will be findings, not advice or guidelines. A working group may propose what research needs to be done, but not how it is to be done. For example, an investigator from a university that has developed a rapid field measure for exposure may serve on a working group in which the need to develop such a measure comes under discussion. To avoid conflict of interest, the working group may discuss and propose a rapid field measure for exposure but may not propose to pilot test a specific measure.

However, Dr. Scheidt noted that if a working group is engaged in proposing specific findings for the design of the study, institutions with which working group members are affiliated can compete to be centers to collect data in NCS without conflict of interest. Such an arrangement is allowed because NCS is a broad study and will collect measures that combine efforts of all working groups. Consequently, members from any specific working group will not have a conflict of interest by having participated in their narrower component of the overall study design and measures.

Dr. Scheidt added that whenever possible and feasible, meetings of working groups should be open to the public. When open meetings are not feasible, the content of the meetings must be kept confidential. For example, members of a working group may not take information about what was proposed back to their institution to help in competing for a pilot study. In addition, working group members may not attempt to influence public officials (e.g., the ICC liaison or other Federal officials) involved with the working group about statements of work describing how research is to be conducted. The program office of the study will discuss specific statements of work.

Finally, each working group will have Federal officials (i.e., the Federal co-chair and the ICC liaison) who are responsible for ethics and conflict-of-interest issues.