The 1st Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
April 7-8, 2002
Sheraton Premiere at Tysons Corner
The National Children’s Study 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).
The National Children’s Study Advisory Committee (NCSAC) convened for its first meeting at 3:06 p.m., on Sunday, April 7, 2002, at the Sheraton Premier at Tysons Corner in Vienna, Virginia. Peter Scheidt, M.D., director, Program Office, National Children’s Study (Study), from NICHD opened the meeting and served as executive secretary. The NCSAC chair, Donald R. Mattison, M.D., a consultant to the NICHD Division of Epidemiology, Statistics, and Prevention Research at NICHD, chaired the meeting.
A complete roster of NCSAC members is available in Appendix A.
NCSAC members present for the first day of the meeting were: David C. Bellinger, Ph.D.; Willa M. Doswell, R.N., Ph.D.; Donald J. Dudley, M.D.; Alan R. Fleischman, M.D.; Lynn R. Goldman, M.D.; Judith A. Graham, Ph.D.; Grace LeMasters, Ph.D.; Donald R. Mattison, M.D.; Robert T. Michael, Ph.D.; Jonathan Michael Samet, M.D.; M. Anne Spence, Ph.D.; Stephen P. Spielberg, Ph.D., M.D.; and Rabbi Daniel J. Swartz.
NCSAC members present for the second day of the meeting were: Drs. Doswell, Dudley, Fleischman, Goldman, Graham, Mattison, Samet, Spence, Spielberg, Mr. Swartz, and Philip R. Landrigan, M.D.
Appendix B contains a list of others present at the meeting.
Sunday, April 7, 2002
I. Call to Order of Day One, Welcome, and Introductions
Dr. Scheidt called the meeting to order at 3:06 p.m. He welcomed the NCSAC members to the meeting and expressed his enthusiasm about their future involvement in the Study.
Dr. Scheidt noted that the first day of the meeting would focus on introducing the NCSAC members to the Study and on clarifying the rules governing the activities of federal advisory committees. The second day of the meeting would serve as the NCSAC’s first chance to discuss official Study business.
Dr. Scheidt introduced Dr. Mattison, chair of the NCSAC and of the meeting. He summarized Dr. Mattison’s distinguished career in the fields of children’s health and public health and added that Dr. Mattison would soon join NICHD as full-time staff. Dr. Scheidt turned the meeting over to Dr. Mattison, who led introductions of the NCSAC members.
II. Overview and Discussion of the National Children’s Study
After introductions were complete, Dr. Scheidt gave an overview of the Study. During his presentation, Dr. Scheidt summarized the following issues as they related to the Study: the increased vulnerability of children to environmental exposures; examples of common adverse environmental effects in children; exposures of particular concern to the Study; the role of the President’s Task Force on Environmental Health Risks and Safety Risks to Children in advocating for a longitudinal study on the relationship between environmental exposures and children’s health; the rationale for making the Study a longitudinal study; the role of the Children’s Health Act of 2000 in outlining the purpose of the Study and authorizing funding/planning for the Study; possible Study concepts; Study population issues; typical models for federally funded research; the organizational structure for the Study planning phase; the role and purpose of the NCSAC and the Study Working Groups; initial pilot studies being planned for the Study; and the projected timeline for the Study.
Dr. Scheidt concluded his presentation by noting that more detailed information on these issues was available on the Study Web site at http://www.nationalchildrensstudy.gov. Dr. Scheidt invited the NCSAC members to ask questions and provide comments.
One member asked for a clarification on the purpose of the Study. Dr. Scheidt indicated that the Interagency Coordinating Committee (ICC) of the Study had not focused on regulatory questions and/or issues; instead it had focused on how the Study could advance scientific understanding of the impact of environmental exposures on child health, development, and safety. Dr. Scheidt noted that the purpose of the Study was clearly outlined in the Children’s Health Act of 2000. He added that administrative responsibility for the Study was given to NICHD and not the U.S. EPA, which would indicate that congress viewed this Study as an opportunity to advance scientific knowledge.
Another NCSAC member inquired about the timeline for developing hypotheses and funding the Study Centers. Dr. Scheidt indicated that the ICC hoped to identify the core Study hypotheses over the next six to nine months, and wanted to fund a series of pilot studies for developing measures to test those hypotheses. Once the Study protocol was finalized, procurements would be issued for multiple centers, with funding made available in two stages.
It was asked how NCSAC members and the Working Groups would be involved in determining core hypotheses. Dr. Scheidt stated that the Working Groups would report to the NCSAC, in accordance with Federal Advisory Committee Act (FACA) guidelines. The Working Groups were expected to present findings concerning potential core hypotheses to the NCSAC, which would review those findings, and make recommendations about core hypotheses to the NICHD director and the ICC.
One participant asked for clarification regarding the difference between the ICC and the Federal Consortium. Dr. Scheidt noted that the ICC was composed of representatives from the agencies involved on the planning the Study "NICHD, CDC, NIEHS, and EPA" all of which have staff dedicated either half-time, or full-time to planning the Study. The Federal Consortium, he noted, consisted of representatives from 25 federal agencies who have an interest in the Study, but not at the level of staff time required of ICC representatives.
When asked whether the role of the NCSAC included setting and enforcing Study priorities, Dr. Scheidt responded that the primary role of the NCSAC was to advise the NICHD director and the ICC on matters related to planning and implementation of the Study. He stated that decisions about the Study’s overarching priorities would be made by the NICHD director, in collaboration with the ICC.
There was also some question about funding for the Study and the timeline for future funding. Dr. Scheidt indicated that congress had given NICHD clear signals to move forward with planning the Study, providing $4.5 million for fiscal year 2002, and $8 million for fiscal year 2003. He explained that the proposed budget called for substantial funding increases in fiscal year 2004, and beyond.
It was also asked to what degree individual NCSAC members would be expected to monitor the activities of the Working Groups, and how the depth and breadth of experience of the NCSAC members would be used in monitoring the activities of the Working Groups. Dr. Scheidt stated that the NCSAC was free to organize itself as it saw fit and to determine how it monitored the activities of the Working Groups. He added that the Working Groups supported the work of the NCSAC in providing recommendations to the NICHD director and the ICC.
In response to an inquiry about ultimate authority to approve the Study protocol, Dr. Scheidt indicated that such authority rested with the NICHD director, and that the NICHD director would rely on the ICC to determine when the Study protocol was ready for approval.
One member underscored the need to reach agreement on the criteria for selecting core hypotheses that would contribute to a better scientific understanding of child health and development, as well as address key public health concerns. It was also noted that focusing on developing hypotheses that could only be tested in a longitudinal cohort design, rather than on questions that may be answered via smaller, less expensive studies was important. Another member added that Working Groups needed to realize that the hypotheses proposed could be substantially revised by the NCSAC.
III. Review of Activities of Federal Advisory Committees and the Federal Advisory Committee Act (FACA)
Dr. Mattison introduced Ms. Mary Plummer of NICHD to summarize how federal advisory committees function. Ms. Plummer stated that all federal advisory committees were governed by Public Law 92-463, also known as the FACA. She explained that the Act defined a federal advisory committee as any committee, board, commission, council, conference, panel, task force, or similar group, or any subcommittee or other group, established by statute, or established or utilized by the president or any agency official, for the purpose of obtaining advice or recommendations. Ms. Plummer stated that congress enacted the FACA for several reasons, including the fact that congress and the public need to be kept informed of the number, purpose, membership, activities, and cost of advisory committees, that the function of advisory committees should be advisory, and that all matters under their consideration should be determined by the official agency or officer involved.
Ms. Plummer noted that the FACA imposed several requirements on federal advisory boards: all federal advisory committees must have a clear purpose, be in the public interest, and have a charter; membership must be balanced in terms of points of view represented and the functions to be performed; financial records must be kept and two annual reports submitted to congress each year to determine if the committee is carrying out its purpose, and to summarize the committee’s activities and related matters that would inform the public; notices of all meetings must be published in the Federal Register; chartered advisory committees must adhere to provisions of the Act with respect to open and closed sessions; detailed minutes must be kept of all meetings and certified by the chairperson; reports, transcripts, minutes, working papers, studies, agendas, and other documents made available to each advisory committee must be available for public inspection and copying; a federal official must attend all meetings and approve the agenda.
Ms. Plummer summarized activities not covered by the FACA, such as meetings to obtain recommendations or advice from one person, or meetings of two or more advisory committee members or subcommittee members solely for the purpose of gathering information, conducting research, or drafting position papers. Ms. Plummer also described the role of the designated federal official.
She then explained that federal advisory committee members served by appointment and had the full right and obligation to participate in the activities of the committee, including voting on committee recommendations. She added that members were compensated for time spent at meetings and site visits, and were reimbursed for travel expenses incurred in connection with those activities. She noted that advisory members were required to refer questions from the public to the designated federal official. Ms. Plummer indicated that members were required to abide by the Standards of Ethical Conflict as described in the FACA. Ms. Plummer concluded that additional information on the requirements associated with serving on federal advisory committees was available at www1.od.nih.gov/cmo.
When asked to elaborate about the specific charge of the Study, Dr. Scheidt stated that the NCSAC was to advise, consult with, and make recommendations on the planning and implementation of the Study to the NICHD director and the ICC. He added that NCSAC could create subcommittees to perform specific functions within the committee’s jurisdiction, including adding ad hoc members for special purposes. Dr. Scheidt restated that all meetings of the NCSAC conducted to deliberate and vote/prioritize were to be open to the public except as determined by the secretary of HHS.
Dr. Scheidt outlined the following tasks for members of the NCSAC: becoming knowledgeable about the goals, structure, and plans of the Study; defining needed subcommittees; providing advice regarding the structure and membership of the Working Groups; and developing procedures for receiving findings and information from the Working Groups. He added that the objectives of the NCSAC were to: provide expertise for various aspects of the study; propose hypotheses that addressed different areas of the Study; identify and propose studies, reviews, and analyses for developing Study methods and measures; and produce findings that contributed to development of the Study protocol. He concluded that the ultimate product of the NCSAC would be recommendations to the director of NICHD.
IV. Discussion of the Role of the Working Groups
Dr. Scheidt explained that many Working Groups were established to support the role of the NCSAC in the Study planning process. He added that the President’s Task Force called for extensive public-private partnerships, while the Children’s Health Act of 2000 directed that a consortium of federal agencies be involved in planning and implementing the Study. Dr. Scheidt stated that the Study structure provided a means to enlist the best possible scientific expertise to support the role of the NCSAC in reaching conclusions about planning the Study. He explained that the expertise was especially critical because the study was expected to cover a diverse range of environmental exposures and outcomes. In addition, it was thought that this approach would help generate broad ownership in the Study, as well as long-term support of the scientific community and key stakeholders.
Dr. Scheidt explained that many Working Groups were established to support the role of the NCSAC in the Study planning process. He added that the President’s Task Force called for extensive public-private partnerships, while the Children’s Health Act of 2000 directed that a consortium of federal agencies be involved in planning and implementing the Study. Dr. Scheidt stated that the Study structure provided a means to enlist the best possible scientific expertise to support the role of the NCSAC in reaching conclusions about planning the Study.He explained that the expertise was especially critical because the Study was expected to cover a diverse range of environmental exposures and outcomes. In addition, it was thought that this approach would help generate broad ownership in the Study, as well as long-term support of the scientific community and key stakeholders.
Dr. Scheidt then described the characteristics of the Working Groups, which support the work/deliberations of the NCSAC:
- Working Groups fell into two categories:crosscutting/methodological Working Groups; and hypotheses-generating Working Groups that deal with a particular exposure or outcome.
- The life-span and activities of each working group would be determined by the NCSAC. It was expected that some Working Groups would continue across the course of the Study to support the work of the NCSAC.
- The number of people serving on each Working Group would vary, but most would consist of approximately 15 core members.
- The Working Groups would meet two or three times each year, but would also hold frequent conference calls and communicate with one another via e-mail and the Study Web-based portal.
- Each working group would have a federal and non-federal co-chair, who were to be recommended by the ICC and reviewed and approved by the NCSAC. One co-chair would be designated as the primary contact person for the Working Group. The co-chairs would be responsible for convening and chairing meetings and conference calls, presenting Working Group findings and proposals to the NCSAC, and for devoting up to 20 percent of their time to the Study planning process in support of NCSAC work.
- Working Group members were expected to devote up to 10 percent of their professional time to sharing their scientific expertise.
- Non-federal members would be reimbursed for travel and other expenses.
- Each Working Group would include an unlimited number of at-large members, who would also make up the Study Assembly, to review Working Group products, provide comments, and fill core member vacancies as they arose.
- Each Working Group should have at least one representative from the ICC, who would be knowledgeable of the subject matter and provided administrative and technical support to the group. The ICC liaisons would be responsible for reporting Working Group progress and needs to the ICC. Dr. Scheidt explained that having representatives of the ICC involved in Working Group activities assured that simultaneous tasks being carried out across the Working Groups were properly coordinated and consistent with the overarching Study goals. He also raised the possibility of having NCSAC members serve as liaisons to various Working Groups.
- According to the FACA, Working Groups were allowed to gather facts and information, perform studies, draft reports, identify alternatives, and provide a forum for the exchange of views and ideas in support of the NCSAC. However, Working Groups were not permitted to make major decisions about the Study, provide consensus advice, or communicate information, ideas, or views directly to a federal official, as that was the role of the NCSAC. Since the Working Groups would be composed partially of federal officials, the NIH Ethics Counsel had been actively involved in advising the Study Program Office on what Working Groups could and could not do, in support of the NCSAC.
V. NCSAC Member Discussions
Dr. Scheidt invited questions and comments from the NCSAC members, which resulted in the following guidance:
- All NCSAC materials would be used as NCSAC members saw fit. However, information provided in closed meetings would not be shared with others.
- The NCSAC, not the Working Groups, was the only non-federal group involved in the Study that was allowed to communicate advice or recommendations to federal officials. The work of the Working Groups would support the NCSAC.
- Each Working Group would have its own charter. Each group would be able to suggest hypotheses and pilot studies, and would support the NCSAC in determining the power calculations associated with proposed hypotheses.
- The Study was expected to consist of a core study of common hypotheses across all centers. It would be possible that some hypotheses, requiring smaller samples, could also be tested.
- Under guidance and direction from the NCSAC, the Working Groups would work together, as necessary, to reduce duplication and resolve issues of mutual concern.
- Whether or not the Study would be a nationally representative study had not yet been determined. All along, Study planners expressed a desire that the Study be as representative as possible. However, logistical and financial limitations could make this impossible. A contract funded by the National Center for Health Statistics would analyze various sampling strategies.
- The Study Design Working Group had already begun to discuss the challenges associated with prioritizing hypotheses. It was working on draft evaluation criteria for ranking hypotheses, which was to be shared with the NCSAC to support their recommendations in this regard.
- The term "vanguard centers" would be used to refer to the first group of centers funded under the Study.
- The Study would capitalize on the lessons learned in planning and implementing other longitudinal studies. Study planners conducted a consultation meeting with principal investigators from other large, longitudinal studies. Information about this consultation meeting was posted on the Study Web site. NCSAC members noted that it would be helpful to have a summary document that highlighted lessons learned in conducting other longitudinal studies. It was noted that this document was in development and would be provided at the next NCSAC meeting.
- NCSAC members were to get information on the status and activities of the Working Groups.
- One NCSAC member noted insufficient American Indian representation on the Working Groups.
- The NCSAC would provide guidance in developing the scope of work for the data collection centers, and in designing the Study protocol. However, NCSAC members could not participate in selecting the centers to be funded; that responsibility would rest with either a standing peer review committee or a special emphasis panel.
Dr. Mattison adjourned the meeting at 5:29 p.m. The NCSAC agreed to reconvene the next day at 8:30 a.m.
Monday, April 8, 2002
I. Call to Order of Day Two and Opening Remarks
Dr. Mattison called the meeting to order at 8:37 a.m., and outlined the agenda for the day’s activities.
II. Discussion of Major Issues Facing the NCSAC
Dr. Mattison presented the major topics of discussion for the NCSAC:
- Interactions with the Working Groups
- Transmission of individual products from the Working Groups to the NCSAC
- Interactions with the ICC and recommendations regarding the Study design, implementation, and conduct of the Study
- Timeline for completing critical tasks during the next year
Dr. Mattison reiterated the various entities involved in the planning phase of the Study and their roles, including the ICC, the NCSAC, the 22 Working Groups, the Study Assembly, and the NICHD Program Office.
III. Working Group Assignments and Discussions
Dr. Mattison explained that NCSAC members would attend two Working Group meetings later in the morning, one of which would be assigned, the other the member’s choice. The following Working Group assignments were made:
- Study Design, Dr. Samet
- Ethics, Dr. Fleishman
- Community Outreach and Communications, Dr. Doswell
- Asthma, Dr. LeMasters
- Birth Defects, Dr. Goldman
- Chemical Agents and Exposures, Dr. Graham
- Development and Behavior, Dr. Bellinger
- Fertility and Early Pregnancy, Dr. Dudley
- Gene-Environment Interactions, Dr. Spence
- Health Services, Mr. Swartz
- Infection, Immunity and Vaccines, Dr. Michael
- Medicine and Pharmaceuticals, Dr. Spielberg
- Pregnancy and the Infant, Dr. Mattison
- Early Origins of Adult Health, Dr. Landrigan
The NCSAC members discussed Dr. Mattison’s presentation and a range of issues related to planning and implementing the Study, including:
- Developing a clearly defined set of goals for the NCSAC
- Making sense of the large amount of information expected to come from the Working Groups
- Developing procedures for making recommendations to the NICHD director and the ICC
- Identifying staff resources available to the NCSAC
- Noting gaps in expertise represented on the committee (e.g., a statistician with extensive experience in longitudinal design and information technology)
- Ensuring the diversity of the NCSAC
IV. Status of the Working Groups
Dr. Scheidt reminded the NCSAC members that they had received a series of handouts summarizing the status of the Working Groups. As of the meeting, 17 Working Groups were operational. Some of them had existed for a year or more, while others were just recently formed. Two other Working Groups were holding their first meeting as part of the concurrent Study Assembly meeting. Other Working Groups were scheduled to meet ad hoc.
V. Distribution of Hypothesis Proposal and Pilot Study Request Forms
Dr. Scheidt presented copies of a form developed by the Study Design Working Group that asked Working Groups to describe their proposed hypotheses, including the public health significance of the proposal, justification, scientific merit, potential for innovative research, feasibility of the proposal, and other pertinent information. Dr. Scheidt provided examples of proposed hypotheses that were currently available on the Study portal. He encouraged the NCSAC members to learn more about the portal and how it works.
Other information provided to the NCSAC members included copies of the form for requesting pilot studies, literature reviews, white papers and workshops, and a list of the proposed pilot studies.
Dr. Scheidt indicated that pilot study requests had not yet been reviewed by the ICC, and that the ICC needed recommendations from the NCSAC about how to handle such requests. He added that the NCSAC might want to consider developing subcommittees to collaborate with the Working Groups in addressing issues of mutual concern, such as ranking proposed hypotheses.
Dr. Mattison adjourned the meeting so that participants could attend Working Group meetings. The NCSAC was scheduled to reconvene at 10:45 a.m.
VII. NCSAC Member Reports on the Working Group Meetings
Dr. Mattison reconvened the meeting at 10:49 a.m. and asked the NCSAC members to report on the Working Group meetings they attended. The following common themes marked the members’ reports:
- Working Groups were in various stages of development.
- Some Working Groups had developed well-defined hypotheses, while others were just getting started.
- Some Working Groups were unclear about the process of obtaining resources for pilot studies.
- Working Groups needed direction regarding whether the Study would be an intervention study, or whether it would be purely observational, and information regarding sampling strategies and intervals.
- Many Working Groups were looking forward to collaboration.
- Some Working Groups were unclear if they should be using validated measures, or if they should create new measures.
- Some Working Groups were developing overlapping hypotheses.
- Some Working Groups were concerned about retaining Study subjects and what incentives would be offered to promote retention.
- Some Working Groups were unclear about how to interact with the NCSAC and other study components.
- Many Working Groups recognized the need to share information on their activities with other Working Groups.
- Some Working Groups were asking if the Study would be flexible enough to incorporate new hypotheses as the Study evolved, and what changes could be implemented after the Study was initiated.
- Some Working Groups were asking for guidance regarding when individuals would be enrolled in the Study (prior to pregnancy, during pregnancy, at birth, or in infancy).
- The Working Groups wanted to know the proprietary nature of the data, how quickly data would be made available to the research community, and where the data would be stored.
- Many Working Groups were struggling with balancing what is known about certain exposures and outcomes, and what remains uncertain.
- Many Working Groups were unclear if or when feedback would be provided to subjects, the community, or public health departments.
VIII. Presentation by the NICHD Director
Dr. Mattison introduced NICHD director Duane Alexander, M.D., who thanked the NCSAC members for taking the time to participate in this important endeavor. He indicated that the NCSAC had a critically important role in the success of the Study, and reiterated that it was the only group in the Study that could provide advice to the federal government on matters related to the Study. He added that the NICHD and the federal partners overseeing the Study would rely heavily on the NCSAC to provide wise, solid, and tempered advice, even though final decision-making authority rested with the federal government.
Dr. Alexander explained that the NCSAC had not been established prior to this meeting because of a HHS moratorium on advisory committees. Dr. Alexander noted that, to this point, a subcommittee of the National Advisory Child Health and Human Development Council had been filling the role of advisory group for the Study, to ensure that the Study could move forward as quickly as possible. Dr. Alexander restated that the Working Groups would report to the NCSAC, and that the NCSAC should be prepared to receive a significant amount of information from the 22 Working Groups.
Dr. Alexander defined some of the more crucial tasks of the NCSAC that remain to be completed, including: determining the size and scope of the Study; establishing procedures for recruiting subjects, and incentives for keeping them involved in the Study; obtaining informed consent that would eliminate the need to seek consent from patients repeatedly throughout the Study; outlining procedures for data collection and management; making decisions about competing scientific demands; determining sampling intervals, and how often researchers could visits patients’ homes; and other critically important decisions related to the Study.
Dr. Alexander closed his presentation by stating that no one had ever attempted to plan and implement a study of the magnitude of the Study. But, he added, it was worth the time and effort because such a study would make an enormous contribution to scientific understanding of environmental exposures and their impact on child health and development.
Dr. Alexander invited questions and comments from the NCSAC members. The following issues were noted: how centers funded through the Study would interact and collaborate with sites already heavily invested in NIH randomized, controlled clinical trials; the Study’s sample size; whether the Study would be purely observational, or if some interventions would be permitted; the diversity and delineation of the sample; oversampling and geographic distribution of the sample; how the Study Assembly would interact with the Working Groups and the ICC; balancing the need to move forward as soon as possible without sacrificing much-needed flexibility as the Study evolved; and the leadership role of the NCSAC.
Dr. Mattison thanked Dr. Alexander for his participation and adjourned the meeting at 12:26 p.m., so that NCSAC members could attend portal training.
IX. Providing Leadership to the Working Groups
Dr. Mattison reconvened the meeting at 1:42 p.m., and suggested that the NCSAC prepare a memorandum asking each Working Group to list up to five key questions related to the Study that, if answered by the NCSAC, would expedite their work and give them much-needed direction. One NCSAC member proposed that the NCSAC give the Working Groups a few sample questions that would point them in the right direction.
In discussing potential questions, several issues arose, including: the core values of the Study; boundaries for democracy and decision making; whether the Working Groups would submit hypotheses directly to the NCSAC; whether the Study Design Working Group would provide some level of filtering for hypotheses; evaluation criteria for ranking hypotheses; whether the NCSAC was responsible for ranking hypotheses, or whether the Working Groups would rank their own hypotheses; unit of observation to be used throughout the Study; whether there would be any core child outcomes to which all core hypotheses must relate (e.g., obesity); the degree to which the Study would capture parental issues; data collection, storage, and analysis issues; where responsibility would rest for collecting, storing, and analyzing data; potential for investigator-initiated awards in the Study; degree of latitude individual centers would have to conduct their own studies under the Study; feedback that would be provided to Study participants; need for exposure-based and outcome-based Working Groups to collaborate in developing hypotheses; the timeline for completion of Working Group activities; and which Working Groups would continue once the Study design was established.
The NCSAC then drafted a memorandum for distribution to the Working Groups. A copy of the memorandum is included in Appendix C.
X. Immediate Goals of the NCSAC
Dr. Mattison proposed holding a meeting with the Working Group chairs within the next few months. He noted that FACA guidelines required adequate public notification of the meeting, so it was critical to begin planning the meeting as soon as possible. The NCSAC members agreed that, for the time being, all NCSAC meetings would be face-to-face. Dr. Scheidt reminded the NCSAC members that the Study portal provided a means to exchange information between face-to-face meetings. NCSAC members briefly discussed the possibility of making the portal public to satisfy FACA public access standards.
One member suggested that the NCSAC meet more often during the first year. However, Dr. Scheidt noted that neither the budget, nor the NCSAC charter provided for such frequent meetings, although the NCSAC was free to propose an alternative meeting schedule to allow for sufficient interaction among the members.
Dr. Mattison asked NCSAC members to identify the type of information they wanted from the Working Groups regarding status and activities. Members included the following: each Working Group’s charge; the Group’s function in a longitudinal study; a brief summary of each existing hypothesis, with links to existing background information on the portal; justification and scientific merit of each hypothesis; unresolved issues; and recommendations for pilot studies.
NCSAC members suggested that the information provided by the Working Groups not exceed three pages. They agreed that meeting with the Working Group chairs would provide an opportunity to establish standardized reporting schedules for the Working Groups, and that information submitted by each Working Group should be shared with other Working Groups via the portal.
One NCSAC member noted that participants in the morning Working Group meetings were under the impression that an NCSAC member of a Working Group would also serve as the group’s NCSAC liaison. NCSAC members discussed this issue and decided that they should not be members of any Working Groups. Dr. Mattison agreed to notify the Working Group chairs of this decision in the memorandum requesting information from the Working Groups. Dr. Mattison also agreed to consult with the NCSAC members to ensure that the Working Groups did not filter information and ideas, and that the information they provided to the NCSAC contained adequately analyzed and settled ideas.
XI. Evaluation Criteria for Proposed Hypotheses
Once NCSAC member noted that the draft evaluation criteria crafted by the Study Design Working Group could be endorsed if additional information was provided on the power calculations associated with the proposal. The NCSAC members discussed this proposal. One member suggested that a discussion of community outreach concerns associated with a hypothesis also be included in the proposal. The NCSAC members agreed that the criteria would be modified to include more information on power calculations and community outreach concerns.
XII. Procedures and Timeline for Submitting Hypotheses
It was suggested that proposed hypotheses should be submitted concurrently to the Study Design Working Group and the to NCSAC. One member added that the Study Design Working Group would be able to provide technical evaluation regarding the overall Study design, opportunities for integrating hypotheses, and possible conflicts among hypotheses. This information would be shared with both the NCSAC and the appropriate Working Group. The NCSAC members discussed the possibility of setting a deadline for submission of hypotheses; however, it was also noted that some of the Working Groups were just getting started and would need sufficient time to develop hypotheses.
XIII. Content of the Meeting with the Working Group Chairs
Dr. Mattison suggested that the upcoming meeting with the Working Group chairs cover the following key issues: the functions of the Working Groups; interactions between the NCSAC and the Working Groups; development of hypotheses; the pilot studies proposed by the Working Groups; a status report on pilot studies that are underway (e.g., the NCHS-funded pilot study on sampling strategies), and future pilot studies proposed for NCSAC review.
The meeting chair noted that meeting with the Working Group chairs would help NCSAC members better understand the composition, mission, and function of the Working Groups. He added that it would provide NCSAC members with needed information to better understand the hypotheses that had been or would be proposed, areas of overlap, and which Working Groups should be collaborating in developing specific hypotheses. Dr. Scheidt noted that the NICHD Program Office had started planning for this meeting.
XIV. The Next NCSAC Meeting, June 2002
Dr. Mattison explained that, with information from meeting with the Working Group chairs in hand, NCSAC members could begin making decisions about core hypotheses at the June 2002 meeting. Dr. Scheidt noted that the Study was scheduled to begin in 2005, which would mean that the NICHD would need recommendations from the NCSAC regarding hypotheses as soon as possible, to allow sufficient time for conducting hypotheses-driven pilot studies and developing the Study protocol. It was inquired whether, although all deliberations must be conducted in a public forum, the NCSAC members could hold telecom meetings between face-to-face meetings. Dr. Scheidt indicated that he would check to see if such communication was permissible under the FACA.
XV. The Role of the Ethics Working Group
One NCSAC member asked for clarification regarding the roles of the Ethics Working Group. Based on what was explained at the Ethics Working Group meeting earlier in the day, it was noted that the Working Group may not be comfortable with functioning as a "gatekeeper" for the Study. The member explained that the ethical issues involved in the Study were extremely complicated, and that many institutions seeking funding as Study Centers may have difficulty obtaining approval from their Institutional Review Board (IRB). Dr. Mattison agreed that ensuring all of the ethical issues identified by the Ethics Working Group were built into the Study design represented a serious challenge. Dr. Scheidt suggested that the NICHD IRB could serve as a resource to the NCSAC in addressing complicated ethical issues. He noted that it may also be necessary to add an ethicist to the NCSAC membership, either as a full-time member or an ex-officio member. While the NCSAC already counted an ethicist in its membership, participants explained that, given the complex nature of the ethical issues involved, the NCSAC could benefit from additional guidance of a non-voting NCSAC member.
It was recommended that the Ethics Working Group follow a “parallel process” for submitting information to the NCSAC, similar to the one suggested for the Study Design Working Group. In the meantime, Dr. Mattison indicated that the Ethics Working Group would be asked to review hypotheses and to identify ethical issues associated with specific hypotheses. Dr. Scheidt noted that this role was consistent with the ICC’s vision of the Ethics Working Group.
XVI. NCSAC Membership
One NCSAC member expressed a desire for members of the public, nonprofessionals, and parent advocacy groups to have input on the NCSAC. Other NCSAC members expressed the same desire, but questioned how the NCSAC could expand its membership and maintain a manageable structure. The NCSAC members agreed that involving communities and the public early in the Study was critical to its success. Dr. Scheidt pointed out that the NCSAC had a layperson in its membership, but NCSAC members noted that the NCSAC needed to represent the diversity of the nation, and that these issues must be discussed in more detail in the near future. It was noted that the centers could be required to address community outreach and participation in order to receive funding.
Dr. Mattison adjourned the first meeting of the NCSAC at 5:22 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment are accurate and complete.
| May 30, 2002
Donald Mattison, M.D.
National Children’s Study Federal
Appendix A: Committee Roster
Appendix B: List of Attendees
Appendix C: April 8, 2002 Memorandum to the Working Groups
Appendix D: Working Group Responses to Memorandum
Appendix A: National Children’s Study Advisory Committee (NCSAC) Roster
|MATTISON, Donald R., M.D. Chairperson
Division of Epidemiology, Statistics, and
SCHEIDT, Peter, M.D. Executive Secretary
Medical OfficerDivision of Epidemiology, Statistics,
and Prevention Research
BELLINGER, David C., Ph.D.
Director of Research
Behavioral Pediatrics Fellowship Program
DOSWELL, Willa M., R.N., Ph.D.
Department of Health
University of Pittsburgh
School of Nursing
Center for Nursing Research
DUDLEY, Donald J., M.D.
Department of Obstetrics and Gynecology
University of Texas Health Sciences
Center at San Antonio
FLEISCHMAN, Alan R., M.D.
Senior Vice President
The New York Academy of Medicine
GOLDMAN, Lynn R., M.D.
ProfessorEnvironmental Health Sciences
Johns Hopkins University
Bloomberg School of Public Health
GRAHAM, Judith A., Ph.D.
Senior Scientist/Senior Director
Long-Range Research Initiative (LRI) Team
American Chemistry Council
|LANDRIGAN, Philip J., M.D.|
Professor of Environmental Medicine
and Preventive Medicine
Chairman, Department of Community
and Preventive MedicineMount Sinai School of Medicine
LEMASTERS, Grace, Ph.D.
ProfessorDivision of Epidemiology and Biostatistics
Department of Environmental Health
College of Medicine
University of Cincinnati
MICHAEL, Robert T., Ph.D.
Harris Graduate School of Public
University of Chicago
SAMET, Jonathan Michael, M.D.
Institute for Global Tobacco
Department of Epidemiology
Bloomberg School of Public Health
The Johns Hopkins University
SPENCE, M.A., Ph.D.
Department of Pediatrics
University of California
Irvine Medical Center
SPIELBERG, Stephen P., Ph.D, M.D.
Pediatric Drug Development
Johnson & Johnson Pharmaceutical
Research and Development
SWARTZ, Daniel J.
Children’s Environmental Health Network
Appendix B: List of Attendees
Federal Advisory Members
Carole Kimmel, EPA
Denise Dougherty, Agency for Healthcare Research Quality (AHRQ), HHS
Duane Alexander, NICHD, NIH, HHS
Edward J. Sondik, CDC, HHS
Gwen Collman, National Institute of Environmental Health Sciences, NIH, HHS
J. Richardo Martinez, NIH, HHS
Jeanellen Kallevang, NICHD, NIH, DHHS
Lisa Simpson, AHRQ, HHS
Mark Klebanoff, NICHD, NIH, HHS
Marshalyn Yeargin-Allsopp, CDC, HHS
Martin Dannenfelser, HHS
Mary Overpeck, Heath Resources and Services Administration, HHS
Peter C. Scheidt, NICHD, NIH, HHS
Sherri Park, NICHD, NIH, HHS
David Longerbeam, NICHD, NIH, HHS
Jan Leahey, NICHD, NIH, HHS
Beverly Warden, Analytical Sciences, Inc.
Sherry Selevan, EPA
Allisen Stewart, NICHD, NIH, HHS
Lynn Salo, NICHD, NIH, HHS
Woodie Kessel, HHS
Jose F. Cordero, CDC, HHS
Lee Salamone, American Chemistry Council
Rosemary Zalesk, Exxon Mobil, Biomedical Science
George Jesien, Association of University Centers on Disabilities
Pauline Mendola, EPA
Elizabeth Julien, International Life Sciences Institute
Appendix C: April 8, 2002 Memorandum to the Working Groups
||Working Group Chairs|
||National Children’s Study Advisory Committee (NCSAC)|
||April 8, 2002|
This morning during the NCSAC visits to the Working Groups, we became aware of boundary issues that would be facilitated by more clarification, such as procedural issues, ethical issues, etc.
The NCSAC requests that you submit any key questions for which you need answers in order to facilitate your progress, or the absence of which impedes your progress.
Examples of issues include:
- How detailed to be (for example, design or protocol)
- Ethical issues surrounding pilot studies
- Structure of pilot studies
We would appreciate receiving such questions by 5 p.m. today at the Study registration desk.
Appendix D: Working Group Responses
- Will any considerations be made that actual enrollment be larger than 100,000?
- Are we limited to 100,000 pregnancies?
- What types of pilot studies are acceptable?
- When would pilot studies or workshops need to be completed in order to inform Study design decisions?
- What is the length of pilot studies (period of funding) and funding amount?
- Will enrollment be rolling? Can more than one child be enrolled per family?
- Is rolling enrollment an option?
- Can secondary analysis of existing health databases be used for pilot studies?
- What are the ethical limitations of genetic testing and evaluating and ranking samples for future genetic tests?
- Could we get information of psychiatric histories?
- Will there be any resources to address inequities identified use of other resources?
- Will children be recruited in a fashion such that the sample could be weighted to form a nationally representative sample?
- To what extent will steps be taken to ensure that minority colleges and institutions in underserved population (areas) will be competitive?
- How will U.S. citizens abroad be handled (i.e., military)?
- How will hand-to-mouth populations be recruited, included, maintained, and followed?
Working Group-Specific Responses
Questions Posed by Unnamed Working Groups
- Can a more realistic, coordinated timeline be developed for project products that would facilitate (for example) Working Group pilot studies being approved and completed before working group hypotheses are due to the Study design group?
- Are there better ways to facilitate the Working Groups having quicker access to developments in the Study Design and Ethics Working Groups? Other Working Groups?
- We’ve experienced some Working Group attention (Social Environment). We need two-to-three new members with specific expertise to complete our work. Is there a reasonable and timely way to make this happen?
- Are there ethical limitations of genetic testing and evaluating and ranking samples for future genetic tests?
- Will information of psychiatric histories be available?
- What are the ethical limitations on domestic violence?
- Testing for drug abuse in mom/baby-ethical limitations—can we get a certificate of confidentiality?
- How big is the sample going to be, are we limited to 100,000 pregnancies?
- When do we get pilot studies approved?
Ethics Working Group
- There is still confusion among Working Group members about how some of the pilot activities can be accomplished in a timely manner. There is also a concern that the Study would like to have white papers from certain individuals (not necessarily on the Working Group, but associated with the Working Group), but that putting these through a competitive process would take too long, and that the small amount of money involved would eliminate bidders. In addition, some public research such as discussion groups could be conducted in study populations that the Working Group members have ongoing. However, having to compete the process might take too long. Most of the activities we identified would need to be completed in the fall or early winter of 2002.
- One of the additional procedural issues involves the concern that the pilot projects may be altered such that the Working Group would not get (incoming field?) information from the people.
- One suggestion is to designate a member of the NCSAC work with the Working Group to develop the projects.
- Another suggestion is to have Working Group members who are federal employees work with program staff to develop the statement of work.
Early Origins of Adult Health Working Group
- Length of pilot studies (period of funding) and funding amount, concern regarding ethics of allowing Working Group members to conduct pilot studies, especially field studies (less important for lit. reviews). Do white papers/lit reviews get funding?
- Concern regarding: haphazard method of getting Working Groups together, communication could be better (e.g., we corralled a few groups but may have missed others that are important).
Health Disparities/Environmental Justice Working Group
- Will there be any resources to redress inequities identified concerning use of other resources? To not do so may inhibit ability to enroll participants and keep them.
- How will you inform communities/pop-sub group that they are being exposed disproportionately to something?
- How/ often (how?) will you communicate to communities on Study finding (Biannually? Annually? Newsletter?)?
- What steps will be taken to assure that the Study Centers develop meaningful partnerships with the communities?
- To what degree will community-based participatory research be integrated into the Study?
- What efforts will be taken to ensure that minority colleges and institutions in underserved population (areas) will be competitive? Can community based applications apply?
- What steps will the Study take to assure that health disparities and environmental justice will be addressed in the Study design and in the implementation (i.e., how will hand-to-mouth populations be recruited, included, maintained, and followed)?
Repository Working Group
- Who has overall responsibility for quality assurance (QA) and quality control (QC)?
- How will U.S. citizens abroad be handled (i.e., military)?
- Sources sought in federal business opportunities needs to occur:
- Query industry to determine capabilities
Information Technology capabilities for information sharing/transfer
Collection of fees upon dispersal of specimens to collaborators that may want to use specimens for other than the core hypothesis
Adherence to strict QA/QC standards a requirement
Data repository being maintained by IT (i.e., sonogram results, etc)?
Is there a mechanism for funding research and development associated with specimen collection, processing, transport, and storage?
Will enrollment be rolling? Can more than one child be enrolled per family?
- Specimen handling/ processing capabilities
- Specimen storage/facility capabilities
Asthma Working Group
- When would pilot studies or workshops need to be completed in order to be able to inform Study design decisions?
- Is rolling enrollment an option?
- Do you favor centers versus “ NHANES” approach to sampling the Study population?
- What will be the next product from the FACA or ICC regarding of the design and timeline (basic outline) of the Study?
Exposure to Chemical Agents Working Group
- Timing of the pilot studies relative to protocol generation deadlines (i.e., funding from pilot studies may not be available in time to assist protocol development)