Appendix BChair: George Daston, Ph.D., NCSAC Member
National Children’s Study Advisory Committee 7 th Meeting
Thematic Sub-Group Breakout Meeting Summary: Undesirable Outcomes of
Pregnancy: Birth Defects and Pre-Term Birth
September 15-16, 2003
Holiday Inn Select
Proctor & Gamble Company
Dr. Daston called the meeting to order, asked the observers in attendance to introduce themselves, and suggested guidelines for the session. During the course of reviewing eight hypotheses, participants raised several major concerns and recurrent issues.
Carole Kimmel, Ph.D., ICC Member, National Center for Environmental Assessment, EPA, stressed the importance of increasing the specificities of Study measures. Participants repeatedly noted gaps in proposals with respect to the specifics of what needed to be measured, when measurements should be made, and what methodologies should be utilized.
A questionnaire was frequently cited as a way to obtain information, but Donald Dudley, M.D., NCSAC Member, University of Texas Health Sciences Center at San Antonio, wondered about what would be asked and how questions would be phrased or otherwise presented. Dr. Dudley also pointed out the risks of recall bias when subjects would be asked about past events.
Other methods for obtaining information were discussed. These included reviews of medical records, access to pharmaceutical databases, readings of physiological indices, and procurement of biological samples. Dr. Kimmel pointed out that it was not clear what the threshold would be for when additional information would be sought from sources other than the questionnaire.
Mark Klebanoff, M.D., M.P.H., ICC Member, National Institute of Child Health and Human Development, NIH, DHHS, called attention to the impracticality of conducting lengthy interviews. Lucina Suarez, Ph.D., NCSAC Member, Texas Department of Health, added that consideration of the expense of the measurement procedure was important, particularly when dealing with a sample size of 100,000 subjects.
Measurement Versus Hypotheses
A recurring issue emerged concerning whether the Working Groups had confused measures with hypotheses. Judith Graham, Ph.D., NCSAC Member, American Chemistry Council, suggested that a focus on a basic set of measurements was important as part of the whole Study.
Sherry Selevan, Ph.D., ICC Member, Office of Research and Development, EPA, noted that data collection did not always have to be directly related to a specific hypothesis, but could be useful for general analyses. Dr. Dudley pointed out that collecting certain data could prove to be useful at a later time when more refined theories were developed.
Dr. Klebanoff discussed the value of storing biological samples for future analysis when improved technological methods become available.
Recommendation: Working Groups should develop a list of core measures as a way of building the remainder of the protocol.
Overlap/Duplication of Hypotheses
Another recurring issue centered on the similarity or overlap of hypotheses proposed by different Working Groups, or, in a few cases, by the same Working Group. This Sub-Group debated the assignment of particular hypotheses to certain Working Groups, and suggested reassignment to a different Working Group. Moreover, in considering the need for reassignment or combination of hypotheses, the Sub-Group repeatedly emphasized the importance of collaborative efforts among different Working Groups.
- Several hypotheses should be combined into one large broad hypothesis, or the Working Group should select one of several hypotheses, with the recognition that they cannot measure everyone and everything.
- In some instances, Working Groups should be instructed to work together, or they should seek out individuals from other Working Groups with particular expertise relevant to their proposals.
Questions repeatedly arose about the appropriate operational definitions of conditions such as birth defects, infertility, and stress.
- Studies relating to the developmental stage of puberty should be reassigned to the Obesity and Physical Development thematic area.
- Create a new thematic area, called Reproductive Development (including puberty); or, broaden the Birth Defects and Pre-Term Birth thematic area.
Participants discussed the issue of ethical considerations and legal obligations of the researchers when they encountered subjects in the Study who engaged in illegal activities, such as illicit drug use, or who were victims of physical abuse. An observer, Warren Galke, National Children’s Study Program Office, National Institute of Child Health and Human Development, NIH, DHHS, discussed similar issues related to the discovery of environmental hazards throughout the course of the Study.
Recommendation: The Ethics Working Group should be changed to a standing committee to address overall legal and ethical issues.
Follow Up with Working Groups
Before the meeting came to a close, Dr. Daston asked participants to come to consensus on a timetable for communicating with the Working Groups. Dr. Graham expressed disappointment at how long it had taken to address the hypotheses since their review a year earlier.
Recommendation: Develop a more aggressive schedule leading to the December meeting.
Thematic Sub-Group Members
Chair: George P. Daston, Ph.D., Proctor & Gamble Company
Adolfo Correa, M.D., Ph.D., M.P.H., CDC, DHHS
Donald J. Dudley, M.D., University of Texas Health Sciences Center at San Antonio
Judith A. Graham, Ph.D., American Chemistry Council
Mark A. Klebanoff, M.D., M.P.H., NICHD, NIH, DHHS
Carole A. Kimmel, Ph.D., EPA
Sherry G. Selevan, Ph.D., EPA
Lucina Suarez, Ph.D., Texas Department of Health
Observers and Other Participants
Marion Balsam, M.D., National Children’s Study Program Office, NICHD, NIH, DHHS
Jennifer Benz, National Opinion Research Center
Rebecca Brown, EPA
Beth Davis, National Children’s Study Program Office, NICHD, NIH, DHHS
Warren Galke, National Children’s Study Program Office, NICHD, NIH, DHHS
Adrienne Goslee, Booz, Allen, Hamilton
Doris B. Haire, American Foundation for Maternal and Child Health
Jan L. Leahey, NCSAC Executive Secretary, NICHD, NIH, DHHS
Pauline Mendola, Ph.D., EPA
Beth Roy, Society for Scientific Systems
Kathy Schneider, Iowa Foundation for Medical Care