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 A Report from the National Children's Study Ethics Working Group (November 2003)

Mark Your Calendars

National Children's Study Assembly Meeting

Date: Wednesday, December 17, 2003
Location: Atlanta, GA

Upcoming Events

Psychosocial Stress and Pregnancy and Infancy Workshop

November 12-13, 2003, Bethesda, MD, Working Group: Pregnancy and the Infant

Measuring Physical Activity in the National Children's Study Workshop

November 17-18, 2003, Arlington, VA, Sponsored by: Special Committee of the National Children's Study Advisory Committee, Interagency Coordination Committee, and Working Group members

Pilot Study Review Workshop

November 21, 2003, Research Triangle Park, NC, Sponsored by: Interagency Coordinating Committee

NCSAC Meeting

December 15-16, 2003, Atlanta, GA

Use of Herbal Products in Pregnancy, Breastfeeding, and Childhood Workshop

December 16, 2003, Atlanta, GA, Working Group: Medicine and Pharmaceuticals

Sampling Design Workshop

Date and Location TBD, Sponsored by: Special Committee of the National Children's Study Advisory Committee, Interagency Coordination Committee, and Working Group members

Media Workshop

Date and Location TBD, Working Group: Social Environment

Fertility and Early Pregnancy Workshop

Date and Location TBD

Information on these meetings will be posted on the National Children's Study Web site as it becomes available.

Good To Know

Adolescent Health Study Reveals Parents Influence in Risk Behaviors

The National Longitudinal Study of Adolescent Health, known as the Add Health Study, is a school-based study designed to assess the health status of adolescents in grades 7 through 12, explore the causes of their health-related behaviors, and focus on the effects of the social and physical environments in which they live.

Study findings show that mothers' values and beliefs have a significant influence on adolescents, particularly their daughters. According to a recent article in the Journal of Midwifery and Women’s Health, mothers who do not smoke, stay connected with their daughters, and screen the smoking behavior of their daughters’ peers may significantly reduce smoking initiation in their adolescent daughters.1 Adolescents who have close relationships to their mothers and perceive them to favor abstinence tend to postpone first sexual intercourse, according to an article in the Journal of Adolescent Health.2

1 Dittus P, Jaccard J. Adolescents’ Perceptions of Maternal Disapproval of Sex: Relationship to Sexual Outcomes. Journal of Adolescent Health 2000; 26: 268-278.
2 Faucher M. Factors That Influence Smoking in Adolescent Girls. Journal of Midwifery & Women’s Health 2003; 48 (3): 199-205.


A Report from The National Children's Study Ethics Working Group

childThe National Children's Study Ethics Working Group has been working over the last two years to address a range of ethical issues related to the design and conduct of the Study.

In its work, the Ethics Working Group has issued a paper examining how pediatric research regulations would be applied to the National Children's Study. The group is also developing a statement on the ethical complexity of recruiting and enrolling pregnant adolescents — one population that may participate in the Study.

Last June, the National Children's Study convened a workshop, Ethical Issues in Longitudinal Pediatric Studies: Looking Back, Thinking Forward, that focused on recruitment, retention, consent, confidentiality, information sharing, interventions, and interactions with communities.

Other Similar Studies

According to Ben Wilfond, M.D., co-chair of the Ethics Working Group, the purpose of the workshop was to have other researchers, who have conducted similar longitudinal studies, "discuss the good and the bad [experiences] and to identify questions that would be helpful to National Children's Study designers." Among the presentations, the group heard from researchers of studies that shared some similarities with the National Children's Study such as: Project Viva, a Boston-based study of over 2,000 pregnant women and their infants recruited in utero to assess pregnancy outcomes; The Tucson Children's Respiratory Study of 1,246 newborns followed from birth to age 20 to assess acute lower respiratory tract illnesses in early childhood and chronic obstructive airways disease in later life; and the Wisconsin Cystic Fibrosis Neonatal Screening Study Group that screened 650,341 newborn infants for cystic fibrosis.

Several broad themes emerged from the workshop including the central role of community involvement in all steps of the process, the importance of relationship building between participants and research staff to ensure participation, the challenge of communicating ethical issues to diverse communities, and how to relay study information and data to study participants.

Dr. Wilfond reported that, "It is clear that other studies have confronted and addressed issues similar to those faced by the National Children's Study. What was presented in the workshop reinforces our view that the ethical issues in the National Children's Study are not that different from those faced in previous studies. What is different is that the size and scope of the National Children's Study are broader. We are at the beginning of a process to try and address these issues, which are not, 'Study stoppers,' but are fully resolvable. But, because of the Study's size and scope, we need to work out the details carefully and fully."

Informed Consent

Workshop participants also discussed new approaches to the informed consent process that might include interactive computer-based approaches, as well as the challenges of Institutional Review Board (IRB) review in a multisite study of this scope. Future plans for the Working Group include a workshop at the annual IRB meeting next fall to assess the IRB willingness to consider different review approaches.

Expansion of the National Children's Study Being Explored

The National Human Genome Research Institute, along with other interested federal agencies, is exploring the possibility of launching a large, adult longitudinal cohort to study relationships between genes, environment, and chronic disease. Consideration of the benefits and possible alternatives of expanding the National Children's Study to include grandparents and parents for this purpose is under discussion.

Warren Galke Joins the National Children's Study Program Office

Warren Galke, Ph.D., recently joined the National Children's Study Program Office as a Health Science Administrator. Dr. Galke is an accomplished epidemiologist with more than 30 years of environmental and occupational health experience. The primary focus of his career has been the study of childhood lead poisoning. Prior to joining the Program Office, Dr. Galke was the Director of Research and Evaluation at the National Center for Healthy Housing (NCHH), formerly the National Center for Lead-Safe Housing. While at NCHH, he was the principal investigator of the largest study ever conducted on implementing lead hazard control treatments in housing that presented a high risk of lead poisoning to children.

Dr. Galke will participate in the Study protocol development and help implement pilot studies and workshops. His early focus will be on the chemical and physical environment, including: serving on the Fertility and Early Pregnancy Working Group planning committee for a workshop concerning day-specific probability of pregnancy, responsibility for the creation of a white paper concerning the measurement of housing quality and conditions as proposed by the Social Environment Working Group, and plans for the development of the repository for biological environmental samples that will be collected for the Study.

National Children's Study in the News

The National Children's Study continues to gain attention in the media. Following are two recent mentions:

U.S. News & World Report—September 15, 2003
"Ills From The Womb"

Washington Fax—September 29, 2003
"National Children's Study Funding"

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The National Children's Study is led by a
consortium of federal agency partners:

National Institutes of Health
Centers for Disease Control and Prevention