The National Children's Study Develops New Informed Consent Tool
Informed consent is the mechanism by which an individual voluntarily agrees to participate in research on the basis of a full understanding of a study's goals and potential risks and benefits. To ensure that every participant is as fully informed as possible, and to ensure that potential participants receive consistent information, the National Children's Study has developed an informed consent process involving the use of a new video tool.
The informed consent video presentation will be shown to potential participants on a laptop computer or tablet during recruitment, and walks the viewer through all aspects of the Study, including:
- The purpose of the Study and duration of participation;
- Risks and benefits of the Study;
- Processes and procedures to ensure confidentiality;
- Compensation for participation;
- Types of procedures that will be used, such as questionnaires, physical exams, medical tests, and the collection of biologic and environmental samples;
- How often the participants can expect home and center visits and phone contact to collect the information; and
- Information about the long-term storage and use of the participant's biological and environmental samples.
The video features questions at the end of each section to assure that the information is presented clearly and is understood. If a viewer answers incorrectly, the video provides additional information about that topic and offers additional chances to respond correctly. Study staff will be present while the video is viewed to clarify information and help answer questions about participation.
"This technology has never been used before in a study of this kind," said Alan Fleischman, M.D., Ethical Advisor and Chair of the National Children's Study Federal Advisory Committee. "Most studies use printed materials and a consent form to educate participants, and it's not always clear whether they grasp everything involved. We hope this method increases the likelihood that participants will have a much more complete understanding," he said.
Before Study teams visit potential participants' homes about being involved in the Study, they will receive information in the mail outlining the Study's goals and participation requirements. Participants will be shown the informed consent video once they indicate their interest in enrolling. If they decide they want to join the Study, they will be asked to provide an electronic signature.
To ensure that the video is appropriate for all audiences, Study planners tested the video tool with women meeting criteria for potential participation, who represent diverse ethnic and socioeconomic groups. The video was also designed for low literacy audiences and includes closed captioning for the hearing impaired. It will be made available in English, Spanish, and potentially other languages as necessitated by minority populations in the Study's counties, and translators will be made available when necessary.
During the informed consent process, women will provide consent during pregnancy for themselves and for their child. Fathers and caregivers, who will also be asked to provide data during the Study, will also provide written informed consent.
Children and Assent
Once children reach age 7 and again when they are 14, they will be asked to give assent as they are developmentally and cognitively able. Assent is an affirmative agreement given by a minor acknowledging that he/she understands what is being asked and that he/she gives permission to continue participation. It differs from consent in that it is not legally binding. When they reach the legal age of majority, generally 18, young adults will be asked to provide their own informed consent.
"This is a study about children, and we have an ethical obligation to respect them," said Dr. Fleischman. "We hope that by age seven, they will feel pride in being a part of the Study and assent will be a natural outcome of that. But if they don't want to participate, they don't have to. If they do not wish to continue to participate, we will follow up with them later to see if they wish to resume participation when they are older."
The National Children's Study is considered an observational study and risks to Study participants are expected to be minimal. The informed consent process and other aspects of the Study have been reviewed by the Study's ethics advisors and its Human Subjects Working Group made up of representatives from the Vanguard Centers. Before implementation, all informed consent procedures will be reviewed and approved by the Institutional Review Board of each Study Center in their respective locations, as well as by the National Institute of Child Health and Human Development Institutional Review Board.
"We're asking people to volunteer their time for an endeavor that will help future children," said Dr. Fleischman. "They're inviting us into their homes and lives. We need to show them we are worth their trust and that what the Study seeks to achieve is worth their involvement. We are developing a long-term relationship with families and, as such, we need to make sure participants are as informed as possible."
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National Children's Study Meetings
The National Children's Study Conducts Federal Consortium and Federal Advisory Committee Meetings
Approximately 50 senior leaders from more than 10 federal agencies gathered in Crystal City, VA, on July 25 to discuss the latest progress of the National Children's Study and potential areas for collaboration at the fifth meeting of the National Children's Study Federal Consortium. Rear Admiral Kenneth Moritsugu, M.D., M.P.H., Acting Surgeon General, called on federal leaders to lend their support for the Study. Anand K. Parekh, M.D., M.P.H., Senior Medical Advisor, Office of the Assistant Secretary for Health, provided an overview of the state of children's health and the role that federal agencies can play in enhancing child health and well being through this research effort.
During the meeting, Study scientists unveiled the Research Plan, a component of the overall Study protocol, which provides a detailed description of the scientific basis and rationale for the Study and its design. Federal leaders were invited to comment on the Plan as well as other aspects of the Study. The general public also has an opportunity to comment on the Study's Research Plan for a 60-day period. To view the Research Plan and provide comments, visit the Federal Register notice.
The National Children's Study Federal Advisory Committee convened on June 26-27 in Gaithersburg, MD, to review the Study's progress to date, including the recent completion of the Research Plan. Study leaders also discussed key topics such as the informed consent process, possible adjunct studies to the National Children's Study, and planned data collection methods. At the end of the meeting, a panel of representatives from several Vanguard Centers gave an overview about plans for engaging health care providers to participate in the Study. Minutes of the meeting will be available on the Study Web site (PDF 159 KB) shortly.
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Principal Investigator Profile
Jennifer Culhane, Ph.D., M.P.H.
Montgomery County, PA, Vanguard Center
As an expert in the role of maternal stress on adverse birth outcomes, Jennifer Culhane, Ph.D., M.P.H., first became involved in the National Children's Study when she was invited to participate in the Study's Pregnancy and the Infant Working Group. In September 2005, Dr. Culhane became Co-Principal Investigator of the Montgomery County, PA, Vanguard Center, along with Co-Principal Investigator Donald Schwartz, M.D., M.P.H., from Children's Hospital of Philadelphia.
"My primary interest lies in understanding the causes of racial/ethnic disparities in rates of early preterm births," said Dr. Culhane. For Dr. Culhane, who also serves as Associate Professor of Obstetrics and Gynecology at Drexel University College of Medicine, the National Children's Study offers the rare opportunity to collect a large amount of prospective data on preterm births. "With the National Children's Study, we have a very good shot at advancing knowledge of risk factors for preterm birth and potentially developing interventions targeted at reducing them," she said.
For now, Dr. Culhane and her staff at the Vanguard Center are busy collecting demographic data and reaching out to community organizations in preparation for the Study's recruitment phase. Some of their key partners in this effort include the Montgomery County Health Department and the Philadelphia Health Management Corporation, an organization that conducts surveys on children's health.
Montgomery County is located west of Philadelphia and includes a combination of urban, suburban, and rural areas. Its affluent suburbs make it one of the wealthiest counties in Pennsylvania. While 85 percent of the county is white, the county's urban center contains pockets of African Americans, Hispanics, and Asian Americans. "We really have a mix of everything, and that's what makes it interesting," Dr. Culhane said.
Since completing her doctorate in Epidemiology at Temple University, Dr. Culhane has focused her research exclusively on the diverse residents of Philadelphia. For the last 10 years, she and her colleagues have studied why the city's African-American women are at greater risk for preterm births than their white counterparts. They have attacked the problem from multiple angles, including social-epidemiological research on the association between preterm births and exposure to adverse neighborhood/social conditions including high crime rates and discrimination. They have also explored physiological explanations by studying factors related to pregnant women's immune and endocrine systems that could predispose them to infection or the adverse consequences of infection. Recently, they've expanded their research to examine how neighborhood conditions influence early childhood outcomes.
Dr. Culhane anticipates that in Montgomery County, geographic diversity will present the greatest challenges when it comes to implementation of the National Children's Study. "Low population densities in the county's rural areas will make door-to-door recruitment difficult," she said. "We are also trying to figure out how to attend every delivery of children enrolled in the Study in light of the county's large number of delivery hospitals."
Looking ahead to the implementation phase of the National Children's Study, to begin in 2008, Dr. Culhane is most excited about the continuum of data from pregnancy through childhood that the Study will provide and its ability to shed light not only on the complexity of risk factors for preterm birth but also the long term consequences of being born too early.
"I believe that there are fetal origins to some adult illnesses. The National Children's Study will enable researchers studying pediatric health conditions to better understand the contributions of the prenatal environment," she said.
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Good to Know
Factors Affecting Childhood Obesity
Over the past decade, significant public attention has focused on the growing obesity epidemic among children. According to a recent article published in the Journal of the American Medical Association, childhood obesity rates have climbed from 5 percent in 1971 to 1974, to 18 percent currently. Researchers contend that obesity is one of several childhood chronic conditions that foreshadow a major rise in adult disability and public health care spending.1
Although genetics play a role in childhood obesity, researchers do not believe that gene pool changes are responsible for the recent dramatic growth in childhood obesity rates. A series of broad social and environmental changes--such as increased parental stress, increased television and other media use, decreased opportunities for physical activity, unsafe neighborhoods, and increased fast food consumption--are likely fueling this crisis.2
A recent longitudinal analysis of children from ages 2 to 12 further points to environmental and behavioral factors behind the increase in childhood obesity.3 In evaluating ecological correlates of excessive weight gain among the study population, researchers found that:
- Children who became overweight in preschool tended to have mothers who were more strict and controlling than children who never became overweight. Their findings suggest that mothers who are more involved with their preschool-age children in a sensitive and flexible fashion are more likely to promote their children's overall health and well being.
- Children who were more physically active and spent less time watching television after school were less likely to be overweight by age 12.4
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1 Perrin, J.M., Bloom, S.R., Gortmaker, S.L. (June 27, 2007). The increase of childhood chronic conditions in the United States. JAMA, 297(24):2755-2759.
3 O'Brien, M., Nader, P.R., Houts, R.M., Bradley, R., Friedman, S.L., Belsky, J., Susman, E., et al. (April 3, 2007). The ecology of childhood overweight: a 12-year longitudinal analysis. International Journal of Obesity, 1-10.
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The National Children's Study is led by a
consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY