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How will medical care providers be asked to help?
Will there be any costs to medical practices or hospitals for cooperating with the Study?
How will medical care providers know who is enrolled in the National Children’s Study?
How will participation in the National Children’s Study impact patient care?
How will informed consent and medical records release authorization be handled?
What safeguards are in place for the protection of each participants’ privacy?
How will medical care providers be asked to help?
Obstetricians, pediatricians, and family medicine practitioners will be contacted by local Study staff and administrators, informed about the research, and consulted about how the research activities might fit within existing clinical practices. In particular, obstetricians will be asked to help identify eligible patients and they may be asked to assist with collection of ultrasounds. At hospitals, they will be asked to allow collection of specimens at delivery and possibly facilitate medical chart abstraction after delivery. Pediatricians and other practitioners will be contacted regarding clinical visits as the children grow.
Will there be any costs to medical practices or hospitals for cooperating with the Study?
We anticipate no costs to clinical practitioners or hospitals for helping the National Children’s Study. Study staff will do all the work of identifying eligible participants, tracking them, and facilitating data collection, although Study staff will need to engage with care providers as described above.
How will medical care providers know who is enrolled in the National Children’s Study?
Eligible participants will be visited in their homes by Study staff and enrolled before their pregnancy, during their pregnancy, or even up to one month after giving birth. Participants will be asked to identify themselves to hospital staff and physicians at the time of registration/admission and present some form of Study identification. To ensure that all participants are identified at the hospital, each participant's medical chart is flagged with a NCS sticker to assist nurses and doctors with identifying participants. Some recruitment may take place at hospitals or birthing centers to ensure that all eligible women within a defined geographic area have been asked to participate in the Study. For these cases, local Study staff will work with hospital and birthing center staff to determine the best approach for recruitment and enrollment in each facility.
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How will participation in the National Children’s Study impact patient care?
Tests and procedures conducted as part of the Study will be for research purposes only and will not replace regular patient care. The Study will cover the costs of any procedures that are conducted as part of the research (e.g., blood pressure measurements, ultrasounds, etc.). When participants are informed about results, they will be provided with normative data to see how their own compare. Any clinically relevant and actionable medical information will be reported to the participants and they will be encouraged to discuss these findings with their physician. A referral mechanism will be in place for participants who do not have a regular care provider.
How will informed consent and medical records release authorization be handled?
All Study protocols and consent materials have been reviewed by multiple Institutional Review Boards (IRBs) at the national and local levels. Each woman enrolling in the National Children’s Study will be informed about participation and asked to consent to it. Prior to her child’s birth, she will also be asked for permission for Study staff to obtain her medical information. This form will be HIPAA compliant, and a copy of the patient’s signed authorization form will be provided to the labor and delivery facility at, or prior to, birth. Study staff will request that participants sign additional authorization forms as facilities require. Assent will be sought from the children themselves as they get older, and when they reach the age of legal consent, they will be asked to provide informed consent.
What safeguards are in place for the protection of each participants’ privacy?
Confidentiality for all Study participants is critical for the Study to be successful. Privacy protection and confidentiality training for all Study staff, use of unique identification numbers, and the design of computer management systems that protect personal identifying information will be carefully implemented. IRB approvals will be secured prior to Study initiation and information gathered for the Study will be used for research purposes only. In addition, the National Children’s Study has acquired a Certificate of Confidentiality from the National Institutes of Health to protect identifiable research data from forced disclosure.