Affiliation:
1. Children’s Hospital Informatics Program, Children’s Hospital, Boston, Massachusetts
2. Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
3. New England Regional Newborn Screening Program, Jamaica Plain, Massachusetts
Abstract
Objective. To define current practice among US newborn screening programs for notification of results, research, and consenting procedures.
Methods. A telephone survey of all US newborn screening program supervisors.
Results. All 51 programs participated. All states reported abnormal results to the infant’s physician, and some also reported to the hospital and parents. Cases with abnormal results were tracked to different endpoints but usually (92.1%) at least until a follow-up appointment was made. A total of 66.6% of programs can communicate with programs in other states; 9.8% enable families to suppress reporting of results to the infant’s physician. No state has a mechanism for parents to prevent results from entering the medical record. Parents or physicians who request results are often authenticated by providing their name (52.9%). Many programs (45.1%) report only to physicians and require just their name (43.5%), an identification number (17.4%), a letter (26.1%), or a parent’s signature (26.1%). A total of 70.6% retain residual blood samples; of these, only 8.3% store them completely devoid of patient identifiers. A total of 49.0% of programs aggregate data for research. In 16.0% of these, the data are publicly available. In 24.0%, researchers obtain approval at their own institution; in 24.0%, researchers obtain approval through the state laboratory Institutional Review Board. In 74.5% of programs, parents are notified but not asked for consent before collection of the sample; 19.6% neither notify parents nor obtain consent before screening.
Conclusions. There is wide variation in practice among the US newborn screening programs. Because the programs collectively manage a comprehensive nationwide genomic databank, careful consideration of how information technology and high-throughput genomic analysis are used will be essential to allow progress in clinical care, public health, and research while protecting individual privacy.
Publisher
American Academy of Pediatrics (AAP)
Subject
Pediatrics, Perinatology, and Child Health
Reference13 articles.
1. Council of Regional Networks for Genetic Services (CORN) Newborn Screening Committee. National Newborn Screening Report—1995. Atlanta, GA: Council of Regional Networks for Genetic Services;1999
2. Therrell BL, Hannon WH, Pass KA, et al. Guidelines for the retention, storage, and use of residual dried blood spot samples after newborn screening analysis: statement of the Council of Regional Networks for Genetic Services. Biochem Mol Med.1996;57:116–124
3. Newborn Screening Task Force. Serving the family from birth to the medical home: a report from the Newborn Screening Task Force convened in Washington DC, May 10–11, 1999. Pediatrics.2000;106(suppl):383–427
4. Hiller EH, Landenburger G, Natowicz MR. Public participation in medical policy-making and the status of consumer autonomy: the example of newborn-screening programs in the United States. Am J Public Health.1997;87:1280–1288
5. Wolfson M, Wu MM. Postrelational database implementation for newborn screening and tracking. J Med Syst.1988;12:105–113
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