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Newborn Screening, Consent and Storage

posted on Wed, Mar 23 2011 3:22 pm by Kelly Leight

Newborn Screening

Two bills are pending in the Texas legislature, House Bill 2110 and Committee Substitute House Bill 411 (companion bill, SB 507), that propose to change the way newborn screening is conducted in Texas and may set dangerous precedents for other states. These bills arose in response to privacy activists’ concerns about patient privacy rights in the state’s storage and use of materials containing DNA.

Newborn screening is required in all states. State statutes that govern screening usually do not require parental consent, although most states will allow the parents to refuse, usually for religious purposes.[1]

Newborn screening is done in the hospital shortly after birth to detect certain life-threatening genetic and metabolic conditions. If detected early, treatment can prevent severe mental and physical disabilities, and, in certain cases, death.

For the blood screening, a few drops of blood are taken from the newborn’s heel, placed on a special filter paper, and sent to the state public health laboratory for testing. In Texas, blood screening currently covers 28 conditions. Approximately 500 children with devastating, but treatable diseases are detected annually through its newborn screening program.[2]

After the screening process, there may be some residual blood remaining on the filter card. The residual blood may be retained and used for quality control and improvement. In addition, in some programs, deidentified or anonymized specimens may be available to researchers seeking to improve the public’s health through their studies. Most important to the newborn screening process, these residual samples are sometimes used to develop newborn screening tests for additional conditions that can provide more children with a healthy start in life. Research use of specimens is subject to approval by institutional review boards that rigorously review the ethics and usage protocols for such studies.

Newborn Screening and Parent’s Informed Consent

Currently in Texas, newborn screening itself does not require informed consent, but rather parents may opt out for religious reasons. HB 2110 would create an individual’s property right in DNA samples, requiring consent to collect, test or store a specimen containing DNA. The bill provides civil and criminal penalties for violating its provisions.

HB 2110 provides no exception for newborn screening. If enacted, instead of universal screening of newborns, screening would only occur if written informed consent was obtained. The likely outcome would be missed cases of conditions currently diagnosable by newborn screening and amenable to life-saving early therapeutic intervention. Missed cases would be devastating to the child and his or her family. Missed cases would increase costs for health care, early intervention and special education. The state’s cost of caring for one child with mental retardation, such as in late-diagnosed children with phenylketonuria or congenital hypothyroidism, was estimated in 2003 at $1,000,000 per child[3] without even including special educational costs or reduced earning potential.

Barriers to Storage and Use of Residual Specimens

In Texas, residual specimens may be stored and used for limited purposes, but parents may opt out of this storage process. CSHB 411 (and companion bill SB 507) seeks to require parental consent for state storage and use of residual blood samples and requires that all use of such samples are overseen and approved by both an IRB and by the Commissioner of Health. These requirements not only impact the use of residual specimens for research that potentially benefits the public’s health, but also affect the availability of specimens for quality control and improvement of newborn screening and development of tests to benefit newborns.

These bills are pending in the Texas House Committee on Public Health.

UPDATE September 2015: Neither of these bills passed. HB 411 was enacted, effective June 17, 2011, which amended the Texas Health and Safety Code, Title 2 - Health, Subtitle B - Health Programs, Chapt. 33 - Phenylketonuria, Other Heritable Diseases, Hypothyroidism, and Other Certain Disorders, Sections 33.001 through 33.056, to address retention, uses and consent regarding residual blood spots and associated information. Administrative rules were revised, effective December 31, 2013, to implement statutory amendments. See, Texas Administrative Code, Title 25 - Health Services, Part 1 - Dept. of State Health Services, Chapt. 37 - Maternal and Infant Health Services, Subchapt. D - Newborn Screening Program, Sections 37.51 through 37.64.

Kelly Leight is the mother of a child with congenital adrenal hyperplasia and a long-time advocate for newborn screening. She is the founder and former Executive Director of CARES Foundation and currently serves as the coordinator of Preserving the Future of Newborn Screening, a coalition of parents, health care and public health professionals, corporations and other individuals passionate about newborn screening. Special thanks to all of those people who helped edit this article.

The opinions in this blog are those of the guest blogger and do not necessarily represent the views of the Network for Public Health Law.


[1] GAO Report to Congressional Requestors, Newborn Screening, Characteristics of State Programs (March 2003) available at http://www.gao.gov/new.items/d03449.pdf.
[2] Figures reported from 2010, National Newborn Screening Genetic Resource Center, University of Texas Health Sciences, Austin, Texas. http://nnsis.uthscsa.edu/
[3] Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment — United States, 2003. MMWR 2004; 53(3): 57–59.

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