P2C116: Newborn Blood Screening – Privacy, Consent and Refusal

Background: There has been an increase in public and parental concern about privacy issues related to newborn testing as DNA technology has advanced, medical research utilizing these newborn samples has proliferated, and as it has been revealed that law enforcement in several states has increasingly been trying to access newborn blood samples for criminal investigations.

Right now, there is no uniform national policy for how newborn screening is conducted and each state currently sets its own policies on privacy – including retention periods, potential law enforcement access, consent provisions for testing and research, and the ability of parents to refuse the testing altogether.

Project Description: This panel will discuss current advocacy work to pass new laws, as well as discuss best practices and policy recommendations for what we can be doing as an AAP community to address privacy implications and foster parental confidence and support for the newborn screening program and the important work that it does to reduce morbidity and mortality in children.

Discussion: This panel brings together pediatric clinicians, experts in pediatric genetics and newborn screening, health law and ethics, and genetic privacy.

Dr. Melissa Wasserstein is the Chief of the Division of Pediatric Genetic Medicine at the Children’s Hospital at Montefiore and Professor of Pediatrics and Genetics at the Albert Einstein College of Medicine. Her research activities include expanding and enhancing newborn screening to optimize the outcome of infants with rare disorders and implementing genomic diagnostics in diverse populations.

Dr. Sean Gamble is a Clinical Assistant Professor at Stanford University. He has worked as a pediatric and neonatal hospitalist for nearly two decades. Dr. Gamble’s experience working with families to answer questions and address increased privacy concerns and refusal of newborn testing animates his advocacy work on this issue.

Natalie Ram is a Professor at the University of Maryland Carey School of Law and adjunct faculty with the Berman Institute of Bioethics at Johns Hopkins University. She is a leading scholar on the intersection of genetic privacy and the law. Professor Ram received her J.D. from Yale Law School and clerked for Justice Breyer on the U.S. Supreme Court.

Dr. Crystal Grant is a Technology Fellow with the ACLU’s Speech, Privacy, and Technology Project. She has a Ph.D. in Genetics and Molecular Biology and has engaged in extensive writing and advocacy on privacy and genetic testing.

Conclusion: We will discuss current public policy issues related to newborn blood screening along with state/federal legislative and other advocacy efforts underway, including in California and New Jersey, to buttress privacy protections, helping to ensure that parents feel confident in the newborn screening program.