Improving Policies for Use of Newborn Screening DBS: An Online Legal Toolkit for State Policy-Makers

The Legal Toolkit for Newborn Screening DBS provides state legislators and other policy-makers with a menu of options to consider as they develop policies related to the retention and secondary use of residual newborn screening dried blood samples (DBS). Developed by the Network for Public Health Law and the Johns Hopkins Berman Institute of Bioethics, the Toolkit provides a survey of current state statutes and/or regulations addressing certain core provisions related to the retention and use of DBS, as well as guidance for newborn screening programs to enable them to 1) clarify what their legal responsibilities are with respect to the retention and secondary use of DBS and related information and 2) delineate clearly what activities they have legal authorization to conduct using DBS and/or related information.

The Toolkit can be accessed at Networkforphl.org/newborndbs.

Newborn screening is a vital public health program that detects serious medical conditions that can cause devastating effects if treatment is not given prior to the onset of symptoms. Many states retain DBS from the testing process, which involves the collection of a few drops of blood from a newborn’s heel. These DBS have a broad range of potential uses, including program evaluation, development of new tests, public health and biomedical research unrelated to newborn screening, and surveillance for environmental contaminants.

State laws vary on whether DBS can be retained, permissible uses, and terms of use. Notification and consent requirements for retention and research use of DBS and associated information also vary. Depending on the state, certain research uses require no consent, others require notice and an opportunity to refuse (“opt-out” consent), and still others require explicit permission (“opt-in” consent).

The potential use of DBS for research without explicit parental consent has generated public controversy, which has led to concerns that the secondary use of DBS could jeopardize the public health mission of newborn screening by leading to increased refusal rates for newborn screening, thereby placing unscreened infants at risk. This controversy is reflected by recent enactment of federal law that requires explicit consent use of DBS for research that is funded or supported under the federal Public Health Service Act.

Michelle Huckaby Lewis

Michelle Huckaby Lewis

The Legal Toolkit for Newborn Screening DBS was developed by Denise Chrysler J.D., Director, at the Network for Public Health Law – Mid-States Region, University of Michigan School of Public Health, and Michelle Huckaby Lewis, M.D., J.D., Research Scholar, at the Johns Hopkins Berman Institute of Bioethics, in collaboration with Aaron Goldenberg, M.P.H., Ph.D., Assistant Director of the Center for Genetic Research Ethics and Law at Case Western Reserve University. Preparation of the toolkit was assisted by a Public Health Law Research Program grant from the Robert Wood Johnson Foundation.

 

 

About the Network for Public Health Law
The Network for Public Health Law provides visionary leadership, insightful legal assistance, helpful resources, and opportunities to build connections for local, tribal, state and federal officials as well as public health practitioners, attorneys, policy-makers and advocates. Organizations and individuals committed to improving public health can join the Network.

About the Johns Hopkins Berman Institute of Bioethics
One of the largest bioethics centers in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental and private sector organizations to address and resolve ethical issues. Institute faculty members represent diverse disciplines including medicine, nursing, law, philosophy, public health and the social sciences. More information is available at www.bioethicsinstitute.org.