Panel looks at national plan for newborn samples
Shaping state policies on research use of blood spots
In an effort to address the wide variance in state laws and policies regarding the research use of newborn screening blood spots, a federal advisory committee is considering a proposal for a national policy.
A draft policy is being considered by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), which advises the U.S. secretary of health and human services on newborn screening issues.
The ACHDNC commissioned a group of researchers and other stakeholders to look at the scientific, legal, financial, policy and ethical issues raised by secondary use of blood spots and to make recommendations for federal and state authorities.
The group, led by Bradford Therrell, PhD, director of the National Newborn Screening and Genetics Resource Center in Austin, TX, and Harry Hannon, PhD, chief of the Newborn Screening Branch of the Centers for Disease Control and Prevention in Atlanta, GA, presented their recommendations to the committee earlier this year.
Recommendations include:
- all state newborn screening programs should have policies addressing what happens to newborn screening blood spots after screening is complete. The policies should include storage conditions, length of time samples will be stored and measures that will be taken to assure donors' privacy and confidentiality.
- each state's policy should include who has access to specimens and for what purposes, both before and after screening is completed.
- all states should distribute educational information to parents about the uses and potential uses of blood spots. This information should be made available in prenatal education materials, and prenatal care providers should be trained to provide it.
- if blood spots are available to be used for research, there should be some procedure in compliance with federal regulations to show parents' willingness to allow that use. The proposal does not specify whether that permission should be in the form of an "opt-in" consent process or an "opt-out" model. Quality assurance activities would not require additional consent.
- the federal government is encouraged to provide support for the states, through model consent/dissent procedures, model education programs and developing national data on the usefulness of different procedures.
Therrell says the ACHDNC hasn't yet decided whether to accept his group's recommendations. The next scheduled meeting of the committee is in January.
In an effort to address the wide variance in state laws and policies regarding the research use of newborn screening blood spots, a federal advisory committee is considering a proposal for a national policy.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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