ARTICLE: Legal Regulation of Banking Newborn Blood Spots for Research: How Bearder and Beleno Resolved the Question of Consent Skip over navigation
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Copyright (c) 2011 Houston Journal of Health Law & Policy
Houston Journal of Health Law & Policy

ARTICLE: Legal Regulation of Banking Newborn Blood Spots for Research: How Bearder and Beleno Resolved the Question of Consent

Fall, 2011

Houston Journal of Health Law & Policy

11 Hous. J. Health L. & Pol'y 1

Author

Katherine Drabiak-Syed, J.D.*

Excerpt



I. Introduction
 
Since 1965, newborns at birth receive a neonatal heel prick to collect blood for conducting newborn screening tests. 1 After collection, the newborn blood spot (NBS) samples are sent to the respective state health department for testing, retained for varying lengths of time, and in some cases used for further research purposes. 2 Most states do not inform parents that the state health department will retain or conduct research using their infant's NBS following the screening process. 3

In this article, I argue that retention and subsequent research projects constitute "human subjects research," should be governed under the Common Rule, and that a waiver of consent does not appropriately protect subjects' interests. 4 Examining the status of NBS collection and research use is important because the federal government has indicated its intent to facilitate research sharing of NBS from each state health department, 5 yet it has not classified the collection and subsequent research use of the NBS samples as human subjects research nor afforded it corresponding protections by addressing whether the Common Rule would apply. 6 Federal guidance related to the sample and its associated information does not fully clarify existing questions of how to apply federal regulations, but rather provides conflicting interpretations of whether use of the sample should be governed under the Common Rule.

This federal regulatory uncertainty is further compounded by how each state addresses NBS retention and research. 7 As states expand their retention and sharing of NBS for ...
 
 
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