Biobanking Newborn Bloodspots For Genetic Research Without Consent

sandra j. carnahan, South Texas College of Law

Abstract

BIOBANKING NEWBORN BLOODSPOTS FOR GENETIC RESEARCH WITHOUT CONSENT

Professor Sandra J. Carnahan

Abstract

State public health programs mandate newborn screening shortly after birth for various genetic disorders that may have serious health consequences if not identified and treated very early in life. Given the individual and public health benefit, most of states conduct newborn screening programs without parental consent. Recently, two high-profile lawsuits have brought to the public's attention that some states are creating research biobanks, storing their newborn bloodspots, and disseminating them to outside entities for genetic research purposes that are unrelated to the original purpose for which the bloodspots were obtained. If the purpose of a newborn blood collection is now two-fold—newborn screening for disease on the one hand, and genetic research on the other—then collecting newborn blood samples without parental consent raises serious ethical and legal issues. This article addresses those issues, including the claims made in lawsuits in Texas and Minnesota. The article then goes beyond the lawsuits to address the larger concern of how to maintain the public's trust in state newborn screening programs as medical research progresses, and newborn blood spots become an essential and highly sought-after research tool. The article constructs an argument that the federal regulations for human subject protection ought to apply to state newborn screening programs, in light of extensive and increasing federal involvement in these programs. Finally, this article analyzes the concept of informed consent for newborn screening and research, and reveals the underlying fallacy of a presumed consent system in the genetic research context. This article concludes that states should adopt the federal regulations for the protection of human research subjects, and require, prior to the point of blood collection, written parental consent to biobank newborn bloodspots for future genetic research. The critically important message of this article is that if states are not forthcoming with parents regarding biobanking and use of their child's blood for genetic research, they risk a potentially disastrous result--undermining the public's trust in essential newborn screening programs.