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Weighing consent in babies' screening

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2009年10月13日(Tue) 11:31

日本語訳を載せました(PDFファイル) http://www.newsobserver.com/opinion/story/134032.html Published Sun, Oct 11, 2009 02:00 AM Modified Fri, Oct 09, 2009 05:00 PM BY SUSANNE B. HAGA DURHAM -- This past spring, families in Minnesota and Texas filed lawsuits over the storage of blood samples taken for newborn screening. Nine families in Minnesota alleged that storing newborn screening samples and potentially using them for research violated the state's genetics privacy law, because the state did not obtain informed consent for the storage and use. Similarly, in Texas several families alleged that the storage of newborn screening samples constitutes unlawful search and seizure and violates basic privacy rights. The cases have not come to trial yet, but they raise the prospect of more lawsuits to come. Given the success of newborn screening programs in preventing the development of some devastating diseases, it is critical that steps be taken now to help parents understand the issues at hand and to give them the opportunity to decline long-term storage if desired. Since the 1960s, all states have provided newborn screening for about 50 inherited and mostly treatable diseases. Once a child affected with one of these rare conditions is identified, families can take steps through treatment or adjustments to the baby's diet that will prevent or significantly reduce the severity of symptoms before they begin to develop. One example is the disease called phenylketonuria (or PKU for short) -- the first for which newborn screening was developed. Infants affected with PKU can't break down a building block in some proteins and therefore must avoid certain foods in order to prevent the onset of symptoms, which can include developmental delays and seizures. Screening requires a very small sample of blood, gathered by pricking the heel of the infant and spotting the blood onto filter paper. Newborn screening often occurs unbeknown to many parents, as most states do not have to obtain permission prior to screening. Following the tests, newborn blood samples may be stored for an indefinite period, also without parental knowledge or consent. Currently, about 46 percent of newborn screening samples are stored for three years or less. But the majority of samples are stored for 18 years or more, with 10 states (including North Carolina) storing samples indefinitely. Texas alone has amassed more than 4 million samples since 2002, storing on average 375,000 samples per year. Why do states store newborn screening samples? Mainly for legal purposes and in case re-testing is needed. However, samples may be used for research related to newborn screening, such as developing new screening tests, and in some cases even for unrelated research. Herein lies the sticking point. Do states have the right to use these samples, even if it is done anonymously and for research that may benefit public health, without parental consent? Often, the research doesn't require personal information and involves research of diseases affecting children, such as Type 1 diabetes, lead poisoning or cytomegalovirus infection. While this may be news to parents, professional groups representing public health officials, pediatricians and researchers have issued reports over the past decade highlighting the benefits of research with stored newborn samples and calling for clearer, more transparent policies. The lawsuits have renewed focus on the issue and triggered yet another round of review, this time by a federal advisory committee to the U.S. secretary of Health and Human Services. The committee has recommended that parents be asked for permission to use their newborns' leftover blood samples for research unrelated to newborn screening. Given that this screening has taken place for decades without the need for any parental consent, any such changes raise some important questions for this extremely successful program. How much choice will parents have about the use of blood samples for research, and what of the added costs? The newborn screening programs now are a bargain, at just a few cents per disease tested. Parental permission has never been required for screening, given its significant benefits and minimal risks. Though some may argue that research with newborn screening samples also comes with considerable benefits, those pluses don't offer any direct benefit to the infant in question, and the potential for harms linked to privacy may go beyond what states should assume parents are willing to accept. In most cases, consent is required for research involving human tissues. It would seem that newborn screening samples should be no exception. States should, therefore, provide parents the choice of allowing their infant's samples to be used in research overall, with restrictions or not at all. Few of us truly understand newborn screening, despite its remarkable successes, let alone the issues of storage and use of the screening samples. Attention to these issues is long overdue and should be quickly and thoughtfully addressed by state public health administrators and doctors. The newborn screening program catches infants affected with one of a list of diseases from the start, allowing parents and doctors to act early, and we must not let that be compromised. Susanne B. Haga is an assistant research professor in the Institute for Genome Sciences & Policy and the Sanford School of Public Policy at Duke University.

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