Bioethicists argue for stricter rules at genetic repositories.
Biobanks should revamp how they handle DNA from healthy children, says an international team of bioethics experts. Children whose parents have signed them up for long-term studies should not have their genetic data distributed or made public until the donors consent at an older age, says the team, which publishes its recommendations today in Science1.
"Children should be able to decide, when they're mature enough, about their full or fuller involvement," says Bartha Maria Knoppers, director of the Centre of Genomics and Policy at McGill University in Montreal, Canada, and an author of the paper. If implemented, the recommendation could help protect young participants' privacy, but critics say that it is arbitrary and will hamper research into children's health.
Many large biobank projects, including the US National Children's Study and the Norwegian Mother and Child Cohort Study, are now routinely collecting biological samples from healthy newborns and children. These young participants present a unique ethical challenge. They are too young to give informed consent, so authorization is needed from parents or guardians. But they will eventually become adults who may not wish to share their DNA.
David Gurwitz, director of the National Laboratory for the Genetics of Israeli Populations at Tel-Aviv University in Israel, and lead author of the study, says that the recommendations are needed to safeguard child donors from the risks associated with revealing personal genetic data. "Don't rush into distributing the DNA samples to external researchers, because DNA is a strong, unique identifier," he says. To avoid delays in paediatric research, in-house research facilities should be built so that analyses can continue without samples leaving the biobank until adult consent is obtained, Gurwitz adds.
The paper makes "some excellent suggestions", says Joan Scott, deputy director of the Genetics and Public Policy Center in Washington DC. "It can be expensive to put these safeguards in place, but I think we really need to look at them if we're going to enrol children."
Only the healthy
The policy recommendations should apply only to biobanks that store DNA and lifestyle information from healthy children, the authors note. For disease-specific repositories that collect samples only from children with disorders, the benefits of would-be therapies outweigh the potential risks of lost privacy, they argue.
But many bioethicists take issue with this distinction. Often what starts out as a disease-specific study ends up providing insights into broader health issues and vice versa, says Mats Hansson of Uppsala University in Sweden. "All of these biobanks are of general use," he says. Karen Maschke, of the Hastings Center, a bioethics research institute in Washington DC, notes that the risks of leaked genetic information are the same in both situations. Moreover, she says, patients with diseases rarely benefit personally from participation in studies. "It doesn't seem to me that that dichotomy is justifiable," she says.
Other critics cite the practical difficulties that biobanks would have in implementing the recommendations. Ronald Green, director of the Ethics Institute at Dartmouth College in Hanover, New Hampshire, says that the requirement to re-contact all children years later is unnecessarily strict and "could be a nightmare". It also might introduce biases into the data by eliminating all but the least mobile individuals. What's more, the mandate for adult consent is not an overwhelming concern for people, says Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children's Hospital in Washington. Last month, he reported the results of a survey that found that 67% of the nearly 1200 respondents wouldn't mind the continued use of childhood DNA samples and data if they couldn't be re-contacted later for consent as adults2.
The arguments over re-contact may be "a red herring", says Lainie Friedman Ross, associate director of the University of Chicago's MacLean Center for Clinical Medical Ethics in Illinois. If biobanks can't track down child donors as adults, then they also won't have all the corresponding information about lifestyle choices and environmental exposures that are needed for long-term studies. "The data are useless unless we're following these individuals," she says.
But Green says there's little point in trying to stop the spread of genetic data. To better protect child donors, Green proposes strengthening legislation, such as the US Genetic Information Nondiscrimination Act of 2008, to prevent biological information from being used in a prejudicial manner. "The reality is we're going into a world where that DNA is going to be available," Green says, "and the protections we need are the legal protections".
Gurwitz, D., Fortier, I., Lunshof, J. E. & Knoppers, B. M. Science 325, 818-819 (2009).
Goldenberg, A. J., Hull, S. C., Botkin, J. R. & Wilfond, B. S. J. Pediatr. advance online publication doi:10.1016/j.jpeds.2009.04.034 (2009).