Prenatal testing is changing dramatically. With greatly expanded low-cost genetic tests - some as simple as a maternal blood test - prospective parents will soon be able to learn far more, far earlier, than ever before about their fetuses' medical conditions and risks, and some nonmedical traits. These tests raise significant questions for doctors, patients, and health policy. What should be tested for? Are there traits that the tests should not be used to investigate? What policy changes are needed to support ethical use of these tests?
With a $1.1 million grant from the National Institutes of Health, The Hastings Center is leading a foundational ethical analysis of next-generation prenatal genetic tests that will inform clinical guidelines and create a research agenda aimed at improving policy and practice. The new three-year project will be led by Josephine Johnston , director of research at The Hastings Center, and Erik Parens , senior research scholar. Co-investigators on the project are Sarah McGraw , also a research scholar at Hastings, and Hastings Center president Mildred Solomon , as well as Paul Appelbaum, a professor of psychiatry, medicine and law, and Wendy Chung, a molecular and clinical geneticist, both of Columbia University.
"The next generation of prenatal tests are set to offer prospective parents an enormous amount of information about the genetic make-up of their fetuses," Johnston explains. "It is our job, through this project, to identify policies and practices that can inform, support and empower patients to make testing decisions that are consistent with their goals and values."
To consider how best to deploy these new prenatal tests The Hastings Center has recruited an international working group of experts and representatives. They include leaders of major clinical societies, clinical researchers and social scientists investigating prenatal testing, philosophers, and patient representatives.
Until recently, prenatal genetic tests could look for a relatively small number of disorders, including Down syndrome. Combined with older technologies for securing samples of fetal DNA, advances in sequencing technology have made it possible and increasingly affordable to analyze a fetus's entire genome. At the same time, new noninvasive prenatal tests involving a maternal blood test make it possible to gather information about the fetus's genome ever earlier in pregnancy.
Although currently recommended only for women over 35, the new noninvasive tests could one day be offered to all of the 4 million women who give birth in the United States each year. These technologies point to a future in which prospective parents are offered a large amount of information about their fetuses, including the presence of gene variants associated with disease susceptibility, adult-onset conditions, and nondisease traits.
"Next-generation prenatal tests are different in ways that are psychologically, socially, and morally salient," says Dr. Solomon. "Because the clinical and policy landscape into which these tests are entering is rapidly evolving, new research is needed to ensure their wise and effective use." To that end, The Hastings Center's project will address these questions:
The Hastings Center's areas of scholarship include Health and Health Care, Children and families, Aging and Care Near the End of Life, Science and the Self, and Human Impact on the Natural World. These areas are ones in which the nation and the global community face serious challenges and where bioethics can help.
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