Hastings Center Awarded NIH Grant
News Sep 14, 2015
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 Hastings Center scholar Sarah McGraw and Hastings Center presidentMildred Solomon. Paul Appelbaum, a professor of psychiatry, medicine, and law, and Wendy Chung, a molecular and clinical geneticist, both of Columbia University, along with Vence Bonham, a health care services and policy researcher at NIH, will join Johnston and Parens to form the project's steering committee.
“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:
• What should be tested for, and how ought testing be conducted?The research will identify principles and values that can guide the use of next-generation prenatal testing. This analysis will examine whether there are any traits that prenatal testing should not be used to investigate as well as the principles and values that are at stake when prenatal testing is offered. It will also identify information and support that should be available to patients.
• Which policies should be altered to support ethical use of next-generation prenatal testing, and in what ways should these policies be changed?Prenatal testing does not take place in a vacuum—clinicians and patients make decisions against the backdrop of a variety of policies, practices and societal norms that influence their decision-making. The project will identify changes to these policies and norms needed to support ethical use of next-generation prenatal testing.
• What further empirical research is needed to examine how the principles, values, and recommended policy and practice changes play out in practice?The project will create a research agenda for empirical researchers to explore over time, not only to discern the impact of its analysis and recommendations, but to formulate new directions for research aimed at improving policy and practice.
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