Ethical Decision Making for Newborn Genetic Screening

New screening technologies and new knowledge about the origin and treatment of genetic conditions are changing the genetic screening environment. This project will focus on the impact of these changes on newborn screening, an on-going public health program that tests virtually all newborns for genetic disorders. The long-term objective is to provide guidance to the professionals, policymakers, and members of the public who must make decisions about newborn screening in this new environment. The specific aims are:1. To carry out an in-depth analysis of a set of closely related current and emerging ethical and social issues that are critical to newborn screening decisions as the area rapidly develops. These issues relate to fairness in the distribution of the costs and benefits of newborn screening; information, consent and privacy; consultation and decision making; and race, ethnicity and socioeconomic status.2. To use this analysis as the basis for a framework for newborn screening policy determination and assessment that adequately responds to these issues.3. To disseminate the results in formats appropriate to the needs of specific groups of decision makers. To pursue these aims, the Hastings Center will assemble an interdisciplinary group with expertise and experience in genetic screening, ethics, public health, economics, law, public policy, and consumer advocacy. The group will hold four meetings to explore the key issues in the identified areas, using four genetic disorders as case studies: Sickle Cell Disease, Cystic Fibrosis, Medium Chain Acyl-CoA Dehydrogenase deficiency (MCAD), and Severe Combined lmmuno-Deficiency (SCID). The project will produce a series of work products: a paper on the evolving scientific and clinical issues in newborn screening; a report on the policy determination and assessment framework; background papers on the supporting analyses; and written and web-based educational materials for decision makers. Through a subcontract, the March of Dimes will provide technical assistance on scientific and clinical issues and work with the Hastings Center to disseminate the project results.