In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

Before conducting an experiment with human subjects, researchers much consider a number of important ethical and regulatory constraints. This chapter reviews the leading ethical concerns that arise in the context of human subjects research in general and experimental research in particular. These ethical concerns have also set in motion regulations, such as The Common Rule, that researchers must follow before launching a study. The chapter concludes by discussing other professional norms, such as research transparency.

The United States does not yet have a comprehensive legal regime to manage germline editing. However, the US Congress, which appropriates funds annually to support the Food and Drug Administration (FDA), has enacted a rider that prevents the agency from using those funds to receive applications for clinical trials. In this manner, Congress has imposed a de facto moratorium that prevents scientists from creating children with modified genomes. In most of the fifty states, scientists remain free to edit human gametes and embryos in the lab as long as they mind federal regulations governing research.In the future, Congress and state legislatures may ban germline editing, in whole or in part. Such bans may face legal challenges. To be sure, the United States has not ratified the International Covenant on Economic, Social and Cultural Rights, and is not bound by its requirement that parties respect scientific freedom. Nor does the US Constitution expressly state a right to engage in scientific research. However, some academics argue that such a right can be derived from the First Amendment. Further, those who cannot conceive a healthy child without germline editing may claim that a ban violates their constitutional right to privacy.