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After human DNA was first defined in 1953, the parallel science of assisted reproductive technology achieved a successful human birth through in vitro fertilization in 1978. Science then went on to facilitate gestational surrogacy, banking human reproductive materials, such as embryos, and greater opportunities for couples and individuals to become parents. Fertility clinics were established throughout the world to help persons and couples achieve parenthood, contributing to a steady increase in babies born through assisted reproductive means. Gradually, both federal and state laws in the United States were enacted to collect data from the fertility clinics, mandate insurance coverage of assisted reproductive procedures, prohibit funding for human embryo research, and either forbid or enable surrogacy contracts. Societal changes occurred, too, including marriage entitlement for same-sex couples, a dramatic rise in the number of nonmarital cohabitants, and the rapid pace of scientific achievements related to human reproduction.

Throughout this evolutionary period there was a concomitant increase in transnational scientific cooperation, illustrated by international committees and treaties. By utilizing medical tourism, individuals who could afford to do so imposed their own medical needs on foreign scientific communities. The global scientific community became increasingly aware that it was now possible to edit both the human genome and a woman's egg to eliminate mitochondrial disease. Both genome editing and mitochondrial replacement have the potential to eliminate serious disease and vastly improve human society. Amidst this scientific optimism, companies that are able to harness the power of new technological achievements have opportunities for monetary gains. However, there are also drawbacks which include the ethical and moral concerns over possible misuse of human materials; the opportunity to create designer babies; the unknown ramifications upon the human germline; the lack of consent of any resulting child; the disparity in the ability to pay for treatment; and the impact on the racial, gender, and the physical plurality existent in human society.

American legislation, illustrated by the federal Dickey-Wicker Amendment and its regulatory system, and as evidenced by the U.S. Department of Agriculture's Coordinated Framework, is inattentive to the challenges posed by genome editing and mitochondrial replacement. In addition, international treaties and agreements are inapplicable to many countries and ineffective to regulate the research of privately funded scientists. For example, in spite of public condemnation, a baby boy was born in Mexico in 2016 following mitochondrial replacement; in 2018 twin girls were born in China following genome editing. This article addresses the scientific opportunities and challenges of recent developments precipitated by the immediacy of genome editing and mitochondrial replacement. Although scientific academies in the United States and the United Kingdom suggest caution, transparency, and international scrutiny, science advances at an accelerating pace. This article suggests immediate congressional involvement, an update to the federal regulatory process, and clear coordination with international scientific communities. Additionally, to safeguard the human values involved, this article suggests specific goals should apply to the construction of a functional pathway that addresses the human possibility and challenge in genome editing and mitochondrial replacement.



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