title: Ethical issues of perinatal human gene therapy.
abstract: This paper examines some key ethical issues raised by trials of human gene therapy in the perinatal period--i.e., in infants, young children, and the human fetus. It describes five resources in ethics for researchers' considerations prior to such trials: (1) the history of ethical debate about gene therapy, (2) a literature on the relevance of major ethical principles for clinical research, (3) a body of widely accepted norms and practices, (4) knowledge of paradigm cases, and (5) researchers' own professional integrity. The paper also examines ethical concerns that must be met prior to any trial: benefits to and safety of subjects, informed assent of children and informed parental permission, informed consent of pregnant women in fetal gene therapy, protection of privacy, and concerns about fairness in the selection of subjects. The paper criticizes the position that cases of fetal gene therapy should be restricted only to those where the pregnant woman has explicitly refused abortion. Additional topics include concerns about genetic enhancement and germ-line gene therapy.
authors.affiliation: Center for Biomedical Ethics, University of Virginia School of Medicine, Charlottesville, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Fletcher
authors.forename: G
authors.initials: G
authors.lastname: Richter
mesh_terms: D000243:Adenosine Deaminase / Q000172:deficiency; D026683:Advisory Committees; D026686:Beneficence; D002675:Child, Preschool; D030881:Disclosure; D033041:Embryo Research; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D035082:Federal Government; D005260:Female; D033042:Fetal Research; D030342:Genetic Diseases, Inborn; D024861:Genetic Enhancement; D015316:Genetic Therapy; D033161:Government Regulation; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007258:Informed Consent; D008297:Male; D008661:Metabolism, Inborn Errors / Q000628:therapy; D018579:Patient Selection; D011247:Pregnancy; D037841:Pregnant People; D035842:Research Subjects; D040841:Resource Allocation; D018570:Risk Assessment; D013789:Thalassemia / Q000628:therapy
chemical_list: D000243:Adenosine Deaminase