title: Ethical issues in fetal surgery research.
abstract: Research in fetal surgery is currently ethically controversial, especially because it poses risks to both the fetus and the pregnant woman. We provide an ethical framework for fetal surgery research based on the concept of the fetus as a patient. This framework results in criteria for preliminary investigation of new fetal surgery techniques, for the initiation and termination of clinical trials, the informed consent process, inclusion or exclusion of women based on abortion preferences and the obligations of physicians to refer patients to fetal research protocols. We demonstrate the applicability of this framework to fetal surgery research for spina bifida, a common fetal anomaly.
authors.affiliation: Department of Obstetrics & Eynecology, The New York-Presbyterian Hospital, Weill Medical College of Cornell University, 525 East 68th Street, J-130, New York, NY 10021, USA. fac2001@med.cornell.edu
authors.forename: Frank A
authors.initials: FA
authors.lastname: Chervenak
authors.forename: Laurence B
authors.initials: LB
authors.lastname: McCullough
authors.forename: David J
authors.initials: DJ
authors.lastname: Birnbach
mesh_terms: D000028:Abortion, Induced / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods; D032984:Ethics, Research; D005260:Female; D005333:Fetus / Q000601:surgery*; D006801:Humans; D007258:Informed Consent; D010819:Physician's Role; D011247:Pregnancy; D012107:Research Design; D016136:Spina Bifida Occulta / Q000601:surgery; D035703:Therapies, Investigational / Q000941:ethics