A comprehensive ethical framework for fetal research and its application to fetal surgery for spina bifida

The transition from innovation to standard of care for fetal surgery should be guided by ethical considerations. We provide an ethical framework that identifies criteria for the investigation of fetal surgery. This framework addresses the initiation and assessment of clinical trials to determine whe...

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Bibliographic Details
Published inAmerican journal of obstetrics and gynecology Vol. 187; no. 1; pp. 10 - 14
Main Authors Chervenak, Frank A., McCullough, Laurence B.
Format Journal Article
LanguageEnglish
Published Philadelphia, PA Elsevier Inc 01.07.2002
Elsevier
Subjects
Abortion, Induced
Bioethics
Biological and medical sciences
Clinical Trials as Topic - standards
Diseases of mother, fetus and pregnancy
Ethics
Ethics, Medical
Female
Fetal Diseases - surgery
fetal patient
fetal research
Fetus - surgery
Gynecology. Andrology. Obstetrics
human subjects
Humans
Informed Consent
Medical sciences
Pregnancy
Pregnancy. Fetus. Placenta
Research - standards
spina bifida
Spinal Dysraphism - surgery
Ethics
human subjects
fetal patient
spina bifida
research
fetal research
Human
Spina bifida
Malformation
Surgery
Diseases of the osteoarticular system
Fetus
Spine disease
Research
Congenital disease
In utero
Genetics and Reproduction
Biomedical and Behavioral Research
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Summary:The transition from innovation to standard of care for fetal surgery should be guided by ethical considerations. We provide an ethical framework that identifies criteria for the investigation of fetal surgery. This framework addresses the initiation and assessment of clinical trials to determine whether they establish a standard of care, describes an appropriate informed consent process, considers whether selection criteria should include the abortion preferences of the pregnant woman, and considers whether physicians have an obligation to offer referral to such investigation. This ethical framework, in a clinically comprehensive fashion, takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. We apply this framework to clinical investigations of fetal surgery for spina bifida. (Am J Obstet Gynecol 2002;187:10-4.)
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:0002-9378
1097-6868
DOI:10.1067/mob.2002.124274