RESEARCH ON THE FETUS - National Institutes of Health

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"Nonviable fetus" refers to the fetus ex utero which, although it is living, cannot possibly survive to the point of sustaining life independently, given the support of available medical technology. Although it may be presumed that a fetus is nonviable at a gestational age less than 20 weeks (five lunar months; four and one-half calendar months) and weight less than 500 grams, a specific determination as to viability must be made by a physician in each instance. The Commission is not aware of any well-documented instances of survival of infants of less than 24 weeks (six lunar months; five and one-half calendar months) gestational age and weighing less than 600 grams; it has chosen lower indices to provide a margin or safety. These indices depend upon present technology and should be reviewed periodically. "Dead fetus" ex utero refers to a fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of umbilical cord (if still attached). Generally, some organs, tissues and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead. "Fetal material" refers to the placenta, amniotic fluid, fetal membranes and the umbilical cord. "Research" refers to the systematic collection of data or observations in accordance with a designed protocol. "Therapeutic research" refers to research designed to improve the health condition of the research subject by prophylactic, diagnostic or treatment methods that depart from standard medical practice but hold out a reasonable expectation of success. "Nontherapeutic research" refers to research not designed to improve the health condition of the research subject by prophylactic, diagnostic or treatment methods. 6
II. THE NATURE AND EXTENT OF RESEARCH INVOLVING THE FETUS AND THE PURPOSES FOR WHICH SUCH RESEARCH HAS BEEN UNDERTAKEN An extensive review of the scientific literature, focusing on a period covering the last ten years, formed the basis for the Commission's investigation of the nature, extent and purposes of research on the fetus. The review was conducted under contract with Yale University, Maurice J. Mahoney, M.D., Principal Investigator. The investigation included an all-language review of published research, utilizing the MEDLARS computer indexing and search system of the National Library of Medicine, a review of selected bibliographies and abstracts, a survey of departments of pediatrics and obstetrics at medical schools in the United States and Canada to identify current research on the fetus, and a review of NIH grant applications and contracts since 1972 involving research on the fetus. In addition, the Food and Drug Administration provided information on fetal research conducted in fulfillment of its regulations. For the purpose of summarizing the review, research involving the fetus has been considered in four general categories. 1. Assessment of Fetal Growth and Development In Utero. Over 600 publications dealing with investigations of fetal development and physiology were identified. In general, the purpose of these investigations was to obtain information on normal developmental processes, as a basis for detecting and understanding abnormal processes and ultimately treating the fetal patient. To this end, numerous experimental approaches were employed. Studies of normal fetal growth relied primarily on anatomic studies of the dead fetus. Studies of fetal physiology involved both the fetus in utero and organs and tissues removed from the dead fetus. In some instances, this research required administration of a substance to the mother prior to an abortion or delivery by caesarean section, followed by analysis to detect the presence of the substance or its metabolic effects in blood from the umbilical cord or in tissues from the dead fetus. Information on the normal volume of amniotic fluid 7
Page 3: Report and Recommendations Research
Page 7: NATIONAL COMMISSION FOR THE PROTECT
Page 11: PREFACE The National Commission for
Page 15 and 16: I. THE MANDATE The National Researc
Page 17 and 18: The Commission has reviewed the com
Page 19: Life Sciences; Richard McCormick an
Page 23 and 24: Once it had been demonstrated that
Page 25 and 26: less than 20 percent of these inclu
Page 27 and 28: for drug administration and blood s
Page 29: iopsies. The most extensive or inva
Page 32 and 33: 1. In the case of congenital rubell
Page 34 and 35: led to success in culturing fetal a
Page 36 and 37: at risk for the disease, and can be
Page 38 and 39: The following conclusions are drawn
Page 40 and 41: Professor Capron states that the va
Page 42 and 43: that causes impairment or subsequen
Page 45 and 46: V. ETHICAL ISSUES Eight ethicists a
Page 47 and 48: Finally, Dr. Fletcher concludes tha
Page 49 and 50: Dr. McCormick judges most abortions
Page 51 and 52: (2) The indeterminancy of the futur
Page 53: Richard Wasserstrom, Ph.D. Dr. Wass
Page 56 and 57: 3. Thomas K. Oliver, Jr., M.D. (Ass
Page 58 and 59: Finally, she urged the adequate rep
Page 60 and 61: therapeutic research on the fetus.
Page 62 and 63: fetus is no more likely to be dehum
Page 64 and 65: Director, NIH (or, in some cases, t
Page 67 and 68: VII. FETAL VIABILITY AND DEATH The
Page 69 and 70: and use of phototherapy for jaundic
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development are present. Such a pre
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These criteria differ from those su
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is deserving of care and respect. A
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(2) The knowledge to be gained must
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fetus but also women and fetuses as
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as an additional safeguard; this is
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In the interim, the Commission find
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H. Synthesis. The Commission conclu
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4. Nontherapeutic research directed
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11. Decisions made by a personal ph
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so for the third. The confusion is
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up to five months gestational age p
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to bespeak so basic and drastic a c
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amniocentesis would be considered a
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3. Evidence presented to the Commis
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to choose between them. It seems to
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