RESEARCH ON THE FETUS - National Institutes of Health

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H. Synthesis. The Commission concludes that certain prior conditions apply broadly to all research involving the fetus, if ethical considerations are to be met. These requirements include evidence of pertinent investigations in animal models and nonpregnant humans, lack of alternative means to obtain the information, careful assessment of the risks and benefits of the research, and procedures to ensure that informed consent has been sought and granted under proper conditions. Determinations as to whether these essential requirements have been met may be made under existing review procedures, pending study by the Comission of the entire review process. In the judgment of the Commission, therapeutic research directed toward the health care of the pregnant woman or the fetus raises little concern, provided it meets the essential requirements for research involving the fetus, and is conducted under appropriate medical and legal safeguards. For the most part, nontherapeutic research involving the fetus to be carried to term or the fetus before, during or after abortion is acceptable so long as it imposes minimal or no risk to the fetus and, when abortion is involved, imposes no change in the timing or procedure for terminating pregnancy which would add any significant risk. When a research protocol or procedure presents special problems of interpretation or application of these guidelines, it should be subject to national ethical review; and it should be approved only if the knowledge to be gained is of medical importance, can be obtained in no other way, and the research proposal does not offend community sensibilities.
IX. RECOMMENDATIONS 1. Therapeutic research directed toward the fetus may be conducted or supported, and should be encouraged, by the Secretary, DHEW, provided such research (a) conforms to appropriate medical standards, (b) has received the informed consent of the mother, the father not dissenting, and (c) has been approved by existing review procedures with adequate provision for the monitoring of the consent process. (Adopted unanimously.) 2. Therapeutic research directed toward the pregnant woman may be conducted or supported, and should be encouraged, by the Secretary, DHEW, provided such research (a) has been evaluated for possible impact on the fetus, (b) will place the fetus at risk to the minimum extent consistent with meeting the health needs of the pregnant woman, (c) has been approved by existing review procedures with adequate provision for the monitoring of the consent process, and (d) the pregnant woman has given her informed consent. (Adopted unanimously.) 3. Nontherapeutic research directed toward the pregnant woman may be conducted or supported by the Secretary, DHEW, provided such research (a) has been evaluated for possible impact on the fetus, (b) will impose minimal or no risk to the well-being of the fetus, (c) has been approved by existing review procedures with adequate provision for the monitoring of the consent process, (d) special care has been taken to assure that the woman has been fully informed regarding possible impact on the fetus, and (e) the woman has given informed consent. (Adopted unanimously.) It is further provided that nontherapeutic research directed at the pregnant woman may be conducted or supported (f) only if the father has not objected, both where abortion is not at issue (adopted by a vote of 8 to 1) and where an abortion is anticipated (adopted by a vote of 5 to 4). 73
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Report and Recommendations Research
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NATIONAL COMMISSION FOR THE PROTECT
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PREFACE The National Commission for
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I. THE MANDATE The National Researc
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The Commission has reviewed the com
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Life Sciences; Richard McCormick an
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II. THE NATURE AND EXTENT OF RESEAR
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Once it had been demonstrated that
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less than 20 percent of these inclu
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for drug administration and blood s
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iopsies. The most extensive or inva
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1. In the case of congenital rubell
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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
Page 71 and 72: development are present. Such a pre
Page 73: These criteria differ from those su
Page 76 and 77: is deserving of care and respect. A
Page 78 and 79: (2) The knowledge to be gained must
Page 80 and 81: fetus but also women and fetuses as
Page 82 and 83: as an additional safeguard; this is
Page 84 and 85: In the interim, the Commission find
Page 88 and 89: 4. Nontherapeutic research directed
Page 90 and 91: 11. Decisions made by a personal ph
Page 92 and 93: so for the third. The confusion is
Page 94 and 95: up to five months gestational age p
Page 96 and 97: to bespeak so basic and drastic a c
Page 98 and 99: amniocentesis would be considered a
Page 100 and 101: 3. Evidence presented to the Commis
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