RESEARCH ON THE FETUS - National Institutes of Health

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to bespeak so basic and drastic a change in the public philosophy of the United States, it could only be the voice of Congress. Of course there is no reason why the Secretary of DHEW cannot immediately make clear that no researcher need stand in fear of therapeutic research. As noted at the outset, the Commission's work has achieved some good results in reducing the possibilities of manifest abuses and thereby according a measure of protection to humans at risk by reason of research. That it has not been more successful is in my judgment not due so much to the Commission's failings as to the harsh and pervasive reality that American society is itself at risk--the risk of losing its dedication "to the proposition that all men are created equal." We may have to learn once again that when the bell tolls for the lost rights of any human being, even the politically weakest, it tolls for all. David W. Louisell Elizabeth Josselyn Boalt Professor of Law University of California, Berkeley 82
STATEMENT OF COMMISSIONER KAREN LEBACQZ, WITH THE CONCURRENCE OF COMMISSIONER ALBERT R. JONSEN ON THE FIRST ITEM The following comments include some points of dissent from the Recommen- dations of the Commission. For the most part, however, these comments are intended as elaborations on the Report rather than dissent from it. 1. At several points, the Commission established as a criterion for permissible research an acceptable level of risk--e.g., "no risk" or "minimal risk." I support the Commission's Recommendations regarding such criteria, but I wish to make several interpretative comments. First, I think it should be stressed that in the first trials on human subjects or on a new class of human subjects, the risks are almost always unknown. The Commission heard compelling evidence that differences in physiology and pharmacology between human and other mammalian fetuses are such that even with substantial trials in animal models it is often not possible to assess the risks for the first trials with human fetuses. For example, evidence from animal trials in the testing of thalidomide provided grounds for an estimation of low risk to human subjects; the initial trials in the human fetus resulted in massive teratogenic effects. I would therefore urge review boards to exercise caution in the interpretation of "risk" and to avoid the temptation to consider the risks "minimal" when in fact they cannot be fully assessed. Second, I think it important to emphasize the evaluative nature of judgments of risk. The term "risk" means chance of harm. Interpretation of risk involves both an assessment of statistical chance of injury and an assessment of the nature of the injury. Value judgments about what constitutes a "harm" and what percentage chance of harm is acceptable are both involved in the determination of acceptable risk. A small chance of great harm may be considered unacceptable where a greater chance of a smaller harm would be acceptable. For example, it is commonly accepted that a 1-2 percent chance of having a child with Down's syndrome is a "high" risk, where the same chance of minor infection from 83
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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
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at risk for the disease, and can be
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The following conclusions are drawn
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Professor Capron states that the va
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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 86 and 87: H. Synthesis. The Commission conclu
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 98 and 99: amniocentesis would be considered a
Page 100 and 101: 3. Evidence presented to the Commis
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