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National Commission – Research on the Fetus

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

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