a research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. this research is to meet the health needs and directly benefit the fetus only. the pregnant woman is otherwise healthy. per subpart b, the investigator must obtain consent from whom?

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King5688 King5688

12-11-2021
Health

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a research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. this research is to meet the health needs and directly benefit the fetus only. the pregnant woman is otherwise healthy. per subpart b, the investigator must obtain consent from whom?

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luisvaschetto luisvaschetto · Answer 1 · 2021-11-17T13:20:01+01:00

The investigator must obtain consent from the pregnant woman and the father of the fetus. It is a case of parental consent requirement.

Medical information in order to guide non-obstetrical healthcare during pregnancy is a fundamental issue for the health of pregnant women and their offspring.

Paternal consent related to the clinical regulations in research is always required, especially for pregnant women.

In the case of a life-threat condition for pregnant women, consent must be only obtained by the pregnant woman.

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