[Answer] A research project is designed to test a new treatment for eclampsia (a life-threatening condition in pregnant women). Which of the following conditions must be satisfied for the research to be potentially approvable under subpart B?

Answer: Consent must be sought and obtained from the pregnant woman. - If the research has the prospect of direct benefit to the mother (or to the mother and the fetus) only the mother's consent is needed. Further the research is potentially approvable under subpart B even if the risk to the fetus is greater than minimal. The risk to the fetus however must be minimized to the greatest extent possible.

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A research project is designed to test a new treatment for eclampsia (a life-threatening condition in pregnant women). W...

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