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An IRB determines a research study is greater than minimal risk with no potential direct benefit to subjects. The study includes pregnant women. Per Subpart B, can the IRB approve this study? Yes because there is not a scientific justification to exclude pregnant women from the study. No, because this study presents no potential benefit and it is more than minimal risk. Yes because there are appropriate safeguards in place. No, because greater than minimal risk research is not allowed to include pregnant women.
SCIENCE
HEALTH SCIENCE
NURSING

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