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Y Title: This form is to be completed for any research study targeting or enrolling pregnant women, human fetuses, and neonates (as referenced in the Summary Safeguard Statement, section IV). State the necessity for involving pregnant women, human fetuses, and neonates in the research: Indicate below the category that best fits your proposed research and answer the questions that immediately follow. 1. Research Involving Pregnant Women or Fetuses a. Explain why the proposed research is scienti.
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III FAQ
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In general, pregnant women are excluded from drug development clinical trials; however, in certain situations, it may be scientifically and ethically appropriate to include pregnant women in a clinical trial. Health and Human Services (HHS) Human Subject Protection regulations, including pregnant women.
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The research base for many medications is so poor that some in the field have dubbed pregnant women the “last therapeutic orphans.” For one, pregnancy affects how the body metabolizes drugs, so studies in other populations do not provide much-needed data for pregnant women.
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As stated under 45 CFR 46.207, investigators may include pregnant women in research that is undertaken specifically to test an intervention that is reasonably likely to alleviate a serious health condition that affects pregnant women, even if the intervention's risk to the fetus is unknown and might be greater than ...
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The purpose of this Pregnant Partner Informed Consent Form is to obtain your “consent” or permission to collect information about your health and your pregnancy, and, if you carry the pregnancy to term, the birth and health of your child.
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