Understanding both the potential risks of participation and of non-participation, physicians conducting research must obtain the informed, voluntary consent of pregnant or lactating individuals, and adhere to general principles for ethical conduct of research as in all human participant's research. In addition, physicians conducting research should:
- Include pregnant and lactating individuals in research for which they would otherwise be eligible in order to establish a greater knowledge base, produce relevant data, and promote respect for individuals.
- Consider excluding pregnant and lactating individuals only when a study poses a substantial risk of significant harm to them or their fetuses or nursing infants, and:
- specify why the research excludes pregnant and lactating individuals;
- seek alternative research methodologies to rectify gaps in knowledge.
- Where scientifically appropriate and available, base studies that include pregnant and lactating individuals on well-designed, ethically sound, existing research with nonhuman animals or nongravid human participants to better assess potential risks.
- Minimize risks to the fetus or nursing infant to the greatest extent possible, especially when the research is not conducted primarily to investigate potential benefit for fetuses or nursing infants, but rather for the development of important biomedical knowledge that cannot be obtained by any other means.
AMA Principles of Medical Ethics: I,III,V
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