Françoise Baylis and Angela Ballantyne (eds): Clinical research involving pregnant women
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In the context of the bioethical debate on women’s participation in clinical trials, the question of whether, and how, to include pregnant women gains special significance due to the particular vulnerability of mothers and potential risks to the life and health of fetuses. In Clinical Research Involving Pregnant Women, aspects of this question are addressed by key authors in the field.
In the general discussion of clinical research in bioethics, the topic of pregnant women warrants specific ethical conditions: research that may or may not have a potential direct benefit is permitted only when studies cannot be carried out on other persons (i.e., non-pregnant and non-breastfeeding women); for research with potential direct benefit on the subjects, the risk–benefit assessment should consider the specific situation of pregnancy vis-à-vis the fetus, even extending to preconception. In such research, the criteria of minimal risk and minimal/acceptable burden are considered compulsory both...