Abstract
This chapter presents an ethics framework for decisions about whether to exclude pregnant women from a clinical research trial. It begins by articulating several background assumptions about the care of pregnant women in the clinical setting and the involvement of pregnant women in clinical research. The uncontroversial truth of these background assumptions supports the idea that pregnant women should be presumed to be included in clinical research, and that their exclusion requires justification. After making the case for the presumptive inclusion of pregnant women, I outline the ethics framework for the legitimate exclusion of pregnant women from clinical research. This framework consists of nine factors that researchers and research ethics committees should consider when deciding whether to exclude pregnant women. Details about research ethics committee review, the nature of risks in pregnancy, the balance between risk and potential benefit, and the context of clinical care are addressed by the framework.
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Notes
- 1.
See Macklin (2010) for a discussion of the CIOMS guideline on pregnancy and ambiguities found within this guideline.
- 2.
Note that this dependence on pre-clinical animal studies requires that female animals be used in pre-clinical research . The inclusion of female animals has actually lagged behind the inclusion of female humans in clinical studies (Clayton and Collins 2014). In the US, the NIH is attempting to rectify this harmful deficiency of pre-clinical animal studies through policy changes (Clayton and Collins 2014).
- 3.
On the subject of clinical equipoise , Rebecca Kukla (2016) defends a nuanced understanding of equipoise that takes factors other than safety and effectiveness as relevant.
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Acknowledgments
I would like to thank Françoise Baylis for her substantial contributions to this chapter and Angela Ballantyne for her help with revisions.
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Kaposy, C. (2016). Presumptive Inclusion and Legitimate Exclusion Criteria. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_4
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