Conceptual shifts that support inclusion

The increasing consensus on the ethical imperative to conduct research that includes pregnant and lactating women reflects a trio of conceptual shifts in how this population is considered. These include a shift from understanding pregnant and lactating women as a vulnerable population to understanding them as a complex population; a shift from the idea that pregnant women, fetuses and infants should be protected from research to the recognition that they are best protected through research; and a shift from the general practice of summarily excluding pregnant and lactating women from research, without justification (presumed exclusion) to a model in which they have equitable access to both the direct benefits of research and the benefits of a robust evidence base that would result from their fair inclusion in the biomedical research agenda. Further discussion of each conceptual shift can be found below.

Vulnerable population to complex population

Until recently, pregnant and lactating women were categorized alongside children, prisoners, and individuals with intellectual disabilities as a vulnerable population. Yet unlike these populations, there is nothing about pregnancy or breastfeeding per se that constrains a person’s ability to provide valid consent or makes them particularly susceptible to exploitation. This designation is therefore inaccurate, and has had a negative effect on research in pregnancy. Ethical and regulatory guidance no longer uses the term vulnerable to describe pregnant and lactating women. Instead, guidance may designate them as a complex population, thus capturing the scientific and ethical complexities involved in conducting research in pregnancy and during the breastfeeding period.

Protection from research to protection through research

Past approaches to research have focused on protecting pregnant and lactating women, fetuses and infants from research risks by excluding them from research or requiring contraception in non-pregnant participants. Such exclusionary practices have not eliminated risk, however, shifted these risks to a clinical setting where affected women are forced to make decisions without the data to guide them. It is increasingly recognized that the best way to ensure the safety of pregnant women is to conduct research in a responsible manner that will generate the data needed to inform pregnancy- and breastfeeding-specific care.

Presumptive exclusion to fair inclusion

Pregnant women have generally been presumed ineligible to participate in biomedical research. For instance, when pregnant women are excluded from studies, often no justification is required; it is only their inclusion that requires justification. This default of exclusion has contributed to the dearth of pregnancy-specific data. It has also prevented access to studies that provide benefits, including lifesaving treatments. As a matter of justice, pregnant women deserve a fair share of the benefits of research. Changing this default of exclusion may be facilitated by considering whether it is appropriate to exclude pregnant women from a particular study and whether broader investments in biomedical research equitably address the health interests of pregnant and lactating women, fetuses and infants.