Ethical considerations
While ethical concerns are often considered a barrier to research during pregnancy, there is growing international consensus that greater inclusion of pregnant and lactating women in research is an ethical imperative. The historical notion that pregnant women are a vulnerable group (and therefore should be systematically excluded from research) is now being challenged.
TB research in pregnancy and lactation presents a particularly compelling case. In many contexts, adolescents and women of reproductive age are among those at greatest risk of TB and its sequelae. Their routine exclusion from historical TB research, however, has resulted in significant evidence gaps, limiting access to optimal care and contributing to poor outcomes. Gaps in surveillance and implementation prevent a thorough understanding of the burden of TB during pregnancy and the postpartum period. A bioethics subgroup in the consensus process identified key elements of an ethical pathway forward, which include:
- strong calls for the inclusion of pregnant and lactating women and adolescents in the TB research agenda as ethically imperative;
- requirements that pregnancy/lactation exclusions from TB trials be explicitly justified and weighed against potential risks of untreated/undertreated TB and with careful consideration of the full range of benefits and risks to the pregnant/lactating woman and fetus/child from trial participation;
- respect for reproductive autonomy through shared decision-making for contraception use in TB trials and availability of contraception for those who desire it. Researchers must justify any requirement for contraception based on evidence of unacceptable reproductive risk and make available contraception for any research participant who desires it;
- prioritizing study designs that permit study participants who become pregnant to remain on trial and on drug, with a robust reconsent process;
- gathering data to address current and legacy evidence gaps regarding the effects of TB treatment and TB preventive treatment on maternal and child health, including impact on future pregnancies.
To ensure equitable access to the benefits of research, pregnant women/adolescents and their children deserve fair and safe access to inclusion in clinical trials and, ultimately, access to optimal regimens for the treatment and prevention of TB.
Please consult the knowledge portal for additional information on the conceptual shifts and frameworks that support inclusion and considerations regarding paternal consent, inclusion of pregnant adolescents, and inclusion of lactating women in research.