The second wave: Toward responsible inclusion of pregnant women in research

Abstract

Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research.

Clinical Research Enrolling Pregnant Women: A Workshop Summary

“…[1][2][3][4] The long-standing focus on protection of the fetus as the overriding concern is being reevaluated. 5 Clinical research investigates mechanisms of human disease and tests therapeutic interventions for use with various populations, yet pregnant women usually are excluded from clinical studies. Few studies are specifically designed to address health concerns and questions relevant to pregnant women.…”

The Common Rule, Pregnant Women, and Research: No Need to “Rescue” That Which Should Be Revised

“…In the past few years, the routine exclusion of pregnant women from research has been rightly criticized (Baylis 2010a;Baylis 2010b;Baylis and Kaposy 2010;Goldkind et al 2010;Koren and Nickel 2010;Lyerly et al 2008a;Lyerly et al 2008b). Now is the time to make important changes to the rules and regulations governing research involving pregnant women so that women and their fetuses might enjoy the benefits of well-designed biomedical research.…”

Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study

“…While drug development is specifically to include considerations of the influence of menstrual status, hormonal supplementation, and oral contraceptives upon pharmacokinetics, the necessity of considering pregnancy-related changes is conspicuously absent. Lyerly, Little, and Faden (2008) considered these changes to the guidelines as paternalistic in their implicit assumption that a pregnant participant might not exercise responsible judgment regarding potential fetal risks. Revisiting the evidence presented almost two decades ago to justify the inclusion of women also presents cogent arguments for revising the functional and often automatic exclusion of pregnant women from participating in Phase 2, 3, and 4 trials.…”

“…We lack consensus on how to manage the necessity for empirically-supported perinatal treatment against the concerns about cost, liability, and the moral correctness of exposing a fetus or infant to an experimental treatment that might bring harm (Merkatz and Junod 1994;Lyerly, Little, and Faden 2008). However, in our quest to protect the next generation, is it in the best interests of society to continue to exclude perinatal participants from trials of treatments for conditions or illnesses that are experienced during reproductive events?…”