Differentiating Research, Quality Improvement, and Case Studies to Ethically Incorporate Pregnant Women

Pregnant women have been called therapeutic orphans because data supporting common interventions, medications, health teaching, and models of care are meager. The generation of quality evidence benefits from proactive approaches that ensure ethical standards are met to protect participants. The purpose of this article is to differentiate among health care, quality improvement, and research and to discuss ethical involvement of women who are pregnant and potentially childbearing in these initiatives. Health care is provided to protect and improve individual health. Quality improvement aims to enhance delivery of care for all those receiving care in particular settings. Research, whether retrospective or prospective, is designed to contribute to generalizable knowledge. This review includes vignettes to distinguish between research, quality improvement, and case study dissemination and to highlight the value of publication of information with applicability beyond a single site. As a community, perinatal care providers will be able to contribute more evidence to guide care if they err on the side of seeking institutional review board approval for activities that examine the care and outcomes of pregnant women and the fetus. Traditional research activities, including clinical trials, remain crucial. However, to fill gaps in knowledge, we must expedite our ability to report informative cases, examine clinical data, share lessons learned during quality improvement campaigns, and publish and disseminate these findings. Accelerating improvements in care demands expansion of the evidence base.