Ethical challenges in designing, conducting, and reporting research to improve the mental health of pregnant women: The voices of investigators and IRB members

Background: Legitimate concern for fetal safety often precludes women who are pregnant or planning to become pregnant from participating in randomized controlled trials (RCTs), preventing the development of an empirically-derived evidence base for the safety and efficacy of treatments. Perinatal science can only move forward when the research community understands and addresses the practical and ethical roadblocks impeding this research. Methods: To understand these challenges better, our study team interviewed 15 perinatal mental health investigators from 12 leading academic institutions in the United States and 6 members of the respective institutional review boards (IRBs). Results: Respondents confirmed seven broad ethical challenges. Through analyzing interview transcripts, we identified four themes: research design/methodology, safety, participant selection/recruitment, and autonomy. Fifteen subthemes further delineate the complexities of the issues revealed in narratives describing specific experiences related to these themes. Conclusions: The lack of reasonable solutions to these ethical challenges is a barrier to rigorous clinical research in this population, preventing the collection of empirical evidence for psychiatric care in the perinatal setting. Our study population confirms that the current federal human subjects protections guidelines (i.e., 45 CFR 46 Subpart B) do not fully address the themes of concern that emerged in the interviews. There is a need for greater flexibility in accepting women's competence to balance the risks and benefits of research participation for themselves and their fetuses.