Ethical Challenges in Designing, Conducting, and Reporting Research to Improve the Mental Health of Pregnant Women: The Voices of Investigators and IRB Members

Abstract

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.

Keywords:

• clinical research
• pregnancy
• research ethics
• institutional review boards

Notes

Vulnerability can also be applied to those lacking capacity to provide informed consent or at increased susceptibility to risk(s) of the research.

CFR 45 Part 46 Human Subjects Protection, Subpart B, 46.204 (e) states: “If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.”

In the specific text of Subpart B §46.204: “If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions.” It is argued that there has been little guidance on how to interpret key phrases like “minimal risk” when so little is known about the impact of most investigative treatments upon the fetus without sufficient research. For a detailed discussion of this issue, see U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Office of Research on Women's Health (2011).

We use this term to describe the power or right to make judgments about the fetus.