Background Maternal mental health during the peripartum period is critically important to the wellbeing of mothers and their infants. Numerous studies and clinical trials have focused on various aspects of interventions and treatments for perinatal mental health from the perspective of researchers and medical health professionals. However, less is known about women’s experiences of participating in perinatal mental health research, and the ethical issues that arise. Aim To systematically review the literature on the ethical issues that emerge from pregnant and/or (...) postpartum women’s experiences of taking part in perinatal mental health-related research. Methods Systematic review of nine bibliographic databases, from inception to July 2021. Qualitative, quantitative and mixed method studies were included if they reported on ethical issues experienced by perinatal women. Research ethical issues encompassed any issue relating to women’s experiences of being offered study information, recruitment, consent, retention and respect for autonomy. Titles, abstracts and full text screening, appraisal of the methodological quality of included studies, and data extraction, were conducted independently by two reviewers. Ethical considerations Ethical approval was not required for this systematic review. Findings A total of 9830 unique citations was retrieved. Six studies met the inclusion criteria. Studies were clinically and methodologically heterogenous, and only one was purposively designed to explore women’s experiences. The key finding was the establishment of trust between the researcher and participant in all stages of the research process. Findings are presented according to recruitment and consent processes, participation and retention, and study follow-up and completion. Conclusion The establishment of trust between the researcher and perinatal women leads to a dynamic with research ethical implications relevant to all stages of perinatal mental health-related research. Further research on the research ethical issues experienced by perinatal women is required because of the limited literature. (shrink)

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

Interventions performed on a pregnant woman's body can affect the fetus in multiple ways. Such effects can be harmful to beneficial to the fetus. Unfortunately, the effects of new drugs and compoun...

At no time in recent decades has more attention been paid to ethical issues in pregnancy. Particularly riveting—and alarming, to many—was the passage of Senate Bill 8, a Texas law banning abortion...

A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There (...) is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)