Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2009 Nov;22(6):601-6.
doi: 10.1097/YCO.0b013e3283318e6f.

Ethical issues in perinatal mental health research

Anna R Brandon  1 , Geetha Shivakumar, Simon Craddock Lee, Stephen J Inrig, John Z Sadler
Affiliations
Review

Ethical issues in perinatal mental health research

Anna R Brandon et al. Curr Opin Psychiatry. 2009 Nov.

Abstract

Purpose of review: To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain.

Recent findings: Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research.

Summary: Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.

PubMed Disclaimer

Figures

Figure 1
Figure 1
“Points to Consider” from the IRB Guidebook [15]
See this image and copyright information in PMC

References

    1. ACOG Practice Bulletin: Clinical guidelines for obstetrician-gynecologists number 92, April 2008. Use of psychiatric medications during pregnancy and lactation. Obstetrics and Gynecology. 2008;111(4):1001–20. Unauthored. This Practice Bulletin was developed by the American College of Obstetricians and Gynecologists Committee on Practice Bulletins with the assistance of Zachary N. Stowe, MD and Kimberly Ragan, MSW and makes recommendations regarding the psychiatric treatment of perinatal women.

    1. Lyerly AD, Little MO, Faden RR. The second wave: Toward responsible inclusion of pregnant women in research. The International Journal of Feminist Approaches to Bioethics. 2008;1(2):6–22. This thoughtful discussion reviews the history of the exclusion of women from research and presents the ethical responsibility to address the challenges of including pregnant women into research trials.

    1. Sit DK, Perel JM, Helsel JC, Wisner KL. Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. J Clin Psychiatry. 2008;69(4):652–8. This manuscript highlights the need to understand more about potential differences in drug metabolism during pregnancy.

    1. Wisner KL, Appelbaum PS, Uhl K, Goldkind SF. Pharmacotherapy for depressed pregnant women: Overcoming obstacles to optimize treatment. Clin Pharmacol Ther. 2009 In Press. - PMC - PubMed

    1. Rubinow DR. Antidepressant treatment during pregnancy: Between Scylla and Charybdis. American Journal of Psychiatry. 2006;163(6):954–6. Rubinow captures the dilemma clinicians and patients find themselves in when psychiatric disorders exist during pregnancy.

Publication types