Women's Mental Health Center, The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9086, USA.
Curr Opin Psychiatry. 2009 Nov;22(6):601-6. doi: 10.1097/YCO.0b013e3283318e6f.
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.
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.
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.
回顾围产期心理健康研究行为的现行伦理标准的背景，并描述这一研究领域的伦理挑战。
现有文献反映出科学界越来越多的观点，即缺乏关于精神科治疗对母亲和发育中的胎儿/婴儿的影响的信息会带来危险，其风险可能超过研究的风险。然而，由于科学界没有达成充分共识，监管机构和围产期研究人员发现自己没有决策框架，无法令人满意地限制风险，并促进孕妇和哺乳期妇女参与临床研究的利益。
围产期心理健康的精神病学研究至关重要，因为它使临床医生和患者能够就治疗精神障碍做出知情决策。具体关注领域包括胎儿安全、母婴风险、治疗误解、商业利益、法医/法律问题、知情同意过程和研究设计。制定解决伦理挑战的准则，并纳入多方利益相关者的观点和关切，可以改善围产期妇女获得参与精神健康研究的益处，除了为这一亚人群提供基于证据的精神保健之外。
