title: Ethical issues in perinatal mental health research.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Women's Mental Health Center, The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9086, USA. anna.brandon@utsouthwestern.edu
authors.forename: Anna R
authors.initials: AR
authors.lastname: Brandon
authors.forename: Geetha
authors.initials: G
authors.lastname: Shivakumar
authors.forename: Simon Craddock
authors.initials: SC
authors.lastname: Lee
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Inrig
authors.forename: John Z
authors.initials: JZ
authors.lastname: Sadler
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D008603:Mental Health; D018743:Perinatal Care / Q000941:ethics* / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D011247:Pregnancy