Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study

Abstract

Although more than 500,000 women annually experience a psychiatric illness during pregnancy, and approximately 30% will be prescribed medication, no psychotropic medications are approved by the Food and Drug Administration (FDA) for use during pregnancy. In the absence of an evidence base, investigators, clinicians, and patients are concerned that we are “operating in a vast sea of ignorance.” International pregnancy registries and observational studies exist, but there are few randomized controlled trials (RCTs), the gold standard of evidence-based medicine, due to the fear of fetal harm, even in non-pharmacological research. Current research guidelines reflect the ambivalence of regulatory agencies regarding pregnant research participants and use ambiguous language unhelpful to institutional review boards (IRBs), leaving perinatal women the last “therapeutic orphans.” This is a review of the issues as identified by perinatal investigators and a proposal to draft new collaborative guidelines to facilitate perinatal mental health research necessary for empirically-based treatment.