title: A systematic review of ethical issues in vaccine studies involving pregnant women.
abstract: Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy.
  
  
  
  To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women.
  
  
  
  We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories.
  
  
  
  Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs.
  
  
  
  This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.
authors.affiliation: a Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Beeler
authors.affiliation: b Initiative for Vaccine Research , World Health Organization , Geneva , Switzerland.
authors.forename: Philipp
authors.initials: P
authors.lastname: Lambach
authors.affiliation: a Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.|c Department of Epidemiology , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
authors.forename: T Roice
authors.initials: TR
authors.lastname: Fulton
authors.affiliation: a Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.|c Department of Epidemiology , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
authors.forename: Divya
authors.initials: D
authors.lastname: Narayanan
authors.affiliation: b Initiative for Vaccine Research , World Health Organization , Geneva , Switzerland.
authors.forename: Justin R
authors.initials: JR
authors.lastname: Ortiz
authors.affiliation: a Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.|c Department of Epidemiology , Rollins School of Public Health, Emory University , Atlanta , GA , USA.|d Department of Pediatrics , Emory University School of Medicine , Atlanta , GA , USA.|e Emory Vaccine Center , Emory University , Atlanta , GA , USA.
authors.forename: Saad B
authors.initials: SB
authors.lastname: Omer
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D005260:Female; D006801:Humans; D011247:Pregnancy; D037841:Pregnant People; D014612:Vaccines / Q000008:administration & dosage*
chemical_list: D014612:Vaccines
keywords: ethics; maternal immunization; vaccinology