Ethical approval for multicenter cohort studies on drug exposure during pregnancy: A survey among members of the European Network of Teratology Information Services (ENTIS)

Reprod Toxicol. 2018 Sep;80:68-72. doi: 10.1016/j.reprotox.2018.06.002. Epub 2018 Jun 18.


The European Network of Teratology Information Services (ENTIS) is in a privileged position to perform independent post-marketing surveillance of drugs in pregnancy. The aim of this survey was to describe the legal requirements and procedures involved in obtaining ethical approval for collaborative cohort studies. We sent a survey questionnaire to all 28 Teratology Information Services (TIS), of which 25 (89%) in 18 countries completed our questionnaire. For 15 TIS, specific research ethical approval was mandatory. The review process was estimated to last from 2 up to 16 weeks. Procedures for patients' information and consent were oral (12), written (5) or both (3). Five TIS had no requirement to inform patients and seek consent. Since data on drug exposure during pregnancy are scarce, ENTIS research efforts should be further encouraged, and procedures optimized so that legitimate ethical and legal requirements do not translate into deterrent administrative constraints and costs.

Keywords: Multicenter cohort study; Pregnancy; Research ethics; Teratology Information Service.

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology
  • Adverse Drug Reaction Reporting Systems / ethics
  • Cohort Studies
  • Drug Information Services*
  • Ethics Committees, Research / legislation & jurisprudence
  • Europe
  • Female
  • Humans
  • Maternal Exposure / ethics*
  • Multicenter Studies as Topic / ethics*
  • Multicenter Studies as Topic / legislation & jurisprudence
  • Pregnancy
  • Prenatal Exposure Delayed Effects / chemically induced
  • Prenatal Exposure Delayed Effects / epidemiology
  • Surveys and Questionnaires
  • Teratology / ethics*
  • Teratology / methods