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

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

  • Winterfeld U Swiss Teratogen Information Service and Service of Clinical Pharmacology, University Hospital of Lausanne, Switzerland. Electronic address: ursula.winterfeld@chuv.ch.
  • Weber-Schöndorfer C Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany.
  • Schaefer C Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany.
  • von Elm E Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
  • Buclin T Swiss Teratogen Information Service and Service of Clinical Pharmacology, University Hospital of Lausanne, Switzerland.
  • 2018-06-19
Published in:
  • Reproductive toxicology (Elmsford, N.Y.). - 2018
Multicenter cohort study
Pregnancy
Research ethics
Teratology Information Service
Abnormalities, Drug-Induced
Adverse Drug Reaction Reporting Systems
Cohort Studies
Drug Information Services
Ethics Committees, Research
Europe
Female
Humans
Maternal Exposure
Multicenter Studies as Topic
Pregnancy
Prenatal Exposure Delayed Effects
Surveys and Questionnaires
Teratology
English 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.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/20492
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