ABSTRACT
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.
Subject(s)
Drug Information Services , Maternal Exposure/ethics , Multicenter Studies as Topic/ethics , Teratology/ethics , Abnormalities, Drug-Induced/epidemiology , Abnormalities, Drug-Induced/etiology , Adverse Drug Reaction Reporting Systems/ethics , Cohort Studies , Ethics Committees, Research/legislation & jurisprudence , Europe , Female , Humans , Multicenter Studies as Topic/legislation & jurisprudence , Pregnancy , Prenatal Exposure Delayed Effects/chemically induced , Prenatal Exposure Delayed Effects/epidemiology , Surveys and Questionnaires , Teratology/methodsSubject(s)
Humans , Male , Infant, Newborn , Prune Belly Syndrome/diagnosis , Prune Belly Syndrome/genetics , Prune Belly Syndrome/pathology , Prune Belly Syndrome/therapy , Teratology/methods , Teratology/statistics & numerical data , Prune Belly Syndrome , Teratology/ethics , Teratology/standards , Teratology/trendsABSTRACT
In France between 1780 and 1815, doctors opened a broad correspondence with medical faculties and public officials about foetal anomalies ("monstrosities"). Institutional and legal reforms forced doctors to encounter monstrous births with greater frequency, and they responded by developing new ideas about heredity and embryology to explain malformations to public officials. Though doctors achieved consensus on pathogenesis, they struggled to apply these ideas in forensic cases, especially with doubtful sex. Medical networks simultaneously allowed doctors to explore obstetrical techniques, as licensing regulations forced practitioners into emotional encounters with child anomalies. Doctors thus developed a new ethics for treating monstrosities, viewing them as pathological specimens, forensic objects, and obstetrical tragedies.
