Ethical approval for multicenter cohort studies on drug exposure during pregnancy: A survey among members of the European Network of Teratology Information Services (ENTIS)
•Research plays an important role among ENTIS activities.•A majority of TIS contribute patient data for research purposes.•Countries differ in their requirements for approval by research ethics committees.•Optimization of administrative procedures is necessary to expand research efforts. The Europea...
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| Veröffentlicht in: | Reproductive toxicology (Elmsford, N.Y.) N.Y.), 2018-09, Vol.80, p.68-72 |
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| container_title | Reproductive toxicology (Elmsford, N.Y.) |
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| creator | Winterfeld, Ursula Weber-Schöndorfer, Corinna Schaefer, Christof von Elm, Erik Buclin, Thierry |
| description | •Research plays an important role among ENTIS activities.•A majority of TIS contribute patient data for research purposes.•Countries differ in their requirements for approval by research ethics committees.•Optimization of administrative procedures is necessary to expand research efforts.
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. |
| doi_str_mv | 10.1016/j.reprotox.2018.06.002 |
| format | Article |
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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.</description><identifier>ISSN: 0890-6238</identifier><identifier>EISSN: 1873-1708</identifier><identifier>DOI: 10.1016/j.reprotox.2018.06.002</identifier><identifier>PMID: 29913205</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>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 cohort study ; Multicenter Studies as Topic - ethics ; Multicenter Studies as Topic - legislation & jurisprudence ; Pregnancy ; Prenatal Exposure Delayed Effects - chemically induced ; Prenatal Exposure Delayed Effects - epidemiology ; Research ethics ; Surveys and Questionnaires ; Teratology - ethics ; Teratology - methods ; Teratology Information Service</subject><ispartof>Reproductive toxicology (Elmsford, N.Y.), 2018-09, Vol.80, p.68-72</ispartof><rights>2018 Elsevier Inc.</rights><rights>Copyright © 2018 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c368t-e975e578ec30304a6f537aa139891f9cb48670956f5fb7c3c834af5cc8e481ad3</citedby><cites>FETCH-LOGICAL-c368t-e975e578ec30304a6f537aa139891f9cb48670956f5fb7c3c834af5cc8e481ad3</cites><orcidid>0000-0003-0639-5536</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S089062381830073X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29913205$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Winterfeld, Ursula</creatorcontrib><creatorcontrib>Weber-Schöndorfer, Corinna</creatorcontrib><creatorcontrib>Schaefer, Christof</creatorcontrib><creatorcontrib>von Elm, Erik</creatorcontrib><creatorcontrib>Buclin, Thierry</creatorcontrib><title>Ethical approval for multicenter cohort studies on drug exposure during pregnancy: A survey among members of the European Network of Teratology Information Services (ENTIS)</title><title>Reproductive toxicology (Elmsford, N.Y.)</title><addtitle>Reprod Toxicol</addtitle><description>•Research plays an important role among ENTIS activities.•A majority of TIS contribute patient data for research purposes.•Countries differ in their requirements for approval by research ethics committees.•Optimization of administrative procedures is necessary to expand research efforts.
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. 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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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>29913205</pmid><doi>10.1016/j.reprotox.2018.06.002</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0003-0639-5536</orcidid></addata></record> |
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| subjects | 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 cohort study Multicenter Studies as Topic - ethics Multicenter Studies as Topic - legislation & jurisprudence Pregnancy Prenatal Exposure Delayed Effects - chemically induced Prenatal Exposure Delayed Effects - epidemiology Research ethics Surveys and Questionnaires Teratology - ethics Teratology - methods Teratology Information Service |
| title | Ethical approval for multicenter cohort studies on drug exposure during pregnancy: A survey among members of the European Network of Teratology Information Services (ENTIS) |
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