Ethical procedures and patient consent differ in Europe


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Abstract

BACKGROUNDResearch ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation.OBJECTIVETo evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial.DESIGNSurvey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires.SETTINGTwenty-four hospitals in 11 European countries.PARTICIPANTSFrom the 24 hospitals, 23 local investigators responded; 23 answers were analysed.OUTCOME MEASURESComparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions’ procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process.RESULTSThe approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 €. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients’ informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions.CONCLUSIONThere is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved.TRIAL REGISTRATIONeuCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.

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