Ulrike M Stamer1, Nadja Naef, Rouven Porz, Frank Stuber, Brigitte Leva, Winfried Meissner, Dominique Fletcher. 1. From the Department of Anaesthesiology and Pain Medicine, Inselspital and Department of Clinical Research (UMS, NN, FS), Unit for Clinical Ethics, Inselspital, University of Bern, Bern, Switzerland (RP), Clinical Trial Network, European Society of Anaesthesiology, ESA Office Bruxelles, Brussels, Belgium (BL), Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany (WM), and Service d'Anesthésie Réanimation, Hôpital Raymond Poincaré, Garches, France (DF).
Abstract
BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison 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. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. 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. CONCLUSION: There 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 REGISTRATION: euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.
BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison 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. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. 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. CONCLUSION: There 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 REGISTRATION: euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.
Authors: Ascanio Tridente; Paul A H Holloway; Paula Hutton; Anthony C Gordon; Gary H Mills; Geraldine M Clarke; Jean-Daniel Chiche; Frank Stuber; Christopher Garrard; Charles Hinds; Julian Bion Journal: BMC Med Ethics Date: 2019-05-07 Impact factor: 2.652
Authors: Nancy Preston; Johannes Jm van Delden; Francesca Ingravallo; Sean Hughes; Jeroen Hasselaar; Agnes van der Heide; Lieve Van den Block; Lesley Dunleavy; Marieke Groot; Agnes Csikos; Sheila Payne Journal: Palliat Med Date: 2020-03-18 Impact factor: 4.762