Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study

Abstract

Introduction The Declaration of Helsinki states that every experimental procedure involving human subjects should be approved by a research ethics committee.1 All signatory countries must enact the declaration but can also add local requirements which do not reduce the protection. Research ethics committees are well established, though they have been criticised.2 I aimed to describe how countries vary in their requirements for research ethics committees for exactly the same trial protocol. The study was nested within a trial, in 11 signatory countries, of a leaflet intervention aimed at improving the involvement of older patients during consultations with their general practitioners. The trial outcome measures were questionnaires for the general practitioners and their patients before and after the intervention. The documents relevant to research ethics committees comprised the letter of invitation, information leaflet, and questionnaires for patients (patient's pack); the similar, but different general practitioner's pack; and the intervention consultation leaflet.