A paper was submitted which reported a study of observing people with severe learning disabilities and their interactions with staff on a locked hospital ward. The journal was keen to consider the paper further, but had concerns about ethical approval. The authors stated in their cover letter that ‘Ethical approval was sought from the Research Ethics Committee, but the Committee deemed that the research 'can go ahead without the need for Ethical approval'. The editor presumed this was because the research was being done for operational/service reasons. The editor’s main ethical concern was that consent from the individual patients had not been obtained, to which the authors responded that it was not possible to obtain consent as the participants’ learning difficulties were too severe. Instead they had assumed ‘process consent’, whereby the participants made it clear if they did not wish to be interviewed. The editor was not reassured by this response. The paper was reviewed by an expert in research ethics who stated that, in such circumstances, consent should be obtained by proxy (ie from next of kin), and that ‘process consent’ is not a substitute for written informed consent by proxy. What should be the next step?
Case number:
04-17