A study was submitted that required the active participation of nearly 500 patients from a local hospital. The paper made no mention of ethics committee approval or informed consent by the patients, and an enquiry revealed that the authors had not obtained these. The chief executive at the hospital was alerted. Have the editors done the right thing?
- If the data came from an audit/questionnaire/survey neither consent nor ethics committee approval would have been required.
- From the synopsis of this case, however, the patients did appear to have actively participated.
- The medical director of the hospital should also be informed.
- Inform the authors that the hospital’s chief executive has been contacted.
- The ethics committee should be contacted to question the lack of patient confidentiality.
- The GMC should be contacted if hospital management does not take prompt action.
The medical director replied promptly. He had met with the author and made it clear that he should have obtained ethics committee approval for his study. This message has now been transmitted to all those engaged in research in the Trust. The medical director explained that the problem had arisen because the study had been carried out by undergraduate students, for whom appropriate protocols relating to research modules were in the process of being formulated. He ended his letter: “I have taken the view that your letter has afforded the particular clinician the opportunity to learn rather than give Trust management an opportunity to be censorious or to adopt new processes that might run the risk of stifling innovation. ” The editor agreed and accepted this explanation.