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BMJ 2004;329:623 (11 September), doi:10.1136/bmj.329.7466.623-b
| The first 150 words of the full text of this article appear below. |
EDITORJones and Bamford express surprise and frustration that their study was temporarily halted after they introduced an interview to the existing protocol without research ethics committee approval.1 They seem not to have recognised that introducing a new aspect to their project may bring additional ethical considerations and problems for their existing research aims.
They say that they did not mention this interview in the patient information sheets or consent forms, and they seem to have introduced it after data collection had begun. Whether the interview itself had ethical problems that required consideration is unclear, but that is why ethics committee approval is required before beginning a research project. In addition, their interview, however well meant, may have asked sensitive or inappropriate questions that might affect the validity of the data they were collecting.
This is not an issue of researchers accidentally filling in the wrong form or some
Justin T Denholm, hospital medical officer
Austin Hospital, Heidelberg, VIC 3081, Australia neuromalacia@hotmail.com