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BMJ 2004;329:623-624 (11 September), doi:10.1136/bmj.329.7466.623-c
| The first 150 words of the full text of this article appear below. |
EDITORI am concerned that researchers such as Jones and Bamford believe that, having gained research ethics and trust approvals for their work, they are then free to change the protocol and the conduct of the study in whatever manner they choose to fit with any hypotheses that emerge as the research progresses.1
Having recognised that the original proposal required these approvals before the research started, to ask patients personal questions about social contacts, relationships, family, and employment is clearly emotive. Judgments about whether these questions are acceptable in the context of the research should therefore be left to the ethics committees, not to individual researchers, to decide.
Other bodies, such as ethics and the governance team on behalf of the trust, must be aware of the exact nature of the intervention being applied to the participants, whether in the form of a questionnaire or a new drug. This
Tracy M Elliott, research manager
Sheffield Children's NHS Trust, Western Bank, Sheffield S10 2TH tracy.elliott@sch.nhs.uk