Research bureaucracy in the United Kingdom

Editor—I 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 article asserts that the actions of the trust's research office had a major effect on the study, when the effects were the result of the researchers not going through the correct procedures for protocol amendment.

Research governance was introduced to protect patients and ensures the transparent, safe, and fair conduct of research. These procedures must be acknowledged to be a compulsory part of the research process. Instead of arguing about their relevance, researchers and governance teams need to work together to ensure their smooth integration.