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Do researchers know what they are doing?
  1. P D Singleton
  1. Correspondence to Peter Desmond Singleton, Centre for Health Informatics and Multiprofessional Education, University College London, Holborn Union Building, Highgate Hill, London N19 5LW, UK; peter.singleton{at}chi-group.com

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Perspective on the paper by Knowles et al

Research governance has a number of functions: the first is to protect the interests of the research participants themselves and to ensure that they understand the implications of and agree to the risks involved in the particular research project; second, there is the assurance of the research methodology, both in its scientific effectiveness and in its limitation of risks to the individuals concerned; finally, there is a cost-effectiveness or opportunity-cost review to ensure that this piece of research should proceed rather than another, or even not at all.

Generally, the first is the domain of the research ethics committees (RECs), whereas the last is down to funders and/or the healthcare system where it is involved, although RECs might decide that the risks to participants are not worth the likely scientific benefits. The second area is often a bone of contention where researchers may feel it is not for RECs to adjudge their expertise in deciding on a scientific methodology, and funders may not be happy with the increased costs that RECs may effectively add to a project through additional consent procedures.

The article by Knowles et al1 in this issue nicely illustrates some of the three-way tension between researchers who are focused on their scientific interests and want to just do it, patients who may have strong confidentiality and privacy interests to protect and regulatory bodies who want to be seen to be providing that protection.

The article also raises the question of whether researchers know enough about the workings of RECs or the wider approval processes or whether RECs know enough about the wider scope of research rather than clinical trials where the questions of more immediate harm to participants are paramount.

Researchers spend a …

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