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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consent Ethical principles may need to be adapted when research subject is not an individual subject Editor, Most commentaries on consent have centred on the individual research subject. In public health, however, the `subject' is often a population or unit of service, and both the study design and ethical principles may need adaptation. This gets especially tricky when the style of informing people about a service, and inviting them, is itself the focus of study. For example, the effect of inviting women aged 65-69 for breast screening is currently being studied in East Sussex, Leeds and Wakefield, and Nottingham. We have argued, and our local research ethics committees have agreed, that the benefit to individual women is already sufficiently proved (and similar to that for women aged 50-64) that the same routine style of invitation to and acceptance of screening are sufficient to achieve informed consent to the procedure. The research question-the area of `therapeutic uncertainty'-is whether those benefits (set against the costs) justify such screening as a national policy. Response to invitation will be one of the key end points; it would be difficult to predict the national response to a standard form of invitation if the trial districts had used a non-standard invitation involving consent. We could not, in the present state of knowledge, have advanced a similar argument for women aged over 70, and it is a moot point at what stage in the accumulation of evidence our argument became valid for 65-69 year olds. (It is not clear from published accounts how informed consent was secured in previous trials.) The chairman of Wakefield's local research ethics committee thought that one justification for our approach was that the beneficial intervention was being offered to an entire population, with no randomisation or non-intervention group. We hope that journal editors will accept the line taken when the time comes to publish the results. Graham C Sutton Senior clinical lecturer Nuffield Institute for Health, Leeds LS2 9PL For Leeds-Wakefield study Linda Garvican Principal public health specialist South-East Institute for Public Health, Tunbridge Wells TN3 0XT For East Sussex study Robin Wilson Clinical director, breast services National Breast Screening Training Centre, City Hospital, Nottingham NG5 1PB For Nottingham study Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline