Informed consent is crucial in most research but written consent is not without its drawbacks. Written consent serves to protect the researcher more than it serves to protect the participant and this can present a barrier to their relationship. In certain circumstances it can undermine the trust important in research. For ‘simple’ studies, where treatments are largely interchangeable or where consent is implied, written consent can be considered not only to be unnecessary, but actually harmful. Research ethics committees should consider (...) removing the requirement for written consent in these studies. (shrink)

When considering submissions ethics committees should be consistent in all aspects of their review. A wide variation in performance is likely to result in the unfair dismissal of good research on the one hand with inadequate ethical review on the other, neither of which is acceptable. The recent annual reports for UK MRECs suggest that the level of unfavourable opinion ranges from 6.9% to 24.2% Although a certain level of inconsistency is inherent in the system of ethical review there is (...) little research to determine how much of that inconsistency in inevitable and how much of it is the result of poor process. The time has come for high quality research to be done to assess the consistency and hence the validity of ethical review. (shrink)

For a patient to make an informed decision about participation in research, it is fundamental that they can understand what is involved. COREC has produced a model information sheet and consent form that researchers are encouraged and sometimes forced to use by LRECs. By applying readability statistics to these documents we have shown that the majority of the UK population would not be able to read this proposed text.

Ensuring that research is of high quality and is based on sound ethical principles is not easy; it requires a fine balance between adequate oversight and suitable facilitation. The current state of research ethics governance is an ideal environment to maintain a governance ‘ratchet’ rather than produce a well-organized and carefully thought out ‘dial’.