The current system of ethical review for medical research in the United Kingdom is changing from the current system involving large committees of 7–18 members reviewing every individual application to a system involving pre-review by small sub-committees of National Research Ethics Officers , who have a remit to approve studies if they believe there are no material ethical issues imposed by the research. The reliability of this new system depends on the reliability of the NREAs and in particular the ability (...) of small groups to effectively identify and appropriately assess the seriousness of all the material ethical issues that may be posed by an application. There is anecdotal evidence to suggest that many individual research ethics committee members have had experience of believing that a study presents no material ethical concerns, then on reaching the committee and discussing the application they realise that the committee feels it does present significant ethical concerns. If this is the case then this casts doubt on the reliability of NREAs or small groups to effectively identify ethically problematic research and appropriately respond to this to protect research participants. In this paper we describe a small questionnaire based piece of research carried out to assess how common this and other relevant experiences are. (shrink)

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of research ethics review being put (...) in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed. (shrink)

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively (...) identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. (shrink)