Law Reform, Clinical Research and Adults without Mental Capacity – Much Needed Clarification or a Recipe for Further Uncertainty?

This chapter explores the extent to which the recent reform agenda will result in a real improvement in the regulation of clinical research involving adults without mental capacity in England and Wales, and asks whether, on the other hand, it is the case that they are left with a recipe for future uncertainty. The drive to regulate clinical research practices over the last few decades is of course rooted in Nuremberg. The decision of the House of Lords in Re F concerned medical treatment-the sterilisation decision of a woman who lacked mental capacity-but the extent to which adults lacking capacity could be included in clinical research remained uncertain. The 1995 Report was a broad document setting out the structure for comprehensive legislation concerning adults lacking mental capacity. The Law Commission suggested that this category may involve observation or photography and they suggested that while ethical issues may be involved these could be referred to a standard research ethics committee.