The Society is delighted to be given the opportunity to contribute to this debate and would comment as follows:  

This consultation is an addition to the main MCA consultation that included sections on research on people who lack capacity which was responded to previously. There are two issues under consideration:

• Establishment of a specialized research ethics committee to consider the ethics of intrusive research on people who lack capacity to give informed consent. This body requires to be recognized by the Secretary of State in England or the National Assembly of Wales.

This parallels the current situation in Scotland that works well. The proposal should be supported. Legislation should allow for more than one ethics subcommittee of such a body so that there will be adequate capacity to consider ethics applications timely.

• Regulations that allow research to continue on subjects who have previously consented to participate in a study but have subsequently lost capacity.

These regulations allow research to continue whilst no new intervention is contemplated. This includes research using biological sample/tissues that were acquired whilst the participant still had capacity. These are sensible regulations that should be supported. There will be instances where participants have lost capacity unbeknown to the researcher, but where carers/relatives may no longer consider the use of such previously acquired samples in the best interest of the participant. For example, if capacity had been lost due to some accident for which there was a legal claim being pursued and samples retained for research might bias that claim (e.g. random blood alcohol level, detection of other serious pathology etc). There should be a mechanism for carers/relatives to contact researchers in such circumstances when they may not be in possession of the investigators’ contact details, perhaps by some national research register.