The Adults with Incapacity (Scotland) Act
The Adults with Incapacity (Scotland) Act 2008 has much in common with the Mental Capacity Act 2005, which applies in England and Wales.
As with England and Wales, research in Scotland with adults who lack capacity to consent will need to be approved by an NRES ethics committee . This application can be made through IRAS in the normal way (internal links). The Adults with Incapacity (Scotland) Act, however, specifies that if you (the researcher) are professionally based in Scotland and are conducting research on subjects with incapacity, then you will need to ensure that the application goes to the correct Scottish committee, which is currently known as the ‘Adults with Incapacity REC’ or the AWI REC. This committee has been established by statutory instrument for reviewing incapacity cases in Scotland.
The Adults with Incapacity (Scotland) Act also establishes the following conditions under which research can take place :
- It will further knowledge
This needs to be shown with reference to the peer review process that your proposal has gone through.
- It is not possible to do the research on people who are able to consent
The concern here is to exclude cases where it is just easier to do research on people who can’t consent because it is quite difficult to get those people who can consent to consent to the research. If you want to do research with people who cannot consent then you will need to show that it is research which has to be done on those people.
- It is of direct benefit to the adult involved
The Act allows ‘exceptionally’ that it may be carried out where the research would benefit others in a similar condition). This principle seems to have been formulated primarily with medical interventions in mind, and has commonalities with issues arising under the English Mental Capacity Act . The point is that if the people in your sample are likely to lack the capacity to consent, then your research had better be aimed at helping them or people like them. Again, the concern here is that researchers do not merely select people with incapacity because it is convenient to do so
- It entails little or no risk or discomfort
This requirement is fairly self-evident, though more problematic in (for instance) trials of medical interventions. When we gain informed consent from someone, often we are asking for them to consent to their being exposed to risk or discomfort. Thus, it is more important than normal to minimise risks if the potential participant lacks the capacity to consent themselves.
Consider, for instance, that some elements of harm or discomfort are subjective. If someone has a thoroughgoing dislike of something then they are less likely to consent to being exposed to it. Someone who can consent to treatment will be in a position to identify these sorts of factors and refuse to take part in studies which involve them; those who cannot consent may also struggle to communicate such dispositions.
- The adult is not objecting
So while your participants may not fully understand what is happening, if they appear distressed or object to what you are doing, then you will need to stop.
- consent has been obtained from a person with relevant powers (i.e. their guardian, welfare attorney or closest family member if these have not been appointed)
The purpose of the Adults with Incapacity Act is specifically to make legal allowance for decisions to be made on behalf of those without capacity. There will be a specific person who is able to make decisions for your subject. If they are at the time of the project able to understand what is involved, then consent should come from them. Otherwise there will be a nominated family member, or someone who has been appointed by the court.
- the research has been approved by the AWI REC
Your application to the AWI REC will need to show that all of the above conditions have been or will be met. The committee will want to know what steps you are taking to ensure that as far as is possible your participants’ views are taken into account, that you will be doing something which is broadly in their interest and that you will be taking adequate precautions to avoid upsetting them.
Many of the considerations that apply to research under the terms of the Adults with Incapacity (Scotland) Act are also concerns in relation to the English Mental Capacity Act, and so if this applies to your research, we would recommend you refer to that section in this guidebook.