Permission and approval

Mental Capacity Act

The Mental Capacity Act (MCA) (2005) applies in England and Wales.  The equivalent legislation for Scotland is the Adults with Incapacity (Scotland) Act.

The Mental Capacity Act states that research with individuals (adults) who lack the capacity to consent must have the ethics of the research scrutinised and approved by an ‘appropriate body’. An ‘appropriate body’ is defined in law. In England, the ‘appropriate body’ must be a research ethics committee recognised by the Secretary of State. In Wales, the ‘appropriate body’ must be a research ethics committee recognised by the Welsh Assembly Government.

The critical – and practical – point is that university ethics committees are not recognised as appropriate bodies under the terms of the MCA – they are not judged to be sufficiently independent of researchers to be able to give truly independent scrutiny, and thus to satisfy the Act. (The reason given is that universities have a vested interest in research being conducted, because their income and reputation depends on research activity).

NHS Medical Research Ethics Committees (MRECs) in the NRES system have been recognised as appropriate bodies. But because of concern that medical research ethics committees were not suited to the particular characteristics of social care research, the Department of Health has established a Social Care Research Ethics Committee.

 

The important things to know about the Mental Capacity Act

The Department of Health has published a factsheet for social scientists, which provides some guidance about how the Act applies to social science research.

You will need to apply for ethics approval to the SCREC or to an NHS ethics committee (an NRES MREC) if you are doing research with participants that come within the remit of the Mental Capacity Act:

• It applies to 16-17 year olds and adults (18 years and over) who lack capacity to make a particular decision or take a particular action for themselves at the time the decision or action needs to be taken.
• Guidance on the Act notes that lack of capacity may be permanent or temporary. It could be state-related (e.g. due to drug or alcohol use) or the person concerned could gain capacity for decision-making or action (within the legal definition) with appropriate support/training. The key point is whether they have capacity at the time.

If you are including participants who lack capacity

Department of Health guidance states that it is for the research team to decide if it wishes to include people without the capacity to consent in their study. In making this decision, the team is directed to address the following questions:

a) Is the research related to the ‘impairing condition’ that causes the lack of capacity, or to the treatment of those with that condition?

If the answer to this question is ‘no’ then the study should proceed without involving those who do not have the capacity to consent to participation. If the answer is ‘yes’ the researchers need to answer a second question:

b) Could the research be undertaken as effectively with people who do have the capacity to consent to participate?

If the answer to this question is ‘yes’ then the study should exclude those without the capacity to consent to participation. If the answer is ‘no’ then the inclusion of people without capacity in the study can be justified. The research team will still need to decide however - as it would have done prior to the legislation - if it has the time, resources and expertise to ensure the meaningful involvement of people without capacity.

If your research includes participants who lack capacity, as defined in the Act, then an ethics committee will consider your application in relation to these questions – meaning that you will need to satisfy an NRES ethics committee that your research is ‘scientifically meaningful and methodologically viable’.

When does the Mental Capacity Act NOT apply?

Guidance on the Act states that it does not generally apply to:

• Research with children and young people under the age of 16 years.
• Clinical trials that are covered under the Medicines for Human Use (Clinical Trials) Regulations 2004.
• Research that only involves data that has been anonymised (it cannot be traced back to individuals). Confidentiality and data protection laws do not apply in this case.
• Some research involving human tissue:
• Under the Human Tissue Act 2004, research that deals only with human tissue that has been anonymised does not require consent (see paragraphs 11.37–11.40). This applies to both those who have capacity and those who do not. But the research must have ethical approval, and the tissue must come from a living person.
• If researchers collected human tissue samples before 31 August 2006, they do not need a person’s consent to work on them. But they will normally have to get ethical approval.
• Some research using confidential patient information, under regulations made under section 251 of the NHS Act 2006 (formerly known as section 60 of the Health and Social Care Act 2001), for which you would need to apply to the Patient Information Advisory Group for approval on behalf of the Secretary of State.

Who should you get consent from?

Guidance on the Act states that researchers should assume that a person has capacity, unless there is proof that they do not have capacity to make a specific decision, and that potential participants must receive support to try to help the make their own decision. This means you should aim to judge each case individually, and not assume that a participant does not have capacity because of an impairing condition (such as a disability). You may just need to adapt your methods for seeking consent, taking expert advice and undergoing training as appropriate, or you may need to provide support for the participant in the process – e.g., from someone who is experienced in meeting their individual communication needs.

Remember that the potential participant has the right to disagree with the decisions that others (such as relatives or carers) might make. If it is established that an adult does not have the capacity to decide whether to participate, the Act requires that researcher must consult with a specified consultee, as set out in Guidance published in 2008:

• If possible, this should be a personal consultee. The researcher must take reasonable steps to identify someone who knows the person who lacks capacity well but is not acting in a professional or paid capacity. The guidance states that it should be someone whom the person who lacks capacity would trust with important decisions about their welfare. Thus, you could consult with a family member or close friend of the person, but not a paid carer or other professional such as a social worker. Remuneration does not cover family members receiving some of the person’s pension or other benefits as a payment towards their share of the household expenses.
• If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is someone who is prepared to be consulted by the researcher, but has no connection with the research study. According to the published guidance, that could be someone from a relevant organisation (such as a local church or relevant charity), but crucially, it could also be someone who knows the person in a professional capacity (and thus could not be a personal consultee). So, the nominated consultee can be someone such as the person’s GP, social worker or carer – providing they have no connection with the research study.

In either case, it is the researcher’s responsibility to satisfy the REC that the arrangements were appropriate to the nature of the study.

Requirements for research ethics approval under the Act

The Act specifies what is accepted as research under the terms of the legislation, stating that the research must be connected with an impairing condition affecting the participant, or its treatment. This appears to be related to the requirement that it would not be possible to carry out the research with people who do have capacity, and is something that you need to justify in your ethics application. Department of Health guidance sets out the following key questions:

a) Is the research related to the ‘impairing condition’ that causes the lack of capacity, or to the treatment of those with that condition?

If the answer to this question is ‘no’ then the study should proceed without involving those who do not have the capacity to consent to participation. If the answer is ‘yes’ the researchers need to answer a second question:

b) Could the research be undertaken as effectively with people who do have the capacity to consent to participate?

If the answer to this question is ‘yes’ then the study should exclude those without the capacity to consent to participation. If the answer is ‘no’ then the inclusion of people without capacity in the study can be justified. The research team will still need to decide however - as it would have done prior to the legislation - if it has the time, resources and expertise to ensure the meaningful involvement of people without capacity.

In addition, however, guidance states that to secure ethics approval the research team will need to demonstrate that the study will meet one of the following central requirements:

a) that it will be likely to be of benefit to the person lacking capacity, either directly (i.e. by improving her/his personal circumstances) or indirectly (by improving the quality of treatment or care more generally), and that this benefit is in proportion to any burden on that person caused by taking part;

OR

b) that the research will serve to increase knowledge of the cause, treatment or care of people with the same or similar condition and that the risks to participants will be negligible, with no significant interference with their privacy or freedom of action.

These requirements pose some tensions for social science researchers whose focus may not either directly benefit the participant him or herself, or which may not be directly related to the development of treatment or care per se. A couple of brief case examples below highlight the extent to which these requirements may – or may not be - problematic:

Case 1.

Case 2.

A study is concerned with the way in which young adults’ decision making about safe sex is affected by their intoxication, with the intent that the results will have the capacity to inform the development of future health promotion initiatives. Pilot work has indicated that retrospective accounts may be unreliable because of forgetting and socially desirable responding, and so the researchers aim to compare the accounts of participants in night clubs, when they are intoxicated, with those of sober participants who are not in the club environment. It is likely that drug and alcohol use may mean that some potential participants will temporarily lack capacity under the terms of the Act.

The study will not contribute to understanding of the cause of incapacity (drug or alcohol use) (criterion ‘b’), although it could be argued that it meets criterion ‘a’ in terms of generating knowledge that is relevant to broader public health care benefits which could benefit individual participants. Moreover, it may not be feasible to identify appropriate personal or nominated consultees for participants within the nightclub context. In this case, we would suggest the researcher explores with the relevant ethics committee whether the proposed activity meets criterion (a); and whether it might be acceptable to seek consent at the time of interview, adapting the consent process as appropriate at the time (e.g. allowing support of friends, simplifying the explanation), but then to secure valid fully informed consent retrospectively from participants (i.e. to ask for contact details and to seek permission to use the data provided when the person concerned is no longer intoxicated, and has capacity to consent). However, this study clearly falls into two grey areas with regard to the Mental Capacity Act, and could have problems securing ethics approval.

 

Mental Capacity Act: Summing Up

If you are doing research with participants that come under the terms of the Act (or think you might be), have a look at the Code Of Practice for the Act, and guidance for social scientists and at the Guidance on Nominating a Consultee. For a researcher, Chapter 11 of the Code of Practice is probably the most important part. It’s only 13 pages, and it covers useful information that an ethics committee will be informed by in their decision about your research – so worth reading. In particular, it lists:

• the requirements that a research project must meet in order to be approved by an ethics committee. These include the potential for benefit vs. burden and risk; the extent to which the research really needs to involve people who lack capacity; when people should be allowed to withdraw from research; and so on; and
• the specific responsibilities of researchers.  Your ethics application should explain how you meet those responsibilities.

However, as noted above, there are some ambiguities in the guidance, and in the wording of the Act itself, which may be problematic for studies that don’t meet the narrow definition of research. These will probably be clarified over time, but if you have any concerns about how the Act may apply to your research, we recommend you seek advice from NRES or the Social Care Research Ethics Committee before submitting your ethics application.

Further reading

Dixon-Woods, M and Angell, E L (2009) Research involving adults who lack capacity: how have research ethics committees interpreted the requirements? Journal of Medical Ethics, 35, 377-381.