Defining and assessing competence to consent
Whatever the age of your potential participants, you need to consider how you will define and assess their competency to consent to participate in your research. In general, you should start by assuming competency and to consider how to design your methods for seeking consent to ensure that they are appropriate for your sample.
Capacity or competence to consent involves the following features. A competent person has:
- the capacity to make a choice about a proposed course of action;
- knows about the risks, benefits, alternatives;
- understands that that consent is ‘voluntary and continuing permission’;
- understands that consent ‘can be withdrawn at any time’.
Each person has to be informed ‘fully, frankly, and truthfully’ with ‘reasonable care and skill’ (source: Code of Practice Pursuant to Section 118(4) of the Mental Health Act 1983 (1990)).
Specific legal requirements apply to research with adults who lack capacity to consent: The Mental Capacity Act applies to research with 16-17 year olds, and adults, 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. Lack of capacity may be permanent or temporary (e.g. it could be state related, due to drug or alcohol use).
Separate ethics considerations apply to consent in research with children. Overall, it is important to recognise that children should not be assumed to be incompetent to consent just because of their age. However, there are particular considerations that need to be addressed to ensure that child participants in your research have freely given their fully informed consent. In research with children, there could be a space on the form for both parent and child to sign, though some children prefer to give oral but not written consent.
Competence can be assessed in three ways: firstly, by status – groups such as adults or very young children; secondly, by function – through tests of reasoning or other ability; and thirdly, by outcome - if the person makes a choice, which the assessor believes will lead to a reasonable outcome, competence is assumed. This last criterion is set out in the Department of Health’s guidance for social scientists on the Mental Capacity Act, which states that:
’In research, capacity is normally implied by the act of consenting to participate in a study. However, it is important to avoid the possibility that compliance is wrongly taken to imply consent. Demonstrable steps should be taken to ensure that the respondent is able fully to comprehend or retain information about a research study.’
(Department of Health 2009, p 4)
Assessment of competence therefore depends on a judgement by the researcher. The manner of testing is important. For example, a highly competent child, who is afraid or angry about being assessed, could appear to be incompetent by not co-operating. Equally, an individual who is very shy and nervous could appear to consent, but merely comply, without having understood the implications of giving consent.
Function tests usually assess four standards in the person giving consent. These are:
- mental competence, the ability to understand and decide;
- being sufficiently informed;
- having sufficient understanding of the case to make a reasoned choice; and
- voluntariness, having the autonomy to make firm personal decisions based on long term values.
The standards tend to link to factors specific to each individual, such as, age, gender, ethnicity, ability, maturity and personal experience. Also relevant are the individual’s hopes, fears, values, life-plans, temperament and degree of independence and assertiveness and willingness to take risks.
Yet it is equally vital to consider factors around the individual. Are they usually encouraged to share knowledge and decisions or not? Are they used to being listened to? What is the research setting like, welcoming or intimidating? What research is being discussed, how complex is it? Has the potential participant been told all the main points? How is information provided? Is it written down in a way the participant can understand, by summarising key points in a leaflet? Is that appropriate for your sample? See our section on providing information for participants.
Consider how to find enough time and a quiet space to talk. You also need to make sure that the researchers are skilful and confident about sharing information, overcoming language barriers, using appropriate language – e.g. using simple words, and responding to the individual’s cues and body language.