This is an
interesting question which raises a number of issues. For consent to be
considered both legal and ethical, it must be: given by a person with capacity;
voluntarily given, with no undue influence; given by someone who has been
adequately informed; and a fair choice.
What
is capacity?
Capacity refers to the everyday
ability that individuals possess to make decisions or to take actions that
affect them, from simple decisions such as what to have for breakfast to
far-reaching decisions about serious medical treatment or financial affairs. A
person lacks capacity if he or she is unable to make or communicate a decision
about a particular matter because of an impairment of, or a disturbance in, the
mind or the brain. This may be the result of a variety of conditions, including
dementia, mental illness, learning disability, brain damage, intoxication or
any other condition causing confusion, drowsiness or loss of consciousness
(e.g. concussion, stroke, heart attack, epileptic fit, serious accident,
delirium).
Vulnerable
groups
Some groups
of people are regarded as ‘vulnerable’ in terms of giving informed consent to
take part in research studies. Children (under 16 years of age), people with
learning and difficulties and others who may lack capacity to give informed
consent (such as people with dementia or enduring and severe mental health
problems, or those who are unconscious) fall into this category. The interests
of these groups of people are protected in a variety of ways, including by acts
of legislation, an important one being The Mental Capacity
Act (2005).
Lack
of capacity to give consent
The Mental
Capacity Act (2005) provides a comprehensive framework for decision making on
behalf of adults aged 16 and over who are unable to make decisions for
themselves, i.e. they lack capacity. The Act applies to all decisions taken on
behalf of people who permanently or temporarily lack capacity to make such
decisions themselves, including decisions to include such people in research. All
researchers working with research participants who lack, or may lack, capacity
need to be aware of its underlying principles and the provisions relating to
research. The Act is accompanied by a statutory Code
of Practice providing guidance on how it should be used. Researchers and
others making decisions involving people lacking capacity have a legal duty to
have regard to the guidance in the Code of Practice. The Act applies in England
and Wales only.
Children
and young people
There are many ethical and legal
issues to consider when involving children and young people in research,
depending on the type of study being carried out (for example, whether or not
it is a clinical trial of a medicinal product (CTIMP), and whereabouts in the
UK the study is taking place. In particular, it is important to understand the
key concepts of consent and assent.
Consent is a
legally defined decision given by someone who is competent, who has been
adequately informed (and has adequate understanding), and who is free from
undue influence enabling them to make a voluntary decision. The person can
provide consent, provided they are competent. Otherwise someone who is
empowered by law can provide it (e.g. a parent in the case of children). A
child who is not capable of giving consent alone can still be involved in the
decision making process with others who are able in law to provide consent.
There is no legislative statute in England, Wales or Northern Ireland governing
a child’s right to consent to take part in studies other than CTIMPs. Common
law presumes that young people aged between 16 and 18 years old are usually
competent to give consent to treatment.
Assent is
difficult to define and is used in diverse ways e.g. compliance by a child as
young as three years old, to active agreement of a young teenager. Assent is
agreement given by a child/young person or others who are not legally empowered
to give consent. It is important to provide children/young people with
information that matches their capacity when seeking assent.
Gillick
competence
Case law
suggests that if a young person has sufficient understanding and intelligence
to fully understand what is proposed, and can use and weigh this information in
reaching a decision, they are considered ‘Gillick competent’ and can give
consent to treatment. ‘Gillick competence’ is a term originating in medical law
to decide whether a child (16 years or younger) is able to consent to his or
her own medical treatment, without the need for parental permission or
knowledge. The standard is based on a decision of the House of Lords in the
case Gillick versus West Norfolk and Wisbech Area Health Authority (1985). The
case is binding in England and Wales, and has been approved in Australia,
Canada and New Zealand. When a young person is believed to be competent,
consent from those with parental responsibility is not legally necessary,
although the involvement of parents in decision making is encouraged in most
circumstances.
In the
absence of law relating specifically to research, it is commonly assumed that
the principle of ‘Gillick competence’ can be applied not only to consent for
treatment but also to consent for research.
As you can
see from the above, researchers hoping to gain consent from individuals to take
part in a study must give careful consideration to a range of sometimes complex
ethical and legal issues.
Blogger: Dorothy
McCaughan
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