Consent in Biomedical Research

Question 1

What is consent?

Answer 1

Giving permission

Question 2

What are the 3 types of consent?

Answer 2

Implicit / Implied
Verbal
Written

Question 3

Why is consent important?

Answer 3

Respect for the autonomy of the patient, of the potential research participant, of the health care professional, and of anyone else

Question 4

What are the 3 requirements in relation to consent

Answer 4

The patient or research subject:

• Has capacity
• Is informed adequately
• Gives consent voluntarily

Question 5

Why is good practice in relation to consent legally important?

Answer 5

Common law duty to obtain consent

Various statutory laws are relevant, including the Mental Capacity Act 2005 (MCA)

Question 6

What if consent is compromised?

Answer 6

In criminal law:

• You may be liable to assault/battery.
• Battery: ‘an act that directly and either intentionally or negligently causes some physical contact with the person of another without that person’s consent’
• In practice, battery applies almost always only to intentional acts.
• You may be liable to criminal (gross/extreme) negligence (careless or reckless conduct in relation to the presence/absence of communication about risks). [convictions are rare]

In civil law:
- You may be liable to trespass to the person (infringing the bodily integrity or liberty of another) and negligence [quite common].

Question 7

The tort (= legal wrong) of negligence

Answer 7

A person (= a claimant) claiming negligence must satisfy:

• That the defendant owed him or her a duty of care;
• That this duty was breached; and
• That the claimant was harmed by this breach and that this harm was not too remote (i.e. harm must have been reasonably foreseeable)

Question 8

What is capacity?

Answer 8

A necessary condition for valid consent = the person ‘has capacity’ (‘is competent’)

Legal presumption: every person has capacity from the age of 16

If in doubt: assess

Question 9

How do you assess whether someone has capacity?

Answer 9

The Mental Capacity Act 2005 adopts a two-stage test

A person lacks capacity if he/she:
- Has an ‘impairment of, or a disturbance in the functioning of, the mind or brain’ [section 2(1)], and
is unable:
(a) to understand the information relevant to the decision,
(b) to retain that information,
(c) to use or weigh that information as part of the process of making the decision, or
(d) to communicate his decision (whether by talking, using sign language or any other means).’

Question 10

4 questions that need to be considered if an adult lacks capacity

Answer 10

1. Is there a valid advance refusal? - if so respect it
2. Is there a donee? - person appointed on their behalf
3. Is there a deputy? - Deputies can make decisions on matters authorised by the Court of Protection, and are only appointed in situations which are problematic for the Court; Deputies lack the power to refuse life-sustaining treatment
4. What would be in the best interests of an incapacitated person (the ‘best interests standard’)?

Question 11

In general terms, research on adults who lack capacity is possible under MCA if:

Answer 11

• It involves minimal risk;
• Relates to the person’s condition;
• Cannot be done as effectively on people who have capacity;
• (Unpaid) carers or nominated third parties (i.e.: consultees) are consulted;
• The person is not entered or is withdrawn if any resistance is shown;
• The research project has been approved by an appropriate body, such as a Research Ethics Committee.

Question 12

Clinical trial definition

Answer 12

‘“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products
(b) to identify any adverse reactions to one or more such products, or
(c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products’

Question 13

Someone in a clinical trial must:

Answer 13

Speak to a member of the research team about the risks and objectives

Be provided with a contact point

Be told that the subject can be withdrawn at any time

Question 14

Do children have capacity?

Answer 14

Minors are defined as those below the age of 18

Children above 16 are legally assumed to have capacity

The parental right to custody of a child is ‘dwindling’ with the increasing age of the child

Children below 16 may be ‘Gillick competent’

Children who are not Gillick competent must be informed and involved in the decision-making, where possible, e.g. by giving their assent

Question 15

4 possible scenarios for children and consent

Answer 15

The child is incompetent and parents refuse: seek a court decision

The child is incompetent and parents consent: go ahead

The child is competent, consents, and parents refuse: go ahead if you think that what the child consents to is in their best interests

The child is competent, refuses, and parents consent: seek a court decision or go with the parental wishes, unless this is explicitly prohibited

Question 16

What is Gillick competence?

Answer 16

Gillick competence is a term originating in England and Wales and is used in medical law to decide whether a child is able to consent to their own medical treatment, without the need for parental permission or knowledge

Question 17

The law related to clinical trials involving children

Answer 17

Medicines for Human Use (Clinical Trials) Regulations 2004, (Schedule 1, part 4):

• Normally, a person with parental responsibility should be asked to give consent.
• Legal representatives should only be used in emergencies.
• Consent from a person with parental responsibility is required even if children are deemed to be Gillick competent.

Question 18

What are the three different views on providing information?

Answer 18

Professional practice standard

Reasonable person standard

Individual person standard

Question 19

Has the standard shifted to the ‘individual person standard’?

Answer 19

The ‘test of materiality is no longer restricted to what the reasonable person in the patient’s position would consider significant: it now includes the added refinement that a risk is also material if “the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”.’

Question 20

What does it mean for someone to give their consent voluntarily?

Answer 20

People may be incentivised to do something by the offer of a financial incentive. Sometimes, the law either limits this or prohibits this (e.g. organ ‘trafficking’ under the Human Tissue Act 2004). There is no law that prohibits the use of financial incentives in research.

However, the offer of payment may jeopardise one’s capacity to consent voluntarily.

Question 21

The law related to treatment without consent

Answer 21

Whilst the principle of consent is important, note that there are laws that allow treatment without consent, most notably the Mental Health Act 1983 (and its amendments; see also Department of Health, 2015) and various laws related to the treatment of infectious disease, of which a brief summary follows.

Question 22

The law on treating those with (suspected) infectious disease without consent

Answer 22

Public Health (Control of Disease) Act 1984

‘A justice of the peace may make an order under subsection (2) in relation to a person (“P”) if the justice is satisfied that—

(a) P is or may be infected or contaminated,
(b) the infection or contamination is one which presents or could present significant harm to human health,
(c) there is a risk that P might infect or contaminate others, and
(d) it is necessary to make the order in order to remove or reduce that risk.’