consent Flashcards
What is consent?
Giving permission via verbal, written or implied consent for your own body. Must have capacity to give consent.
Why is consent needed?
It is crucial for respecting a potential participants autonomy.
Which consent method is preferred?
Written consent is best as implied consent could be implied wrong and for verbal consent, there may not be any evidence to support that someone has given consent.
What are the issues with written consent?
Although you have the evidence that someone has signed their consent, you cannot be sure that they have read and understood properly.
What is the legal basis of consent?
It is common law to obtain consent. Statutory laws also exist, e.g. Mental Capacity Act 2005, to ensure consent is obtained.
What can happen in consent is compromised?
In the event of consent becoming compromised, you could be liable to assault/battery or criminal negligence. Or you could be liable to trespassing a person.
What are the requirements for consent?
The subject must have capacity, be informed adequately, and give consent without being coerced.
What is capacity?
This is ability to be able to give consent. It is a legal presumption that everyone over the age of 16 has capacity.
What is the Mental Capacity Act 2005?
This is an act for which protects vulnerable people who may lack capacity. A person lacks capacity if they have an impairment of, or disturbance in, the functioning of the mind or the brain. Or it can be that the person is unable to understand the information relevant to the decision, etc.
What is linked-anonymised?
This is when data is not completely anonymous - someone has access to the code which can de-anonymise information.
What is the law for clinical trials with regards to a lack of capacity?
The Medicines for Human Use Regulations 2004 state that a patients legal representative can give consent on behalf of the patient if the clinical trial has gained REC approval. The legal representative might be the patients doctor primarily responsible for that persons medical treatment.
What must a physician do if they’re contacted about their patient (who lacks capacity) participating in a clinical trial?
They must speak to the research team about all the information, including benefits and risks, nature of the procedures, length of the trial, required visits, etc. They must be told that the subject can withdraw at any times. The physician should then weigh up whether there is benefit to the patient for participating. The physician should also then relay this information back to the subject so that they can understand it. For eligibility into the trial via consent from legal representative, the disease must be debilitating, e.g. you don’t want to sign anyone up to a trial unless they really need it.
What law applies to consent in other medical contexts, e.g. medical research?
The Mental Capacity Act 2005 should apply to all other fields, including medical research. Research on adults who lack capacity is only allowed if there is minimal risk, it relates to their condition, it can’t be done on competent people, carers and family are consulted, and withdrawal occurs if any resistance is shown. REC approval must also be received.
What is Gillick competence?
Children who are younger than 16 may be seen as Gillick competent, meaning they are deemed to have the mental capacity to make their own decision, e.g. age is not a good indicator of mental capacity, therefore people younger than this may actually have the capacity.
What happens if a child is not Gillick competent?
In these cases, the child must be involved in the decision making to respect their autonomy, but ultimately it is the parental approval that is needed. Children can still give their assent.
