What is consent?
Giving consent means giving your permission to take part in research. If you are asked to consider this, you’ll need to know what it means and how it works as it's a legal requirement.
The information provided on this page relates to the laws in England around consent. Wales, Scotland and Northern Ireland will be different.
- Whatever the type of research, anyone who is involved will be treated with respect.
- When you take part, research is not being done to you, but with you.
- People who’ve participated in research often share that they felt well cared for and had a dedicated contact within the research staff team to help them feel involved and informed.
Some studies will ask you to consent in writing, others verbally. If you decide to give your consent, your research journey will begin. Make sure you have all the answers you need to make you feel at ease. If you are uncomfortable with any aspect, speak to the research team.
We understand that not everyone feels comfortable taking part and you should know that this is ok - it is your right not to consent. There are many other ways to help.
Safety and protection
For your safety and protection, if you are too unwell to consent yourself, the type of research study will determine who can give consent on your behalf.
Research that is evaluating the safety or how effective a drug is or obtaining other information about the drug e.g. how it is absorbed, is known as a Clinical Trial of a Medicinal Product (CTIMP). All other research is known as Non-CTIMPs. You can read more about this below.
The three rules of consent
Rule #1 You must be legally competent
Being competent means you have the necessary ability, knowledge, or skill to do something successfully. The law sets out some “tests” to make sure researchers can ensure you are competent. You need to be able to understand, remember and weigh up the information given to you - this can be with or without help and then be able to communicate your decision to the research team. The decision you then make must be respected.
Rule #2 You must have all the information
You should be given a patient information leaflet. This will tell you all about the research study, what it will involve and the risks and benefits. It should be written in plain English and you will also be given a chance to ask any questions about the research study.
Rule #3 You must give consent voluntarily
This means that you choose to give your consent without feeling under any pressure from anyone else - regardless of whether this is family, friends, your doctor or nurse.
There is a two-stage test to help healthcare professionals decide if an individual has capacity.
Consent for research in the intensive care unit of a hospital
If you are admitted into critical care in a confused or unconscious state, you will be unable to properly consider the information and won’t be able to consent. This animation talks you through what will happen and how consent might be gained in hospital.
What is a legal representative?
A legal representative is someone who can consent on your behalf. They are used only for Clinical Trials of a Medicinal Product (CTIMP) i.e. when research that involves testing medicines/drugs, or, if you are too unwell to consent and a friend or family member cannot be reached.
Researchers must discuss all the information with them and get their written consent. When you recover, the research team will ask if you want to re-consent to make sure you are still happy to take part. It’s ok to withdraw at this point if you want to.
If you’re waiting to go into a research study, this person must not be ‘a person connected with the conduct of the trial.’ There are two types of legal representatives:
- A personal legal representative - must have a close personal relationship with the participant and fulfil the definition of a legal representative. Rather than advice, the personal legal representative gives informed consent on behalf of the participant. This legally represents their presumed will. Consent must be written.
- If no personal legal representative can be found then a professional legal representative should be consulted. This can be the doctor responsible for the person’s care (GP) or a person nominated by the healthcare provider (e.g. an acute NHS trust medical consultant), but again should have no connection to the research being conducted.
For research studies that don’t involve medicines/drugs (non-CTIMP)
The Mental Capacity Act in England allows research to proceed without the usual consent if no medicines or drugs are being tested.
This only applies if the NHS Research Ethics Committee has pre-approved this. The NHS Research Ethics Committee was established to enable and support ethical research in the NHS and protects the rights, safety, dignity and wellbeing of research participants.
The research team is still expected to:
- Try to find a personal consultee (friend/family) - the researcher must seek advice from this individual on what the patients feelings would be and whether they should take part. A number of people may be capable of acting as a personal consultee, but they should be someone whom the patient (who lacks capacity) would trust with important decisions about their welfare. These could include: a close relative or friend; Carer (unpaid); An individual with Lasting Power of Attorney.
- If you can't find a personal consultee the research team would need to find a nominated consultee. This could be a GP or a paid career. The nominated consultee should be kept informed throughout the study.
Frequently asked questions
Will my care change as a result of volunteering to take part in research?
Caring for you is the priority of any healthcare professional. Your health comes first. If you decide to take part in research, you will still receive the standard of care, but if the research involves the testing of a new treatment, you may be given additional treatment on top of this standard of care.
What happens if I struggle to read or understand the information?
The team will explain and read the information to you in the presence of an independent witness (someone not known to the research team).
What happens if I am unable to sign my name?
You can ask someone to sign on your behalf in front of a witness.
How is my consent stored?
Most of the time, the research team will keep the original consent with the research study documentation. A copy is also filed with your medical records. A copy will be given to you also for you to keep.
Next step - have a conversation
If you know you’d like to help research by consenting to take part - speak to your loved ones or a close friend - and tell them your wishes. By having the conversation early, it means that if anything happens, they will be able to carry out your wishes and feel comfortable doing so.