What is consent?
Giving consent means giving your permission to take part in research. You’ll need to know what consent means and how it works. This is a legal requirement.
The information provided on this page relates to the laws around consent in England and Wales. There may be differences in Scotland and Northern Ireland.
It is important to remember that:
- every person involved in any research 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 support research without taking part in a study.
Safety and protection
If you are not able to provide consent yourself, there are legal arrangements to help determine who is involved in consent decisions on your behalf. Research that evaluates the safety or effectiveness of a drug, or obtains other information about it, is known as 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 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 2: You must have capacity to consent
Having ‘capacity’ means you have the necessary ability, knowledge, or skill to do something successfully. The law assumes that an adult has capacity, unless it is determined otherwise.
To provide consent, you need to be able to understand, remember and weigh up the information given to you. You need to then be able to communicate your decision to the research team. The decision you make must be respected. You will be provided with support at every step as needed.
The law sets out how the research team can determine whether you have capacity to consent to a study, if they have concerns about this. There is a two-stage capacity assessment to help them decide whether you have capacity to consent.
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.
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 may not be able to properly consider the information or to provide consent, even with support. This animation talks you through what will happen and how consent might be gained in the hospital.
Read the video transcript for 'Research in the Intensive Care Unit (ICU)'.
For research studies that are clinical trials involving medicines/drugs (CTIMP)
If you are too unwell to consent to a clinical trial involving a medicine/drug, a legal representative may be asked to provide consent on your behalf.
What is a legal representative?
A legal representative is someone who can consent on your behalf. There are two types of legal representatives.
Personal legal representative
They 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.
Professional legal representative
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 or a person nominated by the healthcare provider (e.g. a GP or a medical consultant). However, they should not be connected to the research being conducted.
Researchers must discuss all the information with your legal representative, personal or professional, 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 okay to withdraw at this point if you want to.
For research studies that don’t involve medicines/drugs (non-CTIMP)
The Mental Capacity Act in England and Wales allows research to proceed without the usual consent if no medicines or drugs are being tested, provided the study is connected with the impairing condition affecting that person or its treatment.
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 expected to help in the following ways:
- The team will try to find a personal consultee (friend/family). Researchers must seek advice from the consultee on what the patient's feelings would be and whether they should take part. A number of people may be capable of acting as a personal consultee. However, they should be someone whom the patient (who lacks capacity) would trust with important decisions about their welfare. These could be a close relative or friend, carer (unpaid), or an individual with Lasting Power of Attorney.
- If the research team can't find a personal consultee, they would need to find a nominated consultee. This could be a GP or a paid carer. 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 research team will make the necessary adjustments according to your accessibility needs, such as providing information in alternative formats (e.g. video or pictures).
What happens if I am unable to sign my name?
You can provide consent in another way (e.g. verbally) in front of a witness who is not connected to the research being conducted. The witness will be asked to confirm in writing that they have witnessed your consent.
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 also be given to you for you to keep.
Have a conversation with family and friends
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.
Interested in finding out more?
What to expect on a study
Health and care research comes in various forms, depending on the study’s goals. Get an idea of what you can expect before, during and after taking part in research.
Find a study
Want to help shape the future of health and care? Find out how you can use our website to find a suitable study.
