If you are asked to take part in a research study
Participant information sheet
Before deciding to participate, you will be given a study summary to read that usually includes information such as:
The aim of the research study
Which organisation/charity is funding the study
How to contact investigators/research team
Why you have been invited to take part
The inclusion and exclusion criteria for participants
What you will have to do if you take part
Why the study is safe for you to take part in
Whether or not you will be paid for your time
The advantages and disadvantages of taking part
How your information will be kept confidential and what will be shared with the research team
What will happen with your data
The research team will be able to answer any other questions that you may have. Some examples of questions that you may have can be found on the page "Questions to ask the research team".
Patient safety
If you are uncertain or uncomfortable about anything involved with the study, speak to the study team (you can also stop taking part).
Studies taking place within the NHS must be approved by an ethics committee who decide if it is safe for participants to take part.
All research with NHS patients also requires approval from the Health Research Authority before they can recruit participants.
Taking part in a study
Taking part is voluntary and you can stop participating at any time.
There may be a reason why you cannot take part, even if you were invited. This can happen for a number of reasons, such as if there are too many participants or if there is a change in the study's focus. The decision will not be personal (even though it can feel that way).
Typically, you will not be paid to take part, but you may be reimbursed for travel expenses.
Studies often randomly allocate participants to the different treatment groups, so the researcher won't be able to change which group you are in.
If the study is testing a new treatment, it is possible that you will be in the "control" arm of the study, which means that you will receive usual care rather than a new treatment. The control arm is very important for good quality research.
A study may be "blinded", which means that you may not know if you are receiving the new treatment or the placebo. In a "double blinded" study, the people delivering the treatment also do not know which participants have received which treatment.
Giving informed consent
If you would like to participate, be sure to take time to think about it carefully.
You should only agree to participate (give informed consent) if you fully understand and are happy with what will be involved.
You can withdraw your consent (stop taking part) at any time and without giving a reason.
You will need to sign the consent form. Online your consent forms can be signed in various ways, such as clicking "I Accept" or by typing your name and the date.
Confidentiality
You will be asked to give your informed consent to take part if the information collected for a study is linked to you personally (the study team will know that your results are related to you).
Many studies will require your active involvement (such as fill in a questionnaire), but others may only want to look at your patient record.
If a study will only use your anonymised patient record data that cannot be tracked back to yourself, you may not be asked for your consent. The Health Regulatory Authority's Patient information and research page explains how your records may be used for research.