Taking part in research is always voluntary. Researchers should not put pressure on you to take part and you don't have to give reasons for saying no.
Yes, you can withdraw from the study at anytime without giving a reason. All researchers know that you have a right to do this.
No, your treatment at the hospital will continue as normal if you decide not to take part in the research.
All medical research carried out on humans must be approved by a research ethics committee. The committees are made up mainly of doctors and other professionals who meet on a regular basis to look at all proposals for new research studies.
The job of the committee is to protect the dignity, rights, safety and well being of people who volunteer to take part in research studies. If they have any doubts about a study they will ask the researcher to make changes before the study can go ahead.
By the time you are asked to take part in a study this process will be complete. While it s reassuring to know that the study has been given careful consideration by the ethics committee, it is also important that you think carefully about whether participating in the study is right for you. Don't sign the consent form unless you are completely happy to take part in the research and are satisfied that you have answers to any questions you may have asked.
The researcher should be able to tell you exactly why the research is necessary.
Research studies can be funded by organisations other than the hospital. These could be charities, universities or pharmaceutical companies.
You should be given an explanation of why you have been chosen to take part in the study. This may be a combination of factors including your current medical condition, age, sex or medical history.
Some studies may take only a few minutes of your time while others may involve one or more extra hospital visits. Occasionally studies can last for several years and you will need to decide whether you will be able or willing to make follow up visits to the hospital.
Sometimes if you are taking a certain kind of medication there may be some restrictions to your lifestyle. Occasionally you may have to avoid certain foods, other medications or alcohol and if you are female you may be asked to agree to avoid pregnancy during the study.
Travel expenses for extra hospital visits will often be paid. If you have a long journey to make to the hospital or are unable to use public transport you need to find out what arrangements can be made for your travel.
Taking part in a research study involves giving information about yourself to the researchers. This information may be the answers you give to questions about your health, or it could be the results of tests which researchers carried out on you.
The Data Protection Act 1998 gives you the right to expect that your personal details will be kept secure and confidential. All researchers must comply with this act and respect the confidentiality of your information. Members of the research team should be able to answer the following question:
What information will be kept about you?
Who will be responsible for keeping the information confidential?
What will this person do to make sure that you cannot be recognised – from the information which is held about you?
Do the researchers plan to share the information with anyone else? (this could be researchers at another hospital or university)
Will your GP be told about your participation in the study?
Be sure that you are happy with the answers to these questions before you agree to take part in the research.
Once you have been given all the information about the study, you will be ready to decide whether you want to take part. If you do decide to go ahead you will be asked to sign a consent form.
The consent form should include the study title, the name of the principal investigator (the person in charge of the study) and details of how to make a complaint if necessary. You should also be asked the following questions:
A copy of the form should be given to you to keep. If you are not asked to sign a form you should speak to the researcher about this.
Researchers should tell you whether the study treatment will still be available to you once the study is finished. If it is not they should tell you what will be available instead.
The researchers should also tell you what will happen to the results of the study, where they are likely to be published and how you can obtain a copy.
Details about you from which you could be identified will not be used in any report or publication.