Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. It is also a continuing process throughout the study to provide information for participants. The researchers conducting the trial must explain it to you - the aim of the trial, the treatments that are being tested, the possible benefits and any risks involved and how taking part in the trial will affect you. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss.
The consent form will include details about the study approach, the intervention given in the trial, the possible risks and benefits and the tests you may have. Informed consents must be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Don't hesitate to ask questions until you have all the information you need and you should feel free to ask the health-care team any questions you have at any point.
Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want - before the study starts or at any time during the study or follow-up period. You should be completely happy with the trial before you give your consent and be confident that you have been given all the information you need. This may mean taking some time to think about it and talk it over with family or friends before you make a decision. You should be given the time and space to do this.
If you do decide to take part you will be asked to sign a form to say that you are agreeing to take part in a clinical trial and have understood what that will involve. This is called giving your 'informed consent'.
In every informed consent, the following have to be clearly declared:
- that the study involves research of an unproven drug or device
- the purpose of the research
- how long the study will take
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that some other persons or institutions apart from study team (like regulatory authorities) may look at study records, but the records will be kept secret
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study, your rights, or if you get hurt
- you can quit at any time
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