- Can I take part in a Clinical Trial?
- If I am asked to take part in a study will I have to sign an informed consent form?
- What should I do before signing the informed consent form?
- What will the side effects be?
- Will I be safe?
Q. Can I take part in a Clinical Trial?
A. There are rules about who can and can’t take part in a clinical trial these rules are often referred to as inclusion or exclusion criteria.
These Inclusion and exclusion criteria are designed to help ensure the safety of the people taking part and help make sure that the trial produces accurate results. These criteria could be based on your age, sex, any current or previous medical history and numerous other factors. As these selection criteria differ from study to study it is essential that your suitability for the trial is assessed before you are allowed to participate.
Q. If I am asked to take part in a study will I have to sign an informed consent form?
A. “Informed consent” is the process of describing / learning the facts about a clinical trial before deciding whether or not to participate. It is essential that you are able to make in “informed” decision about taking part in a study hence the name. If there are any changes made once a study has started you will be given additional information to ensure that you are kept informed.
To help you decide if you would like to take part, the doctor involved will explain the study to you. You will then be provided with an informed consent form that will include a lot of information about the trial; why it is taking place, how long it will take, the standard procedures, any risks or side effects you might experience and who will be involved.
The risks to you and potential benefits are explained in the informed consent form. You should take your time to consider this information carefully and then decide if you would like to sign it. Keep a copy of the informed consent form as it is helpful to refer to before, during and after the trial. If you aren’t given one immediately ask for a copy. You can also request more information, for example, a copy of the protocol (full study plan). No informed consent form may include any language that asks or appears to ask you to waive your legal rights, or that releases or appears to release the investigator, the sponsor, or the institution from liability for negligence.
PLEASE NOTE: IF AT ANY TIME YOU CHANGE YOUR MIND YOU CAN PULL OUT OF THE STUDY. BY SIGNING THE INFORMED CONSENT FORM THIS DOES NOT OBLIGATE YOU TO TAKE PART. IT MERELY CONFIRMS THAT YOU HAVE RECEIVED AND UNDERSTOOD THE STUDY INFORMATION THAT YOU HAVE BEEN GIVEN
Q. What should I do before signing the informed consent form?
A. Strongly consider what questions you would like to ask the doctors and nurses involved. You may also want to ask somebody else to come along to the meeting with you to support you or to ask any questions that you might forget It is not unheard of for people to take tape recorders or at the least a pen and paper into this meeting to record all the relevant answers to your questions. You may like to ask:
- When will the trial start?
- Is there anything I need to do to prepare (e.g stop drinking or smoking for a period before)?
- Why is the trial being conducted (what is its aim?)?
- Who will be running the trial and who will be looking after me before, during and afterwards?
- Has the compound / treatment been tested before? If so can they tell you more about this?
- What kinds of tests might you have to have?
- Will there be any lasting effects of this study after its finished?
- If I am a woman of childbearing potential, how long will I need to wait after the study has finished before becoming pregnant?
- How long will the trial take and will you need to stay overnight or in hospital?
- Will there be any side effects? (see below)
- Will I be compensated for my expenses or my time? If so how?
- Will I be told the outcome of the trial I take part in?
- Will there be any need for aftercare or follow up visits after the study has been completed? If so what will these involve?
Q. What will the side effects be?
A. It is very difficult to answer this question because it very much depends on the nature of the study and the treatments involved. You should discuss this thoroughly with your doctor and the people running the trial. However some of the more common side effects seen during Medical Trials include headaches, nausea, rashes / skin irritation, fatigue or other physical discomfort. Alternatively, there may be no side effects at all.
Q. Will I be safe?
A. There are very strict regulations and guidelines covering both ethical and legal aspects that apply to both medical practice and clinical trials. The trial that you are on should follow a carefully controlled protocol, and a study plan. Your safety is of primary importance to the conduct of the trial.
Every clinical trial has to be approved by an Ethics Committee (EC) in the EU to make sure the risks are as low as possible and are worth any potential benefits. An Ethics Committee is an independent committee of physicians, statisticians, lay persons, and other qualified experts. They make sure that before the study goes ahead (and even throughout the study) it is ethical and that the highest standards of safety are maintained.
It is important that before you consent to take part in a medical trial you appreciate that without your assistance new treatments may not be developed. However, you need to be completely comfortable with the situation and make sure that you know all of the risks that may be involved. Speak to the medical professionals involved and ask as many questions as you like. They are there to help.
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