Back to know more
My doctor says I am eligible: now what?
A doctor will explain the aims and characteristics of the study to you, and give you an information sheet. If you decide to participate in the trial you will be asked to sign the informed consent form.
Informed consent indicates the overall information process and it is not simply the subject’s signature on the informed consent form.
Before participating in a clinical trial you need to know that:
- Participation is voluntary and free
- You have the right to withdraw at any time with no implication for medical care
If you plan to participate in a clinical trial (Clinical trial), you should know that you are protected by the law and by the ethical codes that govern medical practice in your country.
Your protection is ensured by:
- Protocol approval: A clinical trial can include patients only after its protocol has been approved by an Ethics review Board. This assures that the trial meets the required ethical and scientific standards
- Informed consent: this is a mandatory process that each patient must undertake in order to make a decision about taking part in a clinical trial.
How should I be informed?
In order for you to make a conscious decision about taking part in a clinical trial, you should be provided complete key information about the study, including risks and benefits. The doctor involved in the study should focus on your information needs, use plain language and avoid medical technical terms. You should receive this communication in a proper location, and be given enough time to think about the proposal, creating the conditions where you can feel free to ask questions. All such information should be provided both verbally and in writing, through a proper information sheet.
Which information should I receive?
The information on the Clinical trial should include all relevant details, such as, for example: the aims of study, the study treatments, the risks and benefits of the treatment, the outcome of the study, the study design, the availability of alternative treatments, the duration, visits, examinations additional to standard care, the sites where the study will be conducted, the possibility of incidental findings and how they will be managed and communicated, the sources of funding. If you want to know more here you can find a list of potential questions.
Most of this information is presented in the information sheet of the study. However, if something is not clear to you, you can ask for further details.
Biobanks
In several clinical trials, the biological samples of the participants (for example, blood, tissues, stool) are collected in biobanks, i.e. repositories that collect samples and information for research purposes. Biobanks are strictly regulated by law.
In the case of biobanking, a separate information sheet and consent form should be provided, covering, among others: the meaning and scope of biobanking, information on how genetic information is protected, clear information on the results of these tests and traceability of samples.
Secondary use of the data
The patients’ information collected in a clinical trial, including personal and clinical data and biological samples, can be re-used in other studies. This is called “secondary use of individual participant data”. In this case, a separate consent, meaning a separate signature for secondary use of the data, is required. Information should cover: reasons for data sharing; use of external repositories; how and where the data will be stored; how confidentiality will be maintained.
Trial participants must be informed that not giving consent to share their data will not affect their participation in the study or in the care they receive. If you want to know more list of topic.
Before you decide to participate
Before you decide to participate, you need to read the information sheet carefully. You may want to ask the research team or an independent doctor for additional explanation: for instance, you can speak with your general practitioner in order to understand the potential benefits and risks of trial participation. Besides the very important medical issues, you should also consider the logistics of the clinical trial: long journeys to the research centre or having to take several days off for exams or
hospital stays, which might affect your participation and cause your withdrawal from the study.
At the end of the information process you will be able to make a decision and, if you accept to take
part to the trial, you will sign the informed consent form.
4 steps before taking your decision
1. Talk with your doctor
2. Read the form
3. If you have any doubt
4. Print the list of questions
Talk with your doctor
A doctor explains you the study’ s aims and its characteristics,
and gives you a document with
complete information.
The document your doctor gave to you has to be signed and it is called “informed consent form”. Take your time to read carefully.
Contact your doctor or the staff if you have any concerns. It is your right to understand what is going to happen during the clinical trial..
Write a list of questions that may come to your mind and discuss them with your doctor. Here you can find a list of useful questions. Print them and take them with you.
