Many doubts arise when taking part on a clinical study. More than a mere disclaimer, informed consent processes exist to tackle them. Based on frequent Google searches, i-CONSENT has selected 5 frequently asked questions on Informed Consent that you might have come across. Let’s begin!
1. What is informed consent and why is it important?
First things first. Informed consent is a two-way communication process through which the potential participant receives all the necessary information to make an autonomous decision about whether or not to take part in a clinical trial. If an individual accepts to participate, they must read and sign an informed consent document. Communication between the physician and participant will continue throughout the whole study
As positive outcomes in healthcare settings can’t be guaranteed, informed consent at least ensures patients understand the risks they undertake with treatment. Informed consent creates trust between doctor and patient and allow patients to make the decisions right for them.
2. Can informed consent be withdrawn?
You can change your mind at any time, even if you have already started the treatment. Let your health care provider know your concerns and decisions at any point of the process.
3. How long is informed consent valid?
With regards to its validity, informed consent begins with the first contact with the potential participant and continues throughout the entire study until its end. If agreed, the participant’s information will be noted in his/her medical records once the study is finished. From i-CONSENT’s perspective, we advise to give the participant the information on the results as well.
4. How can informed consent be obtained?
Once the potential participant has shown an interest in the study, the investigation team will provide further information through different channels. These channels come in different shapes, some examples would be videos, comic, app, websites. After processing the content, the potential participant can therefore meet the investigator to solve any doubts about the study and his/her participation. The informed consent is «sealed» with a signature, if the participant accepts to participate. Recently, this process has updated and can now be acquired digitaly (eConsent).
5. When do we need informed consent?
Informed Consent is required in most medical settings. With regards to clinical studies, the study can’t start until the document is signed.
When dealing with children, another process called assent starts. Assent is the how the children’s opinion on the participation in reflected. Children’s assent will be complemented by the parents consent.
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