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 Can informed consent be withdrawn?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.
Do you have more questions? Leave us a comment on the post or reach us through our Social Media! Stay tuned.
I would like to know what if an investigator missed getting the informed consent form signed for some unavoidable reasons. However, this patient was informed about the study (regitry) and he had given his oral consent being agreed to take part in the study. As the patient would next be turning up in the hopspital (for next medical check ups) in 2 months later, can investigator continue with this patient. However, patient still likes to take part in the study.
Dear Dan Silva,
The aim of the i-CONSENT project is to improve informed consent processes in order to improve their understanding and better adapt them to the characteristics and needs of potential participants, so the answer we can give you to your question has no legal validity and should not be the basis for your decision on how to proceed.
That said, we know that most national medicines agencies have produced documents describing the procedures to be followed in clinical trials conducted in times of COVID-19.These guidelines usually include some specific modifications in the process of obtaining informed consent, for example in the case of Spain, they include the option of obtaining consent orally and preferably before a witness, documenting it in the patient’s clinical history, and subsequently ratifying it in writing by the signature of the participant and the investigator, as far as possible and making a reasonable effort to achieve it.
We therefore recommend that, on the one hand, you find out whether there is a similar document from the national medicines agency of your country and what it says about it, and on the other hand, that you ask the ethics committee that has evaluated your study. Thank you, Best regards