Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you.
When you give written consent to participate in a clinical trial, you are acknowledging that you understand and accept all aspects of the research study—including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between the research staff and you before, and even after, you decide to become a study volunteer.
To begin, the research staff is obligated to discuss all the pertinent information about the trial—its purpose, the procedures involved, the potential risks and benefits—with you. It is your responsibility to ask questions if there is something you do not understand.
If you do not understand any part of the process, ask the researcher to repeat the information or to explain it in another way, using everyday words. If English is not your first language, inform the researcher that you are not comfortable speaking about a clinical trial in English. Upon request, research centres can and should produce documents that explain every aspect of the study and study personnel should be able to explain the information to you in your preferred language. If this is not possible, you should not participate in the study.
It is the responsibility of the research staff to help you understand the information they provide you and to give you enough time to ask any additional questions you may have. In some instances, this may not be possible to accomplish in a single visit, therefore it is essential to take the time you need to make an informed decision. You may discover important concerns that you did not think about during the first visit.