Informed consent is more than simply getting a verbal or written informed consent from a subject (volunteer) agreeing to participate in a clinical trial. It is a process that involves the following steps:
Suitable potential subjects are recruited by various means including through referrals and advertising
A person knowledgeable about the clinical investigation and capable of answering questions raised by the potential subject (such as the investigating physician or the clinical coordinator) conducts a consent interview to provide the potential subject with adequate information to allow for an informed decision about participation in the clinical investigation. The interview is conducted in the language of choice of the potential subject so as to allow for understanding of the information.
The person conducting the interview and the subject discuss the contents of the informed consent form (ICF) before it is signed.
The potential subject provided sufficient opportunity to ask questions and to consider whether to participate, including allowing enough time to consider the information and time/ is opportunity to ask and get additional questions answered.
A potential subject signs a consent form agreeing to voluntarily participate in the study. The form provides a “take home” reminder of the elements of the clinical investigation, providing contact information in case additional questions or concerns arise, and documenting the subject’s voluntary agreement to participate. The consent form is also in the language of choice of the potential subject.
The informed consent process often continues after the consent form is signed. Study investigators and/or coordinators continue to provide information throughout the clinical investigation as it progresses or as the subject or situation requires.