Informed consent is an ongoing process that must occur before any clinical trial-related procedures are conducted. The process consists of a document and a series of conversations between the clinical trial participant and the principal investigator (PI) and delegated health care professionals, as appropriate.
While the PI may delegate the task of administering and obtaining informed consent to a qualified individual, he or she is ultimately responsible for ensuring the process is conducted properly.
Investigators must follow the International Council on Harmonisation (ICH) good clinical practice (GCP) guidelines. Section 1.28 describes the informed consent process, while the requirements and process for obtaining informed consent from a clinical trial participant are explained in section 4.8.
Besides following ICH guidelines, investigators need to adhere to national and local regulatory requirements, sponsor requirements, and privacy and personal data security regulations applicable in the country in which the study is being conducted.
The informed consent document must be fully approved by an institutional review board (IRB) or an independent ethics committee (IEC) prior to its use with trial participants.
The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8.10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers’ rights.
The document must also have at least two signature and date lines: one for the participant and another for the health care professional conducting the informed consent discussions with the participant.
Both the written document and the verbal consenting process must be presented in language the participant understands. It also needs to be documented appropriately.
Informed consent documents must be revised every time new safety information becomes available or there is a change in trial procedures, participant compensation or personnel noted on the consent form. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the informed consent process with the new information and documentation needs to be repeated with every clinical trial participant. The participant is then required to sign the revised form.