Informed Consent Process and Guidelines

Informed consent is an ongoing process that must occur before any clinical trial-related procedures are conducted. The process consists of documentation and a series of conversations between the clinical trial participant and the principal investigator and delegated health care professionals, as appropriate.

Informed Consent Process

The principal investigator discusses the trial’s risks, benefits and other aspects with the potential participant and, if required, the participant’s legal representative, before the trial begins. The investigator gives the potential participant ample time and opportunity to ask questions about the trial and discuss it with relatives and family members.

If the potential participant decides to get involved in the trial, he or she provides voluntary consent by signing and dating the written informed consent document, of which he or she also receives a copy. The participant has the right to withdraw consent at any time without penalty, repercussions or reason.

While the investigator 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.

Informed Consent Guidelines

Investigators must follow the International Council on Harmonisation (ICH) good clinical practice (GCP) guidelines. Section 1.28 describes the informed consent process, while Section 4.8 explains the requirements and process for obtaining informed consent from a clinical trial participant.

In addition to following ICH GCP 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.

Elements of the Informed Consent Document

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 also must 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.

Revisions to Informed Consent

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 and is provided with a copy.