In this series of blog posts, we’ve been looking at the changes in Revision 3 of the ICH Good Clinical Practice E6 guidance. Today, we look at the Informed Consent section where – no surprise – the pandemic gets name-checked.
First, some general changes:
Next, substantive changes:
Starting Point. R3 clarifies that IRB/IEC written approval must be obtained “prior to consenting and enrolling participants,” replacing the more ambiguous wording “the beginning of the trial.”
Language. Where R2 stated that informed consent language should be “non-technical” and “understandable,” R3 describes desired language as “clear and concise as possible” and “simple,” with an overall goal of ensuring participants’ understanding of the trial. Per R3, informed consents should also “”avoid unnecessary volume and complexity,” music to the ears of those of us who regularly review long, repetitive ICF models.
Alternative methods of consent. R3 adds a step permitting “varied approaches (e.g., text, images, videos, and other interactive methods” for informed consent, as well as remote consent “where appropriate.” Criteria for appropriateness are not specified.
Ample time. The requirement to give participants “ample time” to review the informed consent has been qualified with “unless justified (e.g., in an emergency situation).”
Signatures. In addition to signatures by the subject/legal representative and person conducting informed consent discussion, R3 notes that “where appropriate” the form may be signed by an impartial witness, to bring this section in line with the requirement for an impartial witnesses in cases where both the participant and their legal representative are unable to read. A new statement notes that signatures may be handwritten or electronic.
Minors and Other Participants Requiring a Legal Representative. R3 suggests that a re-consent process should be considered if a minor participant reaches the age of legal consent during the trial. R3 also distinguishes between minor participants who should receive “age-appropriate assent information” and participants who require a legal representative (a group that includes minors), who should receive information “to the extent compatible with the participant’s understanding.”
Required elements. The following new required elements have been added:
Public health emergencies. R3 notes that in exceptional circumstances, alternative methods and technologies for informed consent may be used per local IRB/IEC guidance and regulatory requirements.