Informed Consent

ICH E6(R3) – A process by which a participant or their legally accepted representative voluntarily confirms their willingness to participate in a trial after having been informed and been provided with the opportunity to discuss all aspects of the trial that are relevant to the participant’s decision to participate. Varied approaches to the provision of information and discussion about the trial can be used. This can include, for example, providing text in different formats, images and videos and using telephone or video conferencing with investigator site staff. Informed consent is documented by means of a written or electronic, signed and dated informed consent form. Obtaining consent remotely may be considered when appropriate.

MRCT – The process of learning and discussing the details of a research study before deciding whether to take part.

informed consent


CDISC-Gloss – An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information

session. NOTE: Under 21 CFR 50.20, no informed consent form may include any “language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally authorized representative. See also consent form.