2.1 Freely given informed consent should be obtained and documented from every participant prior to clinical trial participation. For potential participants unable to provide informed consent, their legally acceptable representatives, acting in the participants’ best interest, should provide consent prior to clinical trial participation. These potential participants should be informed about the trial in a manner that facilitates their understanding. In the event that a minor is a participant, assent should be collected from that minor, as appropriate, and in accordance with local regulatory requirements (see ICH E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population).
2.2 The process and information provided should be designed to achieve the primary objective of enabling potential trial participants to evaluate the benefits, risks and burden of participating in the trial and to make an informed decision on whether or not to participate in the trial. The information provided during the informed consent process should be clear and concise so as to be understandable by potential participants or legally acceptable representatives.
2.3 The informed consent process should take into consideration relevant aspects of the trial, such as the characteristics of the participants, the trial design, the anticipated benefits and risks of medical intervention(s), the setting and context in which the trial will be conducted (e.g., trials in emergency situations), and the potential use of technology to inform participants (or their legally acceptable representatives) and obtain informed consent.
2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as
possible in accordance with applicable regulatory requirements and the processes approved by the institutional review board/independent ethics committee (IRB/IEC).