2.8.1 In obtaining and documenting informed consent (paper or electronic format), the investigator should comply with the applicable regulatory requirement(s) and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. The informed consent process should include the following:
(a) Prior to consenting and enrolling participants, the investigator should have the IRB/IEC’s documented approval/favourable opinion of the informed consent materials and process;
(b) The information should be as clear and concise as possible, use simple language and avoid unnecessary volume and complexity. This is to ensure that the trial participants or their legally acceptable representatives have an adequate understanding of the objectives of the trial, alternative treatments, potential benefits and risks, burdens, their rights and what is expected of the participants to be able to make an informed decision as to their participation in the trial;
(c) Varied approaches (e.g., text, images, videos and other interactive methods) may be used in the informed consent process including for providing information to the participant. The characteristics of the potential trial population (e.g., participants may lack familiarity with computerised systems) and the suitability of the method of obtaining consent should be taken into consideration when developing the informed consent materials and process. When computerised systems are used to obtain informed consent, trial participants may be given the option to use a paper-based approach as an alternative.
(d) Obtaining consent remotely may be considered where appropriate.
(e) Whether the informed consent process takes place in person or remotely, the investigator should assure themselves of the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements.
2.8.2 The participant or the participant’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue trial participation. The communication of this information and confirmation of the willingness to continue trial participation should be documented.
New information that could impact a participant’s willingness to continue participation should be assessed to determine if re-consent is needed (e.g., depending on the stage of the trial, consideration should be given to whether the new information is relevant only to new participants or to existing participants). If re-consent is needed (e.g., information on emerging safety concerns), new information should be clearly identified in the revised informed consent
materials. Revised informed consent materials should receive the IRB/IEC’s approval/favourable opinion in advance of use.
2.8.3 Neither the investigator nor the investigator site staff should coerce or unduly influence a participant to participate or to continue their participation in the trial.
2.8.4 None of the information provided to the participant or the participant’s legally acceptable representative during the informed consent process should contain any language that causes the participant to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor or their service providers from liability for negligence.
2.8.5 The informed consent process should be conducted by the investigator or other investigator site staff delegated by the investigator, in accordance with applicable regulatory requirements. If the participant is unable to provide consent themselves (e.g., minors, patients with severely impaired decision making capacity), the participant’s legally acceptable representative should provide their consent on behalf of the participant.
2.8.6 Before informed consent may be obtained, the investigator or investigator site staff delegated by the investigator, in accordance with the protocol and conditions of IRB/IEC favourable opinions/approvals, should provide the participant or the participant’s legally acceptable representative ample time unless justified (e.g., in an emergency situation) and opportunity to enquire about trial details and to decide whether or not to participate in the trial. Questions about the trial should be answered to the satisfaction of the participant or the participant’s legally acceptable representative.
2.8.7 Prior to trial participation, the informed consent form should be signed and dated by the participant or by the participant’s legally acceptable representative and, where appropriate, by an impartial witness and by the investigator or delegated investigator site staff who conducted the informed consent discussion. By signing the consent form, the investigator or delegated investigator site staff attests that the informed consent was freely given by the participant or the participant’s legally acceptable representative and the consent information was accurately explained to and apparently understood by the participant or the participant’s legally acceptable representative. The informed consent process may involve a physical or an electronic signature and date (see the glossary term “signature”).
2.8.8 In emergency situations, when prior consent of the participant is not possible, the consent of the participant’s legally acceptable representative, if present, should be requested. When prior consent of the participant is not possible and the participant’s legally acceptable representative is not available, enrolment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the participant’s rights, safety and well-being and to ensure compliance with applicable regulatory requirements. The participant or the participant’s legally acceptable representative should be informed about the trial as soon as possible, and consent as appropriate should be requested.
2.8.9 If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion. After the informed consent form and any other information is read and explained to the participant or the participant’s legally acceptable representative and they have orally consented to the participant’s trial participation and, if capable of doing so, have signed and dated the informed consent form, the witness should sign and date the consent form. By signing the consent form, the witness attests that the consent information was accurately explained to and apparently understood by the participant or the participant’s legally acceptable representative and that
informed consent was freely given by the participant or the participant’s legally acceptable representative.
2.8.10 The informed consent discussion and the informed consent materials to be provided to participants should explain the following as applicable:
(a) The purpose of the trial;
(b) That the trial involves research and summary of the experimental aspects of the trial;
(c) The trial’s investigational product(s) and the probability for random assignment to the investigational product, if applicable;
(d) The trial procedures to be followed including all invasive procedures;
(e) What is expected of the participants;
(f) The reasonably foreseeable risks or inconveniences to the participant and, when applicable, the participant’s partner, to an embryo, foetus or nursing infant;
(g) The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this;
(h) The alternative procedure(s) or course(s) of treatment that may be available to the participant and their important potential benefits and risks;
(i) The compensation and/or treatment available to the participant in the event of trial- related injury;
(j) Any anticipated prorated compensation to the participant for trial participation;
(k) Any anticipated expenses to the participant for trial participation;
(l) That the participant’s trial participation is voluntary, and the participant may decide to stop taking the investigational product or withdraw from the trial at any time, without penalty or loss of benefits to which the participant is otherwise entitled;
(m) The follow-up procedure for participants who stopped taking the investigational product, withdrew from the trial or were discontinued from the trial;
(n) The process by which the participant’s data will be handled, including in the event of the withdrawal or discontinuation of participation in accordance with applicable regulatory requirements;
(o) That by agreeing to participate in the trial, the participant or their legally acceptable representative allows direct access to source records, based on the understanding that the confidentiality of the participant’s medical record will be safeguarded. This access is limited for the purpose of reviewing trial activities and/or reviewing or verifying data and records by the regulatory authority(ies) and the sponsor’s representatives, for example, monitor(s) or auditor(s), and in accordance with applicable regulatory requirements, the IRB/IEC(s);
(p) That records identifying the participant will be kept confidential and, to the extent permitted by the applicable regulatory requirements, will not be made publicly available. If the trial results are published, the participant’s identity will remain confidential. The trial may be registered on publicly accessible and recognised databases, per applicable regulatory requirements;
(q) That the participant or the participant’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue trial participation;
(r) The person(s) to contact for further trial information and the trial participant’s rights, and whom to contact in the event of suspected trial-related injury;
(s) The foreseeable circumstances and/or reasons under which the participant’s trial participation may be terminated;
(t) The expected duration of the participant’s trial participation;
(u) The approximate number of participants involved in the trial;
(v) That trial results and information on the participant’s actual treatment, if appropriate, will be made available to them should they desire it when this information is available from the sponsor.
2.8.11 Prior to participation, the participant or the participant’s legally acceptable representative should receive a copy (paper or electronic) of the signed and dated informed consent form and any other informed consent materials provided, in accordance with applicable regulatory requirements. During trial participation, the participant or the participant’s legally acceptable representative should receive a copy of the consent form updates and any other updated informed consent materials provided.
2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of the consent process, and assent from the minor to enrol in the trial should be obtained as appropriate. A process for consent should be considered if, during the course of the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.
2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable representative, the participants should be informed about the trial in a manner that facilitates their understanding and, if capable, the participant should sign and date the informed consent form or assent form as appropriate.