Table 1

Overview of consent models discussed in this manuscript

Consent modelDescriptionRationale/enablersConsiderations
Prospective informed consentInformed consent for participation in research is a key principle of good clinical practice. A potential participant (or parent/legal representative of a child) must be adequately informed about the research and their consent sought prior to their participation.Prospective informed consent helps protect an individual’s right to make an informed, uncoerced decision about their participation in research.Informed consent is not feasible or appropriate in certain situations, including emergencies. Without alternatives to informed consent, emergency research could not be conducted and critically ill patients would not benefit from evidence- based healthcare.
Research without prior consentThe research activity is performed, and data are collected without prospective informed consent from the participant. Consent is sought to continue in the study at the earliest appropriate time (eg, when the emergency situation has passed).Enables the conduct of vital research in emergency situations.Restricted to research, including drug trials in emergency situations where: the treatment is required urgently, it is not reasonably practicable to obtain consent prospectively, and ethics committee approval has been given.
Opt-out consentResearch activity is performed and data are collected. Informed consent is not sought, but study information is provided including how participants can opt-out (eg, decline to have their data included in the study).Used in certain types of low risk studies, such epidemiological studies that do not involve additional procedures or change to clinical care.Studies using opt-out only have to provide clear justification to an ethics committee. Opt-out is not suitable for studies such as drug trials or research involving additional interventions or changes to clinical care.