Substitute statement of consent and Deferred Informed Consent in emergency clinical trials

Emergency clinical trials are situations in which it is necessary to recruit subjects even when the time window for the first study treatment does not allow obtaining prior informed consent. In this article, through a review of the main international documents and guidelines that regulate access to this practice, we identify the conditions of possibility for the investigator to recruit patients in an emergency. Useful tools to be submitted to the Territorial Ethics Committee are also presented, developed on the basis of current guidelines: the Substitute Statement of Consent (for the inclusion of subjects in emergency situations, where there is no possibility of previously administering informed consent) and the Deferred Informed Consent (to be administered to the patient or legal guardian/administrator following the first study treatment once the patient has recovered the capacity to consent or the legal representative has been located). Emergency trials are not only desirable, but necessary in various intervention situations. The benefit of this procedure is not to be considered only for the scientific community, but first of all for the patient, through a balanced risk-benefit assessment. Overcoming the impasse due to the conflict of values at stake (autonomy, good for the patient, scientific progress, good for the community) requires practical operational guidelines. This article aims to provide such tools, not to implement the bureaucratic mass of each experiment, but to facilitate, through accessible models, the best dialogue between researchers and the bodies responsible for protecting the rights of research participants.