Opinion 8.085 - Waiver of Informed Consent for Research in Emergency Situations
The current state of emergency medicine and research has resulted in the application of standard treatments that often have not been scientifically evaluated for safety and effectiveness and may render unsatisfactory outcomes. Given the insufficiency of standard treatment alternatives, it is appropriate, in certain situations and with special safeguards, to provide experimental treatments without obtaining the informed consent of the subject. However, in order to protect the rights and welfare of the subjects, several conditions must be met:
(1) This type of research is limited to emergency, life-threatening situations, and may involve only experimental treatments that are ready for trials involving human subjects.
(2) The subject must lack the capacity to give informed consent for participation in the research.
(3) The window of opportunity for intervention must be so narrow as to make obtaining surrogate consent unfeasible.
(4) Obtaining prospective informed consent for the protocol must not be feasible (ie, the life threatening emergency situation could not have been anticipated).
(5) The experimental treatment must have a realistic probability of benefit equal to or greater than standard care.
(6) The risks associated with the research should be reasonable in light of the critical nature of the conditions and the risks associated with standard treatment.
(7) Where informed consent is waived, subjects or their representatives must be informed as soon as possible about inclusion in the study and asked to consent to further participation. Subjects, or their representatives, may choose to discontinue participation at any time after being fully informed about the possible consequences. Additionally, if the patient dies while participating in the research protocol, the patient’s family or representative must be informed that the patient was involved in an experimental protocol.
(8) Community input should be sought prior to approval of the protocol, and public disclosure should be made of study results. Fair randomization of research subjects should be given thorough consideration. Moreover, an independent data monitoring board should be established to oversee the ongoing trial. (I, V)