Surrogate informed consent

Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 

For example, patients with acute head injury and a low Glasgow Coma Score have a dismal prognosis, and therapeutic interventions (if ever likely to be successful) must be instituted quickly. Under these conditions, there is often not even the time to find relatives to provide surrogate informed consent. Even if relatives can be found quickly enough, then their emotional state may not be suited to becoming truly informed before giving consent. 

Ask each patient or legal surrogate to recount what he or she has been told during the informed consent discussion. 

Execute the informed consent procedure and place in chart Document name and signature of the person who explained the procedure Provide informed consent forms written at a fourth-grade reading level Provide consent in primary language of patient (use interpreter if needed) Ensure the patient/legal surrogate recounts the information presented... 

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