•Require community input and
commentary for the proposed research.
§Public disclosure
§Community consultation
•Eligible patients for this
study will require immediate resuscitation, since without intervention, patients in shock face imminent death.
•Traditional informed
consent is impossible because:
§Patients with severe traumatic injury are
unconscious, or in shock and not capable of providing consent.
§Resuscitation has to be started
immediately, and next of kin may not be immediately available, or are likely to be too
distraught to understand an explanation of the study.
EFIC Regulations