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Keywords:

  • community consultation;
  • exception from informed consent;
  • waiver of informed consent

Abstract

Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its intent is to provide an additional patient safeguard in emergency research circumstances when prospective informed consent is not possible. Investigators have reported that community consultation may be the most difficult aspect in implementing research trials using a wavier of or exception from informed consent. This article presents a brief overview of the sparse literature available on the process of community consultation since the inception of the current emergency research regulations. To determine if the process is meeting its goals, more research will be required.