Acute care research is sometimes conducted under Exception from Informed Consent (EFIC) regulations. In many life-threatening illnesses, patients are unconscious or too sick to provide written or verbal informed consent. The federal EFIC rules were developed in 1996 to allow for the waiver of obtaining and documenting informed consent for a strictly limited class of research.

Research carried out under EFIC rules undergoes extremely high levels of scrutiny by multiple agencies to assure that research subjects are afforded every protection available under the law. Research conducted under EFIC rules encompasses research that could not otherwise be conducted because of the nature of illness or injury. Research carried out under EFIC must hold the promise of a new treatment that is better than what is currently available.

Before any EFIC trials are started, the US government requires that participating institutions conduct a process of “community consultation and public disclosure.” During this process, the study is advertised in communities where the research will take place. Community members are invited to give their own thoughts and comments about the proposed study. The results of these interactions are reported to the Institutional Review Boards (IRBs) or committees monitoring the research.

Additional information is available at the EFIC website of the US Food and Drug Administration (FDA) and the Code of Federal Regulations.