Table 1

Regulations governing EFIC Studies

Criteria	United States 21 CFR 50.24 (1996)4	Canada TCPS2 (2014)7 Chapter 3
Terminology	Exception from informed consent (EFIC)	Exception from consent
Medical condition	Life threatening	Serious compromise to health
Capacity	Lacking	Lacking
Risk	Reasonable to what is known about the underlying medical condition of the class of subjects, the risks and benefits of standard therapy and what is known of the intervention itself	Not greater than standard care or clearly justified by the benefit
Standard of care	Available treatment unproven or unsatisfactory In need of evidence to determine safety and efficacy	No standard efficacious care exists
Intervention	Hold prospect of direct benefit to subject Study cannot be carried out without waiver	Must address needs of the patient Must offer realistic potential for direct benefit over standard of care
Surrogate decision maker	Timing prevents surrogate consent Must indicate therapeutic window for intervention Outline plan to contact SDM	Document all attempts to contact SDM
Pre-clinical trial data	Animal and other pre clinical data has been considered and completed
Advance Directives		No prior directives
Prospective consent	Cannot be determined ahead of time	Cannot be determined ahead of time
Public Disclosure	Required dissemination of information to communities, and the public prior to initiation of the study
Community Consultation	Consultation with representatives from community where the research is conducted and from the population of potential subjects	If feasible and appropriate, consultation with former or prospective patients and additional expert review
Misc. Requirements	Public disclosure prior to and after trial Provide IRB details at each continuing review Show requirements for informing participants and SDM Keeping related records for 3 years Allowance of refusal from any family member