Table 1

Regulations governing EFIC Studies

CriteriaUnited States
21 CFR 50.24 (1996)4
TCPS2 (2014)7 Chapter 3
  • Exception from informed consent (EFIC)

  • Exception from consent

Medical condition
  • Life threatening

  • Serious compromise to health

  • Lacking

  • Lacking

  • 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

  • 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