White Paper

Planned Emergency Research and Exception from Informed Consent

While informed consent is imperative to ethical research, U.S. federal regulations permit institutional review boards (IRBs) to waive consent under specific conditions. Planned emergency research – often referred to as research involving an exception from informed consent (EFIC) – is one example.

This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies, including:

  • Defining planned emergency research
  • Regulatory criteria for IRB approval
  • Balancing therapeutic advances and public trust in research

Plus: The paper concludes with a bonus “Points to Consider” appendix, which suggests helpful questions for sponsors and IRBs to ask regarding EFIC research.

Download the white paper to learn more about planned emergency research and exception from informed consent

Who Should Watch?

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Time: 1 p.m. ET, 12 p.m. CT, 10 a.m. PT
Duration: 1 hour

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