White Paper
Planned Emergency Research and Exception from Informed Consent
U.S. regulations permit institutional review boards (IRBs) to waive consent under specific conditions. One of these conditions is planned emergency research – often referred to as research involving an exception from informed consent (EFIC).
Developed to assist those planning, designing, conducting, or reviewing EFIC studies, this white paper explores:
- Regulatory criteria for IRB approval
- How to meet community consultation and public disclosure requirements
- The inherent controversial nature of these studies
- Questions sponsors and IRBs should ask about EFIC research