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
  

Download the white paper to learn more.