Exception from Informed Consent (EFIC) for Planned Emergency Research

Planned emergency research is a type of research that is conducted in an emergency, life-threatening setting "where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each participant's legally authorized representative" FDA Guidance, 2013. 

Important: Planned emergency research is not the same as a one-time emergency use of a test article. Planned emergency research involves the prospective identification and enrollment of participants into a study. Emergency use of an investigational drug or device involves treating a patient with the investigational product outside of a research setting. See HRPP SOP 502G: Emergency Use of a FDA-Regulated Product for more information about one-time emergency use.

EFIC for planned emergency research studies require additional safeguards and significant preparation by investigators due to the vulnerable nature of the participant population, and the likelihood this research will be conducted without obtaining informed consent. The IRB will review all planned emergency research studies to ensure all regulatory requirements are met for research involving human participants as well as the requirements for EFIC.

Submission packets must include all study documents as required for any human research study as well as the following attachments for EFIC:

1. EFIC Sub-Application
2. Community Consultation & Public Disclosure (CCPD) Plan
3. Community Consultation Materials
4. Pre-Study Public Dislosure Materials

New EFIC studies will undergo multiple cycles of IRB review before final IRB approval of the study is granted. Review the EFIC Submission Process Guidance for more information.

FDA regulations for planned emergency research requesting an EFIC requires a lot of preparation by investigators, and it also requires that the IRB find and document many criteria before final approval. Investigators are strongly encouraged to read through all of the requirements before preparing and submitting an EFIC study to the IRB.

FDA regulations also have additional safeguards in place due to the vulnerable nature of the participant population. The additional safeguards include:

• Community consultation (CC) with representatives of the community where participants will be drawn;
• Public disclosure (PD) to the communities prior to the initiation of the research to disclose plans for the research, the risks, and expected benefits;
• PD plans for the conclusion of the study to share with the community the demographic characteristics and results;
• Establishing an independent data safety monitoring committee; and
• Committing to attempt to contact a family member of the participant, when the LAR is not readily available, to obtain consent within the therapeutic window.

Investigators will be required to develop a Community Consultation and Public Disclosure (CCPD) Plan and submit the plan to the IRB with their initial submission packet in iRIS. Please refer to the CCPD guidance document for more information.