During life-threatening emergencies, it may not be possible for you to provide consent to participate in research. Given the nature of emergencies, some treatments must begin very quickly, and there may not be time to contact a family member to ask for permission. The Food and Drug Administration has special rules for these situations that allow patients to be treated in research studies using a process called Exception From Informed Consent for Emergency Research (EFIC).
EFIC studies are special and rare. An extensive vetting and community consultation process takes place before any study is approved to enroll patients without their consent. EFIC can only be used when all of the following criteria are met:
- There is the possibility of direct patient benefit
- There is a life-threatening emergency when treatment decisions cannot be delayed
- There is no reasonable way to identify the people who are likely to become eligible for participation in a study (for example: accident victims)
- Getting consent is not possible from you or a family member
- When doctors don’t know if existing treatments work or when they know they won’t work well enough
- The risks are reasonable in relation to what is known about your medical condition, any risks and benefits of standard therapy, and risks and benefits of study treatment
You and/or your family members will always be told about participation and given information about a study as soon as possible. You’ll also be asked if you want to continue participating in a study.