Exception from Informed Consent Research

What is Exception from Informed Consent Research? (EFIC)

(21 CFR 50.24)

To conduct a clinical trial to inform best practices in an emergency, researchers use a set of federal regulations, commonly known as “EFIC.”

EFIC regulations allow research to begin BEFORE asking the patient or their family for consent.
Consent is the process researchers use to ask patients (usually, sometimes their family) if they would like to participate in a research study.
Patients who are having a life-threatening medical emergency (like a heart attack) can be enrolled in a study when researchers aren’t sure what the best practice is to treat the emergency.
There has to be good EVIDENCE the treatment might HELP the patient having a medical emergency.

Exception from informed consent research only allows researchers to begin a study without receiving your or your loved one's permission/consent. As soon as there is time to meet with you or your loved ones, the research team will ask for permission to continue the research.

In this video, Dr. David Wright discusses the different kinds of consent, and a previously completed trial, PROTECT III, where EFIC was used. While this video specifically discusses a trial researching a traumatic brain injury treatment; EFIC may be used for other emergency conditions, such as seizures, cardiac arrests, or other conditions where treatments/care must be given very quickly and there is not time to have a meaningful conversation with the family or patient prior to the treatment being done.

What should I expect if I or my family/friend is enrolled in an EFIC study?

If you or your loved one is enrolled in an EFIC trial you will be notified by the team of researchers or care providers involved with the study as soon as possible.

A member of the research team will:

Tell you what the study is about.
Tell you what has happened in the study so far.
Tell you what else will happen moving forward if the study continues.
Discuss the potential risks and benefits of the study.
Ask for permission from you or your family member to continue with the study.
- If you or your loved one agrees to continue with the study then the study will continue from that point forward.
- If you or your loved one does not want to participate in the study, then the study will stop at that point and no additional study-related procedures will be performed and any data collection will stop.

Finally, participation in research is always voluntary. In EFIC studies, once the study team approaches you or your loved one to request your permission to continue with the study, it is your choice if you continue or decide you no longer want to participate. The clinical care you or your loved one is receiving will NEVER be affected by their decision to continue a study or not.

Why do you ask my loved one and not me for permission sometimes?

Sometimes when you are having a medical emergency, or have been injured, you are not able to give permission/consent yourself. This could happen if you are unconscious due to your medical emergency or injury; or if you were awake but not able to make decisions. For example, this could happen if you were in a car crash and injured your brain, or if you had a seizure and were not yet awake enough to answer questions or follow along in a conversation.

In the case where you are not able to make decisions for yourself, we will ask your legally authorized representative. This is usually your family member (spouse, parent, sibling or child) but it could also be a close friend you have requested be your medical decision-maker (typically this is done through legal paperwork such as by filing a medical power of attorney.) As the family member of someone who cannot make their own decisions during an emergency, we ask you to consider what your loved one would be willing to be involved in the study if they were able to make the decision themselves. This can be a hard decision to make. The research team will try to give you as much time to make the decision as we are able to.

Regardless of who is making the decision about whether to continue with the research study, be sure to ask any questions you may have! It is important that you understand the study before you agree to participate or continue participation. Having a medical emergency or injury is a stressful situation, and it is OK to ask as many questions as you might have.