Emergency Research

In emergency situations when getting permission before study enrollment is not possible, researchers use a process called Exception from Informed Consent, or EFIC for short. The information below explains how EFIC works. You can also click on the links at the end to read more information about current LITES projects that are using EFIC.

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What is EFIC?

Normally, researchers get permission (consent) before a person can be enrolled in a study. But sometimes research involves people who are not able to give consent at the time of enrollment. Because an emergency medical situation—such as major trauma—must be treated right away, there is no time to get permission.

It is important to learn about the best way to treat people under these circumstances, so in 1996 the Food and Drug Administration developed special rules that describe when and how to do research in emergency situations. These rules are written in the Code of Federal Regulations in section 21 CFR 50.24. Since the regulations were published, the FDA has approved more than 40 studies enrolling over 45,000 patients in EFIC studies across the country

What specific conditions qualify research as EFIC?

    • The research must involve patients suffering from a life-threatening injury.
    • The usual treatments for the injury don’t exist, aren’t good enough, or there is uncertainty about which treatment is best.
    • The researchers and regulators must believe that the treatment being studied might help the patient.
    • The patient’s medical condition makes it impossible to obtain informed consent.
    • The treatment must be started before the patient can consent.
    • It is impossible to know ahead of time who will need treatment.

How are EFIC studies regulated?

​It is important to learn about the best way to treat people under these circumstances, so in 1996 the Food and Drug Administration (FDA) developed special rules that describe when and how to do research in emergency situations. These rules are written in the Code of Federal Regulations in section 21 CFR 50.24. 

There are multiple levels of regulation for Exception from Informed Consent (EFIC) studies to protect patients. Each study conducted under EFIC must be reviewed by FDA to ensure that it meets the specific conditions required for EFIC and to monitor patient safety. Each EFIC study is also reviewed by an oversight board called an Institutional Review Board (IRB), whose primary purpose is to protect the rights and welfare of human subjects involved in research. Last, LITES studies are funded by the Department of Defense (DoD), so they are also reviewed by DoD’s Office of Human Research Oversight, which also monitors EFIC studies to protect enrolled patients.

How is the public informed about EFIC studies?

Before anyone is enrolled in the study, people in areas where the study will take place must be told about the study and asked for their opinions about it. Community members will be told that informed consent will not be obtained before enrollment for most people in the study. They will also be told how they can opt out of potentially being in the study.

This process is called Community Consultation and Public Disclosure. This can be done in many different ways, including using advertisements, surveys, fliers, and in-person meetings and conversations. Community Consultation and Public Disclosure must be done in every area the study will be enrolling. It is impossible to inform every member of the community about EFIC studies, but the Community Consultation and Public Disclosure process is designed to consult a representative sample of the community.

Information about the study, like where the study will be conducted and whether the study is currently enrolling patients, is also available to the public throughout the study on the clinicaltrials.gov website.

Why can’t patients in emergency situations provide informed consent?

Giving consent for medical research usually involves reading documents, talking with doctors and nurses, and having time to think about whether to participate. Someone in an emergency situation is usually unable to take part in this consent process. For example, they might be in a coma or in extreme pain, making it impossible to make an informed decision.

Sometimes it is possible to contact the patient’s family to discuss consent. However, in the emergency situations where LITES research will be done, the family is often not available or cannot be found before treatment must be given.

Why can’t we have a central database of people who do not want to be in an EFIC study?

Trauma patients with severe injuries need to be treated quickly. Prehospital and emergency healthcare providers need to prioritize patient care and cannot spend time searching a database for patients who do not want to be enrolled in EFIC studies. Additionally, not all patients in emergency situations can be identified quickly and accurately.

What happens after the emergency is over?

Often, the patient is still too sick to consent, so the research team will try to find a family member to talk to about the study. Once the patient’s family member is located and is given information about the research, he or she will be asked if they want to give permission for the research to continue.

If and when the participant is able to give informed consent, the research team will also talk to him or her about the study. After the patient is informed about the study, they will also be asked if they want to continue in the study.

Who decides when a study can be done with EFIC?

EFIC Studies are held to the highest ethical standards and undergo multiple reviews by independent groups of experts before they begin. Each study conducted under EFIC must be reviewed by FDA to ensure that it meets the specific conditions required for EFIC. In addition, each study is reviewed by an oversight board called an Institutional Review Board (IRB), whose primary purpose is to protect the rights and welfare of human subjects involved in research. Because LITES studies are funded by the Department of Defense (DoD), they are also reviewed by DoD’s Office of Human Research Oversight.

Who is enrolled in EFIC studies - only people who live in the area where the study is being conducted, or any person who is temporarily in the area?

For LITES EFIC studies, anyone who is injured and who meets all the criteria for the study may be enrolled in an EFIC study, whether or not they permanently live in the area.

Please note, the federal government has careful regulations about granting an EFIC for emergency research, and this study has undergone rigorous review and approvals prior to starting.

Do you expect there to be future studies that are conducted without the need for patient consent?

Yes, EFIC trials are the only way to study how to treat patients with emergency conditions who cannot provide consent before treatment.

Is it common for studies to receive Exception from Informed Consent?

Many studies have used and continue to use Emergency Exception from Informed Consent. Such studies are permitted under a rule issued by the Department of Health and Human Services in 1996, which recognized that these types of studies are one of the only ways to improve care for patients with emergency conditions. For example, these studies have been instrumental in improving the way we perform CPR and treat patients with massive bleeding or strokes.

Which LITES studies are using EFIC?

The LITES research project(s) using EFIC are listed below. Please click on the link(s) for more information.

    • Prehospital Airway Control Trial (PACT)
    • Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS)
    • Cold Stored Platelet Early Intervention in Traumatic Brain Injury (CriSP-TBI)
    • Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR)
    • Prehospital Analgesia Intervention (PAIN)
    • Calcium and Vasopressin following Injury Early Resuscitation (CAVALIER)