In emergency situations when receiving permission ahead of time is not possible, researchers use a process called Exception from Informed Consent, or EFIC for short. The informed 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.
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, and so 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.
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 is better.
- The researchers must believe that the treatment being studied might give a real and direct benefit to the patient.
- Proof about whether a treatment is safe and effective is needed.
- The patient’s current medical condition makes it impossible to obtain informed consent.
- The treatment has to be started before the patient can consent.
- It is impossible to know ahead of time who will need treatment.
How is the public informed?
Before anyone is enrolled in the study, the public in areas where the study will take place must be told about the study and be asked for their opinions about the study and about emergency research. This can be done in many different ways, including using advertisements, surveys, fliers, and in-person meetings.
These communications inform the public that informed consent will not be obtained for most individuals participating in the study. People must also be informed about how to opt out of potentially being in the study.
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 a life-threatening situation is often unable to take part in this consent process. For example, they might be in a coma or feeling extreme pain and cannot 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.
Who decides when a study can be done with EFIC?
EFIC Studies are held to the highest ethical standards. These studies are reviewed multiple times by independent groups of experts, such as government agencies like the FDA and hospital oversight boards (IRBs) to make sure they meet the requirements.
What happens after the emergency is over?
Normally, the patient is still too sick to consent, so the study team will try to find a family member to talk to. Once the patient’s family member is located and is given information about the research, he or she will be asked to give permission for the research to continue.
If and when the participant is able to give informed consent, he or she will be asked to give permission to continue in the study.