Exception from Informed Consent (EFIC)
Participation in clinical trials is voluntary, and individuals receive information prior to agreeing to take part in a clinical trial. However, emergency clinical research is different. When serious medical conditions result in an unconscious patient, that patient cannot give informed consent or refuse to participate in a trial. That’s why in specific and rare situations, clinical trials are allowed to enroll and treat patients as part of a research trial using an exception from informed consent for emergency research, also known as “EFIC.”
The U.S. Department of Health and Human Services is a federal agency that oversees human research protection. The department has created a set of special rules, called “Waiver/Exception from Informed Consent,” or EFIC. These special rules allow research trials in certain emergency situations to be conducted without consent.
EFIC can only be used when:
- The person’s life is at risk, AND,
- The best treatment is not known, AND
- The study might help the person, AND
- It is not possible to get permission from the person because of his or her medical condition OR from the person’s guardian because there is a very short amount of time required to treat the medical problem.
Before researchers may conduct a trial using EFIC, they must provide information about the trial to the community and get their feedback.
Application of EFIC on Emergency Medicine Trials
Emergency medicine trials involve life-threatening situations with a possibility for direct benefit to participants, which is why these types of trials can utilize EFIC when consent is not possible. Because of the short treatment window, providers need to act within the first 45 minutes following emergency department arrival.
Study coordinators will try to get in-person contact with a legally authorized representative (LAR) and have a formal informed consent discussion. If that is not possible, coordinators will try telephone contact with the patient’s family to ask whether the patient is known to have any objections to enrollment in any research. If they are unable to reach the patient’s LAR within the first 45 minutes, the patient will be treated in the trial under EFIC. The patient and/or their LAR will always be informed as soon as possible after the treatment has been started.
There are two methods for opting out of participation. If a qualifying individual does not wish to participate in an exception from informed consent trial, (s)he receives the standard medical treatment provided for resuscitated cardiac arrest patients at the hospital.
Adults can opt-out of trial participation through a MedicAlert membership. With an existing MedicAlert tag or bracelet, individuals can add the trial they wish to decline to it. With a MedicAlert membership, individuals can add the trial they wish to decline to their Emergency Medical Information Record. Information about existing MedicAlert services and new memberships are available on the MedicAlert website.
People who do not want to be enrolled in the trial can request an Opt Out bracelet that specifies which trials they are declining participation in. Individuals must wear this bracelet at all times during the trial period (approximately four years); otherwise (s)he may be enrolled. Individuals interested in obtaining this bracelet can email name and address to email@example.com.