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.”
Exception from Informed Consent (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 the ACCESS Trial
The ACCESS Trial involves life-threatening situations with a possibility for direct benefit to participants, which is why the trial 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 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.
The ACCESS Trial is specifically targeting treatment of out-of-hospital cardiac arrest. Patients are only enrolled based on the emergent situation of cardiac arrest and identified through the resuscitation process. If 9-1-1 is called during this type of emergency, the potential for enrollment in the ACCESS Trial exists.
- Adults presumed or known to be 18-75 years old
- Adults resuscitated from out-of-hospital cardiac arrest (have a heart beat in the emergency department)
- Patients with initial cardiac arrest rhythm of pulseless ventricular tachycardia (VT) or ventricular fibrillation (VF)
- Patients with no ST-segment elevation myocardial infarction (N-STEMI) on ED 12-lead EKG as interpreted by a physician
Sites across the United States are in various stages of ACCESS Trial community awareness. Questions about state or community participation can be emailed to firstname.lastname@example.org. Indiana University School of Medicine is conducting community consultations/focus groups in preparation for notifying the public that enrollment for the trial is active.
There are two methods for opting out of ACCESS Trial participation. If a qualifying individual does not participate in the ACCESS Trial, (s)he receives the standard medical treatment provided for resuscitated cardiac arrest patients at the hospital.