What is EFIC?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception From Informed Consent” (EFIC), for clinical research trials that apply to critically ill patients who require emergent therapy when prospective informed consent is not possible or may put the patient at risk for increased harm by delaying potentially life-saving therapies. Under some circumstances, there may not be time to seek prospective informed consent from every eligible patient and, in some cases, discussing a possible option to enroll in a research study may itself cause dangerous delays in a person’s care. Nonetheless, many critically ill patients could benefit from enrollment into an appropriate clinical research trial. Therefore, to ensure that clinical research trials can be conducted for patients in emergency situations, the FDA established rules for EFIC that require special safeguards to ensure that most people would consider the research study to be ethical and appropriate. These special rules allow research studies in certain emergency situations to be conducted without prospective informed consent.
EFIC can only be used when the person’s life is at risk, the best treatment is not known, the research study might help the person, it is not possible to get permission from the person because of his or her medical condition nor from the person’s guardian because there is a very short amount of time required to treat the medical problem. Before researchers can start a research study using EFIC, they must provide information about the research study to the community and get their feedback.
In preparation for this research trial, we completed a rigorous process of discussing this research study with providers and also a group of 28 parents of patients and one adult patient with congenital heart disease – many of whom had experience with ECPR – to get their input on the research study. From these meetings, we learned the following:
- All participants agreed that cardiac arrest treated with ECPR is a very important problem, and that outcomes from the current standard of care are very poor.
- Based on the information available, participants felt that hydrogen is safe and that the benefits of enrolling in the research study outweighed the risks.
- No participants felt that they would opt-out of the research study.
- The majority of participants expressed that we should not try to approach family members with an opportunity to object during the ECPR event itself for a number of reasons, including not wanting to distract the clinical team from the resuscitation effort and allowing parents time to process the very challenging clinical situation. Therefore, we will only provide an opportunity to object prior to enrollment in very rare instances.