What is Exception From Informed Consent (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 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 study may itself cause dangerous delays in a person’s care. Nonetheless, many critically ill patients could benefit from enrollment into an appropriate clinical trial. Therefore, to ensure that clinical 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 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, 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 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 study using EFIC, they must provide information about the study to the community and get their feedback. We will be surveying patients and families at CHOP and asking for volunteers to participate in focus groups so that we may better understand how people view the use of EFIC for the PRoMPT BOLUS clinical trial.
If you would like to volunteer to participate in one of our planned focus groups, please click here.
If you would like to fill out a short on-line survey, please click here.