Exception from Informed Consent Information
What is EFIC?
Since unconscious emergency patients cannot tell us whether they do or do not want to participate in a research study, they cannot provide or refuse to give informed consent (permission). The Food and Drug Administration (FDA) developed special rules (FDA 50.24) that allow patients to be treated as part of research studies using an exception from informed consent for emergency research (EFIC).
These studies are special and rare. EFIC can only be used in life-threatening emergencies, when there is a possibility for direct benefit to participants, and when consent is not possible. It can only be done when we do not know if existing treatments work at all, or when we know they do not work well enough.
Patients and/or their legally authorized representatives (ex. spouse, parent, legal guardian) are always told about their participation and given information about the study as soon as possible after the treatment is given. They are also asked if they want to continue participating in the study.
How do participating communities learn about EFIC studies?
These studies are very public and transparent. The research is discussed in the community (including potential study participants and their family members) and is advertised. Some examples of this are meetings with community leadership, targeted groups, or the general public. The research team attends these meetings and provides information about the research study, asks for the group's feedback, and addresses the group's questions and concerns. The public is also notified about the research study by providing study information on TV, radio, cable access shows, newspapers, billboards, bus displays, websites, and email. Some communities will also participate in a telephone survey to get feedback about the study. There is often a toll-free number that people can call to ask questions about the study and/or express their thoughts and concerns.
How are participants protected in EFIC studies?
There are many protections and rules to make sure the research studies are done in a proper and safe manner. Institutional Review Boards (IRBs) are committees of doctors, researchers, ethicists, lawyers, and members of the general public that are committed to protecting the safety of patients participating in research. IRBs work to make sure that studies are appropriate and comply with research rules before they can start. IRBs also monitor research studies while patients are being treated. They watch for unexpected side effects, and make sure patients are being treated correctly and safely. The IRB reviews every study yearly to make sure it can continue. At the Federal level, oversight of large research studies may involve several agencies including the National Institutes of Health (NIH), the FDA, and the Office of Human Research Protections.
Data Safety and Monitoring Boards (also known as Data Monitoring Committees) are an independent group of researchers and doctors that meet regularly and look at information about every patient in the study, the treatment they received, and how they received it, so that the study can be stopped early if patients getting one treatment are doing better than those getting the other, or if there are unexpected bad side effects.