Because treating a child who has a life-threatening injury must be done immediately, there will not be time to ask parents/guardians for permission. Parents/guardians will be notified after their child is included in the study.
Trauma and acute care research is sometimes conducted under Exception from Informed Consent (EFIC) regulations. In many life-threatening illnesses, children are too sick to allow time for their families to provide written or verbal informed consent; they need treatment right away. The federal EFIC rules were developed in 1996 to allow for the waiver of obtaining and documenting informed consent for a strictly limited class of research.
Research carried out under EFIC rules undergoes extremely high levels of regulation by multiple agencies to be sure that research subjects are afforded every protection available under the law. Research conducted under EFIC rules could not otherwise be conducted because of the life-threatening nature of illness or injury. Research carried out under EFIC must hold the promise of a new treatment that is at least equal to or better than what is currently available.
According to FDA regulations, to qualify for EFIC, the research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate. In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient. Studies must be held to the highest ethical standards.
The use of a randomized clinical trial such as this is the “gold standard” for determining what treatments work best for people. For treatments that must be given immediately to be effective, EFIC research is considered appropriate by federal regulatory bodies and many ethicists who study this field. The obligation to improve standard treatments that yield poor results in life-threatening conditions is also considered an ethical imperative, as is maintaining individual rights of citizens. In EFIC trials, citizens receive standard treatment in addition to research treatment. To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies.
Before any EFIC trials are started, the US government requires that participating institutions conduct a process of “Community Consultation and Public Disclosure.” During this process, the study is advertised in communities where the research will take place. Community members are invited to give their own thoughts and comments about the proposed study. The results of these interactions are reported to the Institutional Review Board (IRB) monitoring the research.
Additional information is available at the EFIC website of the U.S. Food and Drug Administration and the Code of Federal Regulations.
