Damage Control Laparotomy (DCL) Trial

Questions?

Email: dcltrial@uth.tmc.edu

Exception from Informed Consent

Since the vast majority of patients requiring an emergent intervention following trauma are unable to provide informed consent, the Food and Drug Administration allows for the use of Exception from Informed Consent (EFIC).  In order to qualify for an EFIC:

  • The study must involve participants suffering from a life-threatening injury
  • Available treatments must be unproven or unsatisfactory
  • Collection of scientific evidence is necessary to determine the safety and effectiveness of the intervention
  • Obtaining informed consent must not be feasible as a result of their medical condition
  • The intervention must be administered before consent can be obtained
  • There is no reasonable way to identify prospectively individuals likely to become eligible for participation
  • Participation in the research holds out the prospect of benefit to the subjects
  • The study could not be carried out without the waiver.

Additional information regarding EFIC can be obtained on the U.S. Food and Drug Administration website.

Research being performed with an EFIC waiver is highly regulated.  The proposal is first critically appraised by another, uninvolved physician with expertise in the field of study.  The proposal is then thoroughly reviewed by the Committee for the Protection of Human Subjects (CPHS) at the institution proposing the trial.  The Principal Investigator must then lead a process called “community consultation.”  During community consultation, the study is advertised in the region in which it will take place with a request for feedback and comments.  The Principal Investigator also meets with community organizations to describe the proposed study and seek in-person feedback.  These meetings and public announcements are then reported to the CPHS.