Waiving informed consent

The Federal Drug Administration (FDA) has strict guidelines about recruiting participants in medical studies. Subjects must be able to fully consent to the procedures being evaluated. This is all well and good, but what about procedures specifically geared to helping people who have suffered some life-threatening trauma? Such individuals are often in no condition to consent even if doctors had the time to wait for such approval before acting. Yet, without clinical trials, it’s difficult for medical professionals to learn and improve their treatment methods.

Because of this, in 1996, the FDA established an Exception from Informed Consent (EFIC) policy. If an incapacitated patient meets specific criteria (his condition is immediately life-threatening and may benefit from the proposed treatment), doctors can enroll him in a clinical trial without his or his family’s consent. Carrie Sims of the University of Pennsylvania and her colleagues wondered what people think about this.

The researchers queried 172 trauma patients and their family members just prior to discharge from a hospital about their attitudes concerning the EFIC policy. In particular, the subjects were asked whether they would have been willing to participate in trials using a blood substitute if they had suffered extreme blood loss. Well over 90% of participants, both patients and family members, agreed that general research into handling trauma was critical. The same number thought that tests of the specific blood products mentioned should be done. Two thirds of people thought it would have been acceptable to enroll a family member in such studies without anyone having given consent. That number increased to three quarters for enrolling themselves.

Clearly, people see a need for clinical research and understand that such research is especially important for treating people who are on the verge of death. On the other hand, informed consent guidelines exist for a reason, not least to prevent unethical experimentation on vulnerable people. The EIFC policy may be a way to achieve the goal of testing emergency procedures while still adhering to specific codes of conduct.


Sims CA, Isserman JA, Holena D, Sundaram LM, Tolstoy N, Greer S, Sonnad S, Pascual J, & Reilly P (2013). Exception from informed consent for emergency research: Consulting the trauma community. The journal of trauma and acute care surgery, 74 (1), 157-66 PMID: 23271091.