Acute Care Research

Acute Care Research is the best way to test promising new treatments for unexpected and sudden life-threatening situations.

Improving on standard treatments for life-threatening conditions is an ethical imperative. The use of a randomized clinical trial is the "gold standard" for determining what works best for people. Likewise, the “gold standard” for maintaining individual rights of citizens is to ask for informed consent from persons prior to participation in a clinical trial.

Informed Consent in Emergency Situations

In emergent medical situations, a participant or their representative may be unable to provide informed consent in the customary fashion prior to treatment. Some patients are too sick to consent to immediate treatment.

For example, in trauma or in cardiac arrest, participants will either be in a semi-conscious or unconscious state when they are enrolled in research studies. Life-supporting interventions must be given immediately in the field to save their life.

Therefore, some acute care research studies are conducted under federal regulations that allow an “exception from informed consent.” For treatments that must be given immediately to be effective, exception from informed consent research is considered appropriate by federal regulatory bodies and many ethicists who study this field. In exception from informed consent 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.

More Information

Code of Federal Regulations Title 21, Volume 1 Revised as of April 1, 2010 CITE: 21CFR50.24

Title 21: Food And Drugs Chapter I: Food And Drug Administration Department Of Health And Human Services Subchapter A: General Part 50: Protection Of Human Subjects Subpart B: Informed Consent of Human Subjects Sec. 50.24 Exception from informed consent requirements for emergency research.

Exception from Informed Consent for Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators