In 1996, the FDA developed specific regulations to permit research without prospective consent under carefully controlled circumstances. This is in recognition of the unique nature of emergency medical situations in which patients or family members cannot give informed consent before treatment as well as the need to allow emergency care to advance through research. According to FDA regulations, to qualify for an exception from informed consent:
- 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.
- Furthermore, studies must be held to the highest ethical standards. These clinical trials undergo multiple independent rigorous reviews to ensure that they meet these standards.
- Before any patients are enrolled, communities are consulted about participation and made aware that informed consent will not be obtained for most study participants, as required by law.
- Surviving patients and/or their authorized representatives need to be informed about the trial as soon as feasible after the intervention has been given.
Updated Guidance from the FDA. May 2013
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
Food And Drug Administration Department Of Health And Human Services. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. Exception from Informed Consent Requirements for Emergency Research. Update (April 2013)