Have you ever wondered how researchers are able to conduct prospective studies on truly emergent conditions, such as cardiac arrest and status epilepticus? How can they obtain informed consent? In this Research Learning Series podcast episode from SAEM, Dr. Jill Baren (University of Pennsylvania) shares stories, pearls, and roadblocks in her career, conducting emergency research under the Exception From Informed Consent (EFIC) regulations. As an established researcher in this area,1–9 Dr. Baren shares advice and stories which include reaching to the community, getting angry hot-line comments, and getting push-back from the U.S. Food and Drug Administration.
Background: Exception From Informed Consent (EFIC)
Working with one’s Institutional Review Board for an EFIC exemption requires demonstrating a significant, multi-pronged outreach effort to educate and dialogue with the community about the proposed emergency research to get buy-in and acceptance. It allows individuals to give feedback and potentially opt-out of being enrolled even before they are ill or injured.
Take Home Points
- EFIC research is a team sport. Any clinical trial that will be conducted under EFIC is usually logistically complicated. It is best to organize a leadership team with scientific and human subjects co-principal investigators.
- Get early buy-in from the IRB for approval. As an EFIC investigator, that may mean proactively guiding the IRB throughout the process. You can use any of the references cited below to bolster your proposal.
- Be bravehearted. Be aware that there are ethicists and others who believe that the EFIC regulations are unethical and that research should not take place without traditional, prospective informed consent. These people will challenge you and you can find yourself in the midst of controversy that your institution may not want to be a part of due to legal and publicity risk. This is a delicate matter and not for the faint-hearted researcher. When done right, however, the end-results can be very fulfilling.
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1.Stanley R, Johnson M, Vance C, et al. Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study. Acad Emerg Med. 2017;24(1):31-39. https://www.ncbi.nlm.nih.gov/pubmed/27618167.
2.Baren J, Biros M. The research on community consultation: an annotated bibliography. Acad Emerg Med. 2007;14(4):346-352. https://www.ncbi.nlm.nih.gov/pubmed/17400998.
3.Baren J, Fish S. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med. 2005;12(11):1071-1077. https://www.ncbi.nlm.nih.gov/pubmed/16264077.
4.Chamberlain J, Lillis K, Vance C, et al. Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups. Acad Emerg Med. 2009;16(8):763-770. https://www.ncbi.nlm.nih.gov/pubmed/19673713.
5.Dickert N, Scicluna V, Baren J, et al. Patients’ perspectives of enrollment in research without consent: the patients’ experiences in emergency research-progesterone for the treatment of traumatic brain injury study. Crit Care Med. 2015;43(3):603-612. https://www.ncbi.nlm.nih.gov/pubmed/25574795.
6.Silbergleit R, Biros M, Harney D, Dickert N, Baren J, NETT I. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med. 2012;19(4):448-454. https://www.ncbi.nlm.nih.gov/pubmed/22506949.
7.Whitesides L, Baren J, Biros M, et al. Impact of individual clinical outcomes on trial participants’ perspectives on enrollment in emergency research without consent. Clin Trials. 2017;14(2):180-186. https://www.ncbi.nlm.nih.gov/pubmed/28359192.
8.Baren J. Ethical dilemmas in the care of minors in the emergency department. Emerg Med Clin North Am. 2006;24(3):619-631. https://www.ncbi.nlm.nih.gov/pubmed/16877133.
9.Dickert N, Mah V, Baren J, et al. Enrollment in research under exception from informed consent: the Patients’ Experiences in Emergency Research (PEER) study. Resuscitation. 2013;84(10):1416-1421. https://www.ncbi.nlm.nih.gov/pubmed/23603291.