As an academic discipline and separate specialty, emergency medicine is relatively young: the first residency training program in emergency medicine in the U.S. was founded in 1970. Compare that to internal medicine, for which the first U.S. residency program was founded in 1889! Emergency medicine is an area ripe for research and hungry for definition of best practices and rigorous optimization of outcomes. But like every field of research, it holds unique challenges. Two institutes at the NIH, the National Institute of Neurological Disorders and Stroke (NINDS) and the National Heart, Lung, and Blood Institute (NHLBI), have partnered to help overcome these challenges.
One challenge facing research in the emergency setting is that patients can be unconscious or disoriented enough to make it impossible for them to give informed consent to participate in a research study or to receive experimental therapies. Family members are often not present nor reachable in a time frame appropriate to urgent need for intervention. From this challenge, the concept of Exception From Informed Consent (EFIC) was established in 1996, which is a waiver that can be granted for a research protocol involving clinical research in the emergency setting. EFIC allows investigators to enroll patients in research studies without direct consent from the patient, their family, or their legally authorized representatives. Instead, consent through EFIC is granted contingent on engagement of and general consent from the community for the performance of such research studies.
This naturally leads to a number of questions:
- What does “engagement of and consent from the community” mean?
- How is it done?
- Who constitutes the community?
- In the urgency of the life-saving efforts of Emergency Medical Services personnel, what attempts can be made to reach next-of-kin?
Given the variability of such situations and the independence of agencies that provide emergency care from state to state and city to city, it is not surprising that, while the literature contains advice on best practices, there is not yet uniformity of implementation of research for which an EFIC waiver has been granted.
With funding from NINDS and NHLBI, a network of institutions and investigators in the field of emergency medicine called the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) has assembled a booklet entitled “Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research”. The booklet is intended as a starting point for the design and implementation of these clinical trials and as a peer-to-peer tool for the Emergency Medicine research community.
Another challenge of research and clinical practice in emergency medicine is that, when family members are present in a setting in which emergency procedures must be performed, so much of the medical personnel’s energy and focus is on the patient and his or her stabilization and transport to a hospital, that the family’s needs and worries get lost in the shuffle. Often, families wonder long after the event what exactly happened and what was done to the patient during, for example, a resuscitation. If the outcome is not favorable, they may wonder if something else could have been done or even if something might have been done wrong.
How, when, and by whom should these questions and needs be addressed? It is doubtful that there is one right answer. But at a workshop and forum convened by the SIREN Network and funded by NINDS and NHLBI for patients, families, doctors, nurses, and emergency medical technologists, these issues were framed by what little literature exists and by lived experiences. These were then discussed in small groups representative of the diverse stakeholders in this important challenge. Based on this workshop, the SIREN Network published its findings in the March issue of the journal Critical Care Explorations. This observational study led to many recommendations and insights that make it clear that, although this is definitely not a case of “one size fits all”, medical practitioners and the other professionals who support patients and families alongside them can learn immensely their perspectives to better provide for their physical, psychosocial, and spiritual needs in times of crisis, whatever the outcome.
Muehlschlegel S. et al. “The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop. Critical Care Explorations. March 2022. DOI: 10.1097/CCE.0000000000000648