Ethical Challenges with EFIC Studies
January 1, 2026
By Stacey Kusterbeck
For research dealing with major trauma, cardiac arrest, or respiratory failure, obtaining informed consent from participants is not always possible. Because of lack of time, lack of decision-making capacity, and family being unavailable, such studies may meet criteria for Exception from Informed Consent (EFIC).
“The fields of emergency medicine, trauma care, and critical care would not be allowed to advance without this provision. We have decades of scientific experience showing the limitations of using only observation to guide practice. The most important scientific and clinical questions need to be put to the test with a clinical trial. That’s why this rule is extremely important,” says Henry Wang, MD, MS, professor and vice chair for research of the Department of Emergency Medicine at the Ohio State University.
However, it is ethically concerning if investigators cut corners to avoid the work of obtaining informed consent and risk violating the rights of patients, says Jay Brenner, MD, FACEP, vice chair of research at SUNY Upstate Medical University. “There are gray areas where informed consent waivers may or may not be permissible depending on interpretation,” Brenner explains. If waivers are used, Brenner says that researchers should follow publicly available resources, such as the American College of Emergency Physicians’ EFIC primer.1
The central ethical concern with EFIC is the lack of informed consent from the person who is receiving the treatment or intervention, according to Barbara DeCausey, MPH, MBA, director of Virginia Tech’s Human Research Protection Program. This generally happens when there is an emergency and the individual does not have the capacity to give consent, and there is insufficient time to locate a legally authorized representative (LAR) or a family member to give consent.
“Even if a LAR or family member is located, obtaining informed consent while a person is overwhelmed with emotions and information is challenging. In these instances, the person may have very little time to consider complex information to make a ‘do or die’ decision,” says DeCausey. Another ethically challenging situation is cases where a minor is involved, and both parents are present, but do not agree on whether the minor should be enrolled in the research, adds DeCausey. In the absence of a LAR or family member, a person may be enrolled in a research study without consent if all the regulatory criteria have been met. “The criteria for EFIC are outlined in FDA [Food and Drug Administration] regulations and there is also guidance available. However, the interpretation of the regulations and guidance can vary, making it unclear if the EFIC is permissible,” says DeCausey.
The institutional review board (IRB) needs to ensure that the proposed research meets the regulatory criteria for the EFIC. Researchers can mitigate potential harms to research participants in these ways, says DeCausey:
- by having well-designed research protocols that are based on the best scientific evidence that currently is available;
- by ensuring that research team members are well-qualified and experienced;
- by regularly reviewing and updating protocols based on new information, data, and the researcher’s own experience;
- by putting in place an independent data safety and monitoring board to monitor the safety of research participants.
One of the requirements for EFIC studies is for researchers to consult with community members where the research will take place and seek input and support for the trial. “Usually, researchers obtain input by hosting public-facing events that allow for community members to ask questions and make suggestions. Communities often have concerns about the rights of vulnerable patients being violated by not getting the standard of care treatment,” says Brenner. Most frequently, researchers address these concerns by including standard of care treatment in the study protocol.
IRBs should ask how the researchers are engaging with the community to provide feedback and should make sure that the researchers are following best practices for EFIC studies (including incorporating the LAR for post-consent if possible), adds Brenner.
Focus groups give community members the opportunity to share ideas and concerns and also can create an opportunity to develop solutions, suggests DeCausey. “Researchers can discuss different ‘what if’ scenarios and ask community members for their opinions on how situations should be handled and how they would feel. Engaging with community members should be an ongoing process. Researchers should provide updates and solicit feedback throughout the course of the research,” adds DeCausey.
Researchers will report on the community consultation process to the IRB. “That information is used by the IRB to make a final decision about whether the study will be allowed to move forward,” says Wang. In the past, community consultation for EFIC studies was done solely in-person. Researchers informed people about a study at town hall meetings, clinic waiting rooms, supermarkets, or health fairs. “Not only did that take a lot of time, it produced few useful insights. At public meetings, there may be just a few people attending, and you might get only one or two questions,” says Wang.
Now, EFIC researchers are reaching out to communities on a much larger scale, using digital tools such as social media and digital surveys. Wang and colleagues reached community members using commercial survey panels, which are groups of individuals organized to answer surveys. They sought to determine if the demographics of people who responded to digital surveys aligned with the targeted communities.2 The researchers analyzed 6,630 completed surveys and found only minor demographic differences between survey respondents and the overall community population. “This particular study answered a very small but important question: If you use this technique, how does it compare with the census characteristics of that population? The differences were very small and would not be considered important from an IRB perspective,” says Wang.
Overall, digital surveys are more efficient and better represent the demographics of communities, concludes Wang.
The method of using digital surveys is efficient. The time to achieve 200 surveys ranged from five to 28 days per community.3
“Some might think that digital techniques are shortcuts in the community consultation process. But, in fact, these tools are incredible breakthroughs that add to traditional manual methods. In 2026, we communicate and identify as communities through digital modalities. How could you do it any other way? It’s aligned with the practices and expectations of the community,” says Wang.
Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.
References
1. American College of Emergency Physicians. EFIC and WIC Studies: A Primer for Clinical Investigators. https://www.acep.org/siteassets/sites/rsai-section/media/documents/efic_primer_2024.pdf
2. Keister A, Stephens SW, Adelgais K, et al. Exception from informed consent community consultation surveys — Do respondent characteristics accurately reflect targeted communities? Acad Emerg Med. 2025; Nov 10. doi: 10.1111/acem.70189. [Online ahead of print].
3. Wang HE, Stephens SW, Jacobsen K, et al. Application of digital engagement tools for exception from informed consent community consultation and public disclosure in the pediatric prehospital airway resuscitation trial. Resusc Plus. 2025;22:100919.