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Navigating the Complexities of Exception from Informed Consent (EFIC) in Research

A growing area of research involves exception from informed consent, also known as planned emergency research. Under certain conditions, in an emergency setting, participants can be enrolled in a trial without their consent. This article summarizes the podcast hosted by CITI Program with guest Michael Linke, PhD from the University of Cincinnati and the host Justin Osborne from The HRP Consulting Group where they discussed the regulations and ethical considerations around this important area of research.

In the dynamic landscape of medical research, certain situations arise where obtaining informed consent from participants becomes impractical. In these instances, researchers may turn to a mechanism known as Exception from Informed Consent (EFIC) to conduct studies aimed at addressing urgent medical needs. A recent discussion sheds light on the intricacies of EFIC and its role in advancing medical knowledge.

EFICinvolves conducting research without obtaining prospective informed consent from participants. The regulations governing EFIC, outlined in 50.24 CFR 40, set strict criteria for its approval. Central to EFIC is the need for studies to address life-threatening conditions with no acceptable treatments, offering potential benefits to participants. Additionally, there must be a limited timeframe to find a legally authorized representative (LAR) for surrogate consent.

One of the key elements of EFIC studies is community consultation and public disclosure. Before initiating a study, investigators engage with the local community to inform them about the research, address concerns, and seek feedback. This process ensures transparency and community involvement in research activities, although challenges exist in effectively implementing it, particularly in diverse and dynamic communities.

Despite the regulatory framework established in 1986, recent discussions have highlighted the need for continued review and potential updates to EFIC guidelines. A meeting hosted by the National Institutes of Health (NIH) brought together stakeholders to discuss current practices, challenges, and potential improvements in EFIC implementation.

One notable topic of discussion was the distinction between EFIC studies and waivers of informed consent, with EFIC presenting a higher threshold due to its stringent criteria and community engagement requirements. The meeting also addressed the evolving definition of “minimal risk” and the scope of conditions eligible for EFIC studies.

While no immediate regulatory changes are anticipated, ongoing dialogue and collaboration among researchers, regulatory agencies, and institutional review boards (IRBs) are essential to ensure the ethical conduct of EFIC studies. Additionally, advancements in technology, such as remote community engagement through social media, offer new avenues for conducting community consultation activities.

The ultimate goal of EFIC research remains unchanged: to advance medical knowledge and improve patient outcomes in emergency situations where traditional consent procedures are not feasible. With careful consideration of ethical principles, rigorous oversight, and ongoing dialogue, EFIC studies can continue to contribute meaningfully to medical research while upholding participant welfare and community engagement.

Listen to the podcast here: On Research Podcast on Exception from Informed Consent (

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