Improving the compliance of informed consent documentation for expanded access patients
Elias Samuels, Misty Gravelin, Ellen Champagne, Haj Ghaffari Dorsa, Jeanne Wright
Journal of Clinical and Translational Science, April 2025
Abstract
Objectives/Goals
The informed consent (IC) process is similar between clinical trials and expanded access (EA), which allows clinical use of investigational products outside studies. Physicians face unique barriers to IC in clinical environments. This project assesses IC documentation, identifies potential barriers, and evaluates efforts to improve compliance.
Methods/Study Population
This is a continuous quality improvement project. To assess the compliance of IC processes for EA patients, informed consent documents signed by EA patients in 2023 were collected and reviewed against institutional standards. Five components of each form were evaluated, and the number and type of noncompliant documentation were tracked. Five physicians who provided EA treatments in 2023 were interviewed and the transcripts were analyzed to identify barriers to physician’s and teams’ IC processes. Efforts made to address these barriers and improve the compliance of informed consent documentation are being tracked and trends in compliance are being evaluated.
Results/Anticipated Results
Sixty seven (67) signed informed consent documents for EA treatments were systematically reviewed and 34% were found to be compliant in all key aspects assessed. Analyses of interview notes, transcripts, and memos identified barriers to informed consent processes for expanded access treatments, including the infrequent or irregular occurrence of EA treatments making it difficult for care teams to develop and maintain their understanding of IC process and resources. Efforts made to improve compliance by pre-populating available information into informed consent documentation and removing unnecessary boxes in these forms may have driven improvement in compliance with further efforts underway.
Discussion/Significance of Impact
This project evaluated the compliance of IC documentation for EA treatments and identified drivers affecting physicians’ IC processes for these patients. Different strategies to improve the compliance of IC documentation were evaluated and potential best practices for EA support were identified.

Changing FDA Approval Standards: Ethical Implications for Patient Consent
Viewpoint
Jonathan J. Darrow, Sanket S. Dhruva, Rita F. Redberg
Journal of General Internal Medicine, 8 April 2021
Open Access
Excerpt
The pace of new drug and medical device introductions has accelerated in recent years. In 2018, 59 novel drugs were approved in the USA, the most since 1996. A rising proportion of drugs and devices qualify for one of the US Food and Drug Administration’s (FDA) expedited programs, which allow approval based on less rigorous clinical trials. Expanded access and emergency use authorization allow access to products—such as remdesivir (Veklury) and COVID-19 vaccines—even before they are approved.

The growing array of products made available with limited evidence poses important challenges for patients and physicians. Ethical principles require that patients consent to treatment after being informed of the benefits and harms of each alternative. In routine practice, however, the consent process is often truncated, with limited presentation of alternatives, risks, and outcome data. As regulatory processes have evolved, the consent process—already criticized by some as inadequate—has changed little. We review the evolution of drug and device evidence requirements and consider the implications for informed consent…

Navigating the Informed Consent Process When Using Innovative Surgery
Research Article
Daniel Wehrmann, Glenn E. Green, MD, Kevin J. Weatherwax, Andrew G. Shuman
Otolaryngology–Head and Neck Surgery, 24 December 2019
Excerpt
… Expanded access (EA), also referred to as “compassionate use,” is a Food and Drug Administration (FDA) mechanism by which patients with serious or life-threatening conditions for which there is no approved treatment may access novel investigational drugs, biologics, or medical devices. The benefits of the proposed drug/device must outweigh the risks to that patient or group of patients… Obtaining informed consent in this setting is complicated due to the conflation of clinical care and research, with each directed at different primary goals. Traditionally, clinicians are expected to solely focus on the best possible outcome for the patients they are treating. Researchers, on the other hand, are primarily focused on creating generalizable knowledge to help all patients. Of course, these goals may be more or less divergent, especially when surgeon-scientists are acting in both capacities… Surgical innovation using the EA program represents a thoughtful balance between patient/family choices, our duty to potential future patients, and the regulatory landscape in which we practice. The informed consent process represents an amalgam of standard clinical components, as well as clinical research regulations that necessarily meet a higher standard and level of scrutiny. As such, our obligations as researchers, clinicians, and our dual roles as both, highlight the need for us to uphold the highest levels of morality, ethics, and professionalism.