Association for Academic SurgeryEthical and Legal Issues in Emergency Research: Barriers to Conducting Prospective Randomized Trials in an Emergency Setting
Introduction
Trauma is the number one cause of death in the United States for individuals between the ages of 1 and 45 y of age, and has steadily continued to rise 1, 2. Even in the developing world, trauma is rapidly becoming a major killer of young adults, now following only infectious disease as the leading cause of death in low- and middle-income countries [3]. It is somewhat surprising, then, to note that in an era of vast expenditures on research for treatment of other public health concerns, such as cancer [4] and cardiovascular disease [5], comparatively little recent research has been done to improve outcomes in trauma resuscitation 6, 7. Patients are frequently enrolled in research trials to evaluate the latest developments in the management of a variety of diseases, yet randomized controlled trials in the trauma literature are much more difficult to find [7]. While the management of many conditions has changed drastically over the past several decades—and continues to evolve at an extraordinary pace—evolution of the initial management and resuscitation of trauma patients seems to have followed a slower, more circuitous path. In fact, much of what is considered “standard of care” in trauma resuscitation today is based largely on outdated animal studies rather than randomized controlled trials [8]. Beyond the obvious detrimental effects that a lack of human trauma research might have from a public health standpoint, this void in trauma research also has intriguing ethical implications. Accidental and intentional injuries disproportionately affect minorities and individuals with low socioeconomic status 9, 10, 11.These same “vulnerable” [12] groups also tend to have worse outcomes when treated with current resuscitation strategies 12, 13, 14, 15. Therefore, it can be argued that those who suffer most from the lack of advancement and innovation in trauma resuscitation are individuals who are likely to come from disadvantaged or minority populations. Ironically, difficulty with obtaining informed consent, a practice that was originally instituted to protect vulnerable populations, is probably one of the major reasons that such little emergency trauma research exists to benefit these populations today. Until relatively recently, U.S. regulations made it virtually impossible to conduct any human research without obtaining informed consent prospectively. Since the vast majority of severely injured patients are not able to give their informed consent at the time of injury, it inevitably follows that few prospective trauma trials are undertaken, despite the fact that this type of research could potentially be immensely valuable to society. In order to understand the reasoning behind this stringent requirement for informed consent, one must first consider the history of human research and human rights in the United States.
Section snippets
The Development of Informed Consent
Ethical issues regarding human experimentation first became a major focus of international attention in the late 1940s, after several Nazi physicians were convicted of human rights violations for conducting horrendous experiments on prisoners in concentration camps, including the intentional exposure of patients to harmful and/or fatal conditions [16]. Despite the shocking nature of the Nazi experiments and the significant publicity they garnered, the perception amongst most Americans was that
Vulnerable Populations in Trauma Research
Numerous documents have addressed the importance of protecting the rights of individuals who have diminished capacity to consent for participation in research; 45 CFR 46 explicitly outlines separate regulations for research involving fetuses, children, and prisoners as requiring additional protections, but leaves it up to individual institutional review boards (IRBs) to determine whether additional protections are needed for other groups of individuals who might also have diminished autonomy
Waiver of Informed Consent in Emergency Research: The Final Rule
In non-research emergency settings, procedures that normally require informed consent are allowed to proceed without obtaining informed consent from the patient if he or she is incapacitated. In these instances, the physician is permitted to act in the best interest of the patient because failure to do so in a timely fashion might result in significant harm or death. Typically, what is considered to be in the patient's “best interest” is whatever is generally accepted as the best available
The Consideration of Deontological Versus Teleological Ethics
Underlying the issue of “informed consent” is the historical lesson that regardless of amount of education or position of authority, researchers' judgment cannot always be trusted beyond their own self-interest. Unfortunately, under current regulations, even those clinicians who currently wish to do good for their patients are faced with an ethical conundrum when trying to provide what they feel is the best treatment in situations where consent cannot be obtained. For example, if trauma
Need for Clinical Trials in Trauma Resuscitation
It should be noted that the regulations discussed herein refer specifically to the practice of trauma research in the civilian setting. Opportunities for improving the delivery of trauma research have also arisen in the combat setting during times of war, and have contributed significantly to our understanding and management of hemorrhagic shock. Discovery of the association between crystalloid use and acute respiratory distress syndrome during the Vietnam War era, and advances in transfusion
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A cross-sectional study of participant recruitment rates in published phase III influenza therapeutic randomized controlled trials conducted in the clinical setting
2022, American Journal of Emergency MedicineWhen Time Is Critical, Is Informed Consent Less So? A Discussion of Patient Autonomy in Emergency Neurosurgery
2019, World NeurosurgeryCitation Excerpt :One survey showed that the vast majority of the public would find it acceptable if a surrogate or their next of kin provided consent for a trial in an emergency setting.15 The RESCUEicp (Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure) and RESCUE-ASDH (Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute SubDural Haematoma) trials demonstrated that formal research in incompetent patients in an emergency setting can be done safely and ethically.16-19 However, there are currently no guidelines or specific requirement for the informed consent procedure for emergency neurosurgery.
Taking the bull by the horns: Ethical considerations in the design and implementation of an Ebola virus therapy trial
2016, Social Science and MedicineThe inadequacies of community consultation in emergency medicine research: A proposal for revising the rule
2015, American Journal of Emergency MedicineEthical and regulatory considerations in the design of traumatic brain injury clinical studies
2015, Handbook of Clinical NeurologyCitation Excerpt :It is unclear how the discordance between the US and the EU will effect international research collaborations on neuroprotection and critical care for TBI, but certainly this is another important consideration. Even within the US, EFIC has not been uniformly embraced and many of the criticisms surround the requirement for community consultation (Morrison et al., 2009). The definition of “community” is viewed as being ambiguous and the requirement for “consultation” is unclear and left to the interpretation of local IRBs (Holloway, 2006; Richardson et al., 2006).