Head injuries are an inherent risk of participating in the major collision sports played in Australia. Protocols introduced by the governing bodies of these sports are ostensibly designed to improve player safety but do not prevent players suffering from repeated concussions. There is evidence that repeated traumatic brain injuries increase the risk of developing a number of long term problems but scientific and popular debates have largely focused on whether there is a causal link between concussion and chronic traumatic (...) encephalopathy. We argue that the governing bodies of collision sports played in Australia have used uncertainty about CTE to justify a “wait and see” approach instead of attempting to prevent repeated head injuries. This stance is difficult to defend when these governing bodies claim to give a high priority to protecting player welfare. (shrink)

The effects of head injury, even mild traumatic brain injury, are wide-ranging and profound. Persons with adult-onset head injury offer feminist philosophers important perspectives for philosophical methodology and philosophical research concerning personal identity, mind-body theories, and ethics. The needs of persons with head injury require the expansion of typical teaching strategies, and such adaptations appear beneficial to both disabled and non-disabled students.

We conducted two experiments using naturalistic scene stimuli to test the resource theory and mindlessness theory of sustained attention. In experiment 1, 28 participants completed a traditional formatted vigilance task consisting of non-repeating forest or urban picture stimuli as target stimuli. Participants filled out pre- and post-task assessments of arousal and conscious thoughts. There was still a vigilance decrement, despite non-repetitive, natural target stimuli. Participants found the task demanding and were actively engaged in the task. In experiment 2, 25 participants (...) completed a Sustained Attention to Response Task using the stimuli from experiment 1. Participants performed significantly worse on this SART than either brain injury patients or controls performing equivalent numeric stimuli SARTs have in previous studies. Participants thought the task was demanding and they were actively engaged with the task. Overall, the results of both studies support a resource theory of sustained attention lapses, not a mindlessness theory. (shrink)

The idea that acquired brain injury (ABI) caused by stroke, hemorrhage, infection or traumatic insult to the brain can result in post-traumatic growth (PTG) for individuals is increasingly attracting psychological attention. However, PTG also attracts controversy as a result of ambiguous empirical findings. The extent that demographic variables, injury factors, subjective beliefs, and psychological health are associated with PTG following ABI is not clear. Consequently, this systematic review and meta-analysis explores the correlates of variables within these four broad (...) areas and PTG. From a total of 744 published studies addressing PTG in people with ABI, eight studies met inclusion criteria for detailed examination. Meta-analysis of these studies indicated that growth was related to employment, longer education, subjective beliefs about change post-injury, relationship status, older age, longer time since injury, and lower levels of depression. Results from homogeneity analyses indicated significant inter-study heterogeneity across variables. There is general support for the idea that people with ABI can experience growth, and that various demographics, injury-related variables, subjective beliefs and psychological health are related to growth. The contribution of social integration and the forming of new identities post-ABI to the experience of PTG is explored. These meta-analytic findings are however constrained by methodological limitations prevalent in the literature. Clinical and research implications are discussed with specific reference to community and collective factors that enable PTG. (shrink)

Rationale: Deep brain stimulation (DBS) of the hippocampus is proposed for enhancement of memory impaired by injury or disease. Many pre-clinical DBS paradigms can be addressed in epilepsy patients undergoing intracranial monitoring for seizure localization, since they already have electrodes implanted in brain areas of interest. Even though epilepsy is usually not a memory disorder targeted by DBS, the studies can nevertheless model other memory-impacting disorders, such as Traumatic Brain Injury (TBI). Methods: Human patients undergoing Phase II invasive (...) monitoring for intractable epilepsy were implanted with depth electrodes capable of recording neurophysiological signals. Subjects performed a delayed-match-to-sample (DMS) memory task while hippocampal ensembles from CA1 and CA3 cell layers were recorded to estimate a multi-input, multi-output (MIMO) model of CA3-to-CA1 neural encoding and a memory decoding model (MDM) to decode memory information from CA3 and CA1 neuronal signals. After model estimation, subjects again performed the DMS task while either MIMO-based or MDM-based patterned stimulation was delivered to CA1 electrode sites during the encoding phase of the DMS trials. Each subject was sorted (post hoc) by prior experience of repeated and/or mild-to-moderate brain injury (RMBI), TBI, or no history (control) and scored for percentage successful delayed recognition (DR) recall on stimulated vs. non-stimulated DMS trials. The subject’s medical history was unknown to the experimenters until after individual subject memory retention results were scored. Results: When examined compared to control subjects, both TBI and RMBI subjects showed increased memory retention in response to both MIMO and MDM-based hippocampal stimulation. Furthermore, effects of stimulation were also greater in subjects who were evaluated as having pre-existing mild-to-moderate memory impairment. Conclusion: These results show that hippocampal stimulation for memory facilitation was more beneficial for subjects who had previously suffered a brain injury (other than epilepsy), compared to control (epilepsy) subjects who had not suffered a brain injury. This study demonstrates that the epilepsy/intracranial recording model can be extended to test the ability of DBS to restore memory function in subjects who previously suffered a brain injury other than epilepsy, and support further investigation into the beneficial effect of DBS in TBI patients. (shrink)

Decision making for children who suffer abusive head trauma invokes multiple ethical considerations. The degree to which parents are permitted to participate in decision making after the injury has occurred is controversial. In particular, in this issue of The Journal of Clinical Ethics, Grigorian and colleagues raise concerns about the potential for conflict of interest in end-of-life decision making if the parents are facing criminal charges that could be escalated if the child dies. There are additional concerns about (...) the parents’ capacity to make decisions that are best for the child, given that the injury occurred. We argue that there are important reasons not to exclude parents from the decision-making process and that, with appropriate safeguards in place, parents are integral to determining what is best for the child. (shrink)

In this paper, we explore the issue of the elimination of sports, or elements of sports, that present a high risk of brain injury. In particular, we critically examine two elements of Angelo Corlett’s and Pam Sailors’ arguments for the prohibition of football and Nicholas Dixon’s claim for the reformation of boxing to eliminate blows to the head based on the empirical assumption of an essential or causal connection between brain injuries incurred in football and the development of (...) a degenerative brain disease known as chronic traumatic encephalopathy ; and John Stuart Mill’s rejection of consensual domination. We present four arguments to contest the validity of Corlett, Dixon’s and Sailor’s positions. Specifically, we argue that certain autonomy-based arguments undermine paternalist arguments for reform; the nature of the goods people pursue in their lives might justify their foregoing future autonomy; Mill’s argument against consensual domination draws on ambiguous and arbitrary distinctions; the lack of consensus and empirical evidence regarding CTE arising from brain injuries in sport underdetermines calls for reform. We conclude that these proposals for reforming or eliminating sports with high risks of brain injuries are not well founded. (shrink)

This special issue examines critical ethical, legal, and policy debates surrounding brain trauma in sport, focusing on challenges in concussion management practices and protocols. Brain injury concerns extend beyond traditional contact sports like boxing, encompassing sporting activities involving rapid acceleration, deceleration, and surface impacts, such as cycling and equestrian sports. Among such problems are the identification and management of brain injuries, the roles of officials and healthcare professionals, and the broader implications for sport integrity and athlete careers. The special (...) issue is organized into four sections: ethics of concussion medicine, socio-legal aspects, sport ethical dimensions, and public health policies. Contributions discuss concussion management in youth sport, sport federations’ and athletes’ duties involvement in concussion-related research, strategies to support and enhance athlete autonomy, public health-informed brain injury frameworks, conflict of interest in concussion management protocols, litigation and liability in concussion research and collaboration, race and genomics in brain-injury scientific discourses, rule changes in sport to reduce head impact, the contextual nature of brain injury and athlete decision-making, the ethical use of genetic testing in brain-injury related research, marketing strategies to advertise tackle football to children and adolescents, and policy purposes and evidence underpinning concussion management practices. This comprehensive exploration offers diverse disciplinary insights, making it a crucial resource for sport humanities scholars, policymakers, and medical professionals. Keywords: brain injury, sport ethics, concussion, sport law, sport policy. (shrink)

This volume provides, for the first time, multidisciplinary perspectives on the problem of awareness of deficits following brain injury. Such deficits may involve perception, attention, memory, language, or motor functions, and they can seriously disrupt an individual's ability to function. However, some brain-damaged patients are entirely unaware of the existence or severity of their deficits, even when they are easily noticed by others. In addressing these topics, contributors cover the entire range of neuropsychological syndromes in which problems with awareness (...) of deficit are observed: hemiplegia and hemianopia, amnesia, aphasia, traumatic head injury, dementia, and others. On the clinical side, leading researchers delineate the implications of awareness of deficits for rehabilitation and patient management, and the role of defense mechanisms such as denial. Theoretical discussions focus on the importance of awareness disturbances for better understanding such cognitive processes as attention, consciousness, and monitoring. (shrink)

Using a longitudinal case study design, we have tracked the recovery of motor function following severe traumatic brain injury (TBI) through a multimodal neuroimaging approach. In 2006, Canadian Soldier Captain (retired) Trevor Greene (TG) was attacked with an axe to the head while on tour in Afghanistan. TG continues intensive daily rehabilitation, which recently included the integration of physical therapy (PT) with neuromodulation using translingual neurostimulation (TLNS) to facilitate neuroplasticity. Recent findings with PT+TLNS demonstrated that recovery of motor (...) function occurred beyond conventional time limits, currently extending past 14-years post-injury. To investigate whether PT+TLNS similarly resulted in associated cognitive function improvements, we examined event-related potentials (ERPs) with the brain vital signs framework. In parallel with motor function improvements, brain vital signs detected significant increases in basic attention (as measured by P300 response amplitude) and cognitive processing (as measured by contextual N400 response amplitude). These objective cognitive improvements corresponded with TG’s self-reported improvements, including a noteworthy and consistent reduction in ongoing symptoms of post-traumatic stress disorder (PTSD). The findings provide valuable insight into the potential importance of non-invasive neuromodulation in cognitive rehabilitation, in addition to initial indications for physical rehabilitation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Figuring Myself Out:Certainty, Injury, and the Poststructuralist Repositioning of Bodies of IdentityJames Haywood Rolling Jr. (bio)CertaintyI have been attempting to figure myself out. Out of chaos and incompletion, toward increased certainty. I have been at this task of construction for quite some time now. I have just proposed my dissertation and my intentions are once again uncertain. My dissertation is to be a self-study. It is also a (...) story about uncertainty and my attempts to redeem a clear definition, to be named a peer and a colleague among artists, writers, and teachers. I have been uncertain as a little boy; uncertain as a son; uncertain as a student of architecture; uncertain as an artist and writer; uncertain as a teacher; uncertain as a black man. To compensate, I have sought the conferral of certainty, a name among leaders in many fields of inquiry. Still, it is not easy to forget that certainty has also been the cause of great injury to my body, to my mind.On sunny afternoons after school all the kids came outside to play. The air would fill with echoes going back and forth between the red brick and stone buildings on both sides of our narrow street. Pounding rubber balls, the taps and scratches of shoe heels, and the slapping of sneakers on the cement and asphalt.Sometimes white chalk would appear and hopscotch boxes were quickly drawn on the neat squares of cement pavement in front of my Grandma's house. Grandma lived next door to us. Houses on our block were side by side, sharing each other's walls.On a particular day, similar to other days, I watched as a small flat stone was tossed to bounce across the cement into a numbered box. I watched the one foot, two feet, one foot hops from box to box to stop and balance on one small hopping foot, steadying itself, to drop a hand to pick up the stone. Some little girl came to sit beside me and asked me to look at her. We were sitting on one of Grandma's two wooden benches, just inside the front gate. [End Page 46] Two steps down was the sidewalk and other kids. I ignored the girl. I made sure my body had no contact with hers on the bench. Why was she talking to me anyway? Didn't she see I didn't have anything I wanted to say?"Look at me!" she said, tugging at my arm."Will you stop it!" I snapped back, jerking my arm away. Being touched was not natural to me. My family didn't touch. I tightened the skin of my eyebrows and the bridge of my nose into a frown."Smile!" the little girl said slyly, trying to tickle me."Leave me alone!" I yelled. I tried to move away from the touching.I must have grinned. Grinning relaxes the frowns on faces. The girl clapped a hand over her mouth, all giggles. I asked what she was laughing so loud for. The kids out in front of us now had our attention. I felt like I was now being watched. I can't remember the faces, just the noise and voices that seemed to stop. The little girl stood up, pointed at my face and declared, finger in my face, pointing, speaking out loud, "Look! He only has one dimple! See?! Look at his face!""No I don't," I said, dropping my face, my eyes, my voice. My head was down and I didn't want to see if anyone was looking. The attention made my face warm and I needed to move away fast. "No I don't," I repeated, stiffly. My whole head seemed to glow brightly, very hot, drawing lots of attention. I was beneath windows, very near, on both sides of the street, always with onlookers. I rushed through the painted iron gate, going quickly next door, upstairs to "our house," to the second floor apartment we lived in, down the hallway so dark after the bright outside, around a curve and a corner, into the bathroom, closing the door behind me. Locking the door... (shrink)

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa. A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration. The search focused on three (...) main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy, Psychiatry, & Psychology 10.1 (2003) 25-27 [Access article in PDF] Gender, Body, Meaning:Anthropological Perspectives on Self-Injury and Borderline Personality Disorder Carolyn Sargent THE CENTRAL THEMES OF "Commodity Body/Sign: Borderline Personality Disorder and the Signification of Self-Injurious Behavior" reflect issues that cut across the disciplines represented by this journal and have received increasing attention from anthropologists. Medical anthropologists, as well as psychological anthropologists and others interested in symbolic (...) analysis of the body, have addressed such topics as the culture of biomedicine and the cultural shaping of psychiatric classification, the multiple meanings of body modifications, power relations in therapeutic interactions between doctor and patient, and cultural variation in understandings of normality and abnormality.Curiously, there is little anthropological literature that directly focuses on either borderline personality disorder (BPD) or self-injurious acts per se. Indeed anthropological research on psychiatric diagnosis, classification, and treatment, as well as ethnopsychiatry, include scant reference to personality disorders. One exception is Nuckolls' 1992 article, "Toward a Cultural History of the Personality Disorders," which raises pertinent questions for one of Potter's introductory statements—that the majority of those diagnosed with BPD are women. Nuckolls directly addresses gender ideology and gender roles in the United States in his comparison of antisocial personality and histrionic personality diagnoses. In his paper, he argues that these personality disorders have cultural histories and are strongly congruent with prevailing gender stereotypes, such that men are many times more likely to be diagnosed as antisocial than women and women much more likely to be diagnosed as histrionic (Nuckolls 1992, 37). He also historicizes the emergence of certain behavioral styles that have been seen as characteristic of women and men, and the evolution of psychiatric diagnoses that classify extreme manifestations of these behavioral styles.The issue of why women, rather than men, are more frequently diagnosed with BPD is not elaborated in Potter's article, although she notes the importance of considering the intersection of gender and "identifying behaviors" associated with BPD. Cultural analyses of gender ideology in the [End Page 25] United States might suggest that the connection involves gendered expectations concerning emotionality and relational context but these articulations remain intriguing and underexplored. One might speculate that BPD/self-injury occurs in the context of particular gender ideologies, perhaps in class-based, industrialized societies where the body is highly commodified. It appears that the history of this constellation of symptoms and behaviors remains to be written.Cultural analysis of self-injury, a theme that runs through Potter's article, tends to be embedded in the anthropological literature on body ornamentation, initiation rituals, and "culture-bound" syndromes. Mascia-Lees and Sharpe (1992, 1) describe the body as "a site of adornment, manipulation, and mutilation," practices with roots reaching back as far as 30,000 years, and include as examples head deformation, scarification, foot binding, tooth filing, lip plates, nose rings, tattoos, subincision, and genital cutting.However, the concept of self-injury, as Potter notes, is problematic in the discipline of anthropology given the significance historically accorded to cultural relativism. Correspondingly, body "modification" is not "self-injury" as long as it is socially normative, for example, a facet of an initiation ordeal or body ornamentation (e.g., circumcision, scarification, piercing). Among the rare examples of acts that seem readily identifiable as "self-injury" are New Guinea practices of cutting off a finger to demonstrate mourning and Baatombu (West African) male finger amputation to show grief and anger over a wife's infidelity. Both are, however, considered culturally legitimate and not indicative of pathology.Potter's argument draws heavily on the notion of "body as text," derived largely from literary theory and feminist philosophy (Butler 1990; Jaggar and Bordo 1989). The perspective of "body as text" has influenced anthropological theory over the past two decades, particularly in the interpretive and postmodernist schools of thought. The body as a text of femininity is aptly characterized by Bordo, who argues that the continuum between female disorder and normal femininity is revealed by means of an analysis of symbolic meaning of gender in... (shrink)

The aim of this study was to explore the relationship between the protein S100B level, cognitive dysfunction, and Glasgow Outcome Scale (GOS) in moderate traumatic brain injury patients. Thirty patients suffering from head injuries undergoing neurosurgery in Dr. Hasan Sadikin General Hospital Bandung, Indonesia, and who were considered eligible based on the inclusion and exclusion criteria participated in this double-blind experimental Randomized Controlled Trial (RCT). The treatment groups (COX-2) were assigned as COX2-I, COX2II, and COX3-IV, six patients in (...) each group. The treatment group was given another dose of sCOX-2 inhibitor 12 hours, 12 and 24 hours after the first dose, and 12, 24 and 36 hours after pre-induction sCOP-2 inhibitor was administered. The GOS score was obtained during the before the surgery and 1 month, 1.5 months, and 2 months postoperative days. The MMSE was performed preoperatively and then on the first to seventh day after the surgery. The results showed that there was a significant decrease in the protein level in all treatment groups including the control group, where the resulting p-value was less than 0.05. Moreover, the treatment group showed a faster time in reaching GOS 5 or be discharged from the hospital compared to the control. In conclusion, it has been demonstrated that the provision of 3 or 4 times of the sCox-2 inhibitor leads to the achievement of a score of 5, while the recovery of the cognitive dysfunction into the normal level is obtained when the SCox2 inhibitor is given 4 times. (shrink)

In this article, we tackle the epistemological and ethical issues related to the use of race concepts in the genomics of sport performance and sport-related concussion (SRC). In the first part of the article, we show how the concept of race is ubiquitous in scientific literature, besides the fact that ‘race’ as other analogous population descriptors like ‘ancestry’ and ‘continent’ carry ancestral genetic heterogeneity and therefore they cannot be used to infer any kind of genetic or physiological property. Then, we (...) investigate the question of whether genomics research focusing on racial categories and race-specific genes of sport performance and of risk of health outcomes due to repetitive head impacts (RHI) is justified from an epistemological point of view, arguing that it is not; we show that the evidence supporting the existence of genetic variants determining an elite athlete status or a predisposition to health outcomes after SRC is scarce, and the use of racial categories (e.g. African or Black, Caucasian or White, Asian, etc.) as proxies for genetic variants associated with an elite athlete status/a predisposition to health outcomes after SRC is ill-conceived. In the second part of the article, we analyze the main ethical issues concerning the reification of race concepts in sport genomics, also considering the more general issue of the ethical and social impact of the use of a genetic framework in the explanation of individual differences in sport performance and SRC. (shrink)

Should the government censor dangerous anti-vaccination propoganda? Should it restrict the praise of terrorist groups, or speech intended to promote discriminatory attitudes? In other words, should the government curb the advocacy of dangerous ideas and actions (i.e. 'harmful advocacy'), or should the government take a more permissive approach? Strong free speech supporters argue that citizens should be free to engage in and to hear harmful advocacy, arguing that restrictions are deeply objectionable at best, and, at worst, wholly impermissible. To support (...) their position, strong free speech supporters have offered a wide range of arguments and ideas. One of the most interesting arguments revolves around the idea that restrictions on harmful advocacy are deeply insulting to citizens. The worry, broadly understood, is that this kind of censorship is demeaning, treats citizens as though they are stupid, or as though they are children. As such, even when censorship is effective in preventing harms to citizens, it nonetheless comes at the significant political cost of failing to properly respect the citizenry at large. By contrast, so the thought goes, an alternative political scheme that prohibits censorship, or permits it only in exceptional cases, does a better job of respecting citizens as independent, rational, morally responsible agents. This alternative political system may, sometimes, be less effective at preventing speech harms. But it is a political system where citizens can stand tall and hold their heads high. In this paper, I consider and reject three versions of the worry that censorship is insulting. §1 explores the idea that censorship is insulting qua involving a negative appraisal of the citizens being interfered with. The key idea here is that censorship involves a lack of what Stephen Darwall terms ‘appraisal respect’, insofar as the government is suggesting that citizens cannot be trusted to manage their own beliefs and intentions. Drawing on the work of Thomas Nagel, §2 explores the idea that censorship diminishes the political status of citizens. Finally, §3 explores the suggestion that censorship is incompatible with a full appreciation of the thinking nature of citizens, and thus involves a lack of what Darwall would term ‘recognition respect’. The paper argues that censorship is not necessarily premised upon an insulting view of the citizenry. On the contrary, it argues that the best kind of censorship stems from a rich appreciation of the diverse range of capabilities, needs, vulnerabilities, and responsibilities of citizens, as well as the need for co-operation between citizens if societal flourishing is going to be achieved on a large scale. Granted, such a vision places an emphasis on the imperfections and liabilities of citizens – at least when compared to the rather solitary, highly intellectual creature one sometimes finds in the philosophical literature. Still, such a vision of citizens as imperfect falls well short of being genuinely insulting. To err is human. And there’s nothing insulting about being treated like a human. (shrink)

There is growing interest in the effects of sports-related repetitive head impacts (RHIs) on athletes’ cognitive capabilities. This study examines the effect of RHIs in data collected from adolescent athletes to estimate the magnitude and longevity of RHIs on sensorimotor and cognitive performance. A non-linear regression model estimated the longevity of RHI effects by adding a half-life parameter embedded in an exponential decay function. A model estimate of this parameter allows the possibility of RHI effects to attenuate over time (...) and introduces a mechanism to study the cumulative effect of RHIs. The posterior distribution of the half-life parameter associated with short-distance headers (<30 m) is centered around 6 days, whereas the posterior distribution of the half-life parameter associated with long-distance headers extends beyond a month. Additionally, the magnitude of the effect of each short header is around 3 times smaller than that of a long header. The results indicate that, on both tasks, response time (RT) changes after long headers are bigger in magnitude and last longer compared to the effects of short headers. Most important, we demonstrate that deleterious effects of long headers extend beyond 1 month. Although estimates are based on data from a relatively short-duration study with a relatively small sample size, the proposed model provides a mechanism to estimate long-term behavioral slowing from RHIs, which may be helpful to reduce the risk of additional injury. Finally, differences in the longevity of the effects of short and long RHIs may help to explain the large variance found between biomechanical input and clinical outcome in studies of concussion tolerance. (shrink)

Driving simulators are becoming increasingly common in driver training and assessment. Since virtual reality is generally regarded as an appropriate environment for measuring risk behavior, simulators are also used to assess hazard perception, which is considered to be one of the most important skills for safe driving. Simulators, which offer challenges that are indeed comparable to driving in real traffic, but at a very low risk of physical injury, have the potential to complement theoretical and practical driver trainings and (...) tests. Although configurations and fidelity differ considerably between driving simulators, studies comparing the impact of their distinct features on driving performance and test validity remain rare. In this context, prior research demonstrated that a wider field of view led to earlier speed adjustments in response to potential hazards—especially for experienced drivers. The wider field of view was assumed to cause the drivers to be more present in the virtual world, which in turn provoked more natural scanning of the road and therefore, earlier hazard detection in experienced drivers. Research on spatial presence in other contexts support this assumption. The present experiment investigated whether this effect could be enhanced by an even more immersive presentation technique for driving simulation: a head-mounted display. Moreover, we studied the interplay between display mode, sense of presence and simulation sickness. Eighty experienced and less experienced drivers completed six simulation-based hazard perception scenarios, which were displayed either via a triple-monitor set-up or an HMD. Results indicate that the experienced drivers showed very similar driving and risk behavior as the inexperienced drivers in both experimental conditions. However, there were significant differences between the two display conditions. The use of an HMD resulted in a clearer and more abrupt speed reduction, more virtual presence, and a higher degree of simulation sickness. However, the interrelation between these three variables could not be conclusively clarified in the present study and thus represents a research aim that could be addressed in future studies. (shrink)

IntroductionIn highly developed countries, as many as 16 percent of children are physically abused each year. Traumatic brain injury (TBI) is the most common injury in non-accidental trauma (NAT) and is responsible for 80 percent of fatal NAT cases, with most deaths occurring in children younger than three years old. Cases of abusers who refuse withdrawal of life-sustaining medical treatment (LSMT) to avoid criminal charges have previously been reported. Therefore, we hypothesized that NAT is associated with a lower (...) risk for withdrawal LSMT in pediatric TBI.MethodsThe pediatric Trauma Quality Improvement Program database was analyzed (2014 to 2016) for patients aged 16 and younger with TBI and Glasgow Coma Scale (GCS) of 8 and lower on admission. Patients with a head Abbreviated Injury Scale (AIS) of 2 or less or who died within 48 hours were excluded. A multivariable logistic regression model was used for analysis.ResultsOf 2,209 TBI patients, 92 (4.2 percent) had withdrawal of LSMT. Compared to those without withdrawal of LMST, those with LMST had statistically similar median age (three years of age versus seven years, p = 0.07) and a higher rate of NAT (33.7 percent versus 13.5 percent, p < 0.001). The most common specified perpetrator was a father/stepfather/ male partner (70 percent). After adjusting for covariates, factors associated with higher risk for withdrawal of LSMT included age of less than three years (OR 2.38, CI 1.34-4.23, p < 0.05) and NAT (OR 1.86, CI 1.02-3.41, p < 0.05).ConclusionNAT is associated with increased risk for withdrawal of LSMT in pediatric TBI. Age of less than three years is similarly associated with a higher risk for withdrawal of LSMT. Future research in this population is needed to determine what other factors predict withdrawal of LSMT and what resources, such as social workers and/or ethics consults, are utilized. (shrink)

Background: Mild traumatic brain injury results from an external force to the head or body causing neurophysiological changes within the brain. The number and severity of symptoms can vary, with some individuals experiencing rapid recovery, and others having persistent symptoms for months to years, impacting their quality of life. Current rehabilitation is limited in its ability to treat persistent symptoms and novel approaches are being sought to improve outcomes following mTBI. Neuromodulation is one technique used to encourage adaptive (...) neuroplasticity within the brain.Objective: To systematically review the literature on the efficacy of neuromodulation in the mTBI population.Method: A systematic review was conducted using Medline, Embase, PsycINFO, PsycARTICLES and EBM Review. Preferred Reporting Items for Systematic Reviews and the Synthesis Without Meta-analysis reporting guidelines were used and a narrative review of the selected studies was completed. Fourteen articles fulfilled the inclusion criteria which were published in English, investigating an adult sample and using a pre- and post-intervention design. Studies were excluded if they included non-mild TBI severities, pediatric or older adult populations.Results: Thirteen of fourteen studies reported positive reductions in mTBI symptomatology following neuromodulation. Specifically, improvements were reported in post-concussion symptom ratings, headaches, dizziness, depression, anxiety, sleep disturbance, general disability, cognition, return to work and quality of life. Normalization of working memory activation patterns, vestibular field potentials, hemodynamics of the dorsolateral prefrontal cortex and excessive delta wave activity were also seen. The studies reviewed had several methodological limitations including small, heterogenous samples and varied intervention protocols, limiting generalisability. Further research is required to understand the context in which neuromodulation may be beneficial.Conclusions: While these positive effects are observed, limitations included unequal representation of neuromodulation modalities in the literature, and lack of literature describing the efficacy of neuromodulation on the development or duration of persistent mTBI symptoms. Better clarity regarding neuromodulation efficacy could have a significant impact on mTBI patients, researchers, clinicians, and policy makers, facilitating a more productive post-mTBI population. Despite the limitations, the literature indicates that neuromodulation warrants further investigation. PROSPERO registration number: CRD42020161279. (shrink)

Objectives The potential effects of exposure to repetitive subconcussive head impacts through routine participation in sport are not understood. To investigate the effects of repetitive subconcussive head impacts we studied boxers following customary training (sparring) using transcranial magnetic stimulation (TMS), decomposition electromyographic (EMG) and tests of memory. Methods Twenty amateur boxers performed three 3-min sparring bouts. Parameters of brain function and motor control were assessed prior to sparring and again immediately, 1 h and 24 h post-sparring. Twenty control (...) participants were assessed following mock-sparring. Results One hour after sparring boxers showed increased corticomotor inhibition, altered motor unit recruitment strategies, and decreased memory performance relative to controls, with values returning to baseline by the 24 h follow up. Conclusion Repetitive subconcussive head impacts associated with sparring resulted in acute and transient brain changes similar to those previously reported in soccer heading, providing convergent evidence that sport-related head impacts produce a GABAergic response. These acute changes in brain health are reminiscent of effects seen following brain injury, and suggest a potential mechanism underlying the damaging long-term effects of routine repetitive head impacts in sport. (shrink)

This article discusses the possibility of practitioners who mistake organic memory loss for dissociative amnesia. It starts with the case of a young man with complete retrograde amnesia due to a traumatic head injury. Because he did not show any gross neurological abnormalities, a neurologist thought his amnesia had a psychological origin. An extensive neuropsychological examination revealed that the man did have an organic reason for his amnesia. Next, the existence of dissociative memory loss as well as isolated (...) organic retrograde amnesia is considered. While cases of organic memory loss are well-documented, there is hardly any evidence for dissociative amnesia. It is argued that organic memory loss might be mistakenly taken for dissociative amnesia. In line with the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, practitioners are advised to rule out the possibility of organic memory loss, before diagnosing a patient with dissociative amnesia. (shrink)

SignificanceElectrical burns can cause severe damage to the nervous system, resulting in autonomic dysfunction with reduced cerebral perfusion. However, few studies have investigated these consequences.AimTo elucidate changes in prefrontal cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS) during the head-up tilt table test (HUT) for patients with electrical burns.ApproachWe recruited 17 patients with acute electrical burns within 1 week after their accidents and 10 healthy volunteers. The NIRS parameters acquired using an fNIRS device attached to the forehead were analyzed in (...) five distinct HUT phases.ResultsBased on their HUT response patterns, patients with electrical burns were classified into the group with abnormal HUT results (APG, n = 4) or normal HUT results (NPG, n = 13) and compared with the healthy control (HC, n = 10) participants. We found trends in hemodynamic changes during the HUT that distinguished HC, NPG, and APG. Reduced cerebral perfusion and decreased blood oxygenation during the HUT were found in both the NPG and APG groups. Patients with electrical burns had autonomic dysfunction compared to the HC participants.ConclusionsUsing fNIRS, we observed that acute-stage electrical burn injuries could affect cerebral perfusion. (shrink)

In Ernst Friedrich's Krieg dem Kriege there is a large section of photographs of survivors of World War I with the most hideous disfigurements of the face: jaws are missing, gaping slashes stare out where mouths should be. Friedrich leaves this gallery of ‘untouchables’ to the end of the book as if to achieve the maximum debasement of military glory and heroism. The head and face are obviously the most vulnerable part of the body in warfare – brutal wounds (...) to the face and decapitations are common. In World War I, a number of hospitals were set up to deal solely with head-wounds, developing the basis of what we now know as plastic surgery. Yet, in the representation of combat on screen, even in the most candid and unsentimental of war films, such as Hamburger Hill and Platoon, injuries to the face are rare or nonexistent. This absence has something to do with the difficulty of producing convincing prosthetic wound-cavities on the head; blown-off limbs can obviously be created with ease through covering up the actor's extant limb with padded clothing; bloody disembowellings can be simulated with the judicious use of imitation innards and the illusionistic application of broken flesh, and so on. But the problems of modelling head-wounds clearly only half-explain the consistency of the absence. (shrink)

Academic scholarship has steadily reported unfavourable clinical findings on the sport of boxing, and national medical bodies have issued calls for restrictions on the sport. Yet, the positions taken on boxing by medical bodies have been subject to serious discussions. Beyond the medical and legal writings, there is also literature referring to the social and cultural features of boxing as ethically significant. However, what is missing in the bioethical literature is an understanding of the boxers themselves. This is apart from (...) their brain injuries, the debates about the degenerative brain disease known as chronic traumatic encephalopathy (CTE), and related issues about the disease. This article argues that the lives of boxers, their relationships, their careers, and their futures, also requires its own research, particularly in telling stories about their lives, and those lives and futures which boxing affects. The article uses two approaches. First, to imagine a more enduring “whole of life viewpoint” by using an extended future timeframe. Second, to consider perspectives of a person’s significant others. After reviewing the boxing literature, the article discusses social settings and then explores the hidden social relationships in life after boxing. With these longer time and close relationship viewpoints, three important themes emerge: family and kinship; age, stage and career; and the effects of boxing fatalities. These analyses are used in conjunction with relevant clinical findings. which complement the telling of stories to improve medical information, and engages professional and public empathy for people’s experience of illness and difficulties in coping. (shrink)

Bicycle helmets protect against head injury. Mandatory helmet laws likely increase their use. Although 21 states and Washington, DC have mandatory helmet laws for youth bicyclists, no U.S. state has a mandatory helmet law that applies to all ages; however, some localities have all-age helmet laws for bicyclists. This study abstracted local helmet laws applicable to all-ages to examine their elements.

Comparisons have been made between the tobacco industry’s historic tactics in defending their products with the responses of some key actors in the sports world to head injuries. Both, it is said, have deployed deceptive marketing and advertising techniques to entice youth to engage with a subjective pleasure-producing product that has undeniable short- and long-term health detriments. Unlike what is called euphemistically, ‘Big Tobacco’, however, the National Football League (NFL) has evaded legal restrictions on the promotion of an inherently (...) dangerous product that targets youth. By contrast, in 1997, the Federal Trade Commission charged tobacco company R.J. Reynolds with violating federal law by using a cartoon character, Joe Camel, to allure children under age 18. The NFL has partnered with Nickelodeon to produce programs such as NFL Rush Zone and NFL Slimetime that target youth by using cartoon mascots, bright colors, 3D iconography, and other child-friendly symbols. In addition to fostering positive associations between tackle football and cartoons, these broadcasts have explicitly minimized the risks of tackling. For example, one NFL Playoffs on Nickelodeon announcer equated a forceful head collision with a scrape of the knee that a child might experience during school recess. The NFL’s marketing strategies deflect public attention away from the risks of repetitive head collisions, concussions, traumatic brain injury (TBI), and chronic traumatic encephalopathy (CTE), portraying football as an appealing activity. The ongoing connections between the NFL and youth-oriented television programming raise crucial questions about how risk is communicated in a sport with inherent dangers of long-term cognitive damage. As long as tackle football is portrayed alongside beloved cartoon characters such as Spongebob Squarepants, impressionable children are likely to form undilutedly positive perceptions of the NFL and ignore the substantial risks of repeated, full-body collisions when enchanted by brightly-colored slime, animated bubbles, and goofy dance moves. (shrink)

The fatal on-field head injury and subsequent death in Sydney of 25-year-old professional cricketer Phillip Hughes has led to an exceptional outpouring of shock and grief throughout Australia, the cricketing world, and beyond. It was not just one more death. Not even the particular poignancy of a promising young life cut brutally short can account for the reaction.There were heartfelt tributes from players, prime ministers, and presidents. Parliament observed a minute’s silence. The Queen sent a private message to (...) Hughes’s parents. Schoolboy cricketers formed guards of honor and wore black armbands. One batsman paused as his run tally reached 63 to kiss his own black armband (63 was as far as Hughes got before his.. (shrink)

The Mental Capacity Act 2005 has stipulated that in England and Wales the ethical implications of carrying out research with people who are unable to consent must be considered alongside the ethical implications of excluding them from research altogether. This paper describes the methods that were used to enable people with severe and profound intellectual disabilities, who lacked capacity, to participate in a study that examined their experience of receiving intimate care. The safeguards that were put in place to protect (...) the rights and well-being of participants are described, and it is argued that the approaches used in this study met the requirements set out in the Mental Capacity Act 2005. Although this paper is based on research involving people with intellectual disabilities, it has implications for research involving other groups who may also lack capacity to consent, including people with mental health problems, head injuries and dementia. (shrink)

Objectives: The N2b is an event-related potential component thought to index higher-order executive function. While the impact of concussion on executive functioning is frequently discussed in the literature, limited research has been done on the role of N2b in evaluating executive functioning in patients with concussion. The aims of this review are to consolidate an understanding of the cognitive functions reflected by the N2b and to account for discrepancies in literature findings regarding the N2b and concussion.Methods: A scoping review was (...) conducted on studies that used the N2b to measure cognitive functioning in healthy control populations, as well as in people with concussions.Results: Sixty-six articles that met inclusion criteria demonstrated that the N2b effectively represents stimulus-response conflict management, response selection, and response inhibition. However, the 19 included articles investigating head injury found widely varied results: some studies found the amplitude of the N2b to be increased in the concussion group, while others found it to be decreased or unchanged.Conclusion: Based on the available evidence, differences in the amplitude of the N2b have been linked to response selection, conflict, and inhibition deficits in concussion. However, due to large variations in methodology across studies, findings about the directionality of this effect remain inconclusive. The results of this review suggest that future research should be conducted with greater standardization and consistency. (shrink)

Interest groups are advancing new statutory provisions to limit the liability of persons involved in equine activities. The first statute was adopted in Washington State five years ago, and subsequently twenty-nine other states have proceeded to adopt legislation regarding this issue. The new statutes, termed “Equine Liability Statutes,” provide immunity from liability for injuries and death arising from ordinary risks of equine activities. Drawing from policies involving the provision of assistance for needy interest groups and voluntary social prerequisites, two recommendations (...) may be proffered. First, the good samaritan and recreational use models suggest that the statutes might require a donation to offset the loss of participants' rights before a person could qualify for the statutory dispensation. Second, an additional safety prerequisite regarding a helmet to encourage action to reduce head injuries may be appropriate to foster safer equine activities. (shrink)

Professional sports with high rates of concussion have become increasingly concerned about the long-term effects of multiple head injuries. In this context, return-to-play decisions about concussion generate considerable ethical tensions for sports physicians. Team doctors clearly have an obligation to the welfare of their patient (the injured athlete) but they also have an obligation to their employer (the team), whose primary interest is typically success through winning. At times, a team’s interest in winning may not accord with the welfare (...) of an injured player, particularly when it comes to decisions about returning to play after injury. Australia’s two most popular professional football codes—rugby league and Australian Rules football—have adopted guidelines that prohibit concussed players from continuing to play on the same day. I suggest that conflicts of interest between doctors, patients, and teams may present a substantial obstacle to the proper adherence of concussion guidelines. Concussion management guidelines implemented by a sport’s governing body do not necessarily remove or resolve conflicts of interest in the doctor–patient–team triad. The instigation of a concussion exclusion rule appears to add a fourth party to this triad (the National Rugby League or the Australian Football League). In some instances, when conflicts of interest among stakeholders are ignored or insufficiently managed, they may facilitate attempts at circumventing concussion management guidelines to the detriment of player welfare. (shrink)

Over the past decade, a flurry of media stories devoted to sports-related concussions have drawn attention to the previously “silent epidemic” of traumatic brain injury in athletes. From 2001 to 2009, the annual number of sports-related TBI emergency department visits in individuals age 19 and under climbed from 153,375 to 248,414, an increase of increase of 62 percent. Multiple head injuries place youth athletes at risk for serious health conditions, including cerebral swelling, brain herniation, and even death — (...) postconcussive conditions that have collectively been referred to as “second impact syndrome.” Studies have shown that children and teens — and girls, in particular — are more likely to sustain a concussion and have a longer recovery time than adults. Recent research also suggests that even subconcussive hits in children and adolescents may result in longer-term health effects such as decreased cognitive functioning, increased rates of depression, memory problems, and mild cognitive impairment. (shrink)

Two pediatric accidents in Jane Austen’s Persuasion and one in Margaret Oliphant’s The Doctor’s Family are examined from the point of view of trauma management with analysis of contributing risk factors, medical management, concerns of parents and bystanders, and course of recovery. Risk factors for injury are impulsivity, poor supervision, and parents who are unable to set limits. Medical attention is swift and competent, but no heroic measures are used; the management of the injuries, concussion with loss of consciousness (...) and dislocation of the collar bone, is consistent with the way these conditions are, for the most part, still managed today, and successful recovery depends on careful nursing and rest. Louisa Musgrove, who suffers a severe head injury, requires ten weeks of convalescence and undergoes a marked personality change, which we might today attribute in part to post-concussion syndrome but which may reflect contemporary debate about the biological basis of personality and behavior. A sudden traumatic injury to a child or adolescent changes the narrative abruptly, in fiction or in life, dividing a story into before and after, introducing grief and anxiety, and requiring that plans be rethought and personal relationships reshuffled with decisions about caretaking and nursing. (shrink)

Abstract:Patients with repeated minor head injury are a challenge to our clinical skills of neurodiagnosis because the relevant evidence objectively demonstrating their impairment was collected in New Zealand (although published in theBMJandLancet) and, at the time, was mired in controversy. The effects of repeated closed diffuse head injury are increasingly recognized worldwide, but now suffer from the relentless advance of imaging technology as the dominant form of neurodiagnosis and the considerable financial interests that underpin the refusal (...) to recognize that acute accelerational injury is the most subtle and insidiously damaging (especially when seen in the light of biopsychosocial medicine), and potentially one of the most financially momentous (given the large incomes impacted and needing compensation) phenomena in modern sports medicine. The vested interests in downplaying this phenomenon are considerable and concentrated in North America where diffuse head injury is a widespread feature of the dominant winter sports code: Gridiron or American Rules football. The relationship of this to shattered lives among the brightest and best of young men and the relatively dated objective evidence are a toxic mix in terms of ethical analysis and, therefore, there is a malignant confluence of social forces that tends toward minimizing the injury. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Death Perception:How Temporary Ventilator Disconnection Helped my Family Accept Brain Death and Donate OrgansThomas B. FreemanThe night of my nephew’s closed head injury in Boston, I was on call as a neurosurgeon at Tampa General Hospital. I was therefore not shocked at first when my telephone rang at four o’clock in the morning, but I soon understood the severity of the tragic news. The next half hour (...) was a blur of frantic phone calls and devastating decisions leading to surgery to remove a subdural hematoma from my nephew’s head, even though he was only two brain stem reflexes away from brain death.I thought that my experience as a neurosurgeon would somehow help me. However, when my sister–in–law asked me if this was just like the other tragic closed head injuries that I had seen in 26 years of practice, my answer was very simple: this was the only severe closed head injury I had ever seen—in my family. At this point, I was no longer a neurosurgeon. I was an uncle. My nephew’s closed head injury overwhelmed both his brain’s capacity to survive and my entire family’s ability to think rationally or objectively while grieving so intensely.It is in this context that we were asked to consider organ donation. The appeal for organ donation is one of altruism. My nephew’s parents agreed that organ donation would be an important way to honor their son’s life, allow him to make one final contribution to save the lives of several patients, and help to bring peace to the family.I will never forget, however, my niece’s distraught response. She is altruistic by nature, but was tremendously conflicted by the choice to donate her own brother’s organs. At this point, all discussions about organ donation stopped until we could understand the source of her conflict. Since she did not have legal authority regarding the final decision, some family members wondered if organ donation should be allowed if she could not come to terms with the choice. She felt isolated, because she was the only person in the room who was experiencing conflict. As a neurosurgeon, I have always advised other families in this situation that they may have more peace if they can make such decisions unanimously, regardless of who has the ultimate legal authority for decision–making. This helps bring healing to the family, eliminates disruption of family values and unity, and reduces possible feelings of guilt.I asked my niece what she was feeling. She stated something that I had never heard before as a neurosurgeon. She had listened to the words that her brother was brain dead, but she felt that he was somehow still alive, since he was breathing on a ventilator and his heart was beating. She felt powerless due to her inability to do anything more for [End Page 9] him. She also wanted to be there when her brother “died,” which she would recognize by the cessation of his heartbeat. She would not abandon her brother.I searched for a way to respect my niece’s wishes and her legitimate request, while preserving the ability to proceed with organ donation. Solving this conundrum proved to be a pivotal part of the beginning of both her mourning process and acceptance of his death.As an uncle, I experienced the clear dissociation that modern medicine creates between medical care and the natural human process of recognizing and accepting death. My family observed the subtle difference between a deep coma and brain death. They noticed that my nephew’s color had changed when his temperature dropped to 94o F before the heating blanket was placed. They perceived the decrease in muscle tone when he stopped breathing faster than the ventilator rate. Outside of that, there was no significant difference in his appearance when he was “alive” or “dead.”In spite of heroic measures and superlative surgical and medical care, his closed head injury progressed unremittingly until he became brain dead 36 hours later. The diagnosis of “brain death” was pronounced to the family. Accepting the death of someone who is... (shrink)

Next SectionMany jurisdictions require cyclists to wear bicycle helmets. The UK is currently not one of these. However, an increasing number of interest groups, including the British Medical Association, want to change the status quo. They argue that mandatory cycle helmet laws will reduce the incidence of head injuries and that this will be both good for cyclists (because they will suffer fewer head injuries) and good for society (because the burden of having to treat cyclists suffering from (...) head injuries will be reduced). In this paper we argue against this position. We suggest that cycle helmets may not be especially effective in reducing head injuries and we suggest that the imposition of such a restrictive law would violate people's freedom and reduce their autonomy. We also argue that those who accept such a restrictive law would be committed to supporting further legislation which would force many other groups – including pedestrians – to take fewer risks with their health. We conclude that cycle helmet legislation should not be enacted in the UK unless, perhaps, it is restricted to children. (shrink)

The Mental Capacity Act 2005 has stipulated that in England and Wales the ethical implications of carrying out research with people who are unable to consent must be considered alongside the ethical implications of excluding them from research altogether. This paper describes the methods that were used to enable people with severe and profound intellectual disabilities, who lacked capacity, to participate in a study that examined their experience of receiving intimate care. The safeguards that were put in place to protect (...) the rights and well-being of participants are described, and it is argued that the approaches used in this study met the requirements set out in the Mental Capacity Act 2005. Although this paper is based on research involving people with intellectual disabilities, it has implications for research involving other groups who may also lack capacity to consent, including people with mental health problems, head injuries and dementia. (shrink)

The patient was a 19-year-old man who was the victim of an accidental head injury. The attending neurosurgeon felt that, due to uncontrollable and repeated elevated intracranial pressures, the patient would die within 48 hours. The patient's mother requested that the neurosurgeon contact a urologist to collect the patient's sperm for implantation into the patient's girlfriend. The neurosurgeon felt that the situation raised a number of ethical issues and requested that the hospital's bioethics committee consider the case.

Decompressive craniectomy is a technically straightforward procedure whereby a large section of the cranium is temporarily removed in cases where the intracranial pressure is dangerously high. While its use has been described for a number of conditions, it is increasingly used in the context of severe head injury. As the use of the procedure increases, a significant number of patients may survive a severe head injury who otherwise would have died. Unfortunately some of these patients will (...) be left severely disabled; a condition likened to the RUB, an acronym for the Risk of Unacceptable Badness. Until recently it has been difficult to predict this outcome, however an accurate prediction model has been developed and this has been applied to a large cohort of patients in Western Australia. It is possible to compare the predicted outcome with the observed outcome at 18 months within this cohort. By using predicted and observed outcome data this paper considers the ethical implications in three cases of differing severity of head injury in view of the fact that it is possible to calculate the RUB for each case. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of Health and Human (...) Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

The cognitive and behavioral functions of the frontal lobes have been of great interest to neuroscientists, neurologists, psychologists and psychiatrists. Recent technical advances have made it possible to trace their neuroanatomical connections more precisely and to conduct evoked potential and neuroimaging studies in patients. This book presents a broad and authoritative synthesis of research progress in this field. It encompasses neuroanatomical studies; experiments involving temporal organization and working memory tasks in non-human primates; clinical studies of patients following frontal lobe excisions (...) for intractable epilepsy; metabolic imaging in schizophrenia and affective disorder; neurobehavioral studies of patients with dementia, frontal lobe tumors, and head injuries; magnetic resonance imaging methods for studying human frontal lobe anatomy; theoretical approaches to describing frontal lobe functions; and rehabilitation of patients with frontal lobe damage including their core problem of diminished awareness. Written by a distinguished group of neuroscientists, psychologists and clinicians, Frontal Lobe Function and Dysfunction provides the best current source of information on this region of the brain and its role in cognition, behavior and clinical disorders. (shrink)