Improving how health care providers respond to medical injury requires an understanding of patients’ experiences. Although many injured patients strongly desire to be heard, research rarely involves them. Institutional review boards worry about harming participants by asking them to revisit traumatic events, and hospital staff worry about provoking lawsuits. Institutions’ reluctance to approve this type of research has slowed progress toward responses to injuries that are better able to meet patients’ needs. In 2015–2016, we were able to surmount (...) these challenges and interview 92 injured patients and families in the USA and New Zealand. This article explores whether the ethical and medico‐legal concerns are, in fact, well‐founded. Consistent with research about trauma‐research‐related distress, our participants’ accounts indicate that the pervasive fears about retraumatization are unfounded. Our experience also suggests that because being heard is an important (but often unmet) need for injured patients, talking provides psychological benefits and may decrease rather than increase the impetus to sue. Our article makes recommendations to institutional review boards and researchers. The benefits to responsibly conducted research with injured patients outweigh the risks to participants and institutions. (shrink)

Background: Informed consent in the modern era is a common and important topic both for the well-informed patient and to prevent unnecessary litigation. However, the effectiveness of informed consent in trauma patients is an under-researched area. This paper aims to assess the differences in patient recall of the consent process and desire for information by performing a comparative analysis between orthopaedic trauma and elective patients. Methods: Information from 41 consecutive elective operations and 40 consecutive trauma (...) operations was collected on the first post-operative day. Results: 100% of elective patients and 90% of trauma patients knew what operation they had received (p = 0.06). Overall recall of complications was poor, but was significantly lower in trauma patients compared with elective patients (62% vs 22%, p<0.001). 30% of trauma patients desired more information about their operation compared to 12% of elective patients (p = 0.049), although only 35% of trauma patients wanted written as well as verbal explanations, compared to 85% of elective patients p<0.001). Overall 100% of elective and 90% of trauma patients were happy with the consent process (p = 0.06). Subset analysis of neck of femur compared to other trauma patients showed that the above factors were not significantly different between the two groups. Conclusions: Recall of complications in the trauma patients is significantly lower than in elective patients, although both groups scored poorly overall. Repeated verbal explanations should be reinforced with the option of additional information leaflets for trauma operations. Further research into the usefulness of DVDs for commonly performed operations is warranted, although official internet resources may be more cost-effective. (shrink)

BackgroundThe impact of a cancer diagnosis may be traumatic, depending on the psychological resources used by patients. Appropriate coping strategies are related to better adaptation to the disease, with coping flexibility, corresponding to the ability to replace ineffective coping strategies, demonstrated to be highly related with self-efficacy to handle trauma. The Perceived Ability to Cope with Trauma scale is a self-rated questionnaire that assesses the perceived ability to cope with potentially traumatic events, providing a measure of coping flexibility. (...) The current study aimed at examining the psychometric properties of the PACT Scale in Portuguese patients with breast cancer.MethodsThe study included 172 patients recently diagnosed with early breast cancer. Participants completed a Portuguese version of the PACT scale, and instruments of self-efficacy for coping with cancer, of quality of life, and of psychological distress that were used as convergent and divergent measures, thus assessing construct validity. A confirmatory factor analysis was performed to test the factor structure of the Portuguese version of PACT scale and reliabilities were examined.ResultsResults from the CFA confirmed the two-factor structure, consistent with the original Forward and Trauma focus subscales. The two subscales demonstrated high internal consistencies. Convergent and divergent validities were confirmed: the PACT scale was related to high self-efficacy to cope with cancer, to high perceived quality of life, and to low psychological distress.DiscussionOverall, the current results support and replicate the psychometric properties of the PACT scale. The scale was found to be a valid and reliable self-reported measure to assess Portuguese breast cancer patients regarding beliefs about their capabilities in managing the potentially traumatic sequelae of cancer. The PACT is a simple and brief measure of coping flexibility to trauma, with potential relevance for application in clinical and research settings. (shrink)

Obtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients. We conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed that had experimental or observational study design and involved adult trauma (...) patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach. A total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information. Many articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients. (shrink)

"This unique text develops an original theoretical framework for understanding the relationship between trauma and time by combining phenomenological and psychoanalytical traditions. Moving beyond Western psychoanalytical and phenomenological traditions, this volume presents new perspectives on the assessment and treatment of trauma patients. Powerfully illustrating how the temporal dimension of a patient's symptoms has until now been overlooked, the text presents a wealth of research literature to deepen our understanding of how trauma disrupts individual temporal experience. (...) Ultimately, the resulting phenomena that occur, positions time as a transdiagnostic psychological dimension, closely connected to the subject's sense of self. This text will benefit researchers, academics, and educators with an interest in psychoanalysis, phenomenology, and trauma and dissociation studies more broadly. Those specifically interested in the philosophy of the mind, Freud, and psychotherapy will also benefit from this book. Selene Mezzalira has completed PhDs in Philosophy and Clinical Psychology at the University of Padova, Italy, and Ryokan College, USA respectively. She has been a visiting scholar at Columbia University in the city of New York and at the University of California, Irvine, USA"--. (shrink)

Recent research supports the hypothesis that more active engagement of the patient in occurring illnesses improves quality of life and probably even life expectancy.In this study experience and theoretical knowledge from psychotherapy is transplanted to clinical practice in order to improve the physician''s engagement in the patient-disease relationship. By defining severe and long-term illnesses as a psychotrauma, the transfer of the psychotherapeutical model leads to the creation of a new triangular relationship: patient-illness-doctor. Practical examples are used (...) as illustrations for the conceptual differences between psychotherapy and clinical medicine. Options for dialogue show the difference between adaptation (learning to live with) and adjustment (active coping strategies and controlling). The hypothesis is that a better dialogue will reduce illness-related stress, giving the patient better and more effective access to personal psychic and physical support systems. (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)

Patients in specialist mental healthcare services who are at risk of suicide may experience their struggles as existential in nature. Yet, research on meaning in life has been relatively scarce in suicidology. This qualitative study aimed to explore how patients at risk of suicide perceived their encounters with specialist healthcare professionals after a suicide attempt (SA), with special reference to meaning in life experiences. The study was conducted in specialised mental healthcare services in Norway. Data were collected via individual (...) interviews with eight patients aged 20–75 years. Using a four-step procedure, the interviews were analysed by systematic text condensation. The participants understood their feelings of shame, self-contempt and challenging life experiences as contributing factors to their SA. They perceived that existential themes in relation to financial difficulties, shame and trauma were resolved, while issues associated with the SA, such as death, loss and beliefs, were given less attention. The participants were either ambivalent about continuing to live or wished to rebuild a meaningful life. Overall, their experiences of meaningfulness were hampered. Assisting patients with meaning in life experiences may help them alter their life interpretations and increase their ability to rebuild their lives as meaningful. The present study should be seen as a contribution to meaning-informed approaches in specialist mental healthcare services. More research is needed to equip healthcare personnel in their overall aims of preventing suicide and supporting patients at risk in their efforts to live a meaningful life. (shrink)

Having a decreased sense of security leads to unnecessary suffering and distress for patients. Establishing trust is critical for nurses to promote a patient's sense of security, consistent with trauma‐informed care. Research regarding nursing action, trust, and sense of security is wide‐ranging but fragmented. We used theory synthesis to organize the disparate existing knowledge into a testable middle‐range theory encompassing these concepts in hospitals. The resulting model illustrates how individuals are admitted to the hospital with some predisposition (...) to trust or mistrust the healthcare system and/or personnel. Patients encounter circumstances increasing their emotional and/or physical vulnerability to harm, leading to experiences of fear and anxiety. Without intervention, fear and anxiety lead to a decreased sense of security, increased distress, and suffering. Nurse action can ameliorate these effects by increasing a hospitalized person's sense of security or by promoting the development of interpersonal trust, also leading to an increased sense of security. Increased sense of security results in diminished anxiety and fear, and increased hopefulness, confidence, calm, sense of value, and sense of control. The consequences of a decreased sense of security are harmful to patients and nurses should know that they can intervene in ways that both increase interpersonal trust and sense of security. (shrink)

Clinical experience suggests that adult survivors of childhood trauma arrive at their memories in a number of ways, with varying degrees of associated distress and uncertainty and, in some cases, after memory lapses of varying duration and extent. Among those patients who enter psychotherapy as a result of early abuse, three general patterns of traumatic recall are identified: relatively continuous and complete recall of childhood abuse experiences coupled with changing interpretations of these experiences, partial amnesia for abuse events, accompanied (...) by a mixture of delayed recall and delayed understanding, and delayed recall following a period of profound and pervasive amnesia. These patterns are represented by three composite clinical vignettes. Variations among them suggest that the phenomena underlying traumatic recall are continuous not dichotomous. Future research into the nature of traumatic memory should be informed by clinical observation. (shrink)

According to the biomedical model of medicine, the subject of the illness event is the pathology rather than the person diagnosed with the disease. In this view, a body-self becomes a ‘patient’ body-object that can be enrolled in a therapeutic protocol, investigated, assessed, and transformed. How can it be possible for cancer patients to make sense of the opposite dimensions of their body-self and their body-diseased-object? Could a creative embodied approach enable the coping with trauma tied to the (...) experience of illness? By applying a phenomenological approach and auto-ethnographic analysis to the experience of cancer, this visual exploration provides support for rethinking the cancer event through a performative perspective. This work previews images and video material collected over ten years of haematological treatments, video dance performances and physical explorations. This work displays how processes of healing can be set in motion by creative embodied practices, physical explorations and unexpected journeys. By resisting the biomedical model and allowing the emergence of new meanings, it illustrates how dance and performative practices offer ground for transformation. (shrink)

INDUS-EM is India’s only level one conference imparting and exchanging quality knowledge in acute care. Specifically, in general and specialized emergency care and training in trauma, burns, cardiac, stroke, environmental and disaster medicine. It provides a series of exchanges regarding academic development and implementation of training tools related to developing future academic faculty and residents in Emergency Medicine in India. The INDUS-EM leadership and board of directors invited scholars from multiple institutions to participate in this advanced educational symposium that (...) was held in Thrissur, Kerala in October 2013. (shrink)

Every person in the course of his or her life has some contact with the medical profession. And in recent years that profession has been revolutionised in the fields of research, of technology and of practice. Hardly has one advance been declared than it is superseded by another. At the same time, while community attitudes themselves change, group practices have taken some weight from doctors but perhaps have diminished the doctor/ patient relationship of previous years. Another change in (...) the oversight of the medical profession has been the growth of what is called medical ethics. What, for example, is the amount of information a doctor should give a patient prior to performing an experimental procedure? Amongst all these changes there are still fundamental issues where doctors have to use their personal judgment as to what to do or what to say. For Max Griffiths this is where ethical considerations become matters of medical morality. He outlines a broad range of situations which frequently confront both doctor and patient, requiring sympathetic understanding on each side. Some of these arise out of the radical changes which have occurred in community attitudes and practices. Abortion and euthanasia are two important examples. Others range from growing pains and teenage trauma to ageing and dealing with dying and with loss. From his extensive associations with patients in a wide variety of situations the author tackles those issues which demonstrate what makes a good doctor. The result is a book that is for doctors and patients alike. Max Griffiths' involvement in medical matters range from responsibility for outback hospitals in places like Birdsville, Oodnadatta, Halls Creek and Fitzroy Crossing to long term membership of the board of the Austin Hospital in Melbourne. In this latter capacity he chaired committees responsible for the oversight of medical research, especially the protection of patients' rights. He was also involved in similar committees at the Royal Children's Hospital in Melbourne and the Royal Darwin Hospital. As a long term minister of religion his visits to his parishioners both at home and in hospitals gave him a deep insight into their anxieties. He was also a foundation member of Ronald McDonald House and chairman of several institutions engaged in the care of children with disabilities. [Subject: Sociology, Health Care, Medical Ethics]. (shrink)

The integrity of critical ethnography requires engagement in reflexive practice at all phases of the research process. In this discussion paper, I explore the insights and challenges of reflexive practice in an ethnographic study of the recovery experiences of black trauma patients in a Philadelphia hospital. Observation and interviews were conducted with twelve patients who were admitted to trauma‐designated units of the hospital over the course of a year. During fieldwork, I learned the ways that my background (...) as a professional nurse structured my way of being in clinical space and facilitated a particular interpretation of clinical culture. In analysis, reflection on subjectivities through which I designed this ethnographic research allowed me to see beyond my preconceived and theoretically informed perspective to permit unexpected features of the field to emerge. Reflexive practice also guided my reconciliation of key practical and epistemological differences between clinical ethnographic research and the anthropologic tradition in which it is rooted. I conclude that with careful reflection to the subjectivities that influence the research process, interdisciplinary clinically relevant applied interpretations of critical ethnographic work can be used to generate detailed knowledge across contexts in clinical care, nursing practice, and patient experiences. (shrink)

Introducción: la formación de profesionales competentes es una de las misiones esenciales de la Educación Médica Superior, esto exige que los tecnólogos posean habilidades comunicativas para un correcto desempeño laboral en aras del mejoramiento humano. Objetivo de la investigación: identificar las barreras que inciden en la comunicación tecnólogo - paciente en las carreras de Licenciatura en Traumatología, Podología, Terapia Física y Rehabilitación Social Ocupacional, en áreas de rehabilitación. Métodos: se presenta un estudio observacional, descriptivo longitudinal y retrospectivo entre junio de (...) 2008 y junio 2011 que consistió en la observación a exámenes estatales prácticos y a la educación en el trabajo, en las carreras de referencia, además se aplicó una encuesta a pacientes para la obtención de información acerca de las barreras que afectan el proceso de la comunicación entre tecnólogos y pacientes. Resultados: existen insuficiencias en la comunicación entre los futuros profesionales y pacientes. Conclusiones: se demuestra un insuficiente dominio de las habilidades comunicativas y por tanto barreras que interfieren en la comunicación como las semánticas y personales. Introduction: the training of competent professionals is one of the essential missions of higher medical education; this requires that technologists have communication skills in order to develop a proper job performance for the sake of human improvement. So the objective of the research is to identify barriers affecting technologist - patient communication in the careers of degree in Trauma, Podiatry, Physical Therapy, and Occupational Social Rehabilitation in areas of rehabilitation. Methods: an observational, longitudinal descriptive and retrospective study is presented between June 2008 and June 2011 that consisted on observation to practical state exams and training at work, in the reference degrees; in addition, a survey was applied to patients to obtain information about the barriers that affect the communication process between technologists and patients. Results: there are communication inadequacies between the future professionals and patients. Conclusions: An insufficient mastery of the communication skills is demonstrated and therefore barriers that interfere with communication as the semantic and personal barriers. (shrink)

Owing to its grappling with a motley of intricate socioeconomic, as well as medico-legal, crises, Haiti has found itself bereft of some of its people, many of whom have had to leave the Caribbean country in search of improved lives elsewhere. Receiving some of the Haitian refugees fleeing abject poverty, unemployment, and other harms and barriers has been the United States, one of Haiti's northern neighbors and a country that has played an outcome-determinative, if not outsized, role in steering the (...) country toward its presently hobbled state. Drawing on the U.S.’s recent treatment of Haitian refugees, this paper argues that U.S. reception of Haitian immigrants rubs salt in the wound of a long history of dehumanizing and oppressive abuses endured by Haitians. Furthermore, and more importantly, this paper posits that U.S. failure to wholly embrace its legal obligation to accept Haitian refugees under international law needs to be understood in the light of the specific horrors inflicted by science, in pre-independence Haiti, on non-consenting, Afro-Haitian experimental subjects. And by extension, such a contextually-nuanced understanding is crucial in shaping the delivery of healthcare services to Haitian refugees fortunate enough to remain in the U.S. —as an awareness and appreciation of the socio-historical context of patients' lived experiences, i.e., their complete social history, can furnish important clues vis-à-vis the presence and etiologies of disease, influence the foci of physical exams, and generally pave the way for the provision of cost-efficient and evidence-based care. (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)

This study appeared in full in the last issue of Research Ethics Review : 68). MJ's research focuses on those patients with brain damage following trauma such as a road traffic accident. She wants to find out about their experiences of daily life once they have been discharged from hospital. She plans to use a phenomenological approach in which each participant will be asked to take part in a series of in-depth interviews, via email, over a period (...) of about two years. These interviews will allow her to compare participants' experiences in different parts of the UK. MJ has a research partner in Auckland; the two of them are planning a similar series of interviews in New Zealand to allow for comparison between participants' experiences in the two countries. (shrink)

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept (...) that in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials. (shrink)

Abstractabstract:Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened with many of the same disorders, calls to expand experimentation to minors are inevitable. This essay examines psychedelic research conducted on children from 1959 to 1974, highlighting methodological and ethical flaws. It provides ethics (...) and policy recommendations for psychedelics research involving children and adolescents, including recognizing that the psychedelic experience is an ineffable one that makes informed proxy consent for parents, guardians, and others especially challenging. Psychedelic experiences are associated with novel benefits and risks, such as significant personality changes, shifts in fundamental values, and possible re-exposure to traumatic memories. These effects may alter the process of personality development in minors. Recommendations for ethically sound psychedelics research in minors include strict adherence to eligibility criteria, including a comprehensive family and individual psychiatric, substance use, and trauma history. An age-appropriate assent process that includes considerations related to the use of therapeutic touch should be developed. In addition, oversight by data safety monitoring boards and patient and family advocates, coupled with the adoption of pharmacoequity best practices, will help to ensure safety and fairness of psychedelics research in children. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction to the Special Section on Psychedelics Research and TreatmentDominic SistiAgainst a backdrop of post-pandemic malaise, diseases of despair, and a fragmented mental health care system, psychedelics have enjoyed a resurgence of interest as powerful psychotherapeutic agents and as catalysts of personal growth. The true power of these substances—some of which are considered sacramental by Indigenous peoples—has been shrouded for half a century by cultural mythology, political propaganda, (...) and misuse. From about 1940 to 1970, psychedelics including psilocybin and LSD were studied and used by clinicians to treat a range of psychiatric disorders from alcoholism and depression in adults to "autistic schizophrenia" in children.In June 1971, the Nixon administration's racist and illiberal War on Drugs inaugurated what was essentially a total ban on psychedelics. Society was robbed of half a century of scientific progress, and one can only speculate how differently our society might now function, and how many people might have been spared the trauma of mental illness and incarceration. Thankfully, it appears the time has arrived for psychedelic medicines to be decriminalized and included again in the pharmacopeia.In June 2023, a group of psychedelic researchers, therapists, bioethicists, Indigenous scholars, and advocates met at the Banbury Conference Center at Cold Spring Harbor Laboratory. There, this interdisciplinary group discussed several pressing ethical issues in psychedelics research and treatment that continue to [End Page 114] challenge the field. The aim of this meeting was to develop a bioethical framework for the use of psychedelics in mainstream medical settings. That is, how should psychedelics be employed responsibly by everyday clinicians, including psychiatrists, psychologists, social workers, and other behavioral health-care providers? This special section offers a sampling of three topics in psychedelic bioethics raised by the Banbury group, several of whom appear as coauthors.In our first paper, Logan Neitzke-Spruill and colleagues offer an overview of explanatory models describing the therapeutic mechanisms of psychedelic substances and how each of these models generates unique ethical quandaries. Starting from molecular biology and moving to neural circuitry and networks, neurobiological models now propel contemporary scientific research into psychedelics. Knowing how these substances work on a molecular level may offer promising ways forward in the development of new molecules designed to treat serious mental illnesses and other neurologic conditions. Perhaps neuroplastic mechanisms will be harnessed to develop new therapies without necessitating a psychedelic trip—a controversial premise discussed in our third paper, by Katherine Cheung, Brian Earp, and David Yaden.Such "neuroreductionism" risks ignoring the subjective psychological and spiritual experiences of patients that appear to be pivotal in psychedelic-assisted therapy, often described as mystical and utterly transformative. At the psychological level, these substances engender a kind of vulnerability and suggestibility requiring clear ethical standards to ensure patients' psychological and physical safety. And so too, practitioners will need structural and cultural competency to recognize the spiritual or moral values that inspire patient reactions during and after their psychedelic experiences. Ethically informed psychedelic practitioners will have to navigate between disciplinary silos and explanatory models. One practical upshot is the open question of how best to train psychedelic practitioners who hold this broad set of competencies.To that end, well-trained practitioners will need to be able to disclose in some way the transformative properties of psychedelics to prepare patients for their experiences. But how does one describe the ineffable? This raises the question of how or if it is possible for patients to truly consent to the transformative experience elicited by psychedelics, often described as one of the most important experiences of a person's life. The experience might stimulate significant emotional healing, or it might be horrifying. This sounds like a problem uniquely attached to psychedelics: after all, most pharmaceuticals don't trigger changes in one's fundamental moral values, life choices, and commitments, nor are they intended to. Yet, Brent Kious, Andrew Peterson, and Amy McGuire challenge the view that the psychedelic experience is uniquely transformative and impervious to the disclosure requirements of informed consent, a bedrock of bioethics. Ultimately, the writers show how consent is possible even if the experiences are dramatically different from most medical interventions, endorsing a practical view of consent [End... (shrink)

Public participation and survivor research in mental health are widely recognized as vital to the field. At the same time, contributions of patient collaborators can present unique challenges to determining authorship. Using an unresolved dispute around research contributions to the American Psychiatric Association’s Psychiatric Services journal, authorship and contribution are addressed. Recommendations are suggested to prevent dilemmas and achieve responsible research credit inclusion, especially among researchers with different backgrounds and asymmetric power relations. Researchers and publishers can (...) prepare proactively for conflict through consensus on authorship criteria, prior agreements around author inclusion, arrangement for third party dispute resolution, transparency in communication and contracts, notification to prospective publications of pending disputes, a contributor-guarantor model of contribution, journal editor “expressions of concern” when authorship disputes go unresolved, and expectation of conflict as generative. (shrink)

The number of traumatic events that occur worldwide is increasing, yet the literature pays little attention to their implications for leader development. This paper calls for a consideration of how collective trauma such as genocides and the Holocaust can shape the cognition of leaders who are second- and third-generation descendants. Drawing on research on the transgenerational transmission of collective trauma, social learning, social identity and psychodynamic theories, we identify three mechanisms through which collective trauma can be (...) transmitted to leaders: cultural artifacts, community events and family narratives. In this article, we introduce the topic of collective trauma in leader development and draw on the theories of psychodynamic, social identity and social learning to explain how the transmission of collective trauma occurs. We also propose how the transmitted trauma shapes leader cognition, values and behaviors. This framework can serve as a basis for future theory-building in leader and leadership development that will be key to the study of authentic and ethical leadership. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Background: The literature has shown a significant association between traumatic experiences and eating psychopathology, showing a greater symptomatology in patients with trauma history. Less is known about the associations between trauma and cognitive schemas, and personality traits and the differences between childhood and adulthood trauma experiences. Thus, this paper aims to assess the clinical and psychological characteristics of eating disorder (ED) patients, looking for differences between patients without a history of trauma and patients with trauma (...) experiences, as well as at possible differences between exposure in childhood, adulthood, or repeated events. Another aim of the paper is to evaluate the possible mediation role of cognitive schemas and personality traits in the relationship between early trauma and eating psychopathology.Methods: From January to November 2020, 115 consecutive inpatients admitted for a specific multidisciplinary ED treatment in a dedicated Unit were evaluated for trauma, differentiating between trauma occurring in childhood and adulthood. The subjects were evaluated for early maladaptive schemas (EMS), personality traits, trauma symptomatology, quality of life, and specific psychopathologies linked to EDs. Mediation analyses between childhood and adulthood trauma and eating psychopathology were performed, with EMS and personality traits as mediators.Results: Patients with a history of trauma showed higher physical and psychological symptomatology scores, with a more impaired clinical profile in patients with both childhood and adulthood trauma exposure. The mediation analysis showed a specific mediator role for the “disconnection and rejection (DR)” EMS factor in the relationship between childhood trauma (cT) and eating psychopathology.Conclusion: Trauma experiences are associated with more severe clinical symptomatology in EDs and may need a specific assessment in patients with failed outpatient standard treatments. Specific cognitive schemas linked to DR domain should be evaluated in treatments for ED patients with history of trauma due to the mediation role between trauma and eating psychopathology. The need for outcome studies about treatment approaches for ED patients with history of trauma is discussed. (shrink)

: When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective. Making treatment conditional on research participation will help researchers complete badly needed studies.

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in (...) a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective. Making treatment conditional on research participation will help researchers complete badly needed studies.

Based on action research as a practitioner‐involving approach, this article communicates the findings of a two‐year study on implementing patient participation as an empowering learning process for both patients and rehabilitation nurses. At a rehabilitation facility for patients who have sustained spinal cord injuries, eight nurses were engaged throughout the process aiming at improving patient participation. The current practice was explored to understand possibilities and obstacles to patient participation. Observations, interviews and logbooks, creative workshops and reflective (...) meetings led to the development and testing of four new rehabilitation initiatives aimed at enhancing patient participation. This study suggests that skills of critical reflection from action research toolbox shed light on both the notion of patient participation and caring in nursing rehabilitation. By actively involving nurses in research, the knowledge development stems from practice and the solutions therefore became practice‐oriented. In addition, the personal and professional development experienced by the involved nurses points to a secondary gain in the form of an analytical and reflective approach to complex issues in relation to patient participation, rehabilitation in general and the individual nurses' sense of professional pride. (shrink)

We propose the ‘patient-worker’ as a theoretical construct that responds to moral problems that arise with the globalization of healthcare and medical research. The patient-worker model recognizes that some participants in global medical industries are workers and are owed worker's rights. Further, these participants are patient-like insofar as they are beneficiaries of fiduciary relationships with healthcare professionals. We apply the patient-worker model to human subjects research and commercial gestational surrogacy. In human subjects research, (...) subjects are usually characterized as either patients or as workers. Through questioning this dichotomy, we argue that some subject populations fit into both categories. With respect to commercial surrogacy, we enrich feminist discussions of embodied labor by describing how surrogates are beneficiaries of fiduciary obligations. They are not just workers, but patient-workers. Through these applications, the patient-worker model offers a helpful normative framework for exploring what globalized medical industries owe to the individuals who bear the bodily burdens of medical innovation. (shrink)

One hundred eighty trauma-focused dissertations published in the United States were examined to determine the variation in risk language used in the informed consents. Level of risk proposed in the informed consents was poorly related to ratings of risk by graduate coders and virtually unrelated to vulnerability factors such as the age of participants and clinical or nonclinical status. Risk language in the informed consents was markedly elevated over that rated by the coders, with more than one third of (...) the dissertations presenting the risk of participation as severe (i.e., associated with substantial risk of reactivity and lasting discomfort). These statements are not in keeping with the literature and raise ethical concerns in relation to (a) nocebo effects, (b) distortion of correlational findings, and (c) discouragement of participants from disclosing trauma in other settings. (shrink)

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, (...) this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of the empirical evidence (...) addressing patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

Patients participating in the shared benefits of publicly funded health care enjoy the benefits of treatments tested on previous patients. Future patients similarly depend on treatments tested on present patients. Since properly designed research assumes that the treatments being studied are—so far as is known at the outset—equivalent in therapeutic value, no one is clinically disadvantaged merely by taking part in research, provided the research involves administering active treatments to all participants. This paper argues that, because no (...) other practical or moral considerations count decisively against so doing, we could and should oblige patients to agree to receive indicated treatment within the terms of any concurrent research protocols. This ensures their treatment will benefit not only themselves but also future patients through contributing to new knowledge. By analogy with the paying of income tax, patients should not be allowed to “veto” their social responsibility to take part in clinical research. (shrink)

Design: Qualitative interview study. Participants: Fifty-nine patients with a family history of cancer who attend a regional cancer genetics clinic in the UK were interviewed about their current and previous research experiences. Findings: Interviewees gave a range of explanations for research participation. These were categorised as social—research participation benefits the wider society by progressing science and improving treatment for everyone; familial—research participation may improve healthcare and benefit current or future generations of the participant’s family; and personal— (...) class='Hi'>research participation provides therapeutic or non-therapeutic benefits for oneself. Conclusions: We discuss the distinction drawn between motives for research participation focused upon self and others, and observe that personal, social and familial motives can be seen as interdependent. For example, research participation that is undertaken to benefit others, particularly relatives, may also offer a number of personal benefits for self, such as enabling participants to feel that they have discharged their social or familial obligations. We argue for the need to move away from simple, static, individualised notions of research participation to a more complex, dynamic and inherently social account. (shrink)

"Patient advocates can help make research more ethical, but advocacy raises ethical issues of its own.

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for (...) patient-based medical research.MethodsWe therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

The argument that a permanent vegetative state equates to death because it marks the death of the person is not a new one, but I wonder whether Ravelingien et al1 need to regard those in a PVS as dead to make a case for animal to human transplantation trials taking place in such people. It is not an argument likely to convince anyone who refuses to accept that only human persons have inherent value, dignity or a right to life, and (...) the arguments on both sides have been well rehearsed, with no sign of reconciliation. My own view is that people in a PVS are still alive, albeit with a poor quality of life. I see no objection in principle to the proposal that competent people can decide, in advance, to participate in research when they become incompetent. At the present time, it is generally accepted that an advance refusal of consent should be respected. Some controversy exists on whether someone can insist on treatment in advance, but in Ravelingien et al’s1 paper, what is being proposed is not that people can insist on becoming research participants, but rather that they can signal a willingness to become such a participant in the future. Indeed, this principle can be extended to competent people such as those with early …. (shrink)

Ravelingien et al1 argue that we should recategorise people in a permanent vegetative state as dead. Although the dilemma they describe is very real, their solution will not work. Other respondents to this paper have advanced several powerful arguments against the attempt to describe patients in a PVS as dead. Fortunately, the original argument contains sufficient resources for developing an alternative solution to this dilemma without having to radically change the current legal or social status of patients in a PVS. (...) In fact, patients in a PVS may be enrolled in xenotransplantation experiments, provided that their prior informed consent has been sought.The motivation for the original paper was to resolve an apparently intractable ethical conflict. On the one hand, there are powerful ethical and medical reasons for proceeding with research into the transplantation of non-human organs into human patients, whereas on the other, there are equally powerful ethical reasons for blocking whole-organ transplant experiments. These reasons are unusual in that special problems with xenotransplantation will block experiments that are permitted in other cases. In particular, the unquantifiable risk of a pandemic triggered by diseases such as porcine endogenous retrovirus crossing the species barrier will either block the research or expose subjects to the risk of indefinite quarantine . The authors also argue that the restrictions placed on transplant recipients and the possibility of long-term and intrusive monitoring, restrictions on sexual contacts and reproduction, and possible confinement represent excessive and ethically unjustifiable burdens. Over time, the recipients may wish to withdraw their consent, but the risks to public health would prevent them from doing so, thereby violating the basic principle that subjects of scientific and medical experiments should be able to revise or withdraw consent . …. (shrink)

Despite recurring efforts, a gap exists across a variety of contexts between the protection of patients' safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients' safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It highlights (...) how the role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; 'non-therapeutic' clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare. Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance. (shrink)

Psychological trauma is ubiquitous, an often hidden yet influential factor in care across clinical specialties. Interdisciplinary health professions education is mobilizing to address the importance of trauma-sensitive care. Given their attention to complex human realities, the health humanities are well-poised to shape healthcare learners’ responses to trauma. Indeed, many such arts and humanities curricula propose narrative exercises to strengthen empathy, self-reflection, and sensitive communication. Trauma, however, is often unwordable, fragmentary, and physically encoded, incompatible with storying methods. (...) This article presents a recent innovation, the Art is Patient seminar series, which focuses on aesthetic exercises to help learners access and share non-verbal, embodied, and relational responses to art. Based in an art museum context, it provides successive experiences of approaching, witnessing, and engaging with visual art as an analogue to developing trauma-sensitive relationships. Reflections on the process locate the seminar vis-à-vis health humanities practices, aesthetics, and trauma-informed approaches. (shrink)

BackgroundThe aim of the present survey was to investigate newly discharged hospital patients’ opinions on secondary use of their hospital data and biospecimens within the context of health research in general and, more specifically, on genetic research, data sharing across borders and cooperation with the health industry.MethodsA paper questionnaire was sent to 1049 consecutive newly discharged hospital patients.ResultsThe vast majority of the respondents preferred to be informed or to receive no notification at all for secondary research on (...) their health data and biospecimens. The rest wanted to be asked for active consent. The same trend applied for the other aspects also. 81% of respondents were positive towards genetic research without active consent. 95% were positive towards cooperating with the health industry, and 90% were positive towards data sharing.ConclusionsThese results suggest that hospital patients generally are very positive to secondary research and support the concept of opting out rather than opting in. (shrink)

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated (...) to inform them about the research use of their items and be subject to self-directed rules. The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust. (shrink)

This paper is a personal account of the events associated with the author’s work at the University of Toronto’s Hospital for Sick Children on a drug, deferiprone, for the treatment of thalassaemia. Trials of the drug were sponsored by the Canadian Medical Research Council and a drug company which would have been able, had the trials been successful, to seek regulatory approval to market the drug. When evidence emerged that deferiprone might be inadequately effective in a substantial proportion of (...) patients, the drug company issued legal threats when the author proposed informing her patients and the scientific community. Until protests were made by international authorities in her field of research, the hospital and university did not adequately support the author’s academic freedom and responsibilities as a medical practitioner. It is argued that underlying cause of this, and of other similar cases, is the political philosophy which is driving the commercialisation of universities and bringing about the deregulation of drug approval procedures. Together these changes constitute a serious threat to the public good. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, (...) how are patients being engaged—and how should they be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)