Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings.

Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.

Overdiagnosis and overimaging: an ethical issue for radiological protection.

AIMS AND OBJECTIVES: This study aimed to analyse the key factors that influence the overimaging using X-ray such as self-referral, defensive medicine and duplicate imaging studies and to emphasize the ethical problem that derives from it. MATERIALS AND METHODS: In this study, we focused on the more frequent sources of overdiagnosis such as the total-body CT, proposed in the form of screening in both public and private sector, the choice of the most sensitive test for each pathology such as pulmonary embolism, ultrasound investigations mostly of the thyroid and of the prostate and MR examinations, especially of the musculoskeletal system. RESULTS: The direct follow of overdiagnosis and overimaging is the increase in the risk of contrast media infusion, radiant damage, and costs in the worldwide healthcare system. The theme of the costs of overdiagnosis is strongly related to inappropriate or poorly appropriate imaging examination. CONCLUSIONS: We underline the ethical imperatives of trust and right conduct, because the major ethical problems in radiology emerge in the justification of medical exposures of patients in the practice. A close cooperation and collaboration across all the physicians responsible for patient care in requiring imaging examination is also important, balancing possible ionizing radiation disadvantages and patient benefits in terms of care.

Recommendations on prevention and screening for breast cancer in Hong Kong.

In Hong Kong, breast cancer is the most common cancer among women and poses a significant health care burden. The Cancer Expert Working Group on Cancer Prevention and Screening (CEWG) was set up in 2002 by the Cancer Coordinating Committee to review and assess local and international scientific evidence, and to formulate recommendations for cancer prevention and screening. After considering the local epidemiology, emerging scientific evidence, and local and overseas screening practices, the CEWG concluded that it was unclear whether population-based breast cancer screening did more harm than good in local asymptomatic women at average risk. The CEWG considers that there is insufficient evidence to recommend for or against population-based mammography screening for such individuals. Women who consider breast cancer screening should be adequately informed about the benefits and harms. The CEWG recommends that all women adopt primary preventive measures, be breast aware, and seek timely medical attention for suspicious symptoms. For women at high risk of breast cancer, such as carriers of confirmed BRCA1/2 deleterious mutations and those with a family history of breast cancer, the CEWG recommends that they seek doctor's advice for annual mammography screening and the age at which the process should commence. Additional annual screening by magnetic resonance imaging is recommended for confirmed BRCA1/2 mutation carriers or women who have undergone radiation therapy to the chest between the age of 10 and 30 years. Women at moderate risk of breast cancer should discuss with doctors the pros and cons of breast cancer screening before making an informed decision about mammography screening every 2 to 3 years.

Potential Reporting Bias in Neuroimaging Studies of Sex Differences.

Numerous functional magnetic resonance imaging (fMRI) studies have reported sex differences. To empirically evaluate for evidence of excessive significance bias in this literature, we searched for published fMRI studies of human brain to evaluate sex differences, regardless of the topic investigated, in Medline and Scopus over 10 years. We analyzed the prevalence of conclusions in favor of sex differences and the correlation between study sample sizes and number of significant foci identified. In the absence of bias, larger studies (better powered) should identify a larger number of significant foci. Across 179 papers, median sample size was n = 32 (interquartile range 23-47.5). A median of 5 foci related to sex differences were reported (interquartile range, 2-9.5). Few articles (n = 2) had titles focused on no differences or on similarities (n = 3) between sexes. Overall, 158 papers (88%) reached "positive" conclusions in their abstract and presented some foci related to sex differences. There was no statistically significant relationship between sample size and the number of foci (-0.048% increase for every 10 participants, p = 0.63). The extremely high prevalence of "positive" results and the lack of the expected relationship between sample size and the number of discovered foci reflect probable reporting bias and excess significance bias in this literature.

The Ethics of "Choosing Wisely": The Use of Neuroimaging for Uncomplicated Headache.

The use of magnetic resonance imaging (MRI) for evaluation of headache remains excessive among physicians across many specialties according to both the American Headache Society and the American College of Radiology, despite recent attempts at limiting overuse of imaging and procedures. As part of the Choosing Wisely campaign, both of these organizations have explicitly recommended against imaging in patients with uncomplicated or typical migraine headaches. Yet, the practice nevertheless remains prevalent, with estimates ranging from 12.4% to 15.9% of patients with uncomplicated headache receiving MRI in outpatient practices. The low prevalence of serious pathological findings on imaging in patients who present without other indicative symptoms and the high cost of such exams necessitates a thorough evaluation of appropriate use of MRI for headache. Here, we debate the problematic use of MRI for uncomplicated headache and put forth a discussion of possible interventions that could promote more efficient use of imaging. Overuse of imaging has the potential to open a box that cannot readily be closed, and physicians upstream of surgical decision making must remain aware of the downstream effects of their clinical choices.

Neurotechnological assessment of consciousness disorders: five ethical imperatives.

Disorders of consciousness (DOCs) cause great human suffering and material costs for society. Understanding of these disorders has advanced remarkably in recent years, but uncertainty remains with respect to the diagnostic criteria and standards of care. One of the most serious problems concerns misdiagnoses, their impact on medical decision-making, and on patients' well-being. Recent studies use neurotechnology to assess residual consciousness in DOC patients that traditional behavioral diagnostic criteria are unable to detect. The results show an urgent need to strengthen the development of new diagnostic tools and more refined diagnostic criteria. If residual consciousness may be inferred from robust and reproducible results from neurotechnological communication with DOC patients, this also raises ethical challenges. With reference to the moral notions of beneficence and fundamental rights, five ethical imperatives are here suggested in terms of diagnosis, communication, interpretation of subjective states, adaptation of living conditions, and care.

Los trastornos de conciencia (TC) provocan grandes sufrimientos humanos y costos materiales para la sociedad. La comprensión de estos trastornos ha avanzado significativamente en los últimos años, pero persiste la incertidumbre respecto a los criterios diagnósticos y estándares de atención. Uno de los problemas más serios se refiere al diagnóstico erróneo, su impacto en la toma de decisiones médicas y en el bienestar de los pacientes. Estudios recientes emplean neurotecnología para evaluar la conciencia residual en los pacientes con TC en que los criterios diagnósticos conductuales tradicionales son incapaces de detectarlos. Los resultados muestran una necesidad urgente de fortalecer el desarrollo de nuevas herramientas diagnósticas y criterios diagnósticos más refinados. Si la conciencia residual se puede inferir de resultados sólidos y reproducibles a partir de la comunicación neurotecnológica con pacientes con TC, esto también plantea desafíos éticos.En relación con las nociones morales de beneficencia y derechos fundamentales, aquí se sugieren cinco imperativos éticos en términos del diagnóstico, comunicación, interpretación de los estados subjetivos, adaptación a las condiciones de vida y atención.

Les troubles de la conscience coûtent en souffrance humaine et en matériel pour la société. Ces dernières années, la compréhension de ces troubles a beaucoup progressé, mais les critères diagnostiques et les standards de soins restent à définir. Un des problèmes les plus importants concerne les erreurs de diagnostic, leur impact sur la prise de décision médicale et sur le bien-être des patients. Des études récentes utilisent la neurotechnologie pour évaluer la conscience résiduelle chez les patients ayant des troubles de la conscience ne pouvant être détectés par les critères de diagnostic comportemental traditionnels. Les résultats montrent un besoin urgent de renforcer le développement de nouveaux outils diagnostiques et de critères diagnostiques plus affinés. Si la conscience résiduelle peut être déduite de résultats solides et reproductibles issus de la communication neurotechnologique avec les patients ayant des troubles de la conscience, cela pose toutefois des problèmes éthiques. En référence aux notions morales de bienfaisance et de droits fondamentaux, cinq impératifs éthiques sont ici proposés en termes de diagnostic, de communication, d'interprétation d'états subjectifs, d'adaptation de condition de vie et de soins.

Evolution of universal review and disclosure of MRI reports to research participants.

BACKGROUND: Although incidental findings (IF) are commonly encountered in neuroimaging research, there is no consensus regarding what to do with them. Whether researchers are obligated to review scans for IF, or if such findings should be disclosed to research participants at all, is controversial. Objective data are required to inform reasonable research policy; unfortunately, such data are lacking in the published literature. This manuscript summarizes the development of a radiology review and disclosure system in place at a neuroimaging research institute and its impact on key stakeholders. METHODS: The evolution of a universal radiology review system is described, from inception to its current status. Financial information is reviewed, and stakeholder impact is characterized through surveys and interviews. RESULTS: Consistent with prior reports, 34% of research participants had an incidental finding identified, of which 2.5% required urgent medical attention. A total of 87% of research participants wanted their magnetic resonance imaging (MRI) results regardless of clinical significance and 91% considered getting an MRI report a benefit of study participation. A total of 63% of participants who were encouraged to see a doctor about their incidental finding actually followed up with a physician. Reasons provided for not following-up included already knowing the finding existed (14%), not being able to afford seeing a physician (29%), or being reassured after speaking with the institute's Medical Director (43%). Of those participants who followed the recommendation to see a physician, nine (38%) required further diagnostic testing. No participants, including those who pursued further testing, regretted receiving their MRI report, although two participants expressed concern about the excessive personal cost. The current cost of the radiology review system is about $23 per scan. CONCLUSIONS: It is possible to provide universal radiology review of research scans through a system that is cost-effective, minimizes investigator burden, and does not overwhelm local healthcare resources.

[Non-medical applications for brain MRI: Ethical considerations]. / Applications non médicales de l'IRM cérébrale : considérations éthiques.

INTRODUCTION: The recent neuroimaging techniques offer the possibility to better understand complex cognitive processes that are involved in mental disorders and thus have become cornerstone tools for research in psychiatry. The performances of functional magnetic resonance imaging are not limited to medical research and are used in non-medical fields. These recent applications represent new challenges for bioethics. OBJECTIVE: In this article we aim at discussing the new ethical issues raised by the applications of the latest neuroimaging technologies to non-medical fields. METHODS: We included a selection of peer-reviewed English medical articles after a search on NCBI Pubmed database and Google scholar from 2000 to 2013. We screened bibliographical tables for supplementary references. Websites of governmental French institutions implicated in ethical questions were also screened for governmental reports. RESULTS: Findings of brain areas supporting emotional responses and regulation have been used for marketing research, also called neuromarketing. The discovery of different brain activation patterns in antisocial disorder has led to changes in forensic psychiatry with the use of imaging techniques with unproven validity. Automated classification algorithms and multivariate statistical analyses of brain images have been applied to brain-reading techniques, aiming at predicting unconscious neural processes in humans. We finally report the current position of the French legislation recently revised and discuss the technical limits of such techniques. DISCUSSION: In the near future, brain imaging could find clinical applications in psychiatry as diagnostic or predictive tools. However, the latest advances in brain imaging are also used in non-scientific fields raising key ethical questions. Involvement of neuroscientists, psychiatrists, physicians but also of citizens in neuroethics discussions is crucial to challenge the risk of unregulated uses of brain imaging.

Ethics of neuroimaging after serious brain injury.

BACKGROUND: Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recent advances in neuroimaging suggest a solution. Both functional magnetic resonance imaging and electroencephalography have been used to detect residual cognitive function in vegetative and minimally conscious patients. Neuroimaging may improve diagnosis and prognostication. These techniques are beginning to be applied to comatose patients soon after injury. Evidence of preserved cognitive function may predict recovery, and this information would help families and health providers. Complex ethical issues arise due to the vulnerability of patients and families, difficulties interpreting negative results, restriction of communication to "yes" or "no" answers, and cost. We seek to investigate ethical issues in the use of neuroimaging in behaviorally nonresponsive patients who have suffered serious brain injury. The objectives of this research are to: (1) create an approach to capacity assessment using neuroimaging; (2) develop an ethics of welfare framework to guide considerations of quality of life; (3) explore the impact of neuroimaging on families; and, (4) analyze the ethics of the use of neuroimaging in comatose patients. METHODS/DESIGN: Our research program encompasses four projects and uses a mixed methods approach. Project 1 asks whether decision making capacity can be assessed in behaviorally nonresponsive patients. We will specify cognitive functions required for capacity and detail their assessment. Further, we will develop and pilot a series of scenarios and questions suitable for assessing capacity. Project 2 examines the ethics of welfare as a guide for neuroimaging. It grounds an obligation to explore patients' interests, and we explore conceptual issues in the development of a quality of life instrument adapted for neuroimaging. Project 3 will use grounded theory interviews to document families' understanding of the patient's condition, expectations of neuroimaging, and the impact of the results of neuroimaging. Project 4 will provide an ethical analysis of neuroimaging to investigate residual cognitive function in comatose patients within days of serious brain injury.

Functional MRI-based lie detection: scientific and societal challenges.

Functional MRI (fMRI)-based lie detection has been marketed as a tool for enhancing personnel selection, strengthening national security and protecting personal reputations, and at least three US courts have been asked to admit the results of lie detection scans as evidence during trials. How well does fMRI-based lie detection perform, and how should the courts, and society more generally, respond? Here, we address various questions ­ some of which are based on a meta-analysis of published studies ­ concerning the scientific state of the art in fMRI-based lie detection and its legal status, and discuss broader ethical and societal implications. We close with three general policy recommendations.

Neuroimaging: beginning to appreciate its complexities.

For over a century, scientists have sought to see through the protective shield of the human skull and into the living brain. Today, an array of technologies allows researchers and clinicians to create astonishingly detailed images of our brain's structure as well as colorful depictions of the electrical and physiological changes that occur within it when we see, hear, think and feel. These technologies-and the images they generate-are an increasingly important tool in medicine and science. Given the role that neuroimaging technologies now play in biomedical research, both neuroscientists and nonexperts should aim to be as clear as possible about how neuroimages are made and what they can-and cannot-tell us. Add to this that neuroimages have begun to be used in courtrooms at both the determination of guilt and sentencing stages, that they are being employed by marketers to refine advertisements and develop new products, that they are being sold to consumers for the diagnosis of mental disorders and for the detection of lies, and that they are being employed in arguments about the nature (or absence) of powerful concepts like free will and personhood, and the need for citizens to have a basic understanding of how this technology works and what it can and cannot tell us becomes even more pressing.

[Magnetic resonance imaging (MRI) in children and adolescents ­ study design of a feasibility study concerning examination related emotions]. / Magnetresonanztomographie (MRT) bei Kindern und Jugendlichen. Studiendesign einer Durchführbarkeitsstudie hinsichtlichuntersuchungsmethodenbezogener Emotionen.

Numerous research centres apply magnetic resonance imaging (MRI) for research purposes in children. In view of this practical research, ethical concerns regarding the strains the study participants are exposed to during the MRI examination are discussed. The study evaluates whether an MRI examination induces negative emotions in children and adolescents which are more intense than the ones caused by electroencephalography (EEG), an examination method currently classified as causing "minimal stress." Furthermore, the emotional stress induced by the MRI examination in children and adolescents is compared with that induced in adults. The study gathers data on examination-related emotions in children (age 8-17;11, male and female) who undergo an MRI examination of the cerebrum with a medical indication. The comparison group is a sample of children and adolescents examined with EEG (age 8-17;11, male and female) as well as a sample of adults (age 18-65, male and female) examined with MRI. At present, the study is in the stage of data collection. This article presents the study design of the MRI research project.

Disclosing incidental findings in brain research: the rights of minors in decision-making.

MRI is used routinely in research with children to generate new knowledge about brain development. The detection of unexpected brain abnormalities (incidental findings; IFs) in these studies presents unique challenges. While key issues surrounding incidence and significance, duty of care, and burden of disclosure have been addressed substantially for adults, less empirical data and normative analyses exist for minors who participate in minimal risk research. To identify ethical concerns and fill existing gaps, we conducted a comprehensive review of papers that focused explicitly on the discovery of IFs in minors. The discourse in the 21 papers retrieved for this analysis amply covered practical issues such as informed consent and screening, difficulties in ascertaining clinical significance, the economic costs and burden of responsibility on researchers, and risks (physical or psychological). However, we found little discussion about the involvement of minors in decisions about disclosure of IFs in the brain, especially for IFs of low clinical significance. In response, we propose a framework for managing IFs that integrates practical considerations with explicit appreciation of rights along the continuum of maturity. This capacity-adjusted framework emphasizes the importance of involving competent minors and respecting their right to make decisions about disclosure.

Two basic ethical problems of incidental findings in population-based, non-intervening magnetic resonance imaging (MRI) research.

Population-based magnetic resonance imaging (MRI) generates many beneficial consequences for future generations of patients. But there are also some unintended implications for present patients and research subjects. The most important of these implications is the occurrence of incidental findings. In what follows, I will explicate two basic ethical problems concerning incidental findings. I will first argue that the main cause of these two problems lies in the conflicted nature of the medical researcher's role. I will then clarify the two problems, which involves appealing to two basic ethical requirements. The first problem originates from specific empirical conditions of epidemiological MRI research, which indicate shortcomings in the process of obtaining informed consent. The second problem is due to a conflict between obligations of beneficence for the research subjects and the researcher's duty to produce valid and generalizable study results. Finally, I will develop some preliminary perspectives for the solution of these problems.

Obscuring surface anatomy in volumetric imaging data.

The identifying or sensitive anatomical features in MR and CT images used in research raise patient privacy concerns when such data are shared. In order to protect human subject privacy, we developed a method of anatomical surface modification and investigated the effects of such modification on image statistics and common neuroimaging processing tools. Common approaches to obscuring facial features typically remove large portions of the voxels. The approach described here focuses on blurring the anatomical surface instead, to avoid impinging on areas of interest and hard edges that can confuse processing tools. The algorithm proceeds by extracting a thin boundary layer containing surface anatomy from a region of interest. This layer is then "stretched" and "flattened" to fit into a thin "box" volume. After smoothing along a plane roughly parallel to anatomy surface, this volume is transformed back onto the boundary layer of the original data. The above method, named normalized anterior filtering, was coded in MATLAB and applied on a number of high resolution MR and CT scans. To test its effect on automated tools, we compared the output of selected common skull stripping and MR gain field correction methods used on unmodified and obscured data. With this paper, we hope to improve the understanding of the effect of surface deformation approaches on the quality of de-identified data and to provide a useful de-identification tool for MR and CT acquisitions.