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.

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.

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.

[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.

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.

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.

A neuroimaging proof of principle study of Down's syndrome and dementia: ethical and methodological challenges in intrusive research.

BACKGROUND: Research into specific illnesses and the development of new treatments may only become possible as new technologies become available. When used for research, such technologies may best be described as 'intrusive', in that they require a considerable willingness and commitment on the part of the participants. This has increasingly been the case for brain disorders and illnesses where novel neuroimaging techniques, often combined with clinical and psychological assessments, have the potential to result in new understanding. People with intellectual disabilities (ID) have a history of under-representation as participants in research using such technologies and are therefore at risk of not receiving equal access to state-of-the-art treatments. We propose that 'intrusive' biomedical research is both possible and ethical in ID, and explore some of the methodological challenges by reference to a recent proof of principle study that used a relatively new ligand-based brain scanning technique in a group of volunteers with Down's syndrome. METHODS: Five overlapping stages of the study methodology were identified and evaluated for their acceptability to volunteers with mild to moderate ID through discussion, reflection, and analysis of structured feedback in the context of key policy documents, ethical guidelines and relevant legislation. RESULTS: Identification of key ethical and methodological challenges from reflective practice and participant feedback facilitated the emergence of strategies that permitted continual refinement of the study design. Important areas considered included (1) being clear about the purpose and scientific justification for the study; (2) reconciling the potential risks and benefits with relevant ethical guidelines and legislation; (3) identifying and implementing effective recruitment strategies; (4) optimising and assessing capacity to consent; and (5) making the 'intrusive' procedures as acceptable as possible to people with ID. CONCLUSION: We were able to demonstrate that a proof of principle study incorporating a novel brain scanning technique in a group of volunteers with ID was feasible, safe and well tolerated, despite the vulnerabilities of the study cohort and the intrusive nature of the research. We consider the study within an ethical and historical discourse about the principles that define current 'best practice' in ID research and propose a number of key recommendations for making intrusive research acceptable in people with ID.

Anxious and non-anxious adolescents' experiences of non-clinical magnetic resonance imaging research.

Magnetic resonance imaging (MRI) has become a ubiquitous research tool for developmental neuroscientists interested in brain structure and function in children and adolescents. However, ethical concerns are sometimes raised about using MRI with children and adolescents, especially when participants have anxiety. We asked 17 clinically/sub-clinically anxious and 19 non-anxious adolescents about their experiences of taking part in MRI for research purposes. Although the anxious group reported experiencing more anxiety during the scan, these differences had attenuated by the time participants got home. We found no evidence that anxious adolescents would be less likely to choose to have another scan or would feel more nervous during another scan. There was some evidence that more trait anxious adolescents found the MRI study enjoyable. These findings should give ethics committees, clinicians, and parents confidence that so long as researchers exercise appropriate care, MRI research is acceptable to adolescents, including those with clinical anxiety.

[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.

Ethical implications of neuroimaging in sports concussion.

The Centers for Disease Control and Prevention estimates that 1.6 to 3.8 million traumatic brain injuries that occur each year are related to sports injuries. New research has broadened the understanding of the acute and chronic pathophysiology of concussion associated with brain injury, and recent advances in diagnostic capabilities with neuroimaging are leading to new ethical questions around sport and care of the head-injured athlete. In this review, we synthesize the current literature on neuroimaging for assessing concussed athletes and explore ethical issues in the context of return to play, short- and long-term neurologic health effects following concussion and resource allocation that are emerging with new implications as neurotechnology becomes an increasingly powerful tool on the playing field of health.

The clinical value of routine whole-body magnetic resonance imaging (MRI) in palliative care.

BACKGROUND: Whole-body MRI (WBMRI) has become an accessible method for detecting different types of pathologies both in the skeleton and the viscera, which may explain painful conditions, for example tumors and inflammation. PURPOSE: To assess a possible value of using WBMRI in order to improve palliative care. MATERIAL AND METHODS: Twenty patients (all eligible patients) admitted to the Department for Palliative Care were consecutively included in this study. They underwent a modified WBMRI, with fewer and shorter pulse sequences than in a standard WBMRI, to reduce patient stress. However, the patients' physicians were to exclude patients where little might be obtained and discomfort, distress, and pain could be induced. The treating physicians registered clinical utility directly after receiving the MRI report in a questionnaire. The registration was repeated after ended treatment. RESULTS: Eighty percent had new findings detected, and 40% of the patients had a change in treatment due to the MRI result, mainly changes in analgesics and/or radiation therapy. CONCLUSION: The WBMRI helped the clinicians to improve treatment and a majority of the patients benefited from this. In eight patients the treatment was changed due to the results. The clinical value (utility) was indicated to be high.

MRI safety of a programmable shunt assistant at 3 and 7 Tesla.

OBJECTIVE: Several new shunt technologies have been developed to optimize hydrocephalus treatment within the past few years. Overdrainage, however, still remains an unresolved problem. One new technology which may reduce the frequency of this complication is the use of a programmable shunt assistant (proSA). Inactive in a horizontal position, it impedes CSF flow in a vertical position according to a prescribed pressure level ranging from 0 to 40 cm H(2)O. METHODS: We exposed the proSA valve in an ex vivo protocol to MR systems operating at 3 and 7 Tesla to investigate its MRI safety. RESULTS: Following 3 Tesla exposure, no changes in valve settings were noted. Adjustment to any pressure level was possible thereafter. The mean deflection angle was 23 ± 3°. After exposure to 7 Tesla, however, there were unintended pressure changes, and the mechanism for further adjustment of the valves even disintegrated. CONCLUSION: According to the results of this study, proSA is safe with heteropolar vertical magnet alignment at 3 Tesla. Following 7 Tesla exposure, the valves lost their functional capability.

Potential for bias in the context of neuroethics. Commentary on "Neuroscience, neuropolitics and neuroethics: the complex case of crime, deception and fMRI".

Neuroscience research, like all science, is vulnerable to the influence of extraneous values in the practice of research, whether in research design or the selection, analysis and interpretation of data. This is particularly problematic for research into the biological mechanisms that underlie behavior, and especially the neurobiological underpinnings of moral development and ethical reasoning, decision-making and behavior, and the other elements of what is often called the neuroscience of ethics. The problem arises because neuroscientists, like most everyone, bring to their work assumptions, preconceptions and values and other sources of potentially inappropriate bias of which they may be unaware. It is important that the training of neuroscientists, and research practice itself, include open and in-depth discussion and examination of the assumptions that underlie research. Further, policy makers, journalists, and the general public, that is, the consumers of neuroscience research findings (and by extension, neurotechnologies) should be made aware of the limitations as well as the strengths of the science, the evolving nature of scientific understanding, and the often invisible values inherent in science.

Neuroscience, neuropolitics and neuroethics: the complex case of crime, deception and FMRI.

Scientific developments take place in a socio-political context but scientists often ignore the ways their innovations will be both interpreted by the media and used by policy makers. In the rush to neuroscientific discovery important questions are overlooked, such as the ways: (1) the brain, environment and behavior are related; (2) biological changes are mediated by social organization; (3) institutional bias in the application of technical procedures ignores race, class and gender dimensions of society; (4) knowledge is used to the advantage of the powerful; and (5) its applications may reinforce existing structures of power that pose ethical questions about distributive justice. The case of crime, deception and functional Magnetic Resonance Imaging (fMRI) shows the complexity, and the political and ethical challenges that confront those who seek to use neuroscience to explain the etiology of crime, and who base policy on its findings. An ethically grounded neuroscience needs to take account of existing structures of power and difference, and to develop a public neuropolitical consciousness that ensures that those subject to risk by the application of science and technology are participants in the decision-making processes involving the implementation of policies that affect them.

Pain as a fact and heuristic: how pain neuroimaging illuminates moral dimensions of law.

In legal domains ranging from tort to torture, pain and its degree do important definitional work by delimiting boundaries of lawfulness and of entitlements. Yet, for all the work done by pain as a term in legal texts and practice, it has a confounding lack of external verifiability. Now, neuroimaging is rendering pain and myriad other subjective states at least partly ascertainable. This emerging ability to ascertain and quantify subjective states is prompting a "hedonic" or a "subjectivist" turn in legal scholarship, which has sparked a vigorous debate as to whether the quantification of subjective states might affect legal theory and practice. Subjectivists contend that much values-talk in law has been a necessary but poor substitute for quantitative determinations of subjective states--determinations that will be possible in the law's "experiential future." This Article argues the converse: that pain discourse in law frequently is a heuristic for values. Drawing on interviews and laboratory visits with neuroimaging researchers, this Article shows current and in-principle limitations of pain quantification through neuroimaging. It then presents case studies on torture-murder, torture, the death penalty, and abortion to show the largely heuristic role of pain discourse in law. Introducing the theory of "embodied morality," the Article describes how moral conceptions of rights and duties are informed by human physicality and constrained by the limits of empathic identification. Pain neuroimaging helps reveal this dual factual and heuristic nature of pain in the law, and thus itself points to the translational work required for neuroimaging to influence, much less transform, legal practice and doctrine.