Data sharing and privacy issues in neuroimaging research: Opportunities, obstacles, challenges, and monsters under the bed.

Collaborative networks and data sharing initiatives are broadening the opportunities for the advancement of science. These initiatives offer greater transparency in science, with the opportunity for external research groups to reproduce, replicate, and extend research findings. Further, larger datasets offer the opportunity to identify homogeneous patterns within subgroups of individuals, where these patterns may be obscured by the heterogeneity of the neurobiological measure in smaller samples. However, data sharing and data pooling initiatives are not without their challenges, especially with new laws that may at first glance appear quite restrictive for open science initiatives. Interestingly, what is key to some of these new laws (i.e, the European Union's general data protection regulation) is that they provide greater control of data to those who "give" their data for research purposes. Thus, the most important element in data sharing is allowing the participants to make informed decisions about how they want their data to be used, and, within the law of the specific country, to follow the participants' wishes. This framework encompasses obtaining thorough informed consent and allowing the participant to determine the extent that they want their data shared, many of the ethical and legal obstacles are reduced to just monsters under the bed. In this manuscript we discuss the many options and obstacles for data sharing, from fully open, to federated learning, to fully closed. Importantly, we highlight the intersection of data sharing, privacy, and data ownership and highlight specific examples that we believe are informative to the neuroimaging community.

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.

A marathon, not a sprint - neuroimaging, Open Science and ethics.

Open Science is calling for a radical re-thinking of existing scientific practices. Within the neuroimaging community, Open Science practices are taking the form of open data repositories and open lab notebooks. The broad sharing of data that accompanies Open Science, however, raises some difficult ethical and legal issues. With neuroethics as a focusing lens, we explore eight central concerns posed by open data with regard to human brain imaging studies: respect for individuals and communities, concern for marginalized communities, consent, privacy protections, participatory research designs, contextual integrity, fusions of clinical and research goals, and incidental findings. Each consideration assists in bringing nuance to the potential benefits for open data sharing against associated challenges. We combine current understandings with forward-looking solutions to key issues. We conclude by underscoring the need for new policy tools to enhance the potential for responsible open data.

Ethical Considerations in Communicating Alzheimer's Disease Neuroimaging Biomarker Test Results to Symptomatic Individuals.

This article examines ethical issues associated with the return of AD neuroimaging results to cognitively symptomatic individuals. Following a review of research on patient and study partner reactions to learning the results of biomarker testing for AD, we examine ethical issues that will be of increasing significance as the field transitions to an era wherein disease-modifying treatments for AD become available. We first review the ethical justification for returning AD biomarker results to individuals who desire them. We then address a more novel question: whether, and to what extent, clinicians or clinical researchers should influence the decisions of individuals who are potentially reluctant to learn their AD imaging results. We argue that in many cases, it is ethically correct to explore, and sometimes alter, factors that may be inhibiting one's desire to know these test results. Our argument is grounded in the premise that having more complete information about changes that may be happening in one's brain will generally yield more informed participation in decisions about one's own care, thereby promoting autonomy. Finally, on the assumption that we have established that it is frequently ethically correct to try to communicate testing information, we examine considerations regarding (not whether but) how this is best accomplished, discussing the concept of responsible transparency. We suggest that both (1) explorations of why one may or may not want to learn results of AD biomarker imaging and (2) the responsible return of such test results is best accomplished using a transactional model of communication.

The Open Brain Consent: Informing research participants and obtaining consent to share brain imaging data.

Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere.

Inside the brain of a killer: the ethics of neuroimaging in a criminal conviction.

With neuroimaging techniques being taken out of the lab and into the court, we ask whether brain scans can - or should - be used to explain a criminal act.

Ethical issues in global neuroimaging genetics collaborations.

Neuroimaging genetics is a rapidly developing field that combines neuropsychiatric genetics studies with imaging modalities to investigate how genetic variation influences brain structure and function. As both genetic and imaging technologies improve further, their combined power may hold translational potential in terms of improving psychiatric nosology, diagnosis, and treatment. While neuroimaging genetics studies offer a number of scientific advantages, they also face challenges. In response to some of these challenges, global neuroimaging genetics collaborations have been created to pool and compare brain data and replicate study findings. Attention has been paid to ethical issues in genetics, neuroimaging, and multi-site collaborative research, respectively, but there have been few substantive discussions of the ethical issues generated by the confluence of these areas in global neuroimaging genetics collaborations. Our discussion focuses on two areas: benefits and risks of global neuroimaging genetics collaborations and the potential impact of neuroimaging genetics research findings in low- and middle-income countries. Global neuroimaging genetics collaborations have the potential to enhance relations between countries and address global mental health challenges, however there are risks regarding inequity, exploitation and data sharing. Moreover, neuroimaging genetics research in low- and middle-income countries must address the issue of feedback of findings and the risk of essentializing and stigmatizing interpretations of mental disorders. We conclude by examining how the notion of solidarity, informed by an African Ethics framework, may justify some of the suggestions made in our discussion.

Ethical Issues Posed by Field Research Using Highly Portable and Cloud-Enabled Neuroimaging.

Highly portable, cloud-enabled neuroimaging technologies will fundamentally change neuroimaging research. Instead of participants traveling to the scanner, the scanner will now come to them. Field-based brain imaging research, including populations underrepresented in neuroscience research to date, will enlarge and diversify databases and pave the way for clinical and direct-to-consumer (DTC) applications. Yet these technological developments urgently require analysis of their ethical, legal, and social implications (ELSI). No consensus ethical frameworks for mobile neuroimaging exist, and existing policies for traditional MRI research are inadequate. Based on literature review and ethics analysis of neurotechnology development efforts, Shen et al. identify seven foundational, yet unresolved, ELSI issues posed by portable neuroimaging: (1) informed consent; (2) privacy; (3) capacity to accurately communicate neuroimaging results to remote participants; (4) extensive reliance on cloud-based artificial intelligence (AI) for data analysis; (5) potential bias of interpretive algorithms in diverse populations; (6) return of research results and incidental (or secondary) findings to research participants; and (7) responding to participant requests for access to their data. The article proposes a path forward to address these urgent issues.

Alive inside.

This article provides an ethical analysis of the U.S. practice guideline update on disorders of consciousness. Our analysis focuses on the guideline's recommendations regarding the use of investigational neuroimaging methods to assess brain-injured patients. Complex and multifaceted ethical issues have emerged because these methods alter the clinical understanding of consciousness. We address issues of false hope, patient suffering, and cost. We argue that, in spite of these concerns, there is significant benefit to using neuroimaging to assess brain-injured patients in most cases.

Do New Neuroimaging Findings Challenge the Ethical Basis of Advance Directives in Disorders of Consciousness?

Some authors have questioned the moral authority of advance directives (ADs) in cases in which it is not clear if the author of the AD is identical to the person to whom it later applies. This article focuses on the question of whether the latest results of neuroimaging studies have moral significance with regard to the moral authority of ADs in patients with disorders of consciousness (DOCs). Some neuroimaging findings could provide novel insights into the question of whether patients with DOCs exhibit sufficient psychological continuity to be ascribed diachronic personal identity. If those studies were to indicate that psychological continuity is present, they could justify the moral authority of ADs in patients with DOCs. This holds at least if respect for self-determination is considered as the foundation for the moral authority of ADs. The non-identity thesis in DOCs could no longer be applied, in line with clinical and social practice.

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.

Ethical and Legal Implications of the Methodological Crisis in Neuroimaging.

Currently, many scientific fields such as psychology or biomedicine face a methodological crisis concerning the reproducibility, replicability, and validity of their research. In neuroimaging, similar methodological concerns have taken hold of the field, and researchers are working frantically toward finding solutions for the methodological problems specific to neuroimaging. This article examines some ethical and legal implications of this methodological crisis in neuroimaging. With respect to ethical challenges, the article discusses the impact of flawed methods in neuroimaging research in cognitive and clinical neuroscience, particularly with respect to faulty brain-based models of human cognition, behavior, and personality. Specifically examined is whether such faulty models, when they are applied to neurological or psychiatric diseases, could put patients at risk, and whether this places special obligations on researchers using neuroimaging. In the legal domain, the actual use of neuroimaging as evidence in United States courtrooms is surveyed, followed by an examination of ways that the methodological problems may create challenges for the criminal justice system. Finally, the article reviews and promotes some promising ideas and initiatives from within the neuroimaging community for addressing the methodological problems.

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.

Naturalizing Responsibility.

In the contemporary debate on the use of the neurosciences in ethics and law, numerous arguments have been bandied about among scientists and philosophers looking to uphold or reject the reliability and validity of scientific findings obtained by brain imaging technologies. Among the most vexing questions is, Can we trust that technology? One point of disagreement is whether brain scans offer a window through which to observe the functioning of the mind, in such a way as to enable lawyers, judges, physicians, and lawmakers to detect anomalies in brain function that may account for criminal unconscious behavior. Those who stand behind brain imaging believe that this can indeed be achieved, whereas those in opposition stress that brain scans are highly open to interpretation and that the data they provide is insufficient to establish causal connections. The question essentially comes down to whether technology can reliably be used to determine the intentions of the individual, thus establishing mens rea, for example, and hence responsibility. This article focuses on the latter notion and explores whether we can rely on the neurosciences to shed light on a complex form of moral and legal reasoning, as well as the role of the neurosciences in reawakening a philosophical and legal interest in trying to set responsibility on an empirical basis.

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.

Neuroethics: the pursuit of transforming medical ethics in scientific ethics.

Ethical problems resulting from brain research have given rise to a new discipline termed neuroethics, representing a new kind of knowledge capable of discovering the neural basis for universal ethics. The article (1) tries to evaluate the contributions of neuroethics to medical ethics and its suitability to outline the foundations of universal ethics, (2) critically analyses the process of founding this universal ethic. The potential benefits of applying neuroimaging, psychopharmacology and neurotechnology have to be carefully weighed against their potential harm. In view of these questions, an intensive dialogue between neuroscience and the humanities is more necessary than ever.

Neuroethics: the pursuit of transforming medical ethics in scientific ethics

Ethical problems resulting from brain research have given rise to a new discipline termed neuroethics, representing a new kind of knowledge capable of discovering the neural basis for universal ethics. The article (1) tries to evaluate the contributions of neuroethics to medical ethics and its suitability to outline the foundations of universal ethics, (2) critically analyses the process of founding this universal ethic. The potential benefits of applying neuroimaging, psy-chopharmacology and neurotechnology have to be carefully weighed against their potential harm. In view of these questions, an intensive dialogue between neuroscience and the humanities is more necessary than ever.

Hot baths and cold minds: neuroscience, mind reading, and mind misreading.

The idea-the possibility-of reading the mind, from the outside or indeed even from the inside, has exercised humanity from the earliest times. If we could read other minds both prospectively, to discern intentions and plans, and retrospectively, to discover what had been "on" those minds when various events had occurred, the implications for morality and for law and social policy would be immense. Recent advances in neuroscience have offered some, probably remote, prospects of improved access to the mind, but a different branch of technology seems to offer the most promising and the most daunting prospect for both mind reading and mind misreading. You can't have the possibility of the one without the possibility of the other. This article tells some of this story.