No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

From a twenty-first century partnership between bioethics and neuroscience, the modern field of neuroethics is emerging, and technologies enabling functional neuroimaging with unprecedented sensitivity have brought new ethical, social and legal issues to the forefront. Some issues, akin to those surrounding modern genetics, raise critical questions regarding prediction of disease, privacy and identity. However, with new and still-evolving insights into our neurobiology and previously unquantifiable features of profoundly personal behaviors such as social attitude, value and moral agency, the difficulty of (...) carefully and properly interpreting the relationship between brain findings and our own self-concept is unprecedented. Therefore, while the ethics of genetics provides a legitimate starting point - even a backbone - for tackling ethical issues in neuroimaging, they do not suffice. Drawing on recent neuroimaging findings and their plausible real-world applications, we argue that interpretation of neuroimaging data is a key epistemological and ethical challenge. This challenge is two-fold. First, at the scientific level, the sheer complexity of neuroscience research poses challenges for integration of knowledge and meaningful interpretation of data. Second, at the social and cultural level, we find that interpretations of imaging studies are bound by cultural and anthropological frameworks. In particular, the introduction of concepts of self and personhood in neuroimaging illustrates the interaction of interpretation levels and is a major reason why ethical reflection on genetics will only partially help settle neuroethical issues. Indeed, ethical interpretation of such findings will necessitate not only traditional bioethical input but also a wider perspective on the construction of scientific knowledge. (shrink)

Recent advances in the brain sciences have dramatically improved our understanding of brain function. As we find out more and more about what makes us tick, we must stop and consider the ethical implications of this new found knowledge. This ground-breaking book on the emerging field of neuroethics answers many pertinent questions, such as: What makes monitoring and manipulating the human brain so ethically challenging? Will having a new biology of the brain through imaging make us less responsible for our (...) behavior and lose our free will? Should certain brain scan studies be disallowed on the basis of moral grounds? A distinguished group of contributors from a wide range of fields make this an invaluable introduction to neuroethics. (shrink)

The handbook contains more than 50 chapters by leaders from around the world and a broad range of sectors of academia and clinical practice spanning the ...

Recent advances in the brain sciences have dramatically improved our understanding of brain function. As we find out more and more about what makes us tick, we must stop and consider the ethical implications of this new found knowledge. Will having a new biology of the brain through imaging make us less responsible for our behavior and lose our free will? Should certain brain scan studies be disallowed on the basis of moral grounds? Why is the media so interested in (...) reporting results of brain imaging studies? What ethical lessons from the past can best inform the future of brain imaging? These compelling questions and many more are tackled by a distinguished group of contributors to this volume on neuroethics. The wide range of disciplinary backgrounds that the authors represent, from neuroscience, bioethics and philosophy, to law, social and health care policy, education, religion and film, allow for profoundly insightful and provocative answers to these questions, and open up the door to a host of new ones. The contributions highlight the timeliness of modern neuroethics today, and assure the longevity and importance of neuroethics for generations to come. (shrink)

The application of neurostimulation techniques such as deep brain stimulation —often called a brain pacemaker for neurological conditions like Parkinson's disease —has generated “currents of hope.” Building on this hope, there is significant interest in applying neurostimulation to psychiatric disorders such as major depression and obsessive-compulsive disorder. These emerging neurosurgical practices raise a number of important ethical and social questions in matters of resource allocation, informed consent for vulnerable populations, and commercialization of research.

The application of neuroimaging technology to the study of the injured brain has transformed how neuroscientists understand disorders of consciousness, such as the vegetative and minimally conscious states, and deepened our understanding of mechanisms of recovery. This scientific progress, and its potential clinical translation, provides an opportunity for ethical reflection. It was against this scientific backdrop that we convened a conference of leading investigators in neuroimaging, disorders of consciousness and neuroethics. Our goal was to develop an ethical frame to move (...) these investigative techniques into mature clinical tools. This paper presents the recommendations and analysis of a Working Meeting on Ethics, Neuroimaging and Limited States of Consciousness held at Stanford University during June 2007. It represents an interdisciplinary approach to the challenges posed by the emerging use of neuroimaging technologies to describe and characterize disorders of consciousness. (shrink)

Neuroethics, in its modern form, investigates the impact of brain science in four basic dimensions: the self, social policy, practice and discourse. In this study, we analyzed a set of 461 peer-reviewed articles with neuroethics content, published by authors from 32 countries. We analyzed the data for: (1) trends in the development of international neuroethics over time, and (2) how challenges at the intersection of ethics and neuroscience are viewed in countries that are considered developed by International Monetary Fund (IMF) (...) standards, and in those that are developing. Our results demonstrate a steady increase in global participation in neuroethics from 1989 to 2005, characterized by an increase in numbers of articles published specifically on neuroethics, journals publishing these articles, and countries contributing to the literature. The focus from all countries was on the practice of brain science and the amelioration of neurological disease. Indicators of technology creation and diffusion in developing countries were specifically correlated with increases in publications concerning policy implications of brain science. Neuroethics is an international endeavor and, as such, should be sensitive to the impact that context has on acceptance and use of technological innovation. (shrink)

Neurosurgery for psychiatric disorders, also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to (...) set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law, what types of regulations are required, and how to approach international harmonization given the potential migration of researchers and patients. (shrink)

Advances in neuroscience are changing how mental health issues such as addiction are understood and addressed as a brain disease. Although a brain disease model legitimizes addiction as a medical condition, it promotes neuro-essentialist thinking and categorical ideas of responsibility and free choice, and undermines the complexity involved in its emergence. We propose a “biopsychosocial systems” model where psychosocial factors complement and interact with neurogenetics. A systems approach addresses the complexity of addiction and approaches free choice and moral responsibility within (...) the biological, lived experience and sociohistorical context of the individual. We examine heroin-assisted treatment as an applied case example within our framework. We conclude with a discussion of the model and its implications for drug policy, research, addiction health care systems and delivery, and treatment of substance use problems. (shrink)

A landmark in the scientific literature, the Oxford Handbook of Neuroethics presents a pioneering review of a topic central to the biosciences. It breaks new ground in bringing together leading neuroscientists, philosophers, and lawyers to tackle some of the most significant ethical issues that face us now and will continue to do so.

Bioethics, Volume 36, Issue 1, Page 25-41, January 2022.

Mental health care providers increasingly confront challenges posed by the introduction of new neurotechnology into the clinic, but little is known about the impact of such capabilities on practice patterns and relationships with patients. To address this important gap, we sought providers’ perspectives on the potential clinical translation of functional neuroimaging for prediction and diagnosis of mental illness. We conducted 32 semi-structured telephone interviews with mental health care providers representing psychiatry, psychology, family medicine, and allied mental health. Our results suggest (...) that mental health providers have begun to re-conceptualize mental illness with a neuroscience gaze. They report an epistemic commitment to the value of a brain scan to provide a meaningful explanation of mental illness for their clients. If functional neuroimaging continues along its projected trajectory to translation, providers will ultimately have to negotiate its role in mental health. Their perspectives, therefore, enrich bioethical discourse surrounding neurotechnology and inform the translational pathway. (shrink)

In October 2022, I had the privilege of joining Hank Greely on the opening panel of the annual International Neuroethics Society (INS) meeting in Montréal, Tiohtiá:ke, situated on the traditional t...

Major depression is among the most common, challenging and disabling conditions. It is highly heterogeneous, affects patients throughout the lifespan and, in up to one-third of people affected, res...

In Phillip Kerr’s 1994 spellbinding novel A Philosophical Investigation, the medical test to which the protagonist refers is a functional brain scan based on positron emission tomography. It is used to run large studies of male and female brains and, following a lead suggested by animal studies, has been used to identify rare cases of human male subjects who lack the ventral medial nucleus. This nucleus, in the experiment, is hypothesized to inhibit the activity of the sexually dimorphic nucleus, a (...) preoptic area of the male brain believed to be a repository of male aggressive response. Prior research, we learn from the plot, shows that 3 in 100,000 human males are VMN-negative. Thirty percent of those affected are believed to be in prison or to have a criminal record; 70% are believed to stabilize levels of aggression by producing increased levels of estrogen. Identities of subjects participating in the brain scan studies are protected through the conversion of real names to those of famous figures of the past — Bertrand Russell, Charles Dickens. Those for whom results are unfavorable are recontacted, and they are offered counseling. (shrink)

As one of the most compelling technologies for imaging the brain, functional MRI (fMRI) produces measurements and persuasive pictures of research subjects making cognitive judgments and even reasoning through difficult moral decisions. Even after centuries of studying the link between brain and behavior, this capability presents a number of novel significant questions. For example, what are the implications of biologizing human experience? How might neuroimaging disrupt the mysteries of human nature, spirituality, and personal identity? Rather than waiting for an ethical (...) agenda to emerge from some unpredictable combination of the concerns of ethicists and researchers, the attention of journalists, or after controversy is sparked by research that cannot be retracted, we queried key figures in bioethics and the humanities, neuroscience, media, industry, and patient advocacy in focus groups and interviews. We identified specific ethical, legal and social issues (ELSI) that highlight researcher obligations and the nonclinical impact of the technology at this new frontier. (shrink)

:Recent neuroimaging research on disorders of consciousness provides direct evidence of covert consciousness otherwise not detected clinically in a subset of severely brain-injured patients. These findings have motivated strategic development of binary communication paradigms, from which researchers interpret voluntary modulations in brain activity to glean information about patients’ residual cognitive functions and emotions. The discovery of such responsiveness raises ethical and legal issues concerning the exercise of autonomy and capacity for decisionmaking on matters such as healthcare, involvement in research, and (...) end of life. These advances have generated demands for access to the technology against a complex background of continued scientific advancement, questions about just allocation of healthcare resources, and unresolved legal issues. Interviews with professionals whose work is relevant to patients with disorders of consciousness reveal priorities concerning further basic research, legal and policy issues, and clinical considerations. (shrink)

Empirical studies and ethical-legal analyses have demonstrated that incidental fndings in the brain, most commonly vascular in origin, must be addressed in the current era of imaging research. The challenges, however, are substantial. The discovery and management of incidental fndings vary, at minimum, by institutional setting, professional background of investigators, and the inherent diferences between research and clinical protocols. In the context of human subjects protections, the challenges of disclosure of unexpected and potentially meaningful clinical information concern privacy and confdentiality, (...) communication, and responsibility for follow-up. Risks, including a blurring of boundaries between research and clinical practice, must be weighed against the possible beneft to subjects and a moral duty to inform. Identifcation and examination of these challenges have been met by scientifc interest and a robust, interdisciplinary response resulting in the pragmatic recommendations discussed here. (shrink)

Direct-to-consumer advertising of healthcare products refers to a variety of marketing practices based on a combination of information and promotion strategies directed at consumers through different media such as radio and television broadcasts, newspaper and magazine ads, and, more recently, through the Internet. The principal form of marketing used by the pharmaceutical industry is the distribution of free samples to physicians but DTCA is an increasing part of global promotional spending for prescription drugs. Latest estimates suggest that DTCA now represents (...) an annual $3.2 billion enterprise for the U.S. pharmaceutical industry. Findings from the literature show that these substantial efforts are geared toward the newer pharmaceuticals for chronic conditions with huge market potentials. The lion's share is going to the 20 most prescribed pharmaceuticals. (shrink)

Environmental ethicists and experts in human health have raised concerns about the effects of hydraulic fracking to access natural oil and gas resources found deep in shale rock formations on surrounding ecosystems and communities. In this study, we analyzed the prevalence of discourse on brain and mental health, and ethics, in the peer-reviewed and grey literature in the five-year period between 2016 and 2022. A total of 84 articles met inclusion criteria for analysis. Seventy-six percent (76%) mentioned impacts on brain (...) (e.g., neural tube defects, neurological symptoms), and mental health (e.g., negative psychological effects, stress, depression) briefly; 11 reports dedicated substantive discourse to either or both together. References to safety (77%) dominated the ethics context. Discussion of environmental injustices as fracking sites disproportionately affect vulnerable communities appeared in 38% of the papers. We examine the findings through the lens of environmental neuroethics that brings human-made changes to the environment, brain and mental health, and ethics together into three interwoven lines of inquiry. (shrink)

Advances in neuroscience have enabled the transition of transcranial direct current stimulation (tDCS) from research and clinical settings to public use. For this primarily home-based context, tDCS has been popularized as a do-it-yourself (DIY) approach to improved cognition and wellness. The line between wellness and health is blurry, however, and little is known about how engagement with therapeutic tDCS impacts users’ interactions with other interventions such as clinical consultations, pharmacotherapy, complementary medicine, and even other neurotechnology. To close this gap, we (...) collected data from the online content aggregator Reddit and analyzed posts pertaining to tDCS. Findings indicate that most users turn to Reddit to request information about tDCS as an adjunct, but not as a bypass, to ongoing or prior approaches. Posts suggest that mainstream medical care is viewed as necessary but not sufficient to address conditions such as depression and anxiety. Users discuss a mix of benefits and harms. This discourse provides valuable insights into the health practices, concerns and priorities of users, and new knowledge for informing applications of neurotechnology both inside and outside the therapeutic setting. (shrink)

There is substantial literature on fetal alcohol spectrum disorder research involving Aboriginal children, but little related literature on other common neurodevelopmental conditions such as autism spectrum disorder or cerebral palsy for this population. As part of our work in cross-cultural neuroethics, we examined this phenomenon as a case study in Canada. We conducted semi-structured interviews with health researchers working on the frontline with First Nation communities to obtain perspectives about: reasons for the lack of ASD and CP research within the (...) Aboriginal context, the potential ethical and social implications of this disparity, and recommendations for change. Participants reported that the major barriers to engage in ASD or CP research are under-reporting and under-diagnosis of these conditions in Aboriginal communities, difficulties in establishing trust between community members and researchers, challenges in accessing children living under the care of child welfare services, and lack of support from universities and funding agencies to encourage community partnerships. They further perceived threats to justice as the population is denied the benefits of ASD and CP research, and stigma related to the possible over-representation of FASD in the population. The adoption of strength- and community-based practices to improve engagement and address disparities, and to create health databases with prevalence rates that are representative of all forms of disability in both Aboriginal and non-Aboriginal populations are critical steps to close these gaps. (shrink)

Supply-side interventions such as prescription drug monitoring programs, “pill mill” laws, and dispensing limits have done little to quell the burgeoning opioid crisis. An increasingly popular demand-side alternative to these measures – now adopted by 38 jurisdictions in the USA and 7 provinces in Canada — is court-mandated involuntary commitment and treatment. In Massachusetts, for example, Part I, Chapter 123, Section 35 of the state's General Laws allows physicians, spouses, relatives, and police officers to petition a court to involuntarily commit (...) and treat a person whose alcohol or drug abuse poses a likelihood of serious harm. This paper explores the ethical underpinnings of this law as a case study for others. First, we highlight the procedural and substantive standards of Section 35 and evaluate the application of the law in practice, including the frequency with which it has been invoked and outcomes. We then use this background to inform an ethical critique of the law. Specifically, we argue that the infringement of autonomy and privacy associated with involuntary intervention under Section 35 is not currently justified on the grounds of a lack of evidenced benefits and a risk of significant of harm. Further ethical concerns also arise from a lack of standard of care provided under the Section 35 pathway. Based on this analysis, we advance four recommendations for change to mitigate these ethical shortcomings. (shrink)

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises (...) a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

To date, ethics discussions about stem cell research overwhelmingly have centered on the morality and acceptability of using human embryonic stem cells. Governments in many jurisdictions have now answered these “first-level questions” and many have now begun to address ethical issues related to the donation of cells, gametes, or embryos for research. In this commentary, we move beyond these ethical concerns to discuss new themes that scientists on the forefront of NRM development anticipate, providing a preliminary framework for further discussion (...) between scientists and ethicists. Fostering strong partnerships between neuroscientists and ethicists that operate and collaborate within this evolving framework will maximize the translation of NRM discoveries on the brain into cures that are safe and address the needs of science and society. (shrink)

The momentum for global neuroscience that is geopolitically-free has never been greater, and neuroethics holds a unique place in this context both in its translational and transnational forms.In th...

Harm reduction initiatives such as the distribution of naloxone have been crucial in saving lives during the opioid crisis in North America. Despite these efforts, today’s drug supply contaminated...

Objectives To characterize recruitment approaches to research on the brain and mind that involves Indigenous peoples. Methods We conducted a secondary analysis of a Harding et al. (2021) scoping review. Reviewers screened studies (_n_ = 66) for sampling methods, recruitment and engagement, positionality statements, and details on ethics approvals. Synthesis We identified twenty-nine (29) English-language articles relevant to the analysis. Of these, 52% (_n_ = 15/29) reported a mix of sampling methods; 45% (_n_ = 13/29) contained statements or information about (...) author positionalities. While, overall, 24% (_n_ = 7/29) of the studies were missing information about ethics protocols, we observe an improvement over time in the reporting of approvals and use of community-engaged participant recruitment methods. Current brain research studies demonstrate ways of collaborating with Indigenous communities that meet existing ethics guidelines. To be wholly responsive to the needs of Indigenous peoples, however, researchers may need to exceed existing ethical benchmarks.. Positionality statements successfully detailed the relationships of the research teams with the communities with which they work, and contextualized recruitment methods. Conclusion Improved quality and meaningfulness of brain research with Indigenous peoples and trust in the research process and public health will be enhanced when remaining gaps in protecting and reporting of participant recruitment methods are closed. (shrink)

In proportion to other serious illnesses, diseases of the brain and mind represent the greatest—and still increasing—public health burden that Western societies are facing. Consequently, scientists, governments, advocacy groups, and public health authorities are committed to research to tackle the causes and consequences of neurological and psychiatric diseases and to find cures for them. As neuroscience research progresses, ethicists and neuroscientists face numerous ethical challenges to the integration of frontier application of research—neurotechnology—with the delivery of high-quality healthcare. In this special (...) neuroethics issue, we have invited distinguished scholars with diverse disciplinary backgrounds to present their reflections and research on the ethical dimensions of this crucial integration. (shrink)

The meaningful consideration of cultural practices, values and beliefs is a necessary component in the effective translation of advancements in neuroscience to clinical practice and public discourse. Society’s immense investment in biomedical science and technology, in conjunction with an increasingly diverse socio-cultural landscape, necessitates the study of how potential discoveries in neurodegenerative diseases such as Alzheimer disease are perceived and utilized across cultures. Building on the work of neuroscientists, ethicists and philosophers, we argue that the growing field of neuroethics provides (...) a pragmatic and constructive pathway to guide advancements in neuroscience in a manner that is culturally nuanced and relevant. Here we review a case study of one issue in culturally oriented neuroscience research where it is evident that traditional research ethics must be broadened and the values and needs of diverse populations considered for meaningful and relevant research practices. A global approach to neuroethics has the potential to furnish critical engagement with cultural considerations of advancements in neuroscience. (shrink)

A brain-computer interface technology that can decode the neural signals associated with attempted but unarticulated speech could offer a future efficient means of communication for people with severe motor impairments. Recent demonstrations have validated this approach. Here we assume that it will be possible in future to decode imagined (i.e., attempted but unarticulated) speech in people with severe motor impairments, and we consider the characteristics that could maximize the social utility of a BCI for communication. As a social interaction, communication (...) involves the needs and goals of both speaker and listener, particularly in contexts that have significant potential consequences. We explore three high-consequence legal situations in which neurally-decoded speech could have implications:Testimony, where decoded speech is used as evidence;Consent and Capacity, where it may be used as a means of agency and participation such as consent to medical treatment; andHarm, where such communications may be networked or may cause harm to others. We then illustrate how design choices might impact the social and legal acceptability of these technologies. (shrink)

We expand on the article “Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force” to consider the ways in which rural...