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)
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)
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 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)
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.
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)
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)
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)
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)
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)
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)
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)
: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)
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)
Background: The research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a constant state of flux, and ongoing challenges place ever greater demands on investigators to be accountable to the public and to answer questions about the implications of their work for health care, society, and policy. Methods: We surveyed US-based investigators involved in neurodegenerative diseases research about how they value ethics-related issues, what motivates them to give consideration to (...) those issues, and the barriers to doing so. Using the NIH CRISP database we identified 1,034 researchers with relevant, active grants and invited them to complete an online questionnaire. We received 193 responses. We used exploratory factor analysis to transform individual survey questions into a smaller set of factors, and linear regression to understand the effect of key variables of interest on the factor scores. Results: Ethics-related issues clustered into two groups: research ethics and external influences. Heads of research groups viewed issues of research ethics to be more important than the other respondents. Concern about external influences was related to overall interest in ethics. Motivators clustered into five groups: ensuring public understanding, external forces, requirements, values, and press and public. Heads of research groups were more motivated to ensure public understanding of research than the other respondents. Barriers clustered into four groups: lack of resources, administrative burden, relevance to the research, and lack of interest. Perceived lack of ethics resources was a particular barrier for investigators working in drug discovery. Conclusions: The data suggest that senior level neuroscientists working in the field of neurodegeneration (ND), and drug discovery specifically, are motivated to consider ethics issues related to their work, but the perceived lack of ethics resources thwarts their efforts. With bioethics centres at more than 50% of the institutions at which these respondents reside, the neuroscience and bioethics communities appear to be disconnected. Dedicated ethical, legal and social implications (ELSI) programs, such as those fully integrated into genetics and regenerative medicine, provide models for achieving meaningful partnerships not yet adequately realized for scholars and trainees interested in drug discovery for ND. (shrink)
Background and PurposeThe decision to perform decompressive craniectomy for patients with malignant MCA syndrome can be ethically complex. We investigated factors that clinicians consider in this decision-making process.MethodsA survey including clinical vignettes and attitudes questions surrounding the use of hemicraniectomy in malignant MCA syndrome was distributed to 203 neurosurgeons, neurologists, staff and residents, and nurses and allied health members specializing in the care of neurological patients. These were practicing health care providers situated in an urban setting in Canada where access (...) to health care is covered by national policy and is a human right.ResultsEighty-eight participants responded to survey. All participants unanimously supported the procedure for young and healthy patients. Advanced age, the presence of aphasia, comorbid medical conditions, and poor baseline functional status were dominant factors associated with increasing reluctance to offer surgical decompression. Patients’ previously expressed wishes were also an important consideration. Eighty-six percent of respondents agreed that withholding surgery is ethically justified if the outcome is perceived as futile.ConclusionsHealth care providers use similar factors to determine if aggressive management is justified given anticipated burden on patient quality of life and extended impact on society. This convergence can be harnessed beneficially for the transparent communication of medical options in the ethically complex setting of decompressive hemicraniectomy post-stroke. (shrink)
The Internet has quickly gained popularity as a major source of health-related information, but its impact is unclear. Here, we investigate the extent to which advocacy websites for three neurodevelopmental disorders—cerebral palsy (CP), autism spectrum disorder (ASD) and fetal alcohol spectrum disorder (FASD)—inform stakeholders about treatment options, and discuss the ethical challenges inherent in providing such information online. We identified major advocacy websites for each disorder and assessed website accountability, the number, attributes, and accessibility of treatments described, and the valence (...) of treatment information. With the exception of FASD websites, we found that advocacy websites provide a plethora of information about a wide variety of readily available products and services. Treatment information is primarily targeted at families and is overwhelmingly encouraging, regardless of the type or conventionality of treatments. Many websites acknowledge corporate sponsors. While the majority do not overtly advertise or endorse specific brands, they also do not prominently display disclaimers about the nature and intent of treatment information. Thus, while advocacy websites are organized to serve as information clearinghouses, they implicitly appear to provide endorsement of selected treatments and services. We conclude with recommendations for new partnerships between government-funded health organizations, advocacy and investigators to make more transparent the role of online information in informing treatment options and improving the evaluation of information. (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.
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