Philosophy, Ethics, and Humanities in Medicine, 2013
The meaningful consideration of cultural practices, values and beliefs is a necessary component i... more 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 pr...
In 2007, a novel pathogenic genetic mutation associated with early onset familial Alzheimer disea... more In 2007, a novel pathogenic genetic mutation associated with early onset familial Alzheimer disease was identified in a large First Nation family living in communities across British Columbia, Canada. Building on a community-based participatory study with members of the Nation, we sought to explore the impact and interplay of medicalization with the Nation's knowledge and approaches to wellness in relation to early onset familial Alzheimer disease. We performed a secondary content analysis of focus group discussions and interviews with 48 members of the Nation between 2012 and 2013. The analysis focused specifically on geneticization, medicalization, and traditional knowledge of early onset familial Alzheimer disease, as these themes were prominent in the primary analysis. We found that while biomedical explanations of disease permeate the knowledge and understanding of early onset familial Alzheimer disease, traditional concepts about wellness are upheld simultaneously. The ana...
In this paper, we reply to Taylor's (2015) peer commentary on consent-inescrow. Specifically, we ... more In this paper, we reply to Taylor's (2015) peer commentary on consent-inescrow. Specifically, we clarify the utility of this novel approach, the way in which it minimizes risks to participants, and how it differs from existing optout methods. We further explore its potential use in fields beyond disaster research.
Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issue... more Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issues are heightened in the context of neuroimaging research involving persons with mental health disorders. There has been growing interest in these issues among legal scholars, philosophers, social scientists, and as well as neuroimagers over the last decade. Less clear, however, is the extent to which members of the neuroimaging community are engaged with these issues when they undertake their research and report results. In this study, we analyze the peer-reviewed review literature involving fMRI as applied to the study of mental health disorders. Our hypothesis is that, due to the critical orientation of reviews, and the vulnerability of mental health population, the penetrance of neuroethics will be higher in the review literature in this area than it is in the primary fMRI research literature more generally. We find that while authors of reviews do focus a great deal of attention on the methodological limitations of the studies they discussed, contrary to our hypothesis, they do not frame concerns in ethical terms despite their ethical significance. We argue that an ethics lens on such discussion would increase the knowledge-value of this scholarly work.
The Canadian journal of neurological sciences, 2006
Neuroscience represents a dynamic area of biomedical research where neuroethical responsibilities... more Neuroscience represents a dynamic area of biomedical research where neuroethical responsibilities for researchers are emerging. This paper is the companion piece to the French-language one also published in this issue of the Canadian Journal of Neurological ...
Discoveries in the field of neuroscience are a natural source of discourse among scientists and h... more Discoveries in the field of neuroscience are a natural source of discourse among scientists and have long been disseminated to the public. Historically, as news of findings has travelled between communities, it has elicited both expected and unusual reactions. ...
The wide dissemination and expanding applications of functional MRI have not escaped the attentio... more The wide dissemination and expanding applications of functional MRI have not escaped the attention of the media or discussion in the wider public arena. From the bench to the bedside, this technology has introduced substantial ethical challenges. Are the boundaries of what it can and cannot achieve being communicated to the public? Are its limitations understood? And given the complexities that are inherent to neuroscience, are current avenues for communication adequate?
Researchers, institutional review boards (IRBs), participants in human subjects research, and the... more Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem-how should incidental findings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant's physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require? An IF is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study. This means that IFs may be on variables not directly under study and may not be anticipated in the research protocol. Examples include: • an IF on a genomic microarray suggesting a genetic or chromosomal variant of potential clinical importance beyond the variants or genotypephenotype associations directly under study, • an IF of misattributed paternity or parentage in a genetic family study, • an unexpected mass or aneurysm visualized in the course of structural magnetic resonance imaging (MRI) of the brain, and • an unexpected mass at the base of the lung discovered in computed tomography (CT) colonography. We focus here on IFs discovered in the course of research, not clinical care. A significant literature already addresses incidental or accidental findings discovered in the course of nonresearch clinical care or screening (e.g., an adrenal tumor serendipitously discovered, sometimes called an "incidentaloma"). 1 However, attention to IFs in research is at an earlier stage. No consensus exists as yet on how to handle them. Research IFs can arise in collecting and analyzing research images and data, but may also arise in determining whether a potential research participant qualifies for inclusion in the study population or in collecting baseline physiological information. Examples of eligibility and baseline IFs include discovery of an anomalous EKG of potential clinical concern in
Deep brain stimulation (DBS) represents a promising new frontier in medicine and neuroscience for... more Deep brain stimulation (DBS) represents a promising new frontier in medicine and neuroscience for managing disorders of mental health that represent an enormous burden of disease on our societies. The caution and significant restraint of leaders in the evolution of DBS today stand in sharp and refreshing contrast to previous episodes in history. In embracing the anticipatory and pragmatic problem-solving
Research on complex health conditions such as neurodevelopmental disorders increasingly relies on... more Research on complex health conditions such as neurodevelopmental disorders increasingly relies on large-scale research and clinical studies that would benefit from data sharing initiatives. Organizations that share data stand to maximize the efficiency of invested research dollars, expedite research findings, minimize the burden on the patient community, and increase citation rates of publications associated with the data. This study examined ethics and governance information on websites of databases involving neurodevelopmental disorders to determine the availability of information on key factors crucial for comprehension of, and trust and participation in such initiatives. We identified relevant databases identified using online keyword searches. Two researchers reviewed each of the websites and identified thematic content using principles from grounded theory. The content for each organization was interrogated using the gap analysis method. Sixteen websites from data sharing orga...
remain in the 'proof of concept' stage, but show substantial promise 1. Neurosurgery is increasin... more remain in the 'proof of concept' stage, but show substantial promise 1. Neurosurgery is increasingly considered as a treatment for mental illnesses and an array of new procedures are under development, including the implantation of devices and tissue 2. Noninvasive transcranial magnetic stimulation (TMS) of targeted brain areas is the basis of promising new treatments for depression and other psychopathology 3 .
There is increasing pressure for neuroscientists to communicate their research and the societal i... more There is increasing pressure for neuroscientists to communicate their research and the societal implications of their findings to the public. Communicating science is challenging and the transformation of communication by digital and interactive media makes the challenge even greater. To successfully facilitate dialogue with the public in this new media landscape we suggest three courses of action for the neuroscience community: a cultural shift that explicitly recognizes and rewards public outreach, the identification and development of neuroscience communication experts, and ongoing empirical research on public communication of neuroscience.
While new generations of implantable brain computer interface (BCI) devices are being developed, ... more While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-inhuman clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by
As the healthcare industry moves from a twentieth century approach of providing treatments of las... more As the healthcare industry moves from a twentieth century approach of providing treatments of last resort to a future of individualized medicine, biobanks will play a pivotal role in this transition. Yet at the cutting edge of biobanking research are new ethical, social and policy challenges beyond those familiar to basic biomedical research.
As the healthcare industry moves from a twentieth century approach of providing treatments of las... more As the healthcare industry moves from a twentieth century approach of providing treatments of last resort to a future of individualized medicine, biobanks will play a pivotal role in this transition. Yet at the cutting edge of biobanking research are new ethical, social and policy challenges beyond those familiar to basic biomedical research.
This 'issues paper' was generated through a 'virtual workshop process' over the course of several... more This 'issues paper' was generated through a 'virtual workshop process' over the course of several months. The authors first outlined relevant issues and key literature. A draft was then distributed, comments were received, and a revised draft was circulated among authors for approval. The use of a 'virtual workshop process' shaped both the tone and coverage of this article, though we hope in a way that still provides a detailed and useful summary of central issues on this topic. We believe that this paper-the collaborative work of globally situated ELSI researchers-exemplifies 'ELSI 2.0' (Jane Kaye et al., Research Priorities. ELSI 2.0 for Genomics and Society, 336 Science 673 (2012)).
Philosophy, Ethics, and Humanities in Medicine, 2013
The meaningful consideration of cultural practices, values and beliefs is a necessary component i... more 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 pr...
In 2007, a novel pathogenic genetic mutation associated with early onset familial Alzheimer disea... more In 2007, a novel pathogenic genetic mutation associated with early onset familial Alzheimer disease was identified in a large First Nation family living in communities across British Columbia, Canada. Building on a community-based participatory study with members of the Nation, we sought to explore the impact and interplay of medicalization with the Nation's knowledge and approaches to wellness in relation to early onset familial Alzheimer disease. We performed a secondary content analysis of focus group discussions and interviews with 48 members of the Nation between 2012 and 2013. The analysis focused specifically on geneticization, medicalization, and traditional knowledge of early onset familial Alzheimer disease, as these themes were prominent in the primary analysis. We found that while biomedical explanations of disease permeate the knowledge and understanding of early onset familial Alzheimer disease, traditional concepts about wellness are upheld simultaneously. The ana...
In this paper, we reply to Taylor's (2015) peer commentary on consent-inescrow. Specifically, we ... more In this paper, we reply to Taylor's (2015) peer commentary on consent-inescrow. Specifically, we clarify the utility of this novel approach, the way in which it minimizes risks to participants, and how it differs from existing optout methods. We further explore its potential use in fields beyond disaster research.
Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issue... more Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issues are heightened in the context of neuroimaging research involving persons with mental health disorders. There has been growing interest in these issues among legal scholars, philosophers, social scientists, and as well as neuroimagers over the last decade. Less clear, however, is the extent to which members of the neuroimaging community are engaged with these issues when they undertake their research and report results. In this study, we analyze the peer-reviewed review literature involving fMRI as applied to the study of mental health disorders. Our hypothesis is that, due to the critical orientation of reviews, and the vulnerability of mental health population, the penetrance of neuroethics will be higher in the review literature in this area than it is in the primary fMRI research literature more generally. We find that while authors of reviews do focus a great deal of attention on the methodological limitations of the studies they discussed, contrary to our hypothesis, they do not frame concerns in ethical terms despite their ethical significance. We argue that an ethics lens on such discussion would increase the knowledge-value of this scholarly work.
The Canadian journal of neurological sciences, 2006
Neuroscience represents a dynamic area of biomedical research where neuroethical responsibilities... more Neuroscience represents a dynamic area of biomedical research where neuroethical responsibilities for researchers are emerging. This paper is the companion piece to the French-language one also published in this issue of the Canadian Journal of Neurological ...
Discoveries in the field of neuroscience are a natural source of discourse among scientists and h... more Discoveries in the field of neuroscience are a natural source of discourse among scientists and have long been disseminated to the public. Historically, as news of findings has travelled between communities, it has elicited both expected and unusual reactions. ...
The wide dissemination and expanding applications of functional MRI have not escaped the attentio... more The wide dissemination and expanding applications of functional MRI have not escaped the attention of the media or discussion in the wider public arena. From the bench to the bedside, this technology has introduced substantial ethical challenges. Are the boundaries of what it can and cannot achieve being communicated to the public? Are its limitations understood? And given the complexities that are inherent to neuroscience, are current avenues for communication adequate?
Researchers, institutional review boards (IRBs), participants in human subjects research, and the... more Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem-how should incidental findings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant's physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require? An IF is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study. This means that IFs may be on variables not directly under study and may not be anticipated in the research protocol. Examples include: • an IF on a genomic microarray suggesting a genetic or chromosomal variant of potential clinical importance beyond the variants or genotypephenotype associations directly under study, • an IF of misattributed paternity or parentage in a genetic family study, • an unexpected mass or aneurysm visualized in the course of structural magnetic resonance imaging (MRI) of the brain, and • an unexpected mass at the base of the lung discovered in computed tomography (CT) colonography. We focus here on IFs discovered in the course of research, not clinical care. A significant literature already addresses incidental or accidental findings discovered in the course of nonresearch clinical care or screening (e.g., an adrenal tumor serendipitously discovered, sometimes called an "incidentaloma"). 1 However, attention to IFs in research is at an earlier stage. No consensus exists as yet on how to handle them. Research IFs can arise in collecting and analyzing research images and data, but may also arise in determining whether a potential research participant qualifies for inclusion in the study population or in collecting baseline physiological information. Examples of eligibility and baseline IFs include discovery of an anomalous EKG of potential clinical concern in
Deep brain stimulation (DBS) represents a promising new frontier in medicine and neuroscience for... more Deep brain stimulation (DBS) represents a promising new frontier in medicine and neuroscience for managing disorders of mental health that represent an enormous burden of disease on our societies. The caution and significant restraint of leaders in the evolution of DBS today stand in sharp and refreshing contrast to previous episodes in history. In embracing the anticipatory and pragmatic problem-solving
Research on complex health conditions such as neurodevelopmental disorders increasingly relies on... more Research on complex health conditions such as neurodevelopmental disorders increasingly relies on large-scale research and clinical studies that would benefit from data sharing initiatives. Organizations that share data stand to maximize the efficiency of invested research dollars, expedite research findings, minimize the burden on the patient community, and increase citation rates of publications associated with the data. This study examined ethics and governance information on websites of databases involving neurodevelopmental disorders to determine the availability of information on key factors crucial for comprehension of, and trust and participation in such initiatives. We identified relevant databases identified using online keyword searches. Two researchers reviewed each of the websites and identified thematic content using principles from grounded theory. The content for each organization was interrogated using the gap analysis method. Sixteen websites from data sharing orga...
remain in the 'proof of concept' stage, but show substantial promise 1. Neurosurgery is increasin... more remain in the 'proof of concept' stage, but show substantial promise 1. Neurosurgery is increasingly considered as a treatment for mental illnesses and an array of new procedures are under development, including the implantation of devices and tissue 2. Noninvasive transcranial magnetic stimulation (TMS) of targeted brain areas is the basis of promising new treatments for depression and other psychopathology 3 .
There is increasing pressure for neuroscientists to communicate their research and the societal i... more There is increasing pressure for neuroscientists to communicate their research and the societal implications of their findings to the public. Communicating science is challenging and the transformation of communication by digital and interactive media makes the challenge even greater. To successfully facilitate dialogue with the public in this new media landscape we suggest three courses of action for the neuroscience community: a cultural shift that explicitly recognizes and rewards public outreach, the identification and development of neuroscience communication experts, and ongoing empirical research on public communication of neuroscience.
While new generations of implantable brain computer interface (BCI) devices are being developed, ... more While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-inhuman clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by
As the healthcare industry moves from a twentieth century approach of providing treatments of las... more As the healthcare industry moves from a twentieth century approach of providing treatments of last resort to a future of individualized medicine, biobanks will play a pivotal role in this transition. Yet at the cutting edge of biobanking research are new ethical, social and policy challenges beyond those familiar to basic biomedical research.
As the healthcare industry moves from a twentieth century approach of providing treatments of las... more As the healthcare industry moves from a twentieth century approach of providing treatments of last resort to a future of individualized medicine, biobanks will play a pivotal role in this transition. Yet at the cutting edge of biobanking research are new ethical, social and policy challenges beyond those familiar to basic biomedical research.
This 'issues paper' was generated through a 'virtual workshop process' over the course of several... more This 'issues paper' was generated through a 'virtual workshop process' over the course of several months. The authors first outlined relevant issues and key literature. A draft was then distributed, comments were received, and a revised draft was circulated among authors for approval. The use of a 'virtual workshop process' shaped both the tone and coverage of this article, though we hope in a way that still provides a detailed and useful summary of central issues on this topic. We believe that this paper-the collaborative work of globally situated ELSI researchers-exemplifies 'ELSI 2.0' (Jane Kaye et al., Research Priorities. ELSI 2.0 for Genomics and Society, 336 Science 673 (2012)).
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