Phoebe Friesen

Increasingly, scholars and advocates are recognizing the importance of including individuals with lived experience of mental health issues in the development of psychiatric research and policy. Here, we hope to contribute to discussions regarding the specific context of the Diagnostic and Statistical Manual of Mental Disorders (DSM) revision process. We argue that this process is not inclusive enough, but also that those who have advocated for better inclusivity have not been responsive enough to the risks reported from other inclusive mental health contexts (in research, practice, and policy). In particular, tokenism and lack of uptake of input from people with lived experience are likely to loom large in relation to DSM efforts at inclusivity as well. In light of this, we suggest that disentangling the reasons for inclusion can help to overcome these problems, and we offer practical recommendations for a more inclusive DSM revision process.

Psychedelic science is haunted. A dark past, and contemporary violations, litter the field with ghosts of appropriation, abuse, and a violent war on drugs. Yet, these forms of haunting often remain unseen in discussions of the ethical aspects of psychedelic science. This manuscript explores various ways in which ghosts populate our collective and individual set and settings when it comes to psychedelic drugs, and what moral demands these ghosts might place on us. The first section examines three forms of haunting in psychedelic science. Colonial harms loom large, as a booming psychedelic industry creates scars of appropriation, biopiracy, and ecological damage. In psychedelic research contexts, various harms to participants haunt the past and present, from unethical experiments funded by MK-Ultra to current concerns related to vulnerabilities and shortcomings within ongoing clinical trials. The War on Drugs has left further damage, preventing racialized communities from feeling safe in psychedelic contexts, given enduring effects of over-policing. The next section examines demands for moral repair that have been made in response to these ghost stories. These demands, which focus on themes of acknowledgement and accountability, compensation, and listening and learning, bear a striking resemblance to discussions of reconciliation in the wake of human rights abuses. In light of these demands, the final section asks whether reconciliation is either possible or desirable in psychedelic science, or if perhaps we’re better off remaining haunted.

Psychedelic science is haunted. A dark past, and contemporary violations, litter the field with ghosts of appropriation, abuse, and a violent war on drugs. Yet, these forms of haunting often remain unseen in discussions of the ethical aspects of psychedelic science. This manuscript explores various ways in which ghosts populate our collective and individual set and settings when it comes to psychedelic drugs, and what moral demands these ghosts might place on us. The first section examines three forms of haunting in psychedelic science. Colonial harms loom large, as a booming psychedelic industry creates scars of appropriation, biopiracy, and ecological damage. In psychedelic research contexts, various harms to participants haunt the past and present, from unethical experiments funded by MK-Ultra to current concerns related to vulnerabilities and shortcomings within ongoing clinical trials. The War on Drugs has left further damage, preventing racialized communities from feeling safe in psychedelic contexts, given enduring effects of over-policing. The next section examines demands for moral repair that have been made in response to these ghost stories. These demands, which focus on themes of acknowledgement and accountability, compensation, and listening and learning, bear a striking resemblance to discussions of reconciliation in the wake of human rights abuses. In light of these demands, the final section asks whether reconciliation is either possible or desirable in psychedelic science, or if perhaps we’re better off remaining haunted.

Around the world, a growing number of communities are voicing their demands for authority in the governance of research involving them. Many such communities have experienced histories of exploitative, stigmatizing, intrusive research that failed to benefit them. To better understand what strategies communities are developing in order to have a say in research oversight, we conducted a scoping review of the international peer-reviewed and grey literature. Three primary strategies were identified: (1) guidelines; (2) community review boards; and (3) community advisory boards. Guidelines include documents developed by, with, or for communities to outline ethical behavior or conduct in research with or within the community. Community review boards offer ethical review of research protocols, much like traditional research ethics boards, but are community led and focus on community interests. Community advisory boards consist of representatives from a given community and are developed to advise institutions or research teams on community-level ethical matters pertaining to research projects. Initiatives led by Indigenous communities far outnumbered others in the sample, reflecting the legacy of continuous Indigenous resistance to research as a tool of colonialism. In several cases, communities in marginalized neighbourhoods, where harmful and exploitative research practices have taken place, emphasized the significance of community-led governance grounded in shared geographical and social contexts. We discuss some of the beneficial and challenging features of each type of strategy and offer recommendations for stakeholders who wish to support community-led efforts in research ethics.

In lieu of an abstract, here is a brief excerpt of the content:Democratizing Psychiatric ResearchRecognizing the Potential and the Limits of Experiential ExpertisePhoebe Friesen, PhD (bio)First, I want to express my gratitude for such thoughtful and generative responses to the manuscript "Why Democratize Psychiatric Research?," which has been in development for several years and is the product of much reflection that has taken place in academic, advocacy, and interpersonal contexts. I am delighted to see such insightful engagement with the piece and to have a chance to respond to both Drs. David Crepaz-Keay and Sam Fellowes here. Given that the authors raise such different questions within their commentaries, I consider each in turn.In his illuminating commentary, Crepaz-Keay makes three important points in response to the epistemic and ethical reasons I lay out as justifications for democratizing efforts in mental health research. First of all, Crepaz-Keay warns that there is "more subjectivity across much of medicine" than in the picture I've painted, and that we might do better to focus on this shared territory, taking up the goal of democratization across all of medicine, rather than risk "othering" psychiatry as uniquely subjective. In this way, Crepaz-Keay emphasizes, mental health service user researchers might "become leaders in progressive medical thinking."I appreciate this call to emphasize the ways in which the importance of subjective experiences cuts across all of medicine and to learn broad lessons from the pioneering participatory work that has been accomplished in the domain of mental health. I agree that much of medicine suffers from a focus on the objective to the neglect of the subjective, and wonder if this focus can sometimes create a distinct kind of worry in territories in which objective measures are widely available. Consider the focus on reducing the size of a tumor at all costs that can sometimes obscure important considerations related to what a good end of life might look like (Gawande, 2014). Particularly [End Page 143] within the process of determining what is worth measuring within research (and what is worth treating within clinical contexts), patient voices are essential to making an informed and beneficial decision. I agree with Crepaz-Keay here—this point applies to all realms of medicine.In contrast, I think other kinds of risks arise in domains in which objective measures are not widely available and therefore subjective reports of patients make up an essential part of any diagnosis or assessment. Another area I often think about is placebo studies, and in this space, stereotypes related to 'real' suffering and 'real' healing circulate widely (Friesen, 2019b). Largely, these stereotypes tend to support the importance and reality of that which occurs at the level of the physical or biological and take much less seriously suffering or healing which is thought to be located 'all in the head' (Friesen & Dionne, 2022). These biases also cut across medicine, influencing which patients are seen as trustworthy, dramatic, or worthy of one's compassion. I would argue that they show up especially in the setting of mental health care and research, in part because of the lack of objective measures and physiological explanations. A psychiatrized patient often has nothing physical or objective to point to with regard to their suffering, and so may be at the whim of a provider in relation to whether they are likely to be believed or discredited. As such, we must be especially alert to the unique risks that arise when evidence for suffering comes in a subjective form, and how efforts toward democratization might help reduce such risks.Second, Crepaz-Keay offers an essential intervention in relation to the importance of anti-racism within participatory practices in psychiatry. Although I do make mention of the lack of representation of racialized communities in participatory psychiatric research in discussing the important role that values play in the development of psychiatric knowledge, Crepaz-Keay accurately points out that this point related to representation is cross-cutting, and highly relevant to several of the other reasons I offer for why psychiatry research ought to be democratized. I am grateful for this invitation to look more broadly at how the exclusion of some voices from participatory efforts might apply across various justifications for...

Building on decades of rich discussions of why 'nothing about us without us' matters in the field of psychiatry, this paper aims to illuminate the justifications underlying participatory research in psychiatry, and how these justifications might shape participatory methodologies. This is accomplished through the examination of several epistemic and ethical features of psychiatry that underlie the importance of engaging in participatory research in the field, unpacking their connection to participatory research, and offering suggestions related to their implications for research methodologies. The epistemic features include: the irreducible value of patient experience, the extent of disagreement and uncertainty in the field, and the value-laden nature of knowledge in psychiatry. The ethical features include: the preponderance of harm, denials of agency and epistemic injustice, and the constant struggle for power. These features offer useful touchpoints for thinking through why participation matters in mental health research.

In lieu of an abstract, here is a brief excerpt of the content:Democratizing Psychiatric ResearchRecognizing the Potential and the Limits of Experiential ExpertiseThe author reports no conflict of interests.First, I want to express my gratitude for such thoughtful and generative responses to the manuscript "Why Democratize Psychiatric Research?," which has been in development for several years and is the product of much reflection that has taken place in academic, advocacy, and interpersonal contexts. I am delighted to see such insightful engagement with the piece and to have a chance to respond to both Drs. David Crepaz-Keay and Sam Fellowes here. Given that the authors raise such different questions within their commentaries, I consider each in turn.In his illuminating commentary, Crepaz-Keay makes three important points in response to the epistemic and ethical reasons I lay out as justifications for democratizing efforts in mental health research. First of all, Crepaz-Keay warns that there is "more subjectivity across much of medicine" than in the picture I've painted, and that we might do better to focus on this shared territory, taking up the goal of democratization across all of medicine, rather than risk "othering" psychiatry as uniquely subjective. In this way, Crepaz-Keay emphasizes, mental health service user researchers might "become leaders in progressive medical thinking."I appreciate this call to emphasize the ways in which the importance of subjective experiences cuts across all of medicine and to learn broad lessons from the pioneering participatory work that has been accomplished in the domain of mental health. I agree that much of medicine suffers from a focus on the objective to the neglect of the subjective, and wonder if this focus can sometimes create a distinct kind of worry in territories in which objective measures are widely available. Consider the focus on reducing the size of a tumor at all costs that can sometimes obscure important considerations related to what a good end of life might look like (Gawande, 2014). Particularly [End Page 143] within the process of determining what is worth measuring within research (and what is worth treating within clinical contexts), patient voices are essential to making an informed and beneficial decision. I agree with Crepaz-Keay here—this point applies to all realms of medicine.In contrast, I think other kinds of risks arise in domains in which objective measures are not widely available and therefore subjective reports of patients make up an essential part of any diagnosis or assessment. Another area I often think about is placebo studies, and in this space, stereotypes related to 'real' suffering and 'real' healing circulate widely (Friesen, 2019b). Largely, these stereotypes tend to support the importance and reality of that which occurs at the level of the physical or biological and take much less seriously suffering or healing which is thought to be located 'all in the head' (Friesen & Dionne, 2022). These biases also cut across medicine, influencing which patients are seen as trustworthy, dramatic, or worthy of one's compassion. I would argue that they show up especially in the setting of mental health care and research, in part because of the lack of objective measures and physiological explanations. A psychiatrized patient often has nothing physical or objective to point to with regard to their suffering, and so may be at the whim of a provider in relation to whether they are likely to be believed or discredited. As such, we must be especially alert to the unique risks that arise when evidence for suffering comes in a subjective form, and how efforts toward democratization might help reduce such risks.Second, Crepaz-Keay offers an essential intervention in relation to the importance of anti-racism within participatory practices in psychiatry. Although I do make mention of the lack of representation of racialized communities in participatory psychiatric research in discussing the important role that values play in the development of psychiatric knowledge, Crepaz-Keay accurately points out that this point related to representation is cross-cutting, and highly relevant to several of the other reasons I offer for why psychiatry research ought to be democratized. I am grateful for this invitation to look more broadly at how the exclusion of some voices from participatory efforts might apply across...

Building on decades of rich discussions of why 'nothing about us without us' matters in the field of psychiatry, this paper aims to illuminate the justifications underlying participatory research in psychiatry, and how these justifications might shape participatory methodologies. This is accomplished through the examination of several epistemic and ethical features of psychiatry that underlie the importance of engaging in participatory research in the field, unpacking their connection to participatory research, and offering suggestions related to their implications for research methodologies. The epistemic features include: the irreducible value of patient experience, the extent of disagreement and uncertainty in the field, and the value-laden nature of knowledge in psychiatry. The ethical features include: the preponderance of harm, denials of agency and epistemic injustice, and the constant struggle for power. These features offer useful touchpoints for thinking through why participation matters in mental health research.

ABSTRACT: Abilify MyCite was granted regulatory approval in 2017, becoming the world’s first “smart pill” that could digitally track whether patients had taken their medication. The new technology was introduced as one that had gained the support of patients and ethicists alike, and could contribute to solving the widespread and costly problem of patient nonadherence. Here, we offer an in-depth exploration of this narrative, through an examination of the origins and development of Abilify, the drug that would later become MyCite. This history illuminates how an antipsychotic can become a top-selling drug and maintain its blockbuster status for more than a decade. It also provides a detailed case study for how knowledge is constructed within the logic of biomedical capitalism, providing impetus to reexamine claims regarding how MyCite addresses patient nonadherence, engenders patient support, and is ethicist-approved.

This article identifies and examines a tension in mental health researchers’ growing enthusiasm for the use of computational tools powered by advances in artificial intelligence and machine learning (AI/ML). Although there is increasing recognition of the value of participatory methods in science generally and in mental health research specifically, many AI/ML approaches, fueled by an ever-growing number of sensors collecting multimodal data, risk further distancing participants from research processes and rendering them as mere vectors or collections of data points. The imperatives of the “participatory turn” in mental health research may be at odds with the (often unquestioned) assumptions and data collection methods of AI/ML approaches. This article aims to show why this is a problem and how it might be addressed.

This paper examines the controversial diagnosis of excited delirium, which is often employed after individuals die during an encounter with the police. Rather than asking the important, and widely explored, question of whether the diagnosis is real or not, here, we consider how it operates in the world and why it seems to stick around, despite growing controversy and resistance to its use. First, we consider the question of what kinds of people are made up through the diagnosis of excited delirium, exploring how racial stereotypes are exploited and certain behaviors are engendered through the illness script offered by excited delirium. Next, we ask what work excited delirium doing is doing in the world, unpacking how it tends to justify force and redirect responsibility, as well as who is it serving, and who is it not benefitting. Finally, we interrogate the slippery logic of excited delirium, examining how the way it is employed renders it non-falsifiable, and therefore impossible to uncover as real or unreal.

In lieu of an abstract, here is a brief excerpt of the content:Excited DeliriumFalsifiability, Causality, and the Importance of AdvocacyArjun Byju, MD (bio) and Phoebe Friesen, PhD (bio)We want to begin by thanking both Kathryn Petrozzo and Paul B. Lieberman for taking the time to read and respond to our article, “Making Up Monsters, Redirecting Blame: An Examination of Excited Delirium,” so thoughtfully. They each offered us an opportunity to consider dimensions of excited delirium that we had not encountered as of yet and encouraged us to think more carefully about them. In our response, we consider each of their commentaries in turn, given that, as a philosopher and a psychiatrist, they each speak to different aspects of our argument.First, we turn to Kathryn Petrozzo’s commentary “Excited Delirium: The Self-Fulfilling Prophecy of Police Brutality.” We are grateful for her generous comments and careful engagement with our arguments. While much of the commentary is supportive of our piece, Petrozzo makes three critical and insightful points that we hope to respond to here.The first point Petrozzo makes is that our assertion that excited delirium is non-falsifiable is not supported. She suggests that those “seeking to exonerate the police/first responders responsible for these deaths, are not accepting this evidence leading them to reject the excited delirium diagnosis, but rather, are crafting an incorrect causal narrative. This is deeply problematic, but it does not necessarily render excited delirium as nonfalsifiable.”Although we are intrigued by this challenge, we would like to hear more about what it would look like to falsify the phenomenon of excited delirium. The way that the causal theories related to it are structured are such that if one causal factor is not present (e.g., drug use), then another causal factor can be located (e.g., mental health), and if that is not found, another may be simply made up (e.g., genetic predisposition), making excited delirium multiply realizable in a seemingly endless fashion. This is precisely what took place in the case of Anthany Dawson, who was initially said to have been experiencing a mental health crisis, but was later said to have died from excited delirium related to a genetic condition never identified before (Hon, 2004; Razack, 2015). [End Page 361]In practice, confirmations of excited delirium are found on the basis of various unrelated factors, such that after a death involving police force, there is almost always the option to reach for excited delirium as an explanation/exoneration. According to proponents, there is no factor that could be present that could rule out the diagnosis of excited delirium as it is currently constructed. Indeed, even in the presence of video evidence showing police officers choking an individual until they stop breathing, these deaths are still attributed to excited delirium. This seems like a clear instance of non-falsifiability.Although Petrozzo might maintain that this is simply “an incorrect causal narrative,” it is a causal narrative that aligns with the current theoretical scaffolding surrounding excited delirium.The second point Petrozzo makes is regarding widespread criticisms of Popper’s demarcation criterion of falsifiability. Indeed, this criterion has been called too inclusive, in that any empirical claim can be called falsifiable in principle—even if it refers to a future apocalypse or a UFO landing. It has also been criticized for being too exclusive, in that it ignores the “remarkable tenacity of scientific theories,” as Lakatos puts it (2009, p. 516). In practice, scientists do not merely abandon a theory if it is not supported by facts; they tend to find other explanations (e.g., the measurement was faulty) rather than accept an instance of falsification.Despite this, we believe it is still worth discussing falsifiability in the context of excited delirium for two reasons. First, while falsifiability may not be successful as a criterion that draws a line between science and pseudoscience, in this case, we argue, it still works well as a signifier of pseudoscience. Recently, many interested in the demarcation question have turned towards pluralism as a way to identify pseudoscientific practices (Pigliucci & Boudry, 2013). And excited delirium offers an excellent example of a phenomenon that bumps up against many of the features that might indicate a pseudoscientific practice...

Urban communities experiencing marginalization often disproportionately bear the risks and burdens of research and are left out of research ethics governance processes. To address this, many communities have created place-based and community-led research ethics governance initiatives to ensure that community voice is included in discussions surrounding research conduct. Place-based strategies in the Vancouver Downtown Eastside, the Bronx, and the Philadelphia Promise Zone successfully mobilize community perspectives in research ethics, filling in a significant gap in our current system of institutional research ethics review and oversight. These cases demonstrate that place-based research ethics governance has the potential to account for the community-level risks posed by research projects and to ensure communities receive more felt benefits. Place-based communities sidestep simplistic notions of identity based on single shared features and make space for intersectional analyses and diverse community viewpoints to be considered. Such communities have a unique claim to expertise given their shared experience of place, which grants them the ability to see problematic assumptions embedded in scientific projects as well as community-level concerns within research. Despite this, many marginalized communities are excluded from current research ethics oversight processes. This exclusion demands critical examination and a way forward to facilitate the integration of place-based community oversight strategies within research ethics governance.

Racial disparities in pain treatment are well documented. Such disparities are explained with reference to factors related to providers, health care structures, and patient behaviors. Racial differences in pain experiences, although well documented, are less well understood. Explanations for such differences usually involve genetic or psychological factors. Here, we argue that racial differences in pain experiences might also be explained by disparities in pain treatment. Based on what we know about the nature of pain, particularly the cognitive and affective aspects of the phenomenon, it is likely that disparities in the treatment of racialized patients can lead to significant racial differences in pain experience that show up at the population level. We argue that the failure of research programs to consider this causal factor is an example of white ignorance. We also consider several implications of the link between racial disparities in pain treatment and racial differences in pain experience.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members.

As participatory research practices are increasingly taken up in health research, claims related to experiential authority and expertise are frequently made. Here, in an exploration of what grounds such claims, we consider how feminist standpoint theory might apply to the psy sciences (psychiatry, psychology, psychotherapy, psychoanalysis, and so on). Standpoint theory claims that experiences of marginalization and critical engagement can lead to a standpoint that offers an epistemic advantage within a domain of knowledge. We examine experiences of marginalization and critical engagement in the mental health system, as well as evidence for epistemic advantages resulting from these experiences. This evidence, found in the identification of problematic assumptions and the development of new tools and theories in the field, grounds our argument that standpoint theory is indeed relevant to the psy sciences and that many of those who have experienced marginalization and have engaged critically have an epistemic advantage when it comes to knowledge-production. The implications of this argument are significant: those who have attained a standpoint within the psy sciences ought to be included in research and given both tools and funding to develop research programs. However, we must be wary of the risks of tokenization, cooptation, and essentialization that are likely to accompany such a transformation.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.

During the COVID-19 pandemic, several hospitals implemented “birthing alone” policies, banning companions from accompanying individuals giving birth. We offer an ethical analysis of these policies. First, we examine them through a consequentialist framework of risks and benefits. Second, we consider the significance of birth, highlighting the unique ways in which risks, relationships, and rights are understood in the context of obstetrics. We conclude that birthing alone policies are largely unjustified, as the harm they are certain to cause outweighs their possible benefits and because they fail to take into account what matters to mothers.

Well before the COVID-19 pandemic, proponents of digital psychiatry were touting the promise of various digital tools and techniques to revolutionize mental healthcare. As social distancing and its knock-on effects have strained existing mental health infrastructures, calls have grown louder for implementing various digital mental health solutions at scale. Decisions made today will shape the future of mental healthcare for the foreseeable future. We argue that bioethicists are uniquely positioned to cut through the hype surrounding digital mental health, which can obscure crucial ethical and epistemic gaps that ought to be considered by policymakers before committing to a digital psychiatric future. Here, we describe four such gaps: The evidence gap, the inequality gap, the prediction-intervention gap, and the safety gap.

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.

Advancements in novel neurotechnologies, such as brain computer interfaces and neuromodulatory devices such as deep brain stimulators, will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, new measures, including “Neurorights,” for data privacy, security, and consent to empower neurotechnology users’ control over their data, new methods of identifying and preventing bias, and the adoption of public guidelines for safe and equitable distribution of neurotechnological devices.

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order to provide an effective mechanism of oversight for health‐related AI research.