This study takes off from the ethical problem that racism grounded in population genetics raises. It is an analysis of four standard scientific responses to the problem of genetically motivated racism, seen in connection with the Human Genome Diversity Project (HGDP): (1) Discriminatory uses of scientific facts and arguments are in principle ‘misuses’ of scientific data that the researcher cannot be further responsible for. (2) In a strict scientific sense, genomic facts ‘disclaim racism’, which means that an epistemically correct grasp (...) of genomics should be ethically justified. (3) Ethical difficulties are issues to be ‘resolved’ by an ethics institution or committee, which will guarantee the ethical quality of the research scrutinized. (4) Although population genetics occasionally may lead to racism, its overall ‘value’ for humankind justifies its cause as a desirable pursuit. I argue that these typical responses to genetically motivated racism supervene on a principle called the ‘ethic of knowledge’, which implies that an epistemically correct account has intrinsic ethical value. This principle, and its logically related ideas concerning the ethic of science, effectively avoids a deeper ethical question of responsibility in science from being raised. (shrink)

A recent systematic review of Machine Learning (ML) approaches to health data, containing over 100 studies, found that the most investigated problem was mental health (Yin et al., 2019). Relatedly, recent estimates suggest that between 165,000 and 325,000 health and wellness apps are now commercially available, with over 10,000 of those designed specifically for mental health (Carlo et al., 2019). In light of these trends, the present chapter has three aims: (1) provide an informative overview of some of the recent (...) work taking place at the intersection of text mining and mental health so that we can (2) highlight and analyze several pressing ethical issues that are arising in this rapidly growing field and (3) suggest productive directions for how these issues might be better addressed within future interdisciplinary work to ensure the responsible development of text mining approaches in psychology generally, and in mental health fields, specifically. In Section 1, we review some of the recent literature on text-mining and mental health in the contexts of traditional experimental settings, social media, and research involving electronic health records. Then, in Section 2, we introduce and discuss ethical concerns that arise before, during, and after research is conducted. Finally, in Section 3, we offer several suggestions about how ethical oversight of text-mining research might be improved to be more responsive to the concerns mapped out in Section 2. (shrink)

Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of bioethics. In this study, (...) we examined the availability and comprehensiveness of COI policies for authors, peer reviewers, and editors of bioethics journals. Methods: After developing a codebook, we analyzed the content of online COI policies of 63 bioethics journals, along with policy information provided by journal editors that was not publicly available. Results: Just over half of the bioethics journals had COI policies for authors (57%), and only 25% for peer reviewers and 19% for editors. There was significant variation among policies regarding definitions, the types of COIs described, the management mechanisms, and the consequences for noncompliance. Definitions and descriptions centered on financial COIs, followed by personal and professional relationships. Almost all COI policies required disclosure of interests for authors as the primary management mechanism. Very few journals outlined consequences for noncompliance with COI policies or provided additional resources. Conclusion: Compared to other studies of biomedical journals, a much lower percentage of bioethics journals have COI policies and these vary substantially in content. The bioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship. (shrink)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Health research ethics training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal (...) education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: define the purposes, intended uses and scope of the framework; describe the context in which practice occurs; gather data using a variety of methods to inform the competency framework; translate the data into competencies that can be used in educational programmes; report on the competency development process and results and evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement. (shrink)

The US National Institute of Health’s Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with microbiome researchers, we argue that negotiations of epistemic, social, and institutional values were inextricable (...) from the reflective and strategic category work that defined and organized the microbiome as an object of study and a potential future site of biomedical intervention. Negotiating the divergence or tension between emerging scientific and regulatory classifications also activated “values levers” and opened up reflective discussions of how classifications embody values and how these values might differ across domains. These data suggest that scholars at the intersections of science and technology studies, ethics, and policy could leverage such openings to identify and intervene in the ways that ethical/regulatory and scientific/technical practices are coproduced within unfolding research. (shrink)

This essay introduces a collection of articles gathered under the theme of “law, science, and constitutions of life.” Together, they explore how revolutions in notions of what biological life is are eliciting correspondingly revolutionary imaginations of how life should be governed. The central theoretical contribution of the collection is to further elaborate the concept of bioconstitutionalism, which draws attention to especially consequential forms of coproduction at the law–life nexus. This introduction offers a theoretical discussion of bioconstitutionalism. It explores the constitutional (...) significance of interplay between scientific and technological power over life and a given political community’s shared imaginary of what modes of reasoning, judgment, and rule are proper and legitimate in a well-ordered state. It argues that knowing what life is for purposes of governance does not follow from scientific knowledge alone. Rather, such knowledge is refracted through culturally distinctive imaginaries that commit societies to particular understandings of what life means and what should be done to encourage its flourishing. (shrink)

It has been argued that bioethicists too often tend to represent the interests of scientists and not of the broader polity. Indeed, bioethicists seem predisposed to discard the voices and viewpoints of all but the cognoscenti. Focusing particularly on human pluripotent stem cell research, this commentary explores a variety of characterizations of bioethics and bioethicists in relation to forbidding science. Rather than proselytizing or prohibiting, bioethicists should work in partnership with scientists and publics to craft scientifically well-informed and morally sophisticated (...) debates about forbidding science. (shrink)

In this paper, I describe a collaborative project involving two feminist trained scientists1 in consultation with a bioethicist, a policy analyst, and a research scientist funded by the National Academies Keck Futures Initiative for the design and implementation of a training program for ethics in synthetic biology. In spring 2011, the project culminated in our coteaching an experimental graduate seminar on ethics and synthetic biology.Synthetic biology most commonly refers to an interdisciplinary field that aims to merge engineering and biology methods (...) to create new technologies. The promise is that these new technologies will solve the world’s most pressing problems: for example, they may provide us with cures.. (shrink)

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions (...) on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself. (shrink)

“Strangers at the Benchside: Research Ethics Consulation” (Cho et al. 2008) proposes what is probably a good idea. Early scrutiny of the ethical dimensions of emerging science seems sensible—at lea...

“Outsiders” addressing ethical issues in medicine—Strangers at the Bedside —became “bioethicists.” Bioethicists providing research ethics consultation have been described as “stranger...

In Australia, along with many other countries, limited guidance or other support strategies are currently available to researchers, institutional research ethics committees, and others responsible for making decisions about whether to return genomic findings with potential value to participants or their blood relatives. This lack of guidance results in onerous decision-making burdens—traversing technical, interpretative, and ethical dimensions—as well as uncertainty and inconsistencies for research participants. This article draws on a recent targeted consultation conducted by the Australian National Health and Medical (...) Research Council to put forward strategies for supporting return of finding decision-making. In particular, we propose a pyramid of decision-making support: decision-making guidelines, technical and interpretative assistance, and ethical assistance for intractable “tough” cases. Each step of the pyramid involves an increasing level of regulatory involvement and applies to a smaller subsection of genomic research findings. Implementation of such strategies would facilitate a growing evidence base for return of finding decisions, thereby easing the financial, time, and moral burdens currently placed on researchers and other relevant decision-makers while also improving the quality of such decisions and, consequently, participant outcomes. (shrink)

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” has raised legitimate concerns about the integrity of the IRB process. One author has described a multicenter trial as being withdrawn from consideration at one institution when rejection was imminent, in order to avoid informing other IRBs reviewing (...) the protocol of the study's rejection. This practice and IRB shopping seem at odds with the spirit, if not the “letter,” of the regulations. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. (shrink)

It has been argued that bioethicists too often tend to represent the interests of scientists and not of the broader polity. Indeed, bioethicists seem predisposed to discard the voices and viewpoints of all but the cognoscenti . Focusing particularly on human pluripotent stem cell research, this commentary explores a variety of characterizations of bioethics and bioethicists in relation to forbidding science. Rather than proselytizing or prohibiting, bioethicists should work in partnership with scientists and publics to craft scientifically well-informed and morally (...) sophisticated debates about forbidding science. (shrink)

We face significant challenges in the translation of basic biomedical research into meaningful improvements in patients' health, moving research from “bench to bedside.” The federal government's ne...

Few could disagree with the starting premise in, “Strangers at the Benchside: Research Ethics Consultation” (Cho et al. 2008). Over the past 40 years, the efforts for addressing the breadth and dep...