The right to privacy extends only to information through which the persons concerned are identifiable. This assumption is widely shared in law and in philosophical debate; it also guides the handling of personal data, for example, in medicine. However, this essay argues that the dissemination of anonymous information can also constitute a violation of privacy. This conclusion arises from two theses: (1) From the perspective of the affected person, judgments by others about anonymous information refer to its originator, even if (...) outsiders do not know who it is; (2) Our self-understanding is co-constituted by the judgment of others about us. This is a consequence of our social nature. There are certain areas of our lives that we do not want to expose to the gaze of others for our own sake. Therefore, the unauthorized dissemination of information concerning these areas can violate our privacy even if they are anonymous. While the question of the extent of privacy poses a general problem, there are reasons to discuss it in the context of digital medicine. (shrink)

Some Indigenous Australians have embraced developmental origins of health and disease (DOHaD) and epigenetic discourses to highlight the legacies of slow violence in a settler colonial context. Despite important differences between Indigenous and scientific knowledges, some Indigenous scholars are positioning DOHaD and epigenetics as a resource to benefit their communities. This article argues that time plays a crucial role of brokering disparate knowledge spaces in Indigenous discourses of postgenomics, with both Indigenous cosmological frames and DOHaD/epigenetics centring a circular temporal model. (...) Drawing on interview data with scientists who work in Indigenous health, and broader ethnographic work in Indigenous Australian contexts where epigenetics is deployed, this article explores how different circularities of space and time become entangled to co-produce narratives of historical trauma. We use the concept of biocircularity to understand the complex ways that Indigenous and postgenomic temporalities are separated and connected, circling each other to produce a postcolonial articulation of postgenomics as a model of collective embodiment and distributed responsibility. (shrink)

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of (...) third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a cornerstone in the ethical conduct of research involving human subjects. Despite its canonic status, t...

Precision medicine relies on data and biospecimens from participants who willingly offer their personal information on the promise that this act will ultimately result in knowledge that will improv...

The history of research in American Indian/Alaska Native communities has been marked by unethical practices, resulting in mistrust and reluctance to participate in research. Harms are not l...

Decades of public investment in molecular technologies and data integration techniques have fueled promises of precision medicine (PM) as a novel, targeted, and data-driven approach that takes into...

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research — misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms — may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation (...) of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms. (shrink)

“Informed consent” implicitly links the transmission of information to the granting of permission on the part of patients, tissue donors, and research subjects. But what of the corollary, informed refusal? Drawing together insights from three moments of refusal, this article explores the rights and obligations of biological citizenship from the vantage point of biodefectors—those who attempt to resist technoscientific conscription. Taken together, the cases expose the limits of individual autonomy as one of the bedrocks of bioethics and suggest the need (...) for a justice-oriented approach to science, medicine, and technology that reclaims the epistemological and political value of refusal. (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)

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

IRBs often face dueling values in research: their historically grounded mission to protect research participants from harm conflicts with more recent attention to the importance of including underr...

A history of colonization inflicts psychological, physical, and structural disadvantages that endure across generations. For an increasing number of Indigenous Australians, environmental epigenetics offers an important explanatory framework that links the social past with the biological present, providing a culturally relevant way of understanding the various intergenerational effects of historical trauma. In this paper, we critically examine the strategic uptake of environmental epigenetics by Indigenous researchers and policy advocates. We focus on the relationship between epigenetic processes and Indigenous views of (...) Country and health—views that locate health not in individual bodies but within relational contexts of Indigenous ontologies that embody interconnected environments of kin/animals/matter/bodies across time and space. This drawing together of Indigenous experience and epigenetic knowledge has strengthened calls for action including state-supported calls for financial reparations. We examine the consequences of this reimagining of disease responsibility in the context of “strategic biological essentialism,” a distinct form of biopolitics that, in this case, incorporates environmental determinism. We conclude that the shaping of the right to protection from biosocial injury is potentially empowering but also has the capacity to conceal forms of governance through claimants’ identification as “damaged,” thus furthering State justification of biopolitical intervention in Indigenous lives. (shrink)

Through the use of culturally appropriate videos on precision medicine research (PMR) that were developed and tailored to five racial and ethnic groups of patients, and subsequent focus-group discu...

Background This paper describes the design, implementation, and process outcomes from three public deliberations held in three tribal communities. Although increasingly used around the globe to address collective challenges, our study is among the first to adapt public deliberation for use with exclusively Indigenous populations. In question was how to design deliberations for tribal communities and whether this adapted model would achieve key deliberative goals and be well received.Methods We adapted democratic deliberation, an approach to stakeholder engagement, for use with (...) three tribal communities to respect tribal values and customs. Public deliberation convenes people from diverse backgrounds in reasoned reflection and dialogue in search of collective solutions. The deliberation planning process and design were informed by frameworks of enclave deliberation and community-based participatory research, which share key egalitarian values. The deliberations were collaboratively designed with tribal leadership and extensive partner input and involvement in the deliberations. Each deliberation posed different, locally relevant questions about genomic research, but used the same deliberation structure and measures to gauge the quality and experience of deliberation.Results A total of 52 individuals participated in the deliberations across all three sites. Deliberants were balanced in gender, spanned decades in age, and were diverse in educational attainment and exposure to health research. Overall, the deliberations were positively evaluated. Participant perceptions and external observer datasets depict three deliberations that offered intensive conversation experiences in which participants learned from one another, reported feeling respected and connected to one another, and endorsed this intensive form of engagement.Conclusion The adapted deliberations achieved key deliberative goals and were generally well received. Limitations of the study are described. (shrink)

In recent years, scholars in science and technology studies have examined the advice that experts make for the governance of biomedicine. This STS scholarship, however, has not yet explained how the credibility of ethics expertise in public bioethics is produced from particular conditions and extended to different settings. This article describes how a bioethics commission created the ethical principle of justice and examines how the ethics expertise established public credibility on the justice principle. The findings suggest that the principle of (...) justice was first explored as the diverse concepts of “equality” with reference to the review of fetal research, redefined as “fairness” or “desert” from theoretical viewpoints, and then circulated as a standard framework in local settings. The credibility of ethics expertise, based on the coproduction of material and moral orders, was made possible by reaching common ground among different data, principles, and background theories. (shrink)

We reject the concept of a default option of withdrawal as proposed by Syltern and colleagues, and will outline here potential consequences on parental trust, particularly in historically marginali...

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

Background Citizen science is increasingly prevalent in the biomedical sciences, including the field of human genomics. Genomic citizen science initiatives present new opportunities to engage individuals in scientific discovery, but they also are provoking new questions regarding who owns the outputs of the research, including intangible ideas and discoveries and tangible writings, tools, technologies, and products. The legal and ethical claims of participants to research outputs become stronger—and also more likely to conflict with those of institution-based researchers and other stakeholders—as (...) participants become more involved, quantitatively and qualitatively, in the research process. It is not yet known, however, how genomic citizen science initiatives are managing the interests of their participants in accessing and controlling research outputs in practice. To help fill this gap, we conducted an in-depth review of relevant policies and practices of U.S.-based genomic citizen science initiatives. Methods We queried the peer-reviewed literature and grey literature to identify 22 genomic citizen science initiatives that satisfied six inclusion criteria. A data collection form was used to capture initiative features, policies, and practices relevant to participants’ access to and control over research outputs. Results This analysis revealed that the genomic citizen science landscape is diverse and includes many initiatives that do not have institutional affiliations. Two trends that are in apparent tension were identified: commercialization and operationalization of a philosophy of openness. While most initiatives supported participants’ access to research outputs, including datasets and published findings, none supported participants’ control over results via intellectual property, licensing, or commercialization rights. However, several initiatives disclaimed their own rights to profit from outputs. Conclusions There are opportunities for citizen science initiatives to incorporate more features that support participants’ access to and control over research outputs, consistent with their specific objectives, operations, and technical capabilities. (shrink)

With emerging technologies such as genome research and the digitization of health records comes the need for new models of informed consent. In this climate of innovation people are often prone to explore the latest technological advancement as possible solutions, including for informed consent. In this paper, we present the design and evaluation of a so-called low-tech informed consent solution that was designed specifically for the informational and cultural needs of a vulnerable indigenous population, i.e., the San of South Africa. (...) This low-tech solution took the form of a comic and, although it could enhance understanding and identification, the costs and labour intensity of comic design and the deriving limitations on its scalability should be critically considered in the light of a digitised and more standardized solution. (shrink)