In various responses to the COVID-19 pandemic, we can observe insufficient sensitivity towards the needs and circumstances of poorer citizens. Particularly in a context of high inequality, policy makers need to engage with the wider public in debates and consultations to gain better insights in the realities of the worst-off within their jurisdiction. When consultations involve members of traditionally underrepresented groups, these are not only more inclusive, which is in itself an ethical aim, but pool ideas and observations from a (...) much more diverse array of inhabitants. Inclusivity increases the odds to identify a larger range of weak spots for health security and to design health interventions that are less burdensome on those worst-off. (shrink)

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

In this commentary we argue for the value of involving people with a diagnosis of mental health disorders and/or their caregivers as co-researchers in mental health research. We claim that co-produ...

Andrea Wiggins and John Wilbanks’ article (2019) presents us with a welcome overview of the neglected, novel ethical issues raised by the advent of citizen science in health and biomedical contexts. This contribution takes a rather different approach, focusing on a very specific (yet also overlooked) problem in this context - the ethical implications of self-administered genetic testing. This problem, however, is particularly illustrative of the “ethics gap” between traditional medical settings and new public-driven scientific practices, emphasized by Wiggins and (...) Wilbanks in their more wide-ranging treatment. (shrink)

I compare two different arguments for the importance of bringing new voices into science: arguments for increasing the representation of women, and arguments for the inclusion of the public, or for “citizen science”. I suggest that in each case, diversifying science can improve the quality of scientific results in three distinct ways: epistemically, ethically, and politically. In the first two respects, the mechanisms are essentially the same. In the third respect, the mechanisms are importantly different. Though this might appear to (...) suggest a broad similarity between the cases, I show that the analysis reveals an important respect in which efforts to include the public are more complex. With citizen science programs, unlike with efforts to bring more women into science, the three types of improvement are often in conflict with one another: improvements along one dimension may come at a cost on another dimension, suggesting difficult trade-offs may need to be made. (shrink)

Background Citizen science and models for public participation in health research share normative ideals of participation, inclusion, and public and patient engagement. Academic researchers collaborate in research with members of the public involved in an issue, maximizing all involved assets, competencies, and knowledge. In citizen science new ethical issues arise, such as who decides, who participates, who is excluded, what it means to share power equally, or whose knowledge counts. This article aims to present an ethics framework that offers a (...) lens of understanding and heuristic guidelines to deal with ethical issues in citizen science. -/- Methods We conducted seven case studies between 2015 and 2021 to attune and validate the ethics framework for the context of citizen science. The cases related to studies with older adults, people with a psychiatric vulnerability, people dependent on community care, people who are unemployed or living in poverty or both, and young adults with respiratory disease. -/- Results Ethics in citizen science reaches beyond the ethical issues in traditional biomedical and health research. It entails more than following procedures about informed consent and privacy and submitting a proposal to a Medical Research Ethics Committee. Ethics in citizen science relates to everyday ethical issues during the study, including relational and moral complexities concerning collaboration, sharing power, and democratic decision-making. Dealing with these issues requires ethics work of researchers. This entails seeing ethically salient issues and reflecting on everyday ethical issues. Ethics work consists of seven features: framing work, role work, emotion work, identity work, reason work, relationship work, and performance work. All are relevant for researchers in citizen science. -/- Conclusions Ethical issues in citizen science often relate to power differentials, partnership, and collaboration between academics and non-academics. The ethics framework prepares researchers for the work needed in citizen science to act responsibly and offers a heuristic guide to reflect on ethics. Reflection on ethics is a pathway towards ethical citizen science, especially if researchers collaboratively reflect in partnership with non-academics who are subject to the moral issue. (shrink)

A wide variety of scientific research projects include public participation in roles going beyond the classic use of subjects in human subjects research. “Participatory research” is an umbrella term for such projects. In this chapter, we begin by surveying the variety of participatory research approaches across fields. We examine what goals participatory research projects seek to achieve, both of social and scientific value. Next, we apply this theoretical framework to challenges that participatory research faces. We then survey three typologies of (...) participatory research projects, each of which can illuminate and guide decisions in project development. We end with a look at participatory research approaches in health contexts, applying the theoretical resources we introduced earlier in the chapter. (shrink)

The underreporting of suspected adverse drug reactions hinders pharmacovigilance. Solutions to underreporting are oftentimes directed at clinicians and health care professionals. However, given the recent rise of public inclusion in medical science, solutions may soon begin more actively involving patients. I aim to offer an evaluative framework for future possible proposals that would engage patients with the aim of mitigating underreporting. The framework may also have value in evaluating current reporting practices. The offered framework is composed of three criteria that (...) are bioethical, social-epistemic, and pragmatic: (i) patients should not be exposed to undue harms, e.g., nocebo effects; (ii) data should be collected, analyzed, and communicated prioritizing pharmacovigilance’s aims, i.e., free from industry bias; and (iii) proposals should account for existing and foreseeable pragmatic constraints like clinician ‘buy in’ and existing reporting infrastructure. Proposals to engage patients in pharmacovigilance that fulfil or address these criteria are preferable to those that do not. (shrink)

Count Me In (CMI) was launched in 2015 as a patient-driven research initiative aimed at accelerating the study of cancer genomics through direct participant engagement, electronic consent and open-access data sharing. It is an example of a large-scale direct-to-patient (DTP) research project which has since enrolled thousands of individuals. Within the broad scope of ‘citizen science’, DTP genomics research is defined here as a specific form of ‘top-down’ research endeavour developed and overseen by institutions within the traditional human subjects research (...) context; in novel ways, it engages and recruits patients with defined diseases, consents them for medical information and biospecimens sharing, and stores and disseminates genomic information. Importantly, these projects simultaneously aim to empower participants in the research process while increasing sample size, particularly in rare disease states. Using CMI as a case study, this paper discusses how DTP genomics research raises new questions in the context of traditional human subjects research ethics, including issues surrounding participant selection, remote consent, privacy and return of results. It aims to demonstrate how current research ethics frameworks may be insufficient in this context, and that institutions, institutional review boards and investigators should be aware of these gaps and their role in ensuring the conduct of ethical, novel forms of research together with participants. Ultimately, a broader question is raised of whether the rhetoric of participatory genomics research advocates for an ethic of personal and social duty for contributing to the advancement of generalisable knowledge about health and disease. (shrink)

Over 30 million people worldwide have taken a commercial at-home DNA test, because they were interested in their genetic ancestry, disease predisposition or inherited traits. Yet, these consumer DNA data are also increasingly used for a very different purpose: to identify suspects in criminal investigations. By matching a suspect’s DNA with DNA from a suspect’s distant relatives who have taken a commercial at-home DNA test, law enforcement can zero in on a perpetrator. Such forensic use of consumer DNA data has (...) been performed in over 200 criminal investigations. However, this practice of so-called investigative genetic genealogy raises ethical concerns. In this paper, we aim to broaden the bioethical analysis on IGG by showing the limitations of an individual-based model. We discuss two concerns central in the debate: privacy and informed consent. However, we argue that IGG raises pressing ethical concerns that extend beyond these individual-focused issues. The very nature of the genetic information entails that relatives may also be affected by the individual customer’s choices. In this respect, we explore to what extent the ethical approach in the biomedical genetic context on consent and consequences for relatives can be helpful for the debate on IGG. We argue that an individual-based model has significant limitations in an IGG context. The ethical debate is further complicated by the international, transgenerational and commercial nature of IGG. We conclude that IGG should not only be approached as an individual but also—and perhaps primarily—as a collective issue. There are no data in this work. (shrink)

In their contribution, Wiggins and Wilbanks (2019) discuss the rise of citizen science and elaborate on several ethical issues that go beyond standard approaches in research ethics. They rightly sa...

Wiggins and Wilbanks (2019) provide an overview of what they consider to be different models of citizen science in health and biomedical research and highlight related ethical issues. They offer, h...

One of the concerns that citizen science shares with the evolving practice of precision medicine is how to approach oversight for N-of-1 or N-of-many-1’s research. In their target article, Wiggins...

Devices that record from and stimulate the brain are currently available for consumer use. The increasing sophistication and resolution of these devices provide consumers with the opportunity to engage in do-it-yourself brain research and contribute to neuroscience knowledge. The rise of do-it-yourself (DIY) neuroscience may provide an enriched fund of neural data for researchers, but also raises difficult questions about data quality, standards, and the boundaries of scientific practice. We administered an online survey to brain–computer interface (BCI) researchers to gather (...) their perspectives on DIY brain research. While BCI researcher concerns about data quality and reproducibility were high, the possibility of expert validation of data generated by citizen neuroscientists mitigated concerns. We discuss survey results in the context of an established ethical framework for citizen science, and describe the potential of constructive collaboration between citizens and researchers to both increase data collection and advance understanding of how the brain operates outside the confines of the lab. (shrink)

Wiggins and Wilbanks (2019) present citizen science as a range of “models” that fall under the rubric of public participation. They seem to have accepted what they call the “‘populist rhetoric’ tha...

In their article “The Rise of Citizen Science in Health and Biomedical Research,” Wiggins and Wilbanks (2019) present a new typology for understanding the complex landscape of health and biomedical...

Citizen science (CS) has been presented as a novel form of research relevant for social concerns and global challenges. CS transforms the roles of participants to being actively involved at various stages of research processes, CS projects are dynamic, and pluralism arises when many non-professional researchers take an active involvement in research. Some argue that these elements all make existing research ethical principles and regulations ill-suited for guiding responsible CS conduct. However, while many have sought to highlight such challenges from (...) CS, few have discussed principles per se providing the foundation for regulations. In this article we will investigate the possibilities of midlevel principlism in guiding responsible CS conduct. Principlism has the potential of accommodating many of the concerns taken to reduce the relevance of existing principles. (shrink)

In recent years, there has been a distinct shift in the relationship between science and society. We have moved away from the classic unidirectional “deficit” model (Simis et al. 2016) focused on t...

In addition to ethical aspects Citizen Science projects also involve social, economic and—not least—regulatory challenges that arise from their very openness and opportunities for participation. So...

In their target article, authors Wiggins and Wilbanks (2019) characterize citizen science initiatives as being well positioned to foster greater and more meaningful public participation in scientif...

Background As citizen science continues to grow in popularity, there remains disagreement about what terms should be used to describe citizen science activities and participants. The question of how to self-identify has important ethical, political, and practical implications to the extent that shared language reflects a common ethos and goals and shapes behavior. Biomedical citizen science in particular has come to be associated with terms that reflect its unique activities, concerns, and priorities. To date, however, there is scant evidence regarding (...) how biomedical citizen scientists prefer to describe themselves, their work, and the values that they attach to these terms.Methods In 2018, we conducted semi-structured interviews with 35 biomedical citizen scientists in connection with a larger study to understand ownership preferences. Interview data were analyzed to identify the terms that interviewees used and avoided to describe themselves and their work, as well as the reasons for their preferences.Results Biomedical citizen scientists self-identified using three main terms: citizen scientist, biohacker, and community scientist. However, there was a lack of consensus among interviewees on the appropriateness of each term, two of which prompted conflicting responses. Self-identification preferences were based on personal judgments about whether specific terms convey respect, are provocative, or are broad and inclusive, as well as the desirability of each of these messages.Conclusions The lack of consensus about self-identification preferences in biomedical citizen science reflects the diversity of experiences and goals of individuals participating in this field, as well as different perceptions of the values signaled by and implications of using each term. Heterogeneity of preferences also may signal the parallel development of multiple communities in biomedical citizen science. (shrink)

Engaging citizens in science projects has a number of epistemic benefits in terms of improving scientific out- comes and adjusting research to develop innovative solu- tions that are likelier to be used. Yet the emphasis on the epistemic benefits of citizen science projects and its risks, such as exploitation and a lack of benefit-sharing, a fail- ure to sufficiently inform participants of possible hazards and privacy issues, and unacknowledged authorship, which we can find in Wiggins and Wilbanks (2019), should not (...) shift to the background important justice- related interests regarding increasing participation, in particular as a prerequisite to providing the human right to participate in science (Timmermann 2014; Vayena and Tasioulas 2015). Beside the social interest in benefiting from scientific advancement—due to its major role in improving welfare—and keeping scientific practice within ethical boundaries, we need to acknowledge sci- entific participation to be very much in the interests of society. (shrink)

Wiggins and Wilbanks (2019) raise a number of interesting concerns vis-à-vis citizen science and research. However, one area of innovation in citizen science that has seen significant advancements...

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks (2019) summarize some of the emerging ethical issues related to citizen sc...

The ethical (and philosophical) issues arising in citizen science are fascinating, challenging, and potentially pathbreaking in that they force us to reconsider the conceptual and regulatory catego...

The target article by Wiggins and Wilbanks (2019) reports on the history and typology of the models of citizen science emerging in health and biomedical research with the rapid dispersion and repur...

Citizen science is touted as a means of making science more inclusive and democratic. However, when citizens are drawn from societies with significant socioeconomic and racial disparities, citizen...

The SARS-CoV-2 pandemic has transgressed biomedical categories. According to Horton, it turned out to be a 'syndrome' that infected virtually all spheres of social life. The pandemic has created toxic social atmosphere highly unfavorable to clinical and clinic-ethical decision making. Constraints and pressures related to micro-, meso-, exo- and macro-environments framing doctors, nurses, and medical students in training were identified. These factors exacerbated moral distress (moral injury) amongst clinicians. In a joint Polish-Lithuanian project (IDUB 2020-2022) we examined predictors of moral (...) distress in pandemic clinical contexts. A survey-based, real-time, correlational and comparative study was conducted in Poland and Lithuania after the first year of pandemic with N=227 participants. Unexpected differences on regular and pandemic-type moral distress levels were found between the two national samples. Polish participants showed significantly higher moral distress levels than their Lithuanian counterparts. The following article discusses these findings and recommends the reinforcement of resilient medical decision making. (shrink)

In their article, “The Rise of Citizen Science in Health and Biomedical Research,” Wiggins and Wilbanks (2019) discuss the rising role of a variety of traditional and newer citizen science models i...

In "The Rise of Citizen Science in Health and Biomedical Research," Wiggins and Wilbanks present an analysis of the ethics of citizen science (Wiggins and Wilbanks 2019). The breadth of the analysi...

Wiggins and Wilbanks’s (2019) article draws attention to the rise of citizen science in the medical domain, part of a larger participatory turn in which citizens and patients are increasingly invol...

The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how (...) it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA’s investigational device exemption requirements. (shrink)

Andrea Wiggins and John Wilbanks offer a rich and nuanced description of citizen science, which they define as “a range of participatory models for involving non-professionals as collaborators in s...

The article by Wiggins and Wilbanks in this issue (2019) provides an important overview of the some of the forms and challenges of citizen involvement in health and biomedical research. Many such r...

The authors of the target article briefly discuss the issue of “sample ownership” when scientists collaborate with citizen science partners (Wiggins and Wilbanks 2019). This is an important issue,...