Nicole Foti

All Publications

• The Open Pharma Movement: Social Action to 'Open' Drug Research and Its Implications for Health. Social studies of science Foti, N. 2025: 3063127251386079

  Abstract

  Concerns over the complexity and costs of drug development have led some to consider whether practices of open science should be extended to pharmaceuticals, a space known for entrenched intellectual property regimes. In this article, I trace the emergence of collective action to apply open science to the research and making of drugs, an area I call open pharma. Drawing on in-depth interviews with open pharma leaders and document analysis of journal articles, organizational policies, and websites, I show that open pharma resembles other scientific/intellectual movements in developing new research practices and transmitting new ideas for sharing data. At the same time, the sociotechnical space of pharmaceuticals is deeply entwined in capitalist political economic structures (legal, regulatory, and financial markets) that shape how actors frame and organize their work. I identify key narratives that actors use to frame the movement and mobilize others, often drawing on market logics. I illustrate the active building and institutionalizing of open pharma infrastructure through the establishment of organizations and open science policies. And I describe structural barriers to open pharma in universities with publishing and commercialization imperatives-which are frequently translated into patent imperatives. 'Open' is often defined and operationalized in particular ways, prioritizing public data sharing of early research (which may later be privatized) over such interventions as public clinical trials and commercialization, raising the question of where, when, and for whom open pharma is beneficial.

  View details for DOI 10.1177/03063127251386079

  View details for PubMedID 41178235

• A qualitative study of diversity in precision medicine research: The development and stakeholder assessment of a Diversity Decision Map JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE Shim, J. K., McMahon, C. E., Saco, L., Bentz, M., Foti, N., Lee, S. 2025; 9 (1)

  View details for DOI 10.1017/cts.2025.45

  View details for Web of Science ID 001467805800001

• Beyond biomedical institutions: An ethnographic study of community science and the rise of alternative therapeutic imaginaries. Social science & medicine (1982) Foti, N. 2025; 367: 117377

  Abstract

  This paper examines the project Open Insulin-a community-based initiative aimed at producing their own insulin in response to rising prices in the United States-as a lens to analyze the emergence of "alternative therapeutic imaginaries." These imaginaries represent a particular form of social activity: a planning approach toward the greater individualization, fragmentation, and corporatization of healthcare. Examples include health and biomedical practices undertaken by citizen scientists, do-it-yourself (DIY) patients, and others who resist or operate outside institutions of medicine. Drawing on ethnographic research, this study analyzes the construction of Open Insulin's health politics, which I argue is inspired by forms of direct social action. Unlike conventional activism approaches that tend to make claims on the state or others in power, direct social action involves direct intervention in segments of society. This paper explores how this approach is complicated by the regulatory economy and materiality of drug research, and the need for diverse expertise in the space of pharmaceuticals. I examine how project members grappled with these complications, surfacing competing perspectives for how to produce insulin safely and the role of industry experts and scientific institutions in this pursuit. I argue that Open Insulin's vision for community-produced and -owned medicines sheds light on growing mistrust of health institutions and diminishing public responsibility over healthcare provisions, leading to technolibertarian logics to address unmet healthcare needs, and potentially exacerbating health disparities by privileging those who can participate in such alternatives. This analysis contributes to broader debates on transformations in healthcare and social activism, highlighting the need for reorienting biomedical institutions toward public benefit.

  View details for DOI 10.1016/j.socscimed.2024.117377

  View details for PubMedID 39892042

• Interrogating the Value of Return of Results for Diverse Populations: Perspectives from Precision Medicine Researchers. AJOB empirical bioethics McMahon, C. E., Foti, N., Jeske, M., Britton, W. R., Fullerton, S. M., Shim, J. K., Lee, S. S. 2023: 1-12

  Abstract

  BACKGROUND: Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the "duty to report" from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.METHODS: Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.RESULTS: Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.CONCLUSIONS: Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom.

  View details for DOI 10.1080/23294515.2023.2279965

  View details for PubMedID 37962912

• Rethinking Benefit and Responsibility in in the Context of Diversity: Perspectives from the Frontlines of Precision Medicine Research PUBLIC HEALTH GENOMICS Vasquez, E. E., Foti, N., McMahon, C. E., Jeske, M., Bentz, M., Fullerton, S., Shim, J. K., Lee, S. 2023

  Abstract

  Federal agencies have instituted guidelines to prioritize the enrollment and retention of diverse participants in precision medicine research (PMR). Prior studies examining participation of minoritized communities have shown that potential benefits represent a key determinant. Human subjects research guidance, however, conceptualizes potential benefits narrowly, emphasizing generalized advances in medical knowledge. Further, few studies have provided qualitative data that critically examine how the concept of 'benefit' is interpreted or challenged in the context of research practice. This paper examines the experiences of PMR investigators and frontline research staff to understand how standard approaches to benefit are received, contested, and negotiated "on-the-ground."Findings are drawn from a qualitative project conducted across five U.S.-based, federally-funded PMR studies. Data collection included 125 in-depth interviews with a purposive sample of investigators, research staff, community advisory board members, and NIH program officers associated with these PMR studies.Researchers report that the standard approach to benefit-which relies on the premise of altruism and the promise of incrementally advancing scientific knowledge-is frequently contested. Researchers experience moral distress over the unmet clinical, psychosocial, and material needs within the communities they are engaging. Many believe the broader research enterprise has a responsibility to better address these needs.Researchers frequently take issue with and sometimes negotiate what is owed to participants and to their communities in exchange for the data they provide. These experiences of moral distress and these improvisations warrant systematic redress, not by individual researchers but by the broader research ethics infrastructure.

  View details for DOI 10.1159/000531656

  View details for Web of Science ID 001032224900001

  View details for PubMedID 37442104

• Community Engagement in Precision Medicine Research: Organizational Practices and Their Impacts for Equity. AJOB empirical bioethics Shim, J. K., Foti, N., Vasquez, E., Fullerton, S. M., Bentz, M., Jeske, M., Lee, S. S. 2023: 1-12

  Abstract

  In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal.Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for.We find that ad hoc, opportunistic, and instrumental approaches to CE exacted significant consequences for the time and resources devoted to engagement and the ultimate impacts it has on research. Critical differences emerged when engagement and research decisionmaking were integrated with each other versus occurring in parallel, separate parts of the study organization, and whether community members had the ability to determine which issues would be brought to them for consideration or to revise or even veto proposals made upstream based on criteria that mattered to them. CE was understood to have a range of purposes, from instrumentally facilitating recruitment and data collection, to advancing community priorities and concerns, to furthering long-term investments in relationships with and changes in communities. These choices about who to engage, what engagement activities to support, how to solicit and integrate community input into the workflow of the study, and what CE was for were often conditioned upon preexisting perceptions and upstream decisions about study goals, competing priorities, and resource availability.Upstream choices about CE and constraints of time and resources cascade into tradeoffs that often culminated in "pantomime community engagement." This approach can create downstream costs when engagement is experienced as improvised and sporadic. Transformations are needed for CE to be seen as a necessary scientific investment and part of the scientific process.

  View details for DOI 10.1080/23294515.2023.2201478

  View details for PubMedID 37126431

• Targeting Representation: Interpreting Calls for Diversity in Precision Medicine Research. The Yale journal of biology and medicine Lee, S. S., Fullerton, S. M., McMahon, C. E., Bentz, M., Saperstein, A., Jeske, M., Vasquez, E., Foti, N., Saco, L., Shim, J. K. 2022; 95 (3): 317-326

  Abstract

  Scientists have identified a "diversity gap" in genetic samples and health data, which have been drawn predominantly from individuals of European ancestry, as posing an existential threat to the promise of precision medicine. Inadequate inclusion as articulated by scientists, policymakers, and ethicists has prompted large-scale initiatives aimed at recruiting populations historically underrepresented in biomedical research. Despite explicit calls to increase diversity, the meaning of diversity - which dimensions matter for what outcomes and why - remain strikingly imprecise. Drawing on our document review and qualitative data from observations and interviews of funders and research teams involved in five precision medicine research (PMR) projects, we note that calls for increasing diversity often focus on "representation" as the goal of recruitment. The language of representation is used flexibly to refer to two objectives: achieving sufficient genetic variation across populations and including historically disenfranchised groups in research. We argue that these dual understandings of representation are more than rhetorical slippage, but rather allow for the contemporary collection of samples and data from marginalized populations to stand in as correcting historical exclusion of social groups towards addressing health inequity. We trace the unresolved historical debates over how and to what extent researchers should procure diversity in PMR and how they contributed to ongoing uncertainty about what axes of diversity matter and why. We argue that ambiguity in the meaning of representation at the outset of a study contributes to a lack of clear conceptualization of diversity downstream throughout subsequent phases of the study.

  View details for PubMedID 36187415

• Strategies of inclusion: The tradeoffs of pursuing "baked in" diversity through place-based recruitment. Social science & medicine (1982) Shim, J. K., Bentz, M., Vasquez, E., Jeske, M., Saperstein, A., Fullerton, S. M., Foti, N., McMahon, C., Lee, S. S. 2022; 306: 115132

  Abstract

  US funding agencies have begun to institutionalize expectations that biomedical studies achieve defined thresholds for diversity among research participants, including in precision medicine research (PMR). In this paper, we examine how practices of recruitment have unfolded in the wake of these diversity mandates. We find that a very common approach to seeking diverse participants leverages understandings of spatial, geographic, and site diversity as proxies and access points for participant diversity. That is, PMR investigators recruit from a diverse sampling of geographic areas, neighborhoods, sites, and institutional settings as both opportunistic but also meaningful ways to "bake in" participant diversity. In this way, logics of geographic and institutional diversity shift the question from who to recruit, to where. However, despite seeing geographic and site diversity as social and scientific 'goods' in the abstract and as key to getting diverse participants, PMR teams told us that working with diverse sites was often difficult in practice due to constraints in funding, time, and personnel, and inadequate research infrastructures and capacity. Thus, the ways in which these geographic and institutional diversity strategies were implemented resulted ultimately in limiting the meaningful inclusion of populations and organizations that had not previously participated in biomedical research and reproduced the inclusion of institutions that are already represented. These prevailing assumptions about and practices of "baked-in" diversity in fact exacerbate and produce other forms of inequity, in research capacity and research representation. These findings underscore how structural inequities in research resources must be addressed for diversity to be achieved in both research sites and research participants.

  View details for DOI 10.1016/j.socscimed.2022.115132

  View details for PubMedID 35728460

• Beyond inclusion: Enacting team equity in precision medicine research. PloS one Jeske, M., Vasquez, E., Fullerton, S. M., Saperstein, A., Bentz, M., Foti, N., Shim, J. K., Lee, S. S. 2022; 17 (2): e0263750

  Abstract

  PURPOSE: To identify meanings of and challenges to enacting equitable diversification of genomics research, and specifically precision medicine research (PMR), teams.METHODS: We conducted in-depth interviews with 102 individuals involved in three U.S.-based precision medicine research consortia and conducted over 400 observation hours of their working group meetings, consortium-wide meetings, and conference presentations. We also reviewed published reports on genomic workforce diversity (WFD), particularly those relevant to the PMR community.RESULTS: Our study finds that many PMR teams encounter challenges as they strive to achieve equitable diversification on scientific teams. Interviewees articulated that underrepresented team members were often hired to increase the study's capacity to recruit diverse research participants, but are limited to on-the-ground staff positions with little influence over study design. We find existing hierarchies and power structures in the academic research ecosystem compound challenges for equitable diversification.CONCLUSION: Our results suggest that meaningful diversification of PMR teams will only be possible when team equity is prioritized as a core value in academic research communities.

  View details for DOI 10.1371/journal.pone.0263750

  View details for PubMedID 35130331