BackgroundRapid data sharing can maximize the utility of data. In epidemics and pandemics like Zika, Ebola, and COVID-19, the case for such practices seems especially urgent and warranted. Yet rapidly sharing data widely has previously generated significant concerns related to equity. The continued lack of understanding and guidance on equitable data sharing raises the following questions: Should data sharing in epidemics and pandemics primarily advance utility, or should it advance equity as (...) well? If so, what norms comprise equitable data sharing in epidemics and pandemics? Do these norms address the equity-related concerns raised by researchers, data providers, and other stakeholders? What tensions must be balanced between equity and other values?MethodsTo explore these questions, we undertook a systematic scoping review of the literature on data sharing in epidemics and pandemics and thematically analyzed identified literature for its discussion of ethical values, norms, concerns, and tensions, with a particular (but not exclusive) emphasis on equity. We wanted to both understand how equity in data sharing is being conceptualized and draw out other important values and norms for data sharing in epidemics and pandemics.ResultsWe found that values of utility, equity, solidarity, and reciprocity were described, and we report their associated norms, including researcher recognition; rapid, real-time sharing; capacity development; and fair benefits to data generators, data providers, and source countries. The value of utility and its associated norms were discussed substantially more than others. Tensions between utility norms (e.g., rapid, real-time sharing) and equity norms (e.g., researcher recognition, equitable access) were raised.ConclusionsThis study found support for equity being advanced by data sharing in epidemics and pandemics. However, norms for equitable data sharing in epidemics and pandemics require further development, particularly in relation to power sharing and participatory approaches prioritizing inclusion. Addressing structural inequities in the wider global health landscape is also needed to achieve equitable data sharing in epidemics and pandemics. (shrink)

Data sharing between housing and education agencies will provide housing agencies with resources to assist them with efforts to decrease segregation and mitigate the adverse health outcomes experienced by people of color. The Fair Housing Act has the potential to fulfill its original integrationist purpose if housing and education agencies combine resources and data to create and implement fair housing plans. The Biden Administration’s restored rule to affirmatively further fair housing pursuant to the Fair Housing Act of (...) 1968 which seeks to reduce segregation and increase housing equity. However, it omits most of the processes set forth by the Obama Administration whereby federal agencies provide the proper tools to housing agencies so that they are able to make data-based decisions about housing policies. This article advocates for the sharing of data between housing and education agencies to optimize the positive impact of fair housing not only within housing, but also on the education, employment, and health opportunities for communities of color. (shrink)

The concept of dual-use encapsulates the potential for well-intentioned, beneficial scientific research to also be misused by a third party for malicious ends. The concept of dual-use challenges scientists to look beyond the immediate outcomes of their research and to develop an awareness of possible future (mis)uses of scientific research. Since 2001 much attention has been paid to the possible need to regulate the dual-use potential of the life sciences. Regulation initiatives fall under two broad categories—those that develop the ethical (...) education of scientists and foster an awareness and responsibility of dual-use issues, and those which assess the regulation of information being generated by current research. Both types of initiatives are premised on a cautious, risk-adverse philosophy which advocates careful examination of all future endpoints of research endeavors. This caution advocated within initiatives such as pre-publication review of journal articles contrasts to the obligation to share underpinning data sharing discussions. As the dual-use debate has yet to make a significant impact on data sharing discussions (and vice versa) it is possible that these two areas of knowledge control may present areas of ethical conflict for scientists, and thus need to be more closely examined. This paper examines the tension between the obligation to share exemplified by data sharing principles and the concerns raised by the risk-cautious culture of the dual-use debates. The paper concludes by reflecting on the issues of responsibility as raised by dual-use as relating to data sharing, such as the chain of custody for shared data. (shrink)

Research, innovation, and progress in the life sciences are increasingly contingent on access to large quantities of data. This is one of the key premises behind the “open science” movement and the global calls for fostering the sharing of personal data, datasets, and research results. This paper reports on the outcomes of discussions by the panel “Open science, data sharing and solidarity: who benefits?” held at the 2021 Biennial conference of the International Society for the (...) History, Philosophy, and Social Studies of Biology, and hosted by Cold Spring Harbor Laboratory. (shrink)

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation, the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of (...) an ethical governance framework, we set out to explore relevant ethical principles and norms. We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust. (shrink)

South Africa shared with the world the warning of a new strain of SARS-CoV2, Omicron, in November 2021. As a result, many high-income countries (HICs) instituted complete travel bans on persons leaving South Africa and other neighbouring countries. These bans were unnecessary from a scientific standpoint, and they ran counter to the International Health Regulations. In short, South Africa was penalized for sharing data. Data sharing during pandemics is commonly justified by appeals to solidarity. In this (...) paper, we argue that solidarity is, at best, an aspirational ideal to work toward but that it cannot ground an obligation to share data. Instead, low-and-middle income countries (LIMCs) should be guided by the principle of reciprocity, which states that we ought to return good for good received. Reciprocity is necessarily a conditional principle. LMICs, we argue, should only share data during future pandemics on the condition that HICs provide enforceable assurances that the benefits of data sharing will be equitably distributed and that LMICs won’t be penalized for sharing information. (shrink)

Making data broadly accessible is essential to creating a medical information commons. Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving (...) transparency. (shrink)

BackgroundWhile genomic data sharing can facilitate important health research and discovery benefits, these must be balanced against potential privacy risks and harms to individuals. Understanding public attitudes and perspectives on data sharing is important given these potential risks and to inform genomic research and policy that aligns with public preferences and needs.MethodsA cross sectional online survey measured attitudes towards genomic data sharing among members of the general public in an Eastern Canadian province.ResultsResults showed a (...) moderate comfort level with sharing genomic data, usually into restricted scientific databases with controlled access. Much lower comfort levels were observed for sharing data into open or publicly accessible databases. While respondents largely approved of sharing genomic data for health research permitted by a research ethics board, many general public members were concerned with who would have access to their data, with higher rates of approval for access from clinical or academic actors, but much more limited approval of access from commercial entities or governments. Prior knowledge about sequencing and about research ethics boards were both related to data sharing attitudes.ConclusionsWith evolving regulations and guidelines for genomics research and data sharing, it is important to consider the perspectives of participants most impacted by these changes. Participant information materials and informed consent documents must be explicit about the safeguards in place to protect genomic data and the policies governing the sharing of data. Increased public awareness of the role of research ethics boards and of the need for genomic data sharing more broadly is also needed. (shrink)

(2013). Open Access Digital Data Sharing: Principles, Policies and Practices☆. Social Epistemology: Vol. 27, No. 1, pp. 47-67. doi: 10.1080/02691728.2012.760663.

Sharing research data has great potential to benefit science and society. However, data sharing is still not common practice. Since public research funding agencies have a particular impact on research and researchers, the question arises: Are public funding agencies morally obligated to promote data sharing? We argue from a research ethics perspective that public funding agencies have several pro tanto obligations requiring them to promote data sharing. However, there are also pro tanto (...) obligations that speak against promoting data sharing in general as well as with regard to particular instruments of such promotion. We examine and weigh these obligations and conclude that all things considered funders ought to promote the sharing of data. Even the instrument of mandatory data sharing policies can be justified under certain conditions. (shrink)

Genome-wide association studies raise important ethical and regulatory issues. This is particularly true of the current move toward broad sharing of genomic and phenotypic data. Our survey study examined the opinions of professionals involved in human subjects protection regarding genetic research review. The majority indicated that it is important for their institutional review board to offer guidance about developing and using a data repository or biobank that includes genetic data, and also about sharing this (...) class='Hi'>data with other investigators. Only one-third of respondents reported that the National Institutes of Health policy regarding data sharing among researchers in genome-wide association studies is clear. Another third answered that they did not know whether this policy is clear. Findings from this study suggest a need for increased education for IRB professionals regarding the existing data sharing policy, collaboration among IRB professionals and researchers to define best practices, and further empirical research into prospective research participants’ information needs and preferences in the context of wide data sharing. (shrink)

Background: Mobile health (mHealth) apps promise to enhance patient empowerment, enable real-time health monitoring, and support self-management. Patients with breast cancer stand to benefit particularly from these capabilities, given the demanding pre- and posttreatment procedures they face. However, the effective adoption of these tools is challenged by issues including accessibility, usability limitations, and privacy concerns. -/- Objective: This study aimed to investigate the current usage behavior and attitudes toward mHealth apps among patients with breast cancer in Germany, focusing on acceptance, (...) usefulness, empowerment, and data-sharing. Specifically, we aimed to identify the incentives and barriers influencing use and the intention to use mHealth apps at the time of this writing to guide their further implementation and use. -/- Methods: A cross-sectional online survey was conducted between November 2023 and June 2024 using a structured questionnaire developed in German. Participants with a self-reported breast cancer diagnosis were recruited via university hospital channels, patient associations, and social media. Topics included technology and health app usage, perceived usefulness, personal empowerment, and attitudes toward data sharing. The survey comprised both closed- and open-ended questions to capture quantitative patterns and qualitative insights into participants’ experiences and perspectives. -/- Results: We collected responses from 90 participants with breast cancer. Participants demonstrated high engagement with digital technology; 97% (87/90) reported daily smartphone use, and 70% (63/90) owned a smartwatch or fitness tracker. Approximately 67% (60/90) of respondents had used health apps in the past year, with many relying on general fitness and lifestyle apps to support their health management. Most participants (62/90, 69%) indicated that health apps contribute to a better understanding of their personal health. Health apps were generally perceived as useful, with users highlighting their ability to provide continuous support and timely, reliable health information (n=31). This, in turn, was seen as instrumental in promoting self-management and empowerment. Respondents also showed a conditional willingness to share personal health data for research, particularly when clear benefits for treatment advancements were evident (n=82). Nonetheless, concerns were raised regarding data privacy, app usability, the need for multiple apps to cover all necessary features, and the potential increase in fear of illness (cyberchondria). -/- Conclusions: The findings underscore the potential of mHealth apps to empower patients with breast cancer by improving health literacy and supporting self-management. To maximize their impact, future digital health tools must align closely with patient needs by incorporating adaptive, interactive features and integrating seamlessly with clinical care. Addressing key barriers—particularly data privacy and usability issues—is essential for broader adoption. Longitudinal studies are warranted to evaluate the long-term effects of health app usage on patient empowerment, quality of life, and clinical outcomes. (shrink)

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that (...) they were either sharing their data or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research. (shrink)

As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to (...) facilitate data sharing. At the same time, we believe it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit. (shrink)

Spurred by a confluence of factors, most notably the decreasing cost of high-throughput technologies and advances in information technologies, a number of population research initiatives have emerged in recent years. These include large-scale, internationally collaborative genomic projects and biobanks, the latter of which can be defined as an organized collection of human biological material and associated data stored for one or more research purposes. Biobanks are a key emerging research infrastructure, and those established as prospective research resources comprising biospecimens (...) and data from many participants are viewed as particularly promising drivers of biomedical progress. Such biobanks, particularly those publicly funded and set up to promote the public interest, have expanded across the globe in recent years. (shrink)

Although data sharing is one of the primary measures proposed to improve the integrity and quality of published research, studies show it remains the exception not the rule. The current study examines the availability of data in papers reporting the results of analyses of empirical data from original research in high-impact addiction journals. Thirteen high-impact journals with data sharing policies were selected from those included in the substance abuse category of the 2018 Clarivate Analytics’ (...) Journal Citation Report. The first 10 full or short original research reports that included empirical data in the most recent complete issue of each journal were electronically searched and reviewed for reference to where their data can be obtained and for a formal data sharing statement. Only eight of the 130 papers contained a data sharing statement in their text or supplementary online materials, and just one contained a direct link to the data analyzed. Data sharing was rare in the 13 high-impact addiction journals reviewed. The nature of the data reported in addiction journals might partly explain this. Currently, data sharing is not a procedure likely to improve the quality and integrity of published addiction research. (shrink)

This article investigates dilemmas in the archiving and sharing of qualitative data in educational research, critically engaging with practices and debates from across the social sciences. Ethical, epistemological and methodological challenges are examined in reference to open access agendas, the politics of knowledge production, and transformations in research practices in the era of data management. We first consider practical and interpretive decisions in archiving qualitative data, then map current policy and regulatory frameworks governing research data (...) management, taking Australia as a case-study. We argue that governance and protocols for data sharing have not attended sufficiently to the distinctive ethical and methodological dimensions and knowledge claims of qualitative research. Instead, approaches associated with quantitative data are extrapolated in ways which construct an imaginary of decontextualised data, abstracted from the conditions of its production. We further argue for more critical attention to the double-edged affordances and ambivalent effects of data sharing and openness and to how data archives are imagined, constructed and curated. This includes greater acknowledgement of the affective and temporal dynamics involved in data archiving, understanding them as practices of (re)invention that also curate ‘archives for the future’ and help to foster an historicising imaginary in educational research. (shrink)

There is a growing chorus of voices in the scientific community calling for greater openness in the sharing of raw data that lead to a publication. In this commentary, we discuss the merits of sharing, common concerns that are raised, and practical issues that arise in developing a sharing policy. We suggest that the cognitive science community discuss the topic and establish a data-sharing policy.

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles (...) require us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

Background: Scientific research entails systematic investigation. Publishing the findings of research in peer reviewed journals implies a high level of confidence by the authors in the veracity of their interpretation. Therefore it stands to reason that researchers should be prepared to share their raw data with other researchers, so that others may enjoy the same level of confidence in the findings. Method: In a prospective study, 29 corresponding authors of original research articles in a medical journal (the British Medical (...) Journal) were contacted to ascertain their preparedness to share the data from their research. The email contact was in one of two forms, a general request and a specific request. The type of request a researcher received was randomly allocated. Findings: Researchers receiving specific requests for data were less likely, and slower, to respond than researchers receiving general requests. Only one researcher released data. Most researchers were reluctant to release their data. Some required further information, clarification, or authorship. Interpretation: The general reluctance of researchers to consider requests for their data is of concern. It raises questions about the level of confidence that should be placed on their interpretations of the data. It also highlights an unfortunate situation where researchers are more concerned with losing an advantage than advancing science. (shrink)

Although data sharing platforms host diverse data types the features of these platforms are well-suited to facilitating biomarker research. Given the current state of biomarker discovery, an innovative paradigm to accelerate biomarker discovery is to utilize platforms such as Vivli to leverage researchers' abilities to integrate certain classes of biomarkers.

As the federal government continues to expand upon and improve its data sharing policies over the past 20 years, complex challenges remain. Our interviews with U.S. academic genetic researchers (n=23) found that the burden, translation, industry limitations, and consent structure of data sharing remain major governance challenges.

Digital farming technologies promise to help farmers make well-informed decisions that improve the quality and quantity of their production, with less labour and less impact on the environment. This future, however, can only become a reality if farmers are willing to share their data with agribusinesses that develop digital technologies. To foster trust in data sharing, in Europe the EU Code of Conduct for agricultural data sharing by contractual agreement was launched in 2018 which encourages (...) transparency about data use. This article looks at the EU Code through the lens of literature on trust and contract agreements. We agree with the makers of the EU Code that a contract can make an important contribution to trust relationships as it is needed to mitigate the detrimental effects of power relationships between experts and non-experts. Building on Onora O’Neills perspective to trust, however, we argued that a contract can only be successful in fostering trust when information is comprehended by the more vulnerable party in this relationship who has to sign the contract, the more powerful partner takes responsibility to provide that information, and information is tailored to the information needs of the party signing the contract, even when data are re-used over a longer period. In addition, we think that differences between trust relationships and relationships of accountability, give reason to add to informed consent other more substantive ethical components in a more encompassing code of conduct. (shrink)

Data sharing is key for artificial intelligenceArtificial intelligence (AI) and for future healthcare systems, but the perspectives of patients are seldom included in the larger debates of how, when, and what data to share. This chapter provides an overview of research on patient perspectivesPatient perspective on data sharing and associated aspects, including patients’ motivations, concerns, and views on privacy and conditions for sharing. Moreover, these perspectives are put into the evolving context of informed consentConsent (...) and today’s European context of the General Data Protection Regulation (GDPR)General Data Protection Regulation (GDPR)and Data Governance Act (DGA)Data Governance Act (DGA). Overall, there seems to be a discrepancy between the patients’ perspective on data sharing and the reality in which their data are to be shared. The current patient views are researched within relatively ‘local’ contexts, where the patient would consentConsent to collecting data for primary use and on patients’ preferences regarding consent and what they see as barriers and motivators for data sharing. However, the reality of data use is moving towards re-use of data for secondary purposes and a context of more altruistic consentConsent such as the DGA. Questions remain regarding how patients perceive sharing and the role of their data in the larger governance of data; seemingly, patient views are lost in the wider debate of innovationInnovation and jurisdictional competitiveness. Ensuring that patients’ voices are heard is essential for public acceptance of data sharing, and thus for inclusiveness and equity of results and innovations originating from patients’ shared data. (shrink)

Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the (...) class='Hi'>data describe. (shrink)

While genomic data sharing enhances transparency and research efficiency, it also raises significant ethical and social challenges. This study explored stakeholders’ perspectives on these issues, particularly around privacy, confidentiality, and equity in collaborative research. A phenomenological qualitative study was conducted between August and December 2023 at Makerere University College of Health Sciences, other research-intensive institutions, and national regulatory bodies. The study engaged 86 participants: 47 key informants (16 researchers, 14 ethics committee members, nine community advisory board members, and (...) eight research regulators) and four deliberative focus group discussions with 39 participants. Interviews were transcribed verbatim, and thematic analysis was conducted using NVivo 14. Three major themes emerged: (1) stakeholders’ experiences in genomic research, including their roles as participants, implementers, or overseers; (2) ethical concerns, such as informed consent, third-party data access, inequities between high-income and low- and middle-income country (LMIC) researchers and participants, and the lack of benefit-sharing frameworks; and (3) social implications, including stigma, discrimination, labeling, community perceptions of fairness, and the need for meaningful engagement. Participants emphasized the importance of protecting participant rights, promoting equity, and ensuring robust data governance and security. The theoretical frameworks of principlism and distributive justice provided a valuable lens for examining these concerns, particularly by highlighting the need to safeguard privacy and fairly distribute responsibilities and benefits in global collaborations. Participants also noted that perceptions of fairness are shaped by trust, local context, and past experiences with research factors that are critical for building equitable and respectful partnerships. This study underscores the urgent need to strengthen protections for research participants and promote fairness in genomic data sharing. Policies should, if adopted, emphasize culturally contextualized consent, active community engagement, restricted third-party data access, and strong data protection mechanisms to address existing inequities and prevent misuse. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data (...) sharing policy and broad consent to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

BackgroundThe foundation of health and medical research is data. Data sharing facilitates the progress of research and strengthens science. Data sharing in research is widely discussed in the literature; however, there are seemingly no evidence-based incentives that promote data sharing.MethodsA systematic review (registration: 10.17605/osf.io/6pz5e) of the health and medical research literature was used to uncover any evidence-based incentives, with pre- and post-empirical data that examined data sharing rates. We were also (...) interested in quantifying and classifying the number of opinion pieces on the importance of incentives, the number observational studies that analysed data sharing rates and practices, and strategies aimed at increasing data sharing rates.ResultsOnly one incentive (using open data badges) has been tested in health and medical research that examined data sharing rates. The number of opinion pieces (n = 85) out-weighed the number of article-testing strategies (n = 76), and the number of observational studies exceeded them both (n = 106).ConclusionsGiven that data is the foundation of evidence-based health and medical research, it is paradoxical that there is only one evidence-based incentive to promote data sharing. More well-designed studies are needed in order to increase the currently low rates of data sharing. (shrink)

A powerful feature of global health research is data‐sharing with regions which bear the heaviest burden of disease. It offers novel opportunities for aggregating data to address critical global health challenges in ways higher than relying on individual studies. Yet there exist important stratifiers of the capacity to share data, particularly across the Global North‐South divide. Systemic challenges that characterize sub‐Saharan Africa and disadvantage the region's scientific productivity threaten the burgeoning data‐sharing culture too. Like (...) all endeavors requiring equal commitments under unequal circumstances, a strong ethical impetus is needed to help reduce inequities and imbalances to encourage adherence. This article discusses mandatory data‐sharing in relation to peculiar challenges faced by sub‐Saharan African scientists to suggest ethical principles for rethinking and reframing solutions. We propose six principles which mirror guidelines from the Institute of Medicine and encapsulate principles from the Emanuel Framework, Nairobi Data Sharing Principles, and the COHRED guidelines. (shrink)

Background The impetus for policies promoting medical data sharing in China has gained significant traction. Nonetheless, the present legal and ethical framework governing the research use of medical data in China, is characterized by a more restrictive rather than permissive approach. The proportion of Chinese medical data being leveraged for scientific research still has room for improvement at present, indicating a significant untapped potential for advancing medical knowledge and improving healthcare outcomes. Building upon this research, we (...) aim to delve deeper into the challenges researchers encounter in the sharing of medical data through focus group interviews. Methods We conducted two focus group interviews study with researchers representing diverse disciplines to explore their perspectives on 21 June 2021 and 28 July 2021. A total of seventeen researchers willingly participated in this study, representing various professional backgrounds. Similar codes were merged. Research team discussions were also utilized to select interviewees’ statements that were regarded as typical or representative. Results The respondents demonstrated a strong understanding that medical data should not be disseminated arbitrarily, recognizing the importance of sharing data in compliance with laws. Through the interview, we found that although respondents stressed the importance of careful consideration regarding if and when this information can be responsibly released, none of the respondents raised the issue of necessitating consent from data subjects for the research use of medical data. This observation sharply contrasts with the stringent separate consent provisions for secondary data use outlined in the PIPL. Conclusions The findings from the focus group studies shed light on researchers’ barriers and ethical challenges towards medical data sharing for scientific research, highlighting their deep concern for data security and cautious approach to sharing. The key objectives aimed at facilitating and enabling the reuse of medical data encompass enhancing interoperability, harmonizing data standards, improving data quality, safeguarding privacy, ensuring informed consent, incentivizing patients, and establishing explicit regulations pertaining to data access and utilization. (shrink)

The idea of commons has been rehabilitated in today’s global bioethics and used to redefine the public domain.

This paper presents reports on discussions among an international group of science and technology studies scholars who convened at the US National Science Foundation to think about data sharing and open STS. The first report, which reflects discussions among members of the Society for Social Studies of Science, relates the potential benefits of data sharing and open science for STS. The second report, which reflects discussions among scholars from many professional STS societies, focuses on practical and (...) conceptual issues related to managing, storing, and curating STS data. As is the case for all reports of such open discussions, a scholar’s presence at the meeting does not necessarily mean that they agree with all aspects of the text to follow. (shrink)

Accessing BRCA1/2 data facilitates the detection of disease-associated variants, which is critical to informing clinical management of risks. BRCA1/2 data sharing is complex and many practices exist. We describe current BRCA1/2 data-sharing practices, in the United States and globally, and discuss obstacles and incentives to sharing, based on 28 interviews with personnel at U.S. and non-U.S. clinical laboratories and databases. Our examination of the BRCA1/2 data-sharing landscape demonstrates strong support for and robust (...) sharing of BRCA1/2 data around the world, increasing global accesses to diverse data sets. (shrink)

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this (...) purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases. Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, establishing independent governance entities in order to minimize the informational risks of genomic research, and implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. (shrink)

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this (...) purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases (NCT). Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients’ prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest (1) comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, (2) establishing independent governance entities in order to minimize the informational risks of genomic research, and (3) implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research. (shrink)

‘Advancing the public interest’ is a criterion for de-identified data use for research via several national data platforms and biobanks. This may be referred to via cognate terms such as public benefit, public good or social value. The criterion is often adopted without it being a legal requirement. It is a legal requirement in some jurisdictions for sharing identifiable data without consent, which does not apply to de-identified data. We argue that, even in circumstances where (...) there are few or no legal restrictions on the sharing of de-identified data, there is a sound ethical reason for platforms to nevertheless impose a public interest criterion on data sharing. We argue that a public interest test is ethically essential for justifying research use of de-identified data via government-funded platforms because (1) it allows to promote public good and to minimise potential harmful consequences of research for both individuals and groups, for example, by offering grounds to reject research that could lead to stigmatisation of marginalised populations; (2) national data platforms hold public data and are made possible by government funds, and therefore should be used to support public interests and (3) it can demonstrate trustworthiness and contribute to promoting the social licence for data platforms to operate, which is especially important for efforts to align data governance policies with public norms and expectations. (shrink)

Key activities in biomedicine and related research rely on collections of biological samples and related files. Access to such resources in industry and in academic contexts has become strategic and represents a central issue in the general framework of rising patenting practices and in debates about the knowledge economy. It raises important issues concerning the organisation of scientific and medical work, the outline of data-sharing guidelines, and science policy's contribution to the elaboration of an adapted framework. This paper (...) presents an ethnographic study of three French human biobanks. Building on field work (participant observation and in-depth interviews), the study focuses on data access in the concrete practices in biobanks. The paper develops a perspective based on an analysis of different exchange regimes. We argue that access practices are submitted to the different regimes that can coexist and be articulated within the daily activities of each biobank. We also discuss how this perspective can further our understanding of biomedical research, and how it might inform data access policy. (shrink)

Secondary electronic health data can provide many benefits and value when used for the following purposes: reasons of public interest in the fields of public health, personalised and occupational medicine; activities to guarantee high levels of quality and safety of healthcare services; advancements in education and scientific research; innovation and development of technological products contributing to population health and social welfare. A literature review was performed to explore health data sharing attitudes or intentions together with associated motivators/barriers, (...) and significant modulators of participants’ sharing behaviour, to provide a qualitative summary in the field of secondary use of health data. Despite the fact that during the last two decades, sharing health data for secondary purposes has gained great attention due to its numerous applications and associated benefits, people’s attitude towards sharing health data are not always positive. These attitudes are in fact influenced by several factors such as: types of health information, privacy concerns, information on security level, results of health information use, altruism, illness histories. Further analyses and studies are needed to better understand healthcare advances through disruptive technologies. (shrink)

In this article I argue that data-sharing risks becoming epistemically extractivist and is a practice sensitive to Linda Martín Alcoff´s challenges for extractivist epistemologies. I situate data-sharing as a socio-epistemic practice that gives rise to ethical and epistemic challenges. I draw on the findings of an institutional ethnography of an international social science research project to identify several ethical and epistemic concerns, including epistemic extractivism. I identify Alcoff’s first and second challenge for extractivist epistemologies in the (...) findings of the empirical investigation and argue that they are important considerations for the ethics and socio-epistemological functioning of data-sharing in social science. (shrink)

BackgroundIn resource-limited settings like Uganda, ethical sharing of health research data is crucial for advancing scientific knowledge. Despite the growing trend of data-sharing in the digital age, its adoption in low-resource contexts is often hampered by complex ethical considerations. This study explored researchers’ perspectives and ethical concerns regarding data-sharing at a public university.MethodsA qualitative phenomenographic approach was employed involving 26 participants at Makerere University College of Health Sciences, including professors, lecturers, research fellows, and PhD (...) students. Data was collected through in-depth interviews conducted via Zoom or in person, using an interview guide. Data were analyzed thematically using ATLAS.ti (V9), using both deductive and inductive approaches.ResultsThe study revealed a complex landscape of data-sharing practices among researchers. Participants exhibited varying understandings of data sharing, with some demonstrating limited awareness. Incentives such as financial rewards and co-authorship were widely viewed as crucial for encouraging data sharing. While acknowledging data sources in publications was appreciated, some researchers emphasized the need for co-authorship in cases of significant contributions. Researchers’ autonomy and control over data-sharing practices were influenced by factors such as research concept origination, funding sources, financial status, and analytical skills. Institutional policies, cultural norms, and customs that promote a ‘siloed’ research environment also significantly influenced of data-sharing behavior.ConclusionThis study revealed a complex landscape of data-sharing practices among researchers. The varying interpretations of data sharing highlight the need for enhanced education and awareness regarding its importance. The identified incentives, such as financial rewards and co-authorship, which encourage data sharing, suggest a need to establish a fair data-sharing reward system. Additionally, policies that facilitate researchers’ autonomy and data control, while fostering trust, are crucial to address the siloed research culture. (shrink)

The sharing of research data has long been an aim of institutions and publishers and has led to the development of new models of scientific research called data-sharing policies based on the ethical obligation to make data freely available or as unrestricted as possible.

Existing data sources have tremendous potential to inform public health activities. However, a patchwork of data protection laws impede data sharing efforts. Nevertheless, a data-sharing initiative in Peoria, IL was able to overcome challenges to set up a cross-sectoral data system to coordinate mental health, law enforcement, and healthcare services.

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The frameworks aim to govern coordinated processing, sharing and transfer of health data across borders thus placing burdens on researchers who are willing or obligated to share data. (...) In this paper, we investigate ethical values and legal principles that can be applied to ensure a more streamlined approach in the governance of cross-border health data sharing during global health emergencies. A scoping review approach was used to better understand emerging evidence about issues related to the ethical and legal governance of cross-border health data sharing. We first highlight the challenges of sharing health data across borders. We then discuss how the challenges might be overcome through the application of ethical values and legal principles that have been identified in literature. This is followed by a proposal for possible ways of streamlining the governance of health data sharing from ethical and legal perspectives in a bid to better prepare for future global health emergencies and promote the responsible sharing of health data. (shrink)

Most scientists recognize the importance of sharing data online in an open fashion. Nonetheless, many studies have documented the concerns that accompany data sharing activities, including loss of credit or IP, misuse and the time needed to curate interoperable data. To this end, discussions around data sharing often identify incentives that could potentially ameliorate these disincentivising concerns. Nonetheless, current Open Data discussions often rely on evidence‐based studies to identify the disincentives to overcome. (...) This results in highly specific and directed interventions. In contrast, this paper offers a different interpretation of these concerns. To do so, it makes use of the Thomas Theorem which suggests that: “If men define situations as real, they are real in their consequences”. Using empirical evidence from sub‐Saharan African (bio)chemistry laboratories, this paper illustrates how individual perceptions of research environments – whether associated with evidence or not – are highly influential in shaping data sharing practices. It concludes with the suggestion that discussion on incentivising data sharing amongst scientific communities need to take a broader set of concerns into account and offer a more creative approach to ameliorating environmental disincentives. (shrink)

Leading agencies, such as the Committee on Publication Ethics (COPE), the World Association of Medical Editors (WAME), and the Open Access Scholarly Publishing Association (OASPA), recommend sharing research data. Further, all major publishers also encourage researchers to practice openness and transparency by sharing the data sets. In contrast, many researchers from social science streams are reluctant to share their data sets. We employ multiple methodologies to understand the causes and repercussions of this contrast. Four case (...) studies show no rationale for social science authors not sharing their data sets. Survey results (391 social science Scopus-Q1 authors worldwide) support the hypothesis that the non-availability of data and non-compulsion from journals/editors/reviewers are the major causes for the non-sharing of research data. Interviews with ten senior editors reveal that publishers are reluctant to impose compulsion out of the fear that there would be a reduced supply of articles if data sharing is made compulsory. The study provides reasonable evidence to conclude that those who do not share their research data are most unlikely to have it. To address this serious flaw, we recommend compulsory data sharing to discourage unauthentic research not backed up by underlying data. This paper uses sizable empirical evidence to highlight the lack of authenticity in social science research. It further recommends policy change to make data sharing compulsory to increase the authenticity of social science research. (shrink)

In order to study the relationship between genes and diseases, the increasing availability and sharing of phenotypic and genotypic data have been promoted as an imperative within the scientific community. In parallel with data sharing practices by clinicians and researchers, recent initiatives have been observed in which individuals are sharing personal genomic data. The involvement of individuals in such initiatives is facilitated by the increased accessibility of personal genomic data, offered by private test (...) providers along with availability of online networks. Personal webpages and on-line data sharing platforms such as Consent to Research, Free the Data, and Genomes Unzipped are being utilized to host and share genotypes, electronic health records and family history uploaded by individuals. Although personal genomic data sharing initiatives vary in nature, the emphasis on the individuals’ control on their data in order to benefit research and ultimately health care has seen as a key theme across these initiatives. In line with the growing practice of personal genomic data sharing, this paper aims to shed light on the potential challenges surrounding these initiatives. As in the course of these initiatives individuals are solicited to individually balance the risks and benefits of sharing their genomic data, their awareness of the implications of personal genomic data sharing for themselves and their family members is a necessity. Furthermore, given the sensitivity of genomic data and the controversies around their complete de-identifiability, potential privacy risks and harms originating from unintended uses of data have to be taken into consideration. (shrink)

BackgroundThe highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of (...) the KIDS Framework from the perspectives of Canadian clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.MethodsTwelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists’ ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists’ written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQR at least 1.0) and strong support.ResultsNine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.ConclusionsThe validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities. (shrink)

Background Sharing of genomic data aims to make efficient use of limited resources, which may be particularly valuable in rare disease research. Adult research participants and parents of pediatric research participants have shown support for data sharing with protections, but little is known about adolescent attitudes on genomic privacy and data sharing.Methods In-depth interviews were conducted with 10 adolescents and 18 parents of children enrolled in a pediatric genomic research repository. Interview transcripts were analyzed (...) for themes on attitudes toward genomic privacy, restricted-access data sharing, and open-access data sharing. Findings in adolescent and parent participants were compared and contrasted.Results No adolescents endorsed privacy concerns for restricted-access data sharing. Both adolescents and parents saw value in data sharing for reaching the goals of research and discussed trust in institutions and researchers to protect their data and use it as intended. Adolescents were more likely than parents to accept open-access data sharing, including after risks were discussed.Conclusions In this exploratory study, adolescents and parents enrolled in a genomic research repository shared many attitudes about genomic data sharing, but adolescents were less concerned about privacy and more agreeable toward open-access data sharing. Future research is needed to investigate this hypothesis in expanded populations and settings, and to clarify whether adolescent attitudes change with age and experiences. (shrink)