A human rights approach to an international code of conduct for genomic and clinical data sharing

Fostering data sharing is a scientific and ethical imperative. Health gains can be achieved more comprehensively and quickly by combining large, information-rich datasets from across conventionally siloed disciplines and geographic areas. While collaboration for data sharing is increasingly embraced by policymakers and the international biomedical community, we lack a common ethical and legal framework to connect regulators, funders, consortia, and research projects so as to facilitate genomic and clinical data linkage, global science collaboration, and responsible research conduct. Governance tools can be used to responsibly steer the sharing of data for proper stewardship of research discovery, genomics research resources, and their clinical applications. In this article, we propose that an international code of conduct be designed to enable global genomic and clinical data sharing for biomedical research. To give this proposed code universal application and accountability, however, we propose to position it within a human rights framework. This proposition is not without precedent: international treaties have long recognized that everyone has a right to the benefits of scientific progress and its applications, and a right to the protection of the moral and material interests resulting from scientific productions. It is time to apply these twin rights to internationally collaborative genomic and clinical data sharing.     

Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan

The National Institutes of Health (NIH) Policy for Data Management and Sharing (DMS Policy) recognizes the NIH’s role as a key steward of United States biomedical research and information and seeks to enhance that stewardship through systematic recommendations for the preservation and sharing of research data generated by funded projects. The policy is effective as of January 2023. The recommendations include a requirement for the submission of a Data Management and Sharing Plan (DMSP) with funding applications, and while no strict template was provided, the NIH has released supplemental draft guidance on elements to consider when developing a plan. This article provides 10 key recommendations for creating a DMSP that is both maximally compliant and effective.     

Data sharing by scientists: practices and perceptions

Background

Scientific research in the 21st century is more data intensive and collaborative than in the past. It is important to study the data practices of researchers – data accessibility, discovery, re-use, preservation and, particularly, data sharing. Data sharing is a valuable part of the scientific method allowing for verification of results and extending research from prior results.

Methodology/Principal Findings

A total of 1329 scientists participated in this survey exploring current data sharing practices and perceptions of the barriers and enablers of data sharing. Scientists do not make their data electronically available to others for various reasons, including insufficient time and lack of funding. Most respondents are satisfied with their current processes for the initial and short-term parts of the data or research lifecycle (collecting their research data; searching for, describing or cataloging, analyzing, and short-term storage of their data) but are not satisfied with long-term data preservation. Many organizations do not provide support to their researchers for data management both in the short- and long-term. If certain conditions are met (such as formal citation and sharing reprints) respondents agree they are willing to share their data. There are also significant differences and approaches in data management practices based on primary funding agency, subject discipline, age, work focus, and world region.

Conclusions/Significance

Barriers to effective data sharing and preservation are deeply rooted in the practices and culture of the research process as well as the researchers themselves. New mandates for data management plans from NSF and other federal agencies and world-wide attention to the need to share and preserve data could lead to changes. Large scale programs, such as the NSF-sponsored DataNET (including projects like DataONE) will both bring attention and resources to the issue and make it easier for scientists to apply sound data management principles.     

The user's view on biodiversity data sharing — Investigating facts of acceptance and requirements to realize a sustainable use of research data —

Data sharing has become an important issue in modern biodiversity research to address large scale questions. Despite the steadily growing scientific demand, data are not easily accessed. Why is this the case? This study explores the reasons for the reluctance to share data on the one hand and the motivations for sharing on the other by summarising results from > 60 interviews and > 700 survey participants within the biodiversity science community. As result, there is a clear commitment to share biodiversity data, but also a reluctance to actually do so due to a mixture of social and technical impediments, such as loss of control over data and lack of professional reward for sharing. This exploratory study summarises the formal and technical requirements for data sharing and reuse, stated by voluntarily participating scientists worldwide. To ensure sustainable data use, user friendly data infrastructure have to be expanded or newly designed, data management plans for all scientific investigations have to be promoted, training for the users has to be provided and motivational aspects at all stages of data submission and re-use have to be considered.     

Changes in Data Sharing and Data Reuse Practices and Perceptions among Scientists Worldwide

The incorporation of data sharing into the research lifecycle is an important part of modern scholarly debate. In this study, the DataONE Usability and Assessment working group addresses two primary goals: To examine the current state of data sharing and reuse perceptions and practices among research scientists as they compare to the 2009/2010 baseline study, and to examine differences in practices and perceptions across age groups, geographic regions, and subject disciplines. We distributed surveys to a multinational sample of scientific researchers at two different time periods (October 2009 to July 2010 and October 2013 to March 2014) to observe current states of data sharing and to see what, if any, changes have occurred in the past 3–4 years. We also looked at differences across age, geographic, and discipline-based groups as they currently exist in the 2013/2014 survey. Results point to increased acceptance of and willingness to engage in data sharing, as well as an increase in actual data sharing behaviors. However, there is also increased perceived risk associated with data sharing, and specific barriers to data sharing persist. There are also differences across age groups, with younger respondents feeling more favorably toward data sharing and reuse, yet making less of their data available than older respondents. Geographic differences exist as well, which can in part be understood in terms of collectivist and individualist cultural differences. An examination of subject disciplines shows that the constraints and enablers of data sharing and reuse manifest differently across disciplines. Implications of these findings include the continued need to build infrastructure that promotes data sharing while recognizing the needs of different research communities. Moving into the future, organizations such as DataONE will continue to assess, monitor, educate, and provide the infrastructure necessary to support such complex grand science challenges.     

Water,Water, Everywhere: Defining and Assessing Data Sharing in Academia

Sharing of research data has begun to gain traction in many areas of the sciences in the past few years because of changing expectations from the scientific community, funding agencies, and academic journals. National Science Foundation (NSF) requirements for a data management plan (DMP) went into effect in 2011, with the intent of facilitating the dissemination and sharing of research results. Many projects that were funded during 2011 and 2012 should now have implemented the elements of the data management plans required for their grant proposals. In this paper we define ‘data sharing’ and present a protocol for assessing whether data have been shared and how effective the sharing was. We then evaluate the data sharing practices of researchers funded by the NSF at Oregon State University in two ways: by attempting to discover project-level research data using the associated DMP as a starting point, and by examining data sharing associated with journal articles that acknowledge NSF support. Sharing at both the project level and the journal article level was not carried out in the majority of cases, and when sharing was accomplished, the shared data were often of questionable usability due to access, documentation, and formatting issues. We close the article by offering recommendations for how data producers, journal publishers, data repositories, and funding agencies can facilitate the process of sharing data in a meaningful way.     

HydroServer Lite as an open source solution for archiving and sharing environmental data for independent university labs

Managing, archiving, and sharing large amounts of data are essential tasks in ecological laboratories, and detailed data management plans are now required by major funding agencies. Many independent research labs may lack the technical or financial resources needed to support some of the more comprehensive data management solutions that have become available. In this paper we describe an open-source solution to data management, archiving, and sharing that can be implemented and customized by someone with limited computer programming experience using free software and standardized web services. This software, HydroServer Lite, is a light-weight database and data management web-based application that integrates with and makes data available on a large data sharing network developed by the Consortium of Universities for the Advancement of Hydrologic Sciences, Inc. (CUAHSI). The CUAHSI Hydrologic Information System facilitates data sharing through a network of local HydroServers that are registered with the central registry. Each HydroServer may contain a variety of ecological and climate data, stored in a standardized relational database model. Someone searching for data that are registered in the central registry can query the network by source, location, variable type, and dates. These data can be downloaded from the local HydroServer to a computer in an office or lab where they can be manipulated and analyzed without compromising the data in the archives. We offer this HydroServer Lite case study as a possible solution for independent research laboratories looking for a data management system that requires little technical expertise or initial cost to set up.     

Caries-preventive effect of glass ionomer and resin-based fissure sealants on permanent teeth: An update of systematic review evidence

Background

The 1980s marked the occasion when Geographical Information System (GIS) technology was broadly introduced into the geo-spatial community through the establishment of a strong GIS industry. This technology quickly disseminated across many countries, and has now become established as an important research, planning and commercial tool for a wider community that includes organisations in the public and private health sectors. The broad acceptance of GIS technology and the nature of its functionality have meant that numerous datasets have been created over the past three decades. Most of these datasets have been created independently, and without any structured documentation systems in place. However, search and retrieval systems can only work if there is a mechanism for datasets existence to be discovered and this is where proper metadata creation and management can greatly help. This situation must be addressed through support mechanisms such as Web-based portal technologies, metadata editor tools, automation, metadata standards and guidelines and collaborative efforts with relevant individuals and organisations. Engagement with data developers or administrators should also include a strategy of identifying the benefits associated with metadata creation and publication.

Findings

The establishment of numerous Spatial Data Infrastructures (SDIs), and other Internet resources, is a testament to the recognition of the importance of supporting good data management and sharing practices across the geographic information community. These resources extend to health informatics in support of research, public services and teaching and learning. This paper identifies many of these resources available to the UK academic health informatics community. It also reveals the reluctance of many spatial data creators across the wider UK academic community to use these resources to create and publish metadata, or deposit their data in repositories for sharing. The Go-Geo! service is introduced as an SDI developed to provide UK academia with the necessary resources to address the concerns surrounding metadata creation and data sharing. The Go-Geo! portal, Geodoc metadata editor tool, ShareGeo spatial data repository, and a range of other support resources, are described in detail.

Conclusions

This paper describes a variety of resources available for the health research and public health sector to use for managing and sharing their data. The Go-Geo! service is one resource which offers an SDI for the eclectic range of disciplines using GIS in UK academia, including health informatics. The benefits of data management and sharing are immense, and in these times of cost restraints, these resources can be seen as solutions to find cost savings which can be reinvested in more research.     

Thirty years of US long-term ecological research: characteristics, results, and lessons learned of--taking the Virginia Coast Reserve as an example

In order to observe and understand long-term and large-scale ecological changes, the US National Science Foundation initiated a Long-Term Ecological Research (LTER) program in 1980. Over the past 30 years, the US LTER program has achieved advances in ecological and social science research, and in the development of site-based research infrastructure. This paper attributed the success of the program to five characteristics, i.e., 1) consistency of research topics and data across the network, 2) long-term time scale of both the research and the program, 3) flexibility in research content and funding procedures, 4) growth of LTER to include international partners, new disciplines such as social science, advanced research methods, and cooperation among sites, and 5) sharing of data and educational resources. The Virginia Coast Reserve LTER site was taken as an example to illustrate how the US LTER works at site level. Some suggestions were made on the China long-term ecological research, including strengthening institution construction, improving network and inter-site cooperation, emphasizing data quality, management, and sharing, reinforcing multidisciplinary cooperation, and expanding public influence.     

PROPHET, a national computing resource for life science research.

PROPHET is a national computing resource tailored to meet the data management and analysis needs of life scientists working in a wide variety of disciplines, ranging from pharmacology to molecular biology. The PROPHET system offers a fully integrated graphics-oriented environment designed to aid research scientists in the manipulation and analysis of scientific spreadsheets of data, graphs, molecular structures, biological simulation models, and protein and nucleic acid sequences, and it includes access to a range of molecular structure and sequence databases. This paper briefly describes the PROPHET system, some of its current capabilities, and plans for a new fully distributed version of the system now under development.     

生命与健康大数据中心资源

生命与健康多组学数据是生命科学研究和生物医学技术发展的重要基础。然而,我国缺乏生物数据管理和共享平台,不但无法满足国内日益增长的生物医学及相关学科领域的研究发展需求,而且严重制约我国生物大数据整合共享与转化利用。鉴于此,中国科学院北京基因组研究所于2016年初成立生命与健康大数据中心(BIG Data Center, BIGD),围绕国家人口健康和重要战略生物资源,建立生物大数据管理平台和多组学数据资源体系。本文重点介绍BIGD的生命与健康大数据资源系统,主要包括组学原始数据归档库、基因组数据库、基因组变异数据库、基因表达数据库、甲基化数据库、生物信息工具库和生命科学维基知识库,提供生物大数据汇交、整合与共享服务,为促进我国生命科学数据管理、推动国家生物信息中心建设奠定重要基础。     

Legislation for trial registration and data transparency

Sharing of final research data from clinical research is an essential part of the scientific method. The U.S. National Institutes of Health require some grant applications to include plans for sharing final research data, which it defines as the factual materials necessary to document, support, and validate research findings. In the U.S., however, the Privacy Rule adopted under the Health Insurance Portability and Accountability Act impedes the sharing of final research data. In most situations, final research data may be shared only where all information that could possibly be used to identify the subject has been deleted, or where the subject has given authorization for specific research, or an Institutional Review Board has granted a waiver.     

What can conservation strategies learn from the ecosystem services approach? Insights from ecosystem assessments in two Spanish protected areas

Biodiversity conservation strategies that overlook the interests of local people are prone to create conflicts. The ecosystem service approach holds potential for more comprehensively integrating the social dimension into decision-making in protected areas, but its implementation in conservation policies is still in its infancy. This research assesses the extent to which ecosystem services have been implemented in conservation strategies in protected areas. The study was conducted in two outstanding Spanish protected areas, covering a wetland (Doñana Natural and National Parks) and a Mediterranean mountain system (Sierra Nevada Natural and National Parks). Data were collected from deliberative workshops with managers and researchers, face-to-face surveys with users and a review of management plans. We found that, beyond intrinsic values of ecosystems and biodiversity, these areas provide multiple ecosystem services that deserve further attention to ensure their sustained delivery. Our research shows that environmental managers and researchers have different perceptions and priorities regarding ecosystem services management compared with ecosystem service users. Environmental managers and researchers in both protected areas perceived that human-nature relationships and ecosystem services are already widely included in management plans, if often not explicitly. We found that different ecosystem service categories receive uneven attention in management plans. These contained measures to manage provisioning and cultural services whereas measures for managing regulating services were perceived to be largely absent. We conclude by summarizing insights on how the ecosystem service approach may enhance the consideration of social interests in the management of management protected areas.     

Research Data in Core Journals in Biology,Chemistry, Mathematics,and Physics

This study takes a stratified random sample of articles published in 2014 from the top 10 journals in the disciplines of biology, chemistry, mathematics, and physics, as ranked by impact factor. Sampled articles were examined for their reporting of original data or reuse of prior data, and were coded for whether the data was publicly shared or otherwise made available to readers. Other characteristics such as the sharing of software code used for analysis and use of data citation and DOIs for data were examined. The study finds that data sharing practices are still relatively rare in these disciplines’ top journals, but that the disciplines have markedly different practices. Biology top journals share original data at the highest rate, and physics top journals share at the lowest rate. Overall, the study finds that within the top journals, only 13% of articles with original data published in 2014 make the data available to others.     

Mosquito control opportunities amid regulations within the tidal marshes of the San Francisco Bay Area

The San Francisco Bay Area is a leader in environmental stewardship and home to numerous wetland restoration projects including the largest tidal wetland restoration project on the American West Coast. As tidal marsh wetlands are restored throughout the Bay Area many opportunities remain to reaffirm the importance of water management that reduces mosquito production and protects public health. Unlike the early 1900s when long term saltmarsh mosquito control was achieved with large scale surface water management projects, regulatory restrictions produce new hurdles that impact mosquito control and restoration projects alike. Work done in the wetlands surrounding the San Francisco Bay must comply with existing management plans, permit requirements, and government regulations. The same is true for emerging technologies. While unmanned airsystems employed for mosquito control improves efficiency and accuracy, regulations in this arena limit their broad use in wetlands that abut the San Francisco Bay. Mosquito abatement districts collect substantial scientific data that inform land management and mosquito control operations. This information is useful for evaluating wetland restoration progress in the Bay Area and fostering partnerships that keep a public health perspective at the forefront.

     

Stakeholders Influence and Internal Championing of Product Stewardship in the Italian Food Packaging Industry

Environmental management is becoming a top issue on managers' agendas in several industries. The adoption and implementation of a sound "green" strategy involves following product stewardship practices. Product stewardship is the idea that manufacturers, rather than consumers, governments, or waste companies, ought to take responsibility for the recycling and disposal of their products at the end of their life cycle. This article is aimed at investigating the relationships between the adoption of product stewardship practices and the involvement of different actors in the decision-making process. By means of discriminant analysis, 120 firms have been classified into two different environmental profiles. Results indicate that firms that are more committed to product stewardship differ from less-committed firms in the influence exerted by different stakeholders and in the supportive role played by the management at different hierarchical and functional levels. In general, it appears that top management involvement in the decision-making process is a critical condition for the successful championship of product stewardship. In addition, the effective implementation of product stewardship along the product life-cycle stages is correlated to a strong commitment on the part of chief technical officers and development engineers rather than of manufacturing or marketing managers.     

中国茶树种质资源研究的主要进展和展望

茶树种质资源是生产利用、品种创新和生物技术研究的物质基础,具有十分重要的价值和意义.本文系统阐述了近20年中国茶树种质资源考察收集、保存编目、鉴定评价、分子标记、遗传稳定性等研究的主要成就与进展.着重提出近期继续征集、在资源个体与基因水平上深入鉴定评价、加强种质创新不断提供新基因源、建立核心种质、建立种质资源共享平台等研究工作的建议和展望.     

The Data Governance Act and the EU's move towards facilitating data sharing

The implementation of the EU General Data Protection Regulation (GDPR) has had significant impacts on biomedical research, often complicating data sharing among researchers. The recently announced proposal for a new EU Data Governance Act is a promising step towards facilitating data sharing, if it can interplay well with the GDPR.Subject Categories: S&S: Ethics

The EU General Data Protection Regulation (GDPR) has affected biomedical research, often complicating data sharing. The recently announced proposal for a new EU Data Governance Act, is a promising step towards facilitating data sharing.

In an attempt to improve and increase data sharing in the EU and to optimize the re‐use of personal and non‐personal data, the European Commission has recently announced the proposal for a new EU Data Governance Act (https://ec.europa.eu/digital‐single‐market/en/news/proposal‐regulation‐european‐data‐governance‐data‐governance‐act). If approved, it will enable the creation and regulation of “secure spaces” where various types of data, including health data, can be shared and re‐used for both commercial and altruistic purposes, including scientific research. The Data Governance Act, within the framework of a European Strategy for Data, (https://ec.europa.eu/info/sites/info/files/communication‐european‐strategy‐dat‐19feb2020_en.pdf), would address some of the shortcomings and drawbacks of the current regulatory framework which holds back sharing and re‐using data for biomedical research purposes.While the proposed Act would apply to all types of personal and non‐personal data, the increasing demand for sharing health data has most likely been a major rationale for this new legislation of data governance. Notably, sharing health and genetic data for scientific research entails an extra layer of complexity, owing to concerns over data protection and privacy when sharing sensitive personal data. Vice versa, there are also concerns in the scientific community over the negative impact of regulatory restrictions on sharing health data in data‐driven biomedical research. The pressing question here is how far the EU’s proposed legislative and policy framework can offset either concerns?     

The filamentous fungal gene expression database (FFGED)

Filamentous fungal gene expression assays provide essential information for understanding systemic cellular regulation. To aid research on fungal gene expression, we constructed a novel, comprehensive, free database, the filamentous fungal gene expression database (FFGED), available at http://bioinfo.townsend.yale.edu. FFGED features user-friendly management of gene expression data, which are assorted into experimental metadata, experimental design, raw data, normalized details, and analysis results. Data may be submitted in the process of an experiment, and any user can submit multiple experiments, thus classifying the FFGED as an “active experiment” database. Most importantly, FFGED functions as a collective and collaborative platform, by connecting each experiment with similar related experiments made public by other users, maximizing data sharing among different users, and correlating diverse gene expression levels under multiple experimental designs within different experiments. A clear and efficient web interface is provided with enhancement by AJAX (Asynchronous JavaScript and XML) and through a collection of tools to effectively facilitate data submission, sharing, retrieval and visualization.     

Unlocking data: Where is the key?

Health‐related data uses and data sharing have been in the spotlight for a while. Since the beginning of the big data era, massive data mining and its inherent possibilities have only increased the debate about what the limits are. Data governance is a relevant aspect addressed in ethics guidelines. In this context, the European project BRIDGE Health (BRidging Information and Data Generation for Evidence‐based Health policy and research) strove to achieve a comprehensive, integrated and sustainable EU health‐information system. One of the aims of the project was to evaluate the requirements to construct a data‐linkage infrastructure for the secure management of health information. In a blueprint provided for this infrastructure, the topics ethics and the intimately related governance occupied a whole section, where the recent ethics guidelines by the Council for International Organizations of Medical Sciences (CIOMS) and the World Medical Association (WMA) were referenced. We explore what has changed in the latest versions of the ethics documents adopted by CIOMS and WMA regarding the management of health data and human tissues, the appropriateness of their application in new forms of research and infrastructures as the proposed in the BRIDGE Health project, and whether society should be so concerned about this topic, in the digital era of social exchange.