Visualizing an Ethics Framework: A Method to Create Interactive Knowledge Visualizations From Health Policy Documents

Background Data have become an essential factor in driving health research and are key to the development of personalized and precision medicine. Primary and secondary use of personal data holds significant potential for research; however, it also introduces a new set of challenges around consent processes, privacy, and data sharing. Research institutions have issued ethical guidelines to address challenges and ensure responsible data processing and data sharing. However, ethical guidelines directed at researchers and medical professionals are often complex; require readers who are familiar with specific terminology; and can be hard to understand for people without sufficient background knowledge in legislation, research, and data processing practices. Objective This study aimed to visually represent an ethics framework to make its content more accessible to its stakeholders. More generally, we wanted to explore the potential of visualizing policy documents to combat and prevent research misconduct by improving the capacity of actors in health research to handle data responsibly. Methods We used a mixed methods approach based on knowledge visualization with 3 sequential steps: qualitative content analysis (open and axial coding, among others); visualizing the knowledge structure, which resulted from the previous step; and adding interactive functionality to access information using rapid prototyping. Results Through our iterative methodology, we developed a tool that allows users to explore an ethics framework for data sharing through an interactive visualization. Our results represent an approach that can make policy documents easier to understand and, therefore, more applicable in practice. Conclusions Meaningful communication and understanding each other remain a challenge in various areas of health care and medicine. We contribute to advancing communication practices through the introduction of knowledge visualization to bioethics to offer a novel way to tackle this relevant issue.

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The Need for Machine-Processable Agreements in Health Data Management

Algorithms ◽

10.3390/a13040087 ◽

2020 ◽

Vol 13 (4) ◽

pp. 87

Author(s):

George Konstantinidis ◽

Adriane Chapman ◽

Mark J. Weal ◽

Ahmed Alzubaidi ◽

Lisa M. Ballard ◽

...

Keyword(s):

Data Processing ◽

Data Management ◽

Data Sharing ◽

Medical Information ◽

Service Providers ◽

Personal Data ◽

Health Data ◽

Coarse Grained ◽

Semantic Web Technologies ◽

Fine Grained

Data processing agreements in health data management are laid out by organisations in monolithic “Terms and Conditions” documents written in natural legal language. These top-down policies usually protect the interest of the service providers, rather than the data owners. They are coarse-grained and do not allow for more than a few opt-in or opt-out options for individuals to express their consent on personal data processing, and these options often do not transfer to software as they were intended to. In this paper, we study the problem of health data sharing and we advocate the need for individuals to describe their personal contract of data usage in a formal, machine-processable language. We develop an application for sharing patient genomic information and test results, and use interactions with patients and clinicians in order to identify the particular peculiarities a privacy/policy/consent language should offer in this complicated domain. We present how Semantic Web technologies can have a central role in this approach by providing the formal tools and features required in such a language. We present our ongoing approach to construct an ontology-based framework and a policy language that allows patients and clinicians to express fine-grained consent, preferences or suggestions on sharing medical information. Our language offers unique features such as multi-party ownership of data or data sharing dependencies. We evaluate the landscape of policy languages from different areas, and show how they are lacking major requirements needed in health data management. In addition to enabling patients, our approach helps organisations increase technological capabilities, abide by legal requirements, and save resources.

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The Fairness Principle in Personal Data Processing

SSRN Electronic Journal ◽

10.2139/ssrn.3641883 ◽

2019 ◽

Author(s):

Daniel-Mihail Sandru

Keyword(s):

Data Processing ◽

Personal Data ◽

Fairness Principle

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GDPR Implementation Series ∙ Latvia: Draft Personal Data Processing Law

European Data Protection Law Review ◽

10.21552/edpl/2018/1/13 ◽

2018 ◽

Vol 4 (1) ◽

pp. 95-96

Author(s):

A. Burkevics

Keyword(s):

Data Processing ◽

Personal Data

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Record linkage of routine data with cohorts’ data of infants under European and Portuguese law

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.178 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

J Doetsch ◽

I Lopes ◽

R Redinha ◽

H Barros

Keyword(s):

Big Data ◽

Data Processing ◽

Data Protection ◽

Record Linkage ◽

Data Science ◽

Personal Data ◽

Routine Data ◽

Cohort Data ◽

Education Data ◽

Explicit Consent

Abstract The usage and exchange of “big data” is at the forefront of the data science agenda where Record Linkage plays a prominent role in biomedical research. In an era of ubiquitous data exchange and big data, Record Linkage is almost inevitable, but raises ethical and legal problems, namely personal data and privacy protection. Record Linkage refers to the general merging of data information to consolidate facts about an individual or an event that are not available in a separate record. This article provides an overview of ethical challenges and research opportunities in linking routine data on health and education with cohort data from very preterm (VPT) infants in Portugal. Portuguese, European and International law has been reviewed on data processing, protection and privacy. A three-stage analysis was carried out: i) interplay of threefold law-levelling for Record Linkage at different levels; ii) impact of data protection and privacy rights for data processing, iii) data linkage process' challenges and opportunities for research. A framework to discuss the process and its implications for data protection and privacy was created. The GDPR functions as utmost substantial legal basis for the protection of personal data in Record Linkage, and explicit written consent is considered the appropriate basis for the processing sensitive data. In Portugal, retrospective access to routine data is permitted if anonymised; for health data if it meets data processing requirements declared with an explicit consent; for education data if the data processing rules are complied. Routine health and education data can be linked to cohort data if rights of the data subject and requirements and duties of processors and controllers are respected. A strong ethical context through the application of the GDPR in all phases of research need to be established to achieve Record Linkage between cohort and routine collected records for health and education data of VPT infants in Portugal. Key messages GDPR is the most important legal framework for the protection of personal data, however, its uniform approach granting freedom to its Member states hampers Record Linkage processes among EU countries. The question remains whether the gap between data protection and privacy is adequately balanced at three legal levels to guarantee freedom for research and the improvement of health of data subjects.

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Levels of research evidence in health policy assessment in Malawi

Leadership in Health Services ◽

10.1108/lhs-09-2018-0050 ◽

2019 ◽

Vol 32 (2) ◽

pp. 226-250

Author(s):

Patrick Mapulanga ◽

Jaya Raju ◽

Thomas Matingwina

Keyword(s):

Health Policy ◽

Empirical Evidence ◽

Systematic Reviews ◽

Health Research ◽

Research Evidence ◽

Health Policies ◽

Services Research ◽

Policy Documents ◽

Content Type ◽

Policy Systems

Purpose The purpose of this study is to examine levels of health research evidence in health policies in Malawi. Design/methodology/approach The study selected a typology of health policies in Malawi from 2002 to 2017. The study adopted the SPIRIT conceptual framework and assessed the levels of research evidence in health policy, systems and services research using the revised SAGE policy assessment tool. Documentary analysis was used to assess levels of health research evidence in health policies in Malawi. Findings In 29 (96.7 per cent) of the health policies, policy formulators including healthcare directors and managers used generic search engines such as Google or Google Scholar to look for heath research evidence. In 28 (93.3 per cent) of the health policies, they searched for grey literature and other government documents. In only 6 (20 per cent) of the heath policy documents, they used academic literature in a form of journal articles and randomised controlled trials. No systematic reviews or policy briefs were consulted. Overall, in 23 (76.7 per cent) of the health policy documents, health research evidence played a minimal role and had very little influence on the policy documents or decision-making. Research limitations/implications The empirical evidence in the health policy documents are limited because of insufficient research citation, low retrievability of health research evidence in the policy documents and biased selectivity of what constitutes health research evidence. Practical implications The study indicates that unfiltered information (data from policy evaluations and registries) constitutes majority of the research evidence in health policies both in health policy, systems and services research. The study seeks to advocate for the use of filtered information (peer reviewed, clinical trials and data from systematic reviews) in formulating health policies. Originality/value There is dearth of literature on the levels of health research evidence in health policy-making both in health policy, systems and services research. This study seeks to bridge the gap with empirical evidence from a developing country perspective.

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Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report ?

Ethics & Human Research ◽

10.1002/eahr.500078 ◽

2021 ◽

Vol 43 (1) ◽

pp. 37-41

Author(s):

Barbara K. Redman ◽

Arthur L. Caplan

Keyword(s):

Research Misconduct ◽

Belmont Report ◽

Ethics Framework

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Reconciliation of anti-money laundering instruments and European data protection requirements in permissionless blockchain spaces

Journal of Cybersecurity ◽

10.1093/cybsec/tyab004 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Iwona Karasek-Wojciechowicz

Keyword(s):

Data Processing ◽

Money Laundering ◽

Data Protection ◽

Task Force ◽

Policy Instruments ◽

Personal Data ◽

General Data Protection Regulation ◽

Terrorist Financing ◽

The Government ◽

High Level

AbstractThis article is an attempt to reconcile the requirements of the EU General Data Protection Regulation (GDPR) and anti-money laundering and combat terrorist financing (AML/CFT) instruments used in permissionless ecosystems based on distributed ledger technology (DLT). Usually, analysis is focused only on one of these regulations. Covering by this research the interplay between both regulations reveals their incoherencies in relation to permissionless DLT. The GDPR requirements force permissionless blockchain communities to use anonymization or, at the very least, strong pseudonymization technologies to ensure compliance of data processing with the GDPR. At the same time, instruments of global AML/CFT policy that are presently being implemented in many countries following the recommendations of the Financial Action Task Force, counteract the anonymity-enhanced technologies built into blockchain protocols. Solutions suggested in this article aim to induce the shaping of permissionless DLT-based networks in ways that at the same time would secure the protection of personal data according to the GDPR rules, while also addressing the money laundering and terrorist financing risks created by transactions in anonymous blockchain spaces or those with strong pseudonyms. Searching for new policy instruments is necessary to ensure that governments do not combat the development of all privacy-blockchains so as to enable a high level of privacy protection and GDPR-compliant data processing. This article indicates two AML/CFT tools which may be helpful for shaping privacy-blockchains that can enable the feasibility of such tools. The first tool is exceptional government access to transactional data written on non-transparent ledgers, obfuscated by advanced anonymization cryptography. The tool should be optional for networks as long as another effective AML/CFT measures are accessible for the intermediaries or for the government in relation to a given network. If these other measures are not available and the network does not grant exceptional access, the regulations should allow governments to combat the development of those networks. Effective tools in that scope should target the value of privacy-cryptocurrency, not its users. Such tools could include, as a tool of last resort, state attacks which would undermine the trust of the community in a specific network.

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Regulatory frameworks for clinical trial data sharing during the Pandemic and beyond: A scoping review (Preprint)

10.2196/preprints.33591 ◽

2021 ◽

Author(s):

Nachiket Gudi ◽

Prashanthi Kamath ◽

Trishnika Chakraborty ◽

Anil G. Jacob ◽

Shradha Parsekar ◽

...

Keyword(s):

Clinical Trial ◽

Data Sharing ◽

Scoping Review ◽

Data Extraction ◽

Grey Literature ◽

Clinical Trial Data ◽

Trial Data ◽

Policy Documents ◽

Regulatory Documents ◽

Share Data

BACKGROUND Data sharing from clinical trials is well recognized and has widely gained recognition amid the COVID-19 pandemic. The competing interests of powerful stakeholders expressed through data exclusivity practices make clinical trial data sharing a complex phenomenon. The wider acceptance of data sharing practices in the absence of mandated policy creates uncertainty among trial investigators to count for risks vs benefit from sharing trial data. Data sharing becomes further complex as the trial data sharing is governed by the regional policies. This drew our attention to explore policies for informed data sharing. OBJECTIVE This scoping review aimed to map the existing literature around the regulatory documents that guide trial investigators to share clinical trial data. METHODS We followed a Joanna Briggs Institute scoping review approach and have reported the article according to the PRISMA extension for Scoping reviews (PRISMA-ScR). In addition to the use of the electronic databases, a targeted website search was performed to access relevant grey literature. The articles were screened at the title-abstract and the full text stages based on the selection criteria. All the included articles for data extraction were in English language. Data extraction was done independently using a pre-tested data extraction sheet. Included literature focused on clinical trial data sharing policies, guidelines, or SOPs. A narrative synthesis approach was used to summarize the findings. RESULTS This scoping review identified four articles and 13 policy documents from the grey literature. A majority of the clinical trial agencies require an agreement for data sharing between the data requestor/organization and trial agency. None of the policy documents mandates informed consent for data sharing. The time interval to share data underlying results, varies from six to 18 months from the time of trial publication. Depending upon trial data, policies follow both controlled and open access models. Regulatory documents identified in both scientific and grey literature emphasized on good research principles of protection of privacy of participant data and data anonymization through data sharing agreement between the data requester and trial agency. Need for an informed consent and cost of data sharing, timeline to share data, incentives, or reward to promote data sharing and capacity building for data sharing have remained grey areas in these policy documents. CONCLUSIONS This paper acknowledges the vital role of clinical data sharing from a public health perspective. We found that given the challenges around clinical trial data sharing, developing a feasible mechanism for data sharing is important. We suggest that standardizing data sharing processes by framing a concise policy with key elements of data sharing mechanisms could be easier to practice rather than a rigid and comprehensive data sharing policy. CLINICALTRIAL This scoping review protocol has not been registered and published.

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