scholarly journals Secondary research use of personal medical data: patient attitudes towards data donation

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gesine Richter ◽  
Christoph Borzikowsky ◽  
Bimba Franziska Hoyer ◽  
Matthias Laudes ◽  
Michael Krawczak
Keyword(s):  
Medical Research ◽  
Data Access ◽  
Patient Data ◽  
Individual Autonomy ◽  
Research Use ◽  
Secondary Research ◽  
Opt Out ◽  
Legitimate Interests ◽  
Legal Entitlement ◽  
High Level

Abstract Background The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research. Methods We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process. Results We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies. Conclusions In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.

scholarly journals The academic viewpoint on Big data and patient data ownership (as seen in the scientific literature)

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
I Mircheva ◽  
M Mirchev
Keyword(s):  
Public Health ◽  
Big Data ◽  
Medical Research ◽  
Information And Communication Technologies ◽  
Patient Information ◽  
Scientific Literature ◽  
Medical Data ◽  
Patient Data ◽  
Academic Community ◽  
Ethical Challenges

Abstract Background Ownership of patient information in the context of Big Data is a relatively new problem, apparently not yet fully understood. There are not enough publications on the subject. Since the topic is interdisciplinary, incorporating legal, ethical, medical and aspects of information and communication technologies, a slightly more sophisticated analysis of the issue is needed. Aim To determine how the medical academic community perceives the issue of ownership of patient information in the context of Big Data. Methods Literature search for full text publications, indexed in PubMed, Springer, ScienceDirect and Scopus identified only 27 appropriate articles authored by academicians and corresponding to three focus areas: problem (ownership); area (healthcare); context (Big Data). Three major aspects were studied: scientific area of publications, aspects and academicians' perception of ownership in the context of Big Data. Results Publications are in the period 2014 - 2019, 37% published in health and medical informatics journals, 30% in medicine and public health, 19% in law and ethics; 78% authored by American and British academicians, highly cited. The majority (63%) are in the area of scientific research - clinical studies, access and use of patient data for medical research, secondary use of medical data, ethical challenges to Big data in healthcare. The majority (70%) of the publications discuss ownership in ethical and legal aspects and 67% see ownership as a challenge mostly to medical research, access control, ethics, politics and business. Conclusions Ownership of medical data is seen first and foremost as a challenge. Addressing this challenge requires the combined efforts of politicians, lawyers, ethicists, computer and medical professionals, as well as academicians, sharing these efforts, experiences and suggestions. However, this issue is neglected in the scientific literature. Publishing may help in open debates and adequate policy solutions. Key messages Ownership of patient information in the context of Big Data is a problem that should not be marginalized but needs a comprehensive attitude, consideration and combined efforts from all stakeholders. Overcoming the challenge of ownership may help in improving healthcare services, medical and public health research and the health of the population as a whole.

Samarinda Grabbike Driver’s Income Analysis in 2019

2021 ◽  
Vol 2 (1) ◽  
pp. 30
Author(s):  
Made Ngurah Partha ◽  
Noor Ellyawati ◽  
Komang Ayu Safitri
Keyword(s):  
Minimum Wage ◽  
Quantitative Research ◽  
Working Hours ◽  
Research Use ◽  
Net Income ◽  
Average Income ◽  
Analysis Technique ◽  
Medium Level ◽  
High Level ◽  
The City

This research purposes to determine the income of Grabbike drivers in Samarinda during March 2019 and to compare the income toward the City Minimum Wage (UMK) in 2019. This research also intends to know the average and the percentage of Grabbike driver’s income in Samarinda toward the City Minimum Wage (UMK) in 2019. This is a descriptive quantitative research. The populations in this research are 1200 Samarinda Grabbike drivers in 2019 with 120 respondents. Data collection techniques in this research use questionnaires, interviews and documentation. The data analysis technique uses the net income formula; the average and percentage income. The research data and analysis of the Samarinda Grabbike driver’s income in 2019 includes several indicators; the number of working hours and working days. The research results show that the Samarinda Grabbike driver’s net income in March 2019 is Rp. 200,758,204. The percentage comparison between Samarinda Grabbike Driver’s incomes toward the City Minimum Wage (UMK) shows 24 drivers achieving high-level income or 20%, 65 drivers achieving medium-level income or 54.2% and 31 drivers achieving low-level income or 25.8%. The average income of Samarinda Grabbike drivers in March 2019 is Rp. 1,672,985.

scholarly journals A 6-YEAR EXPERIENCE OF HEART TRANSPLANTATION IN FEDERAL ALMAZOV NORTH-WEST MEDICAL RESEARCH CENTRE

2017 ◽  
Vol 18 (4) ◽  
pp. 33-42 ◽  
Author(s):  
E. V. Shlyakhto ◽  
M. L. Gordeev ◽  
M. A. Karpenko ◽  
G. V. Nikolaev ◽  
A. S. Gnevashev ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Medical Research ◽  
Heart Transplant ◽  
Graft Loss ◽  
Research Centre ◽  
Tricuspid Valve Repair ◽  
North West ◽  
Transplant Candidates ◽  
Batista Procedure ◽  
High Level

Aim. To estimate the results of 6-year experience of heart transplantation (HT) in Federal Almazov North-West Medical Research Centre. Methods. From 2010 to 2015 we have performed 65 HT. Mean age was 44.3 ± 14 years old (from 10 to 64 years old). We used biventricular assist device (BIVAD, Berlin Heart Excor) support in 7 heart transplant candidates before HT. 19 patients (29%) received thymoglobulin, whereas 46 patients (71%) had basiliximab to induce immunosuppression.Results.Extracorporeal membrane oxygenation machines were implanted in 5 patients (7.7%) after HT due to acute right ventricular failure. Suture annuloplasty (the Batista procedure) for tricuspid valve repair was carried out in 3 cases (4.6%). Venovenous hemodiafi ltration was used in 11 patients (16.9%). A total of 598 endomyocardial biopsies (EMB) were performed after HT. Evidence of cellular rejection (R1 and R2) was presented in 286 biopsies (48%). The 30-day in-hospital mortality rate was 3.1%. The 6-month survival rate after HT was 92%, 1-year – 91% and overall survival for the 6-year period of observation – 89.2%. Maximum observation period was 71 months.Conclusions.The 6-year experience of HT in our Center has shown a high level of survival. BIVAD Excor support can be effectively used as a «bridge» to HT. Prevention of graft loss due to acute rejection in heart transplant recipients can be achieved only through regular EMB monitoring. The rate of viral infection increased in 2 months after HT.

scholarly journals INTERNATIONAL EXPERIENCE OF THEORETICAL AND PRACTICAL ASPECTS OF GROUP LAWSUITS

2020 ◽  
Vol 6 (42) ◽  
pp. 85
Author(s):  
T. Oldak
Keyword(s):  
International Experience ◽  
Class Action ◽  
Procedural Law ◽  
Class Actions ◽  
Opt Out ◽  
Civil Proceedings ◽  
Legitimate Interests ◽  
Scope Of Application ◽  
General Scientific ◽  
Large Groups

The article is devoted to the study of international experience of theoretical and practical aspects of proceedings in class actions. This study will present various models of regulation in this area of the Anglo-Saxon and mixed legal families. By analyzing this legal basis, the practice of application will be possible to establish the essence of the class action in civil proceedings by disclosing the main features that are inherent in it and are such that distinguish it from other procedural structures aimed at protecting violated rights and legitimate interests as effective judicial mechanism.The subject of the study is issues related to one of the jurisdictional ways to protect the rights and legitimate interests of large groups of people. The purpose of this work is to publish the results of the study, which was conducted as part of a dissertation study on "Group lawsuit in civil proceedings in Ukraine." During the study, a general scientific dialectical method of use was used, which allowed to comprehensively study the main provisions of class action in foreign procedural law and the possibility of its development in the legislation of Ukraine, and provided an opportunity to reveal the nature of class actions in civil proceedings. stages. The scope of application of the results of the development of the theoretical basis in the field of mechanisms for the protection of the rights and legitimate interests of large groups of persons in order to introduce the appropriate procedure in the civil procedure legislation of Ukraine.Key words: civil proceedings, group lawsuit, initiating plaintiff, numerous groups, litigation proceedings, model "opt-in", "opt-out".

scholarly journals MRtrix3: A fast, flexible and open software framework for medical image processing and visualisation

2019 ◽  
Author(s):  
J-Donald Tournier ◽  
Robert Smith ◽  
David Raffelt ◽  
Rami Tabbara ◽  
Thijs Dhollander ◽  
...  
Keyword(s):  
Image Processing ◽  
Medical Image ◽  
Medical Image Processing ◽  
Image Data ◽  
Data Access ◽  
General Purpose ◽  
Computational Performance ◽  
Cross Platform ◽  
High Level ◽  
New Applications

AbstractMRtrix3 is an open-source, cross-platform software package for medical image processing, analysis and visualization, with a particular emphasis on the investigation of the brain using diffusion MRI. It is implemented using a fast, modular and flexible general-purpose code framework for image data access and manipulation, enabling efficient development of new applications, whilst retaining high computational performance and a consistent command-line interface between applications. In this article, we provide a high-level overview of the features of the MRtrix3 framework and general-purpose image processing applications provided with the software.

Mediating the Tension between Information Privacy and Information Access

2003 ◽  
pp. 94-119 ◽  
Author(s):  
George T. Duncan ◽  
Stephen F. Roehrig
Keyword(s):  
Public Interest ◽  
Information Access ◽  
Data Access ◽  
International Standards ◽  
Individual Autonomy ◽  
Disclosure Limitation ◽  
What Works ◽  
Conflicting Demands ◽  
Technological Developments ◽  
Administrative Procedures

Government agencies collect and disseminate data that bear on the most important issues of public interest. Advances in information technology, particularly the Internet, have multiplied the tension between demands for evermore comprehensive databases and demands for the shelter of privacy. In mediating between these two conflicting demands, agencies must address a host of difficult problems. These include providing access to information while protecting confidentiality, coping with health information databases, and ensuring consistency with international standards. The policies of agencies are determined by what is right for them to do, what works for them, and what they are required to do by law. They must interpret and respect the ethical imperatives of democratic accountability, constitutional empowerment, and individual autonomy. They must keep pace with technological developments by developing effective measures for making information available to a broad range of users. They must both abide by the mandates of legislation and participate in the process of developing new legislation that is responsive to changes that affect their domain. In managing confidentiality and data access functions, agencies have two basic tools: techniques for disclosure limitation through restricted data and administrative procedures through restricted access. The technical procedures for disclosure limitation involve a range of mathematical and statistical tools. The administrative procedures can be implemented through a variety of institutional mechanisms, ranging from privacy advocates, through internal privacy review boards, to a data and access protection commission.

Part 1 General and Special Reports, 5 UNCITRAL: UNCITRAL Perspectives on the Hague Principles

2021 ◽  
Author(s):  
Castellani Luca ◽  
Emery Cyril
Keyword(s):  
United Nations ◽  
Party Autonomy ◽  
Freedom Of Contract ◽  
Trade Law ◽  
International Trade Law ◽  
Opt Out ◽  
Uniform Model ◽  
The Hague ◽  
The United Nations ◽  
High Level

This chapter evaluates the relationship between the United Nations Commission on International Trade Law (UNCITRAL) and the Hague Principles. The UNCITRAL texts, starting with the early drafts of the United Nations Convention on Contracts for the International Sale of Goods (CISG), have provided solid ground in support of freedom of contract. In providing a uniform model applicable to multiple jurisdictions, the CISG ensures a high level of safeguard of parties’ wills. In particular, the CISG promotes the well-established principle of party autonomy by virtue of its Article 6, which allows parties to the contract to opt out entirely of its provisions and hence to choose another law more appropriate to their needs. Given UNCITRAL’s desire to further facilitate use of the CISG by traders and in light of its focus on freedom of contract and party autonomy, it is not surprising that the UNCITRAL Secretariat took a particular interest in the development by the Hague Conference on Private International Law of the Principles on Choice of Law in International Commercial Contracts (2015) and the related Commentary. The chapter then looks at UNCITRAL’s endorsement of the Hague Principles.

The ‘opt-out’ approach to deceased organ donation in England: A misconceived policy which may precipitate moral harm

2019 ◽  
Vol 14 (2) ◽  
pp. 63-69
Author(s):  
Tobias K Cantrell
Keyword(s):  
Organ Donation ◽  
Public Awareness ◽  
Recent Attempt ◽  
Individual Autonomy ◽  
Presumed Consent ◽  
Opt Out ◽  
The Family ◽  
Deceased Organ Donation ◽  
Tissue Act ◽  
Human Tissue Act

In an effort to solve the shortage of transplantable organs, there have been several proposals to introduce an opt-out approach to deceased organ donation in England (also termed ‘deemed’, or ‘presumed’ consent). In seeking to enact the so-called ‘opt-out proposal’ via an amendment to the Human Tissue Act 2004, The Organ Donation (Deemed Consent) Bill 2017–19 represents the most recent attempt at such legal reform. Despite popular calls to the contrary, I argue in this paper that it would be premature for England, or, indeed, any country, to adopt an opt-out approach at this time. Not only is the available evidence inconclusive on whether introduction of the opt-out proposal would increase the supply of transplantable organs (a common misconception), but there is also a chance that doing so might bring about an otherwise avoidable moral harm through an unjustified interference with individual autonomy. I maintain that the resources required to change the law to such effect would be better expended on alternative, provenly efficacious and less contentious mechanisms for increasing the supply of transplantable organs, such as: improving communication with the family of the deceased, developing infrastructure, raising public awareness and enhancing staff training, attitudes and understanding towards organ donation.

scholarly journals Patient perspectives on research use of residual biospecimens and health information: On the necessity of obtaining societal consent by creating a governance structure based on value-sharing

2020 ◽  
pp. 174701612091433
Author(s):  
Mayumi Yamanaka ◽  
Mika Suzuki ◽  
Keiko Sato
Keyword(s):  
Health Information ◽  
Research Study ◽  
Governance Structure ◽  
Research Community ◽  
Patient Perspectives ◽  
University Hospital ◽  
Research Use ◽  
The Public ◽  
Value Sharing ◽  
Opt Out

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated to inform them about the research use of their items and be subject to self-directed rules (including sanctions). The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust.

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