Challenges of web-based personal genomic data sharing

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 (Portable Legal Consent), 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

Governance of collection, use and storage of RWD in the view of data protection concerns

Collection, storage and sharing RWD raise concerns regarding the privacy, data protection and governance of access. To date, the concerns related to consent and adequate safeguards for data protection in conventional research and health care settings are being discussed in details in the literature. However, collection of RWD from individuals fuels questions regarding the applicability of the regulations for human subjects’ research and personal data protection. Description of the problem : The data collected in the framework of RWD need to be protected in line with the overarching principles of human subjects research and personal data protection regulations such as the EU General Data Protection Regulations (GDPR). In particular, the purposes of data collection, potential further uses, duration of storage of data and the authorized users’ access to data should be managed in compliance with applicable data protection regulations. In addition, the adequate models for de-identifications of data should be used in compliance with the applicable data protection regulations. Ethical oversight on the process of data collection, storage and use should also be scrutinized. Effects/changes In order to respect the privacy rights of the patients, it is essential to first identify the potential risks and assess the adequacy of the existing safeguards in protecting the privacy of the patients. Lessons : The effectiveness of the current access governance in the context of RWD should be assessed and the required safeguards to be proposed. </jats:sec

Collection and sharing of genomic and health data for research purposes : going beyond data collection in traditional research settings

In the recent years collection of health and genomic data for biomedical research purposes has been expanded beyond traditional research settings. In doing so, various online tools and platforms are being utilized to collect data from various sources including Electronic Health Records, mHealth applications, disease registries and patient generated databases. While there is relatively higher certainty regarding the legal grounds for processing health and genomic data in the traditional research setting, the questions remain about the applicable legal framework when collecting data from other sources. In addition, given the diverse nature of collected data, adhering to traditional care-research distinction to determine the applicable legal requirements is confronted with complexities. This is particularly the case when data collected in the care setting are being later used for research purposes. In this article, we discuss the challenges associated with governance of processing data collected outside research settings and underline the steps should be taken to ensure conformity of such data processing by the applicable data protection regulations

Is there a right time to know? The right not to know and genetic testing in children

The increasing implementation of next-generation sequencing technologies in the clinical context and the expanding commercial offer of genetic tests directly-toconsumers has increased the availability of previously inaccessible genetic information. A particular concern in both situations is how the volume of novel information will affect the processing of genetic and genomic information from minors. For minors, it is argued that in the provision of genetic testing, their "right not to know" should be respected as much as possible. Testing a minor early in life eliminates the possibility for the minor to make use of his or her "right not to know." The article discusses the theoretical underpinnings of the right not know, analyzes reasons why various direct-to-consumer companies process samples from minors, and discusses the right not to know in relation to common complex disorders in a pediatric population

Characterization of Mechanically Recycled Polylactic Acid (PLA) Filament for 3D-Printing by Evaluating Mechanical, Thermal, And Chemical Properties and Process Performance

Polylactic acid (PLA) is a biopolymer made from renewable resources such as sugar and corn. PLA filament is a popular material used in Fused Deposition Modeling (FDM) 3D-printing. While this material has many advantages, all the failed parts, support structures, rafts, nozzle tests, and the many prototype iterations during the 3D-printing process contribute to the plastic pollution and release of greenhouse gases. Although PLA is biodegradable, it can take years to degrade in landfills. Instead of throwing away PLA waste and buying new filaments, PLA can be recycled. Amongst the different recycling technologies, mechanical recycling is the most environmentally friendly. In this project, PLA filaments were mechanically recycled. One of the goals in this study was to identify the barriers to recycling and to introduce a more detailed recycling process. To achieve this goal, three different recycling extruders were tested to find the most user-friendly, which was the Noztek Pro Desktop extruder. Moreover, a new and more detailed material preparation process was introduced. In this method, PLA was first shredded. Then liquid nitrogen was added to make the material more brittle and easier to crush, and finally, it was ground. Additionally, the most effective process parameters for extrusion were presented. These parameters included temperature of 200 ºC, a pulley speed of 1.5 m/min, and using fans to cool the extruded filament before winding. The next goal was to evaluate the process with the added details and find the impacts of successive mechanical recycling on the properties of PLA. Therefore, a comprehensive testing was done including thermal (TGA and DSC), chemical (FTIR), and mechanical tests (tensile). Filaments could be recycled for three generations however after the third recycling, the filament no longer printed reliably. The test results demonstrated degradation of PLA. The UTS decreased from 44.7 MPa to 40.5 MPa, strain at break decreased from 10.4% to 7.5%, and the modulus, E, decreased from 1.603 GPa to 1.055 GPa. The FTIR results suggested that all samples had the same chemical structure of PLA. However, decreased intensity peaks around 920/cm show a decrease in crystallinity. In addition, a decrease in the absorbance band in the carbonyl region around 1750/cm, an intensity change from 700/cm to 2000/cm regions, and an intensity decrease around the 1180/cm-1240/cm were also observed. The DSC analysis showed that the Tg values were between 61.97 ℃ and 62.95 ℃, the cold crystallization temperatures had a range from 117.87 ºC to 128.81 ºC, and the melting temperatures ranged from 158.48 ºC to 161.28 ºC. Moreover, The TGA results showed that the decomposition temperatures were between 311.33 and 337.5 ºC. The recycling process was initially successful, however, after the third generation the filament became unprintable. This was due to decrease in crystallinity and molecular weight which caused brittleness, lower strength, and nozzle clogging. This research provided important design data regarding performance and limitations of recycled PLA

From the principles of genomic data sharing to the practices of data access committees

Sharing genomic research data through controlled-access databases has increased in recent years. Policymakers and funding organizations endorse genomic data sharing in order to optimize the use of public funds and to increase the statistical power of databases. Well-established data access arrangements and data access committees (DACs)responsible for reviewing and managing requests for access to genomic databasesare therefore central for implementing the policies and principles of data sharing. This article aims to investigate the functionality of DACs through the perspective of existing practices

Controlled access under review : improving the governance of genomic data access

In parallel with massive genomic data production, data sharing practices have rapidly expanded over the last decade. To ensure authorized access to data, access review by data access committees (DACs) has been utilized as one potential solution. Here we discuss core elements to be integrated into the fabric of access review by both established and emerging DACs in order to foster fair, efficient, and responsible access to datasets. We particularly highlight the fact that the access review process could be adversely influenced by the potential conflicts of interest of data producers, particularly when they are directly involved in DACs management. Therefore, in structuring DACs and access procedures, possible data withholding by data producers should receive thorough attention

Reporting, recording, and communication of COVID-19 cases in workplace : data protection as a moving target

In response to concerns related to privacy in the context of coronavirus disease 2019 (COVID-19), recently European and national Data Protection Authorities (DPAs) issued guidelines and recommendations addressing a variety of issues related to the processing of personal data for preventive purposes. One of the recurring questions in these guidelines is related to the rights and responsibilities of employers and employees in reporting, recording, and communicating COVID-19 cases in workplace. National DPAs in some cases adopted different approaches regarding duties in reporting and communicating the COVID-19 cases; however, they unanimously stressed the importance of adopting privacy-preserving approaches to avoid raising concerns about surveillance and stigmatization. We stress that in view of the increasing use of new data collection and sharing tools such as ‘tracing and warning’ apps, the associated privacy-related risks should be evaluated on an ongoing manner. In addition, the intricacies of different settings where such apps may be used should be taken into consideration when assessing the associated risks and benefits

Data Access Governance

Enabling researchers’ access to large volumes of health data collected in both research and healthcare settings can accelerate improvements in clinical practice and public health. Because the source and subject of those data are people, data access governance has been of concern to scientists, ethics and regulatory scholars, policy-makers and citizens worldwide. This chapter examines the topic of data access governance. We discuss the underlying values and goals of data access governance, focusing in particular on the scientific and social implications for open access and data sharing, on the rights and interests of data subjects as well as those of data producers, and on the ethical conduct of data sharing. We then present existing data access arrangements of organisations and repositories that exemplify varying modes of good practice. We argue these models exemplify the tension between promoting open access to databases on the one hand, and, on the other, protecting the rights and interests of the parties involved, including data subjects, researchers, funding organizations and commercial entities. We suggest that principles of transparency, fairness and proportionality in consideration of all stakeholders’ interests and values is key to achieving this balance