scholarly journals Authority and the Future of Consent in Population-Level Biomedical Research

2019 ◽  
Author(s):  
Mark Sheehan ◽  
Rachel Thompson ◽  
Jon Fistein ◽  
Jim Davies ◽  
Michael Dunn ◽  
...  
Keyword(s):  
Biomedical Research ◽  
Large Scale ◽  
Population Level ◽  
Research Governance ◽  
Choice Making ◽  
Research Activities ◽  
Dynamic Consent ◽  
Governance Process ◽  
Technical Solutions ◽  
Meta Consent

Abstract Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.

scholarly journals Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public’s perspective

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Annabelle Cumyn ◽  
Adrien Barton ◽  
Roxanne Dault ◽  
Nissrine Safa ◽  
Anne-Marie Cloutier ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Large Scale ◽  
Health Data ◽  
Promising Alternative ◽  
New Approach ◽  
Secondary Use ◽  
Awareness Campaigns ◽  
Learning Health System ◽  
Research Activities ◽  
Meta Consent

Abstract Background The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. Methods Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. Results Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions. Conclusions This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

scholarly journals Public involvement in the governance of population-level biomedical research: unresolved questions and future directions

2020 ◽  
pp. medethics-2020-106530
Author(s):  
Sonja Erikainen ◽  
Phoebe Friesen ◽  
Leah Rand ◽  
Karin Jongsma ◽  
Michael Dunn ◽  
...  
Keyword(s):  
Biomedical Research ◽  
Public Involvement ◽  
Ethical Issues ◽  
Population Level ◽  
Research Governance ◽  
Collective Models ◽  
Stakeholder Interests ◽  
Starting Point ◽  
Governance Challenges ◽  
The Individual

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

scholarly journals Meta-Consent for the Secondary Use of Health Data Within A Learning Health System: A Qualitative Study of the Public’s Perspective.

2021 ◽  
Author(s):  
Annabelle Cumyn ◽  
Adrien Barton ◽  
Roxanne Dault ◽  
Nissrine Safa ◽  
Anne-Marie Cloutier ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Large Scale ◽  
Health Data ◽  
Promising Alternative ◽  
New Approach ◽  
Secondary Use ◽  
Awareness Campaigns ◽  
Learning Health System ◽  
Research Activities ◽  
Meta Consent

Abstract Background: The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. Methods: Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. Results: Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.Conclusions: This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

Technical solutions envisaged in managing solids in combined sewer networks

1996 ◽  
Vol 33 (9) ◽  
pp. 237-244 ◽  
Author(s):  
Ghassan Chebbo ◽  
Dominique Laplace ◽  
André Bachoc ◽  
Yves Sanchez ◽  
Benoit Le Guennec
Keyword(s):  
Large Scale ◽  
Suspended Solids ◽  
Drainage Area ◽  
Bed Load ◽  
Urban Drainage ◽  
Combined Sewer ◽  
Wet Weather ◽  
Technical Solutions ◽  
Dry Weather Flow ◽  
Sewer Networks

Solids in combined sewer networks represent two important technical questions: - the clogging of man-entry sewers, and - pollution in urban wet weather discharges, whose main vectors are generally suspended solids. In this paper, we shall present first, curative technical solutions which avoid or remove deposits in man-entry sewers. We shall discuss the partial extraction of the largest solids; selective trapping of bed load solids, which form deposits; and the displacement of deposits using dry weather flow flushing waves. We shall then examine technical solutions to control pollution in urban wet weather discharges. This will show that decantation is an efficient means of fighting pollution. However, it is not always feasible because it involves large scale investments. Complementary methods should, therefore, be developed and used at different points in the water's passage through an urban drainage area.

EBS Behaviour Immediately After Repository Closure in a Clay Host Rock: The HE-E Experiment (Mont Terri URL)

2011 ◽  
Author(s):  
Irina Gaus ◽  
Klaus Wieczorek ◽  
Juan Carlos Mayor ◽  
Thomas Trick ◽  
Jose´-Luis Garcia` Sin˜eriz ◽  
...  
Keyword(s):  
Thermal Conductivity ◽  
Host Rock ◽  
Large Scale ◽  
Process Models ◽  
Research Activities ◽  
Hydraulic Behaviour ◽  
Validation Experiment ◽  
Engineered Barrier ◽  
Mont Terri

The evolution of the engineered barrier system (EBS) of geological repositories for radioactive waste has been the subject of many research programmes during the last decade. The emphasis of the research activities was on the elaboration of a detailed understanding of the complex thermo-hydro-mechanical-chemical processes, which are expected to evolve in the early post closure period in the near field. It is important to understand the coupled THM-C processes and their evolution occurring in the EBS during the early post-closure phase so it can be confirmed that the safety functions will be fulfilled. Especially, it needs to be ensured that interactions during the resaturation phase (heat pulse, gas generation, non-uniform water uptake from the host rock) do not affect the performance of the EBS in terms of its safety-relevant parameters (e.g. swelling pressure, hydraulic conductivity, diffusivity). The 7th Framework PEBS project (Long Term Performance of Engineered Barrier Systems) aims at providing in depth process understanding for constraining the conceptual and parametric uncertainties in the context of long-term safety assessment. As part of the PEBS project a series of laboratory and URL experiments are envisaged to describe the EBS behaviour after repository closure when resaturation is taking place. In this paper the very early post-closure period is targeted when the EBS is subjected to high temperatures and unsaturated conditions with a low but increasing moisture content. So far the detailed thermo-hydraulic behaviour of a bentonite EBS in a clay host rock has not been evaluated at a large scale in response to temperatures of up to 140°C at the canister surface, produced by HLW (and spent fuel), as anticipated in some of the designs considered. Furthermore, earlier THM experiments have shown that upscaling of thermal conductivity and its dependency on water content and/or humidity from the laboratory scale to a field scale needs further attention. This early post-closure thermal behaviour will be elucidated by the HE-E experiment, a 1:2 scale heating experiment setup at the Mont Terri rock laboratory, that started in June 2011. It will characterise in detail the thermal conductivity at a large scale in both pure bentonite as well as a bentonite-sand mixture, and in the Opalinus Clay host rock. The HE-E experiment is especially designed as a model validation experiment at the large scale and a modelling programme was launched in parallel to the different experimental steps. Scoping calculations were run to help the experimental design and prediction exercises taking the final design into account are foreseen. Calibration and prediction/validation will follow making use of the obtained THM dataset. This benchmarking of THM process models and codes should enhance confidence in the predictive capability of the recently developed numerical tools. It is the ultimate aim to be able to extrapolate the key parameters that might influence the fulfilment of the safety functions defined for the long term steady state.

scholarly journals ‘CTRL’: an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research

2021 ◽  
Author(s):  
Matilda A. Haas ◽  
Harriet Teare ◽  
Megan Prictor ◽  
Gabi Ceregra ◽  
Miranda E. Vidgen ◽  
...  
Keyword(s):  
Large Scale ◽  
Genomic Medicine ◽  
International Standards ◽  
Security And Privacy ◽  
Genomic Research ◽  
Return Of Results ◽  
Future Research ◽  
Design And Development ◽  
Participant Engagement ◽  
Dynamic Consent

AbstractThe complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.

scholarly journals 214 Longitudinal Changes in Sleep Duration, Timing, Variability, and Stages during the COVID-19 Pandemic: Large-Scale Fitbit Data

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A86-A86
Author(s):  
Michael Grandner ◽  
Naghmeh Rezaei
Keyword(s):  
New York ◽  
Los Angeles ◽  
San Francisco ◽  
Sleep Duration ◽  
Large Scale ◽  
Age Groups ◽  
Population Level ◽  
Sleep Stages ◽  
Longitudinal Changes ◽  
Timing Variability

Abstract Introduction The COVID-19 pandemic has resulted in societal-level changes to sleep and other behavioral patterns. Objective, longitudinal data would allow for a greater understanding of sleep-related changes at the population level. Methods N= 163,524 deidentified active Fitbit users from 6 major US cities contributed data, representing areas particularly hard-hit by the pandemic (Chicago, Houston, Los Angeles, New York, San Francisco, and Miami). Sleep variables extracted include nightly and weekly mean sleep duration and bedtime, variability (standard deviation) of sleep duration and bedtime, and estimated arousals and sleep stages. Deviation from similar timeframes in 2019 were examined. All analyses were performed in Python. Results These data detail how sleep duration and timing changed longitudinally, stratified by age group and gender, relative to previous years’ data. Overall, 2020 represented a significant departure for all age groups and both men and women (P<0.00001). Mean sleep duration increased in nearly all groups (P<0.00001) by 5-11 minutes, compared to a mean decrease of 5-8 minutes seen over the same period in 2019. Categorically, sleep duration increased for some and decreased for others, but more extended than restricted. Sleep phase shifted later for nearly all groups (p<0.00001). Categorically, bedtime was delayed for some and advanced for others, though more delayed than advanced. Duration and bedtime variability decreased, owing largely to decreased weekday-weekend differences. WASO increased, REM% increased, and Deep% decreased. Additional analyses show stratified, longitudinal changes to sleep duration and timing mean and variability distributions by month, as well as effect sizes and correlations to other outcomes. Conclusion The pandemic was associated with increased sleep duration on average, in contrast to 2019 when sleep decreased. The increase was most profound among younger adults, especially women. The youngest adults also experienced the greatest bedtime delay, in line with extensive school-start-times and chronotype data. When given the opportunity, the difference between weekdays and weekends became smaller, with occupational implications. Sleep staging data showed that slightly extending sleep minimally impacted deep sleep but resulted in a proportional increase in REM. Wakefulness during the night also increased, suggesting increased arousal despite greater sleep duration. Support (if any) This research was supported by Fitbit, Inc.

scholarly journals Progress in Research on Carbon Nanotubes Reinforced Cementitious Composites

2015 ◽  
Vol 2015 ◽  
pp. 1-16 ◽  
Author(s):  
Qinghua Li ◽  
Jintao Liu ◽  
Shilang Xu
Keyword(s):  
Carbon Nanotubes ◽  
Large Scale ◽  
High Strength ◽  
Cementitious Composites ◽  
Scale Production ◽  
Multiwalled Carbon ◽  
Factors Affecting ◽  
Environment And Health ◽  
Research Activities ◽  
Major Factors

As one-dimensional (1D) nanofiber, carbon nanotubes (CNTs) have been widely used to improve the performance of nanocomposites due to their high strength, small dimensions, and remarkable physical properties. Progress in the field of CNTs presents a potential opportunity to enhance cementitious composites at the nanoscale. In this review, current research activities and key advances on multiwalled carbon nanotubes (MWCNTs) reinforced cementitious composites are summarized, including the effect of MWCNTs on modulus of elasticity, porosity, fracture, and mechanical and microstructure properties of cement-based composites. The issues about the improvement mechanisms, MWCNTs dispersion methods, and the major factors affecting the mechanical properties of composites are discussed. In addition, large-scale production methods of MWCNTs and the effects of CNTs on environment and health are also summarized.

scholarly journals Findings from the Section on Bioinformatics and Translational Informatics

2017 ◽  
Vol 26 (01) ◽  
pp. 188-192 ◽  
Author(s):  
H. Dauchel ◽  
T. Lecroq
Keyword(s):  
Intelligent Systems ◽  
Large Scale ◽  
Cancer Genomics ◽  
Clinical Care ◽  
Evaluation Process ◽  
Omics Data ◽  
Health Domain ◽  
Medical Genomics ◽  
Research Activities ◽  
Translational Informatics

Summary Objective: To summarize excellent current research and propose a selection of best papers published in 2016 in the field of Bioinformatics and Translational Informatics with applications in the health domain and clinical care. Methods: We provide a synopsis of the articles selected for the IMIA Yearbook 2017, from which we attempt to derive a synthetic overview of current and future activities in the field. As in 2016, a first step of selection was performed by querying MEDLINE with a list of MeSH descriptors completed by a list of terms adapted to the section coverage. Each section editor evaluated separately the set of 951 articles returned and evaluation results were merged for retaining 15 candidate best papers for peer-review. Results: The selection and evaluation process of papers published in the Bioinformatics and Translational Informatics field yielded four excellent articles focusing this year on the secondary use and massive integration of multi-omics data for cancer genomics and non-cancer complex diseases. Papers present methods to study the functional impact of genetic variations, either at the level of the transcription or at the levels of pathway and network. Conclusions: Current research activities in Bioinformatics and Translational Informatics with applications in the health domain continue to explore new algorithms and statistical models to manage, integrate, and interpret large-scale genomic datasets. As addressed by some of the selected papers, future trends would include the question of the international collaborative sharing of clinical and omics data, and the implementation of intelligent systems to enhance routine medical genomics.

Environmental Development Strategies for an Industrial Area (Kochi Industrial Belt)

2021 ◽  
Vol 6 (2) ◽  
Author(s):  
Annu Reetha Thomas
Keyword(s):  
Natural Environment ◽  
Industrial Pollution ◽  
Large Scale ◽  
Human Life ◽  
Industrial Area ◽  
Health Issues ◽  
Economic Progress ◽  
Planning Approach ◽  
Negative Impacts ◽  
Technical Solutions

Discharging of wastes and toxic pollutants produced by the industrial activities into the natural environment which consist of air, water and land implies the term Industrial Pollution. It has serious consequences on human life and its health along with several ways of negative impacts on the environment and nature. As far as our nation is concerned most of the major cities are filled with these large-scale industries which place a crucial role financial development of a country. Strictly hindering the development of industries cannot be done as it is vital for the Socio-Economic progress of a country. Yet it is our duty to protect our natural environment by limiting the pollution due to industries. This Study consist of the issues occurred in Eloor- Kadungalloor region as result of the industrial pollution followed by policies for a development plan to enhance the natural and environmental conditions with a planning approach at micro study level. As far as the Kerala context is considered, the major spot which is mostly affected by the industrial pollution is the ‘Edayar Industrial belt’ which is the largest industrial belt in Kerala. This became one of most noted spot because of the continuous dumping of dangerous chemical pollutants from adjacent industries (pesticide and fertilizer manufacturing). It has also resulted in health issues for the inhabitants of the site. Though many complaints have been filed against the companies, there has no proper laws or schemes for taking measures for reduction of pollution have come up so far. Hence this paper deals with the application of technical solutions and strategies for an Environment Improvement plan development for an industrial as well as studying on the issues of sire and its inhabitants.

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