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.

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 Citizens, research ethics committee members and researchers’ attitude toward information and consent for the secondary use of health data: Implications for research within learning health systems

2021 ◽  
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Health System ◽  
Research Ethics ◽  
Data Use ◽  
Ethics Committee ◽  
Health Data ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Learning Health System ◽  
Public Perspectives ◽  
Advance Knowledge

A provincial survey was conducted to assess citizens, research ethics committee (REC) members and researchers’ attitude toward information and consent for the secondary use of health data for research within a learning health system (LHS). The results show that: 1) reuse of health data for research to advance knowledge and improve care is values by all parties; 2) consent regarding health data use for research is fundamental particularly to citizens, even when the data are de-identified; 3) a secure website to support the information and consent processes was appreciated by all. Researchers were more comfortable with the use of de-identified health data for research without informing nor seeking consent from people than citizen and REC member respondents. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models in Quebec to take into consideration the unique features of LHS. The revised consent model will need to ensure that citizens are given the opportunity to be better informed about incoming researches with their health data and have their say, when possible, in the use of their data.

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 Citizens, research ethics committee members and researchers’ attitude toward information and consent for the secondary use of health data: Implications for research within learning health systems

2021 ◽  
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Health System ◽  
Research Ethics ◽  
Data Use ◽  
Ethics Committee ◽  
Health Data ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Learning Health System ◽  
Public Perspectives ◽  
Advance Knowledge

A provincial survey was conducted to assess citizens, research ethics committee (REC) members and researchers’ attitude toward information and consent for the secondary use of health data for research within a learning health system (LHS). The results show that: 1) reuse of health data for research to advance knowledge and improve care is values by all parties; 2) consent regarding health data use for research is fundamental particularly to citizens, even when the data are de-identified; 3) a secure website to support the information and consent processes was appreciated by all. Researchers were more comfortable with the use of de-identified health data for research without informing nor seeking consent from people than citizen and REC member respondents. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models in Quebec to take into consideration the unique features of LHS. The revised consent model will need to ensure that citizens are given the opportunity to be better informed about incoming researches with their health data and have their say, when possible, in the use of their data.

scholarly journals Meta Consent – A Flexible Solution to the Problem of Secondary Use of Health Data

Bioethics ◽  
2016 ◽  
Vol 30 (9) ◽  
pp. 721-732 ◽  
Author(s):  
Thomas Ploug ◽  
Søren Holm
Keyword(s):  
Health Data ◽  
Secondary Use ◽  
Meta Consent

Scientific-methodological approach to the substantiation of the rational seasonal scenario of using combine harvesters by large-scale agricultural producers

2020 ◽  
pp. 205-217
Author(s):  
V. Skibchyk ◽  
V. Dnes ◽  
R. Kudrynetskyi ◽  
O. Krypuch
Keyword(s):  
Large Scale ◽  
System Analysis ◽  
Methodological Approach ◽  
Production Unit ◽  
Agricultural Producers ◽  
New Approach ◽  
Rational Use ◽  
Road Map ◽  
Analysis And Synthesis ◽  
Combine Harvesters

Аnnotation Purpose. To increase the efficiency of technological processes of grain harvesting by large-scale agricultural producers due to the rational use of combine harvesters available on the farm. Methods. In the course of the research the methods of system analysis and synthesis, induction and deduction, system-factor and system-event approaches, graphic method were used. Results. Characteristic events that occur during the harvesting of grain crops, both within a single production unit and the entire agricultural producer are identified. A method for predicting time intervals of use and downtime of combine harvesters of production units has been developed. The roadmap of substantiation the rational seasonal scenario of the use of grain harvesters of large-scale agricultural producers is developed, which allows estimating the efficiency of each of the scenarios of multivariate placement of grain harvesters on fields taking into account influence of natural production and agrometeorological factors on the efficiency of technological cultures. Conclusions 1. Known scientific and methodological approaches to optimization of machine used in agriculture do not take into account the risks of losses of crops due to late harvesting, as well as seasonal natural and agrometeorological conditions of each production unit of the farmer, which requires a new approach to the rational use of rational seasonal combines of large agricultural producers. 2. The developed new approach to the substantiation of the rational seasonal scenario of the use of combined harvesters of large-scale agricultural producers allows taking into account the costs of harvesting of grain and the cost of the lost crop because of the lateness of harvesting at optimum variants of attraction of additional free combine harvesters. provides more profit. 3. The practical application of the developed road map will allow large-scale agricultural producers to use combine harvesters more efficiently and reduce harvesting costs. Keywords: combine harvesters, use, production divisions, risk, seasonal scenario, large-scale agricultural producers.

Solid Lipid Nanoparticles: A Promising Drug Delivery Technology

2009 ◽  
Vol 2 (2) ◽  
pp. 509-516
Author(s):  
S. Pragati ◽  
S. Kuldeep ◽  
S. Ashok ◽  
M. Satheesh
Keyword(s):  
Drug Delivery ◽  
Solid Lipid Nanoparticles ◽  
Large Scale ◽  
Colloidal Particles ◽  
Scale Up ◽  
Lipid Nanoparticles ◽  
Scale Production ◽  
Research Activity ◽  
New Approach ◽  
Solid Lipid

One of the situations in the treatment of disease is the delivery of efficacious medication of appropriate concentration to the site of action in a controlled and continual manner. Nanoparticle represents an important particulate carrier system, developed accordingly. Nanoparticles are solid colloidal particles ranging in size from 1 to 1000 nm and composed of macromolecular material. Nanoparticles could be polymeric or lipidic (SLNs). Industry estimates suggest that approximately 40% of lipophilic drug candidates fail due to solubility and formulation stability issues, prompting significant research activity in advanced lipophile delivery technologies. Solid lipid nanoparticle technology represents a promising new approach to lipophile drug delivery. Solid lipid nanoparticles (SLNs) are important advancement in this area. The bioacceptable and biodegradable nature of SLNs makes them less toxic as compared to polymeric nanoparticles. Supplemented with small size which prolongs the circulation time in blood, feasible scale up for large scale production and absence of burst effect makes them interesting candidates for study. In this present review this new approach is discussed in terms of their preparation, advantages, characterization and special features.

Modeling Extinction

2003 ◽  
Author(s):  
M. E. J. Newman ◽  
R. G. Palmer
Keyword(s):  
Evolutionary Biology ◽  
Large Scale ◽  
Competitive Exclusion ◽  
Applied Mathematics ◽  
Santa Fe ◽  
New Approach ◽  
Self Organized ◽  
Self Organized Criticality ◽  
Extinction Events ◽  
Mass Extinction Events

Developed after a meeting at the Santa Fe Institute on extinction modeling, this book comments critically on the various modeling approaches. In the last decade or so, scientists have started to examine a new approach to the patterns of evolution and extinction in the fossil record. This approach may be called "statistical paleontology," since it looks at large-scale patterns in the record and attempts to understand and model their average statistical features, rather than their detailed structure. Examples of the patterns these studies examine are the distribution of the sizes of mass extinction events over time, the distribution of species lifetimes, or the apparent increase in the number of species alive over the last half a billion years. In attempting to model these patterns, researchers have drawn on ideas not only from paleontology, but from evolutionary biology, ecology, physics, and applied mathematics, including fitness landscapes, competitive exclusion, interaction matrices, and self-organized criticality. A self-contained review of work in this field.

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 Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

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