scholarly journals Toward a Risk-Utility Data Governance Framework for Research Using Genomic and Phenotypic Data in Safe Havens: Multifaceted Review

10.2196/16346 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16346
Author(s):  
Kerina Jones ◽  
Helen Daniels ◽  
Sharon Heys ◽  
Arron Lacey ◽  
David V Ford

Background Research using genomic data opens up new insights into health and disease. Being able to use the data in association with health and administrative record data held in safe havens can multiply the benefits. However, there is much discussion about the use of genomic data with perceptions of particular challenges in doing so safely and effectively. Objective This study aimed to work toward a risk-utility data governance framework for research using genomic and phenotypic data in an anonymized form for research in safe havens. Methods We carried out a multifaceted review drawing upon data governance arrangements in published research, case studies of organizations working with genomic and phenotypic data, public views and expectations, and example studies using genomic and phenotypic data in combination. The findings were contextualized against a backdrop of legislative and regulatory requirements and used to create recommendations. Results We proposed recommendations toward a risk-utility model with a flexible suite of controls to safeguard privacy and retain data utility for research. These were presented as overarching principles aligned to the core elements in the data sharing framework produced by the Global Alliance for Genomics and Health and as practical control measures distilled from published literature and case studies of operational safe havens to be applied as required at a project-specific level. Conclusions The recommendations presented can be used to contribute toward a proportionate data governance framework to promote the safe, socially acceptable use of genomic and phenotypic data in safe havens. They do not purport to eradicate risk but propose case-by-case assessment with transparency and accountability. If the risks are adequately understood and mitigated, there should be no reason that linked genomic and phenotypic data should not be used in an anonymized form for research in safe havens.

2019 ◽  
Author(s):  
Kerina Jones ◽  
Helen Daniels ◽  
Sharon Heys ◽  
Arron Lacey ◽  
David V Ford

BACKGROUND Research using genomic data opens up new insights into health and disease. Being able to use the data in association with health and administrative record data held in safe havens can multiply the benefits. However, there is much discussion about the use of genomic data with perceptions of particular challenges in doing so safely and effectively. OBJECTIVE This study aimed to work toward a risk-utility data governance framework for research using genomic and phenotypic data in an anonymized form for research in safe havens. METHODS We carried out a multifaceted review drawing upon data governance arrangements in published research, case studies of organizations working with genomic and phenotypic data, public views and expectations, and example studies using genomic and phenotypic data in combination. The findings were contextualized against a backdrop of legislative and regulatory requirements and used to create recommendations. RESULTS We proposed recommendations toward a risk-utility model with a flexible suite of controls to safeguard privacy and retain data utility for research. These were presented as overarching principles aligned to the core elements in the data sharing framework produced by the Global Alliance for Genomics and Health and as practical control measures distilled from published literature and case studies of operational safe havens to be applied as required at a project-specific level. CONCLUSIONS The recommendations presented can be used to contribute toward a proportionate data governance framework to promote the safe, socially acceptable use of genomic and phenotypic data in safe havens. They do not purport to eradicate risk but propose case-by-case assessment with transparency and accountability. If the risks are adequately understood and mitigated, there should be no reason that linked genomic and phenotypic data should not be used in an anonymized form for research in safe havens.


BMC Genomics ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiujin Li ◽  
Hailiang Song ◽  
Zhe Zhang ◽  
Yunmao Huang ◽  
Qin Zhang ◽  
...  

Abstract Background With the emphasis on analysing genotype-by-environment interactions within the framework of genomic selection and genome-wide association analysis, there is an increasing demand for reliable tools that can be used to simulate large-scale genomic data in order to assess related approaches. Results We proposed a theory to simulate large-scale genomic data on genotype-by-environment interactions and added this new function to our developed tool GPOPSIM. Additionally, a simulated threshold trait with large-scale genomic data was also added. The validation of the simulated data indicated that GPOSPIM2.0 is an efficient tool for mimicking the phenotypic data of quantitative traits, threshold traits, and genetically correlated traits with large-scale genomic data while taking genotype-by-environment interactions into account. Conclusions This tool is useful for assessing genotype-by-environment interactions and threshold traits methods.


2013 ◽  
Vol 76 (3) ◽  
pp. 376-385 ◽  
Author(s):  
YUHUAN CHEN ◽  
SHERRI B. DENNIS ◽  
EMMA HARTNETT ◽  
GREG PAOLI ◽  
RÉGIS POUILLOT ◽  
...  

Stakeholders in the system of food safety, in particular federal agencies, need evidence-based, transparent, and rigorous approaches to estimate and compare the risk of foodborne illness from microbial and chemical hazards and the public health impact of interventions. FDA-iRISK (referred to here as iRISK), a Web-based quantitative risk assessment system, was developed to meet this need. The modeling tool enables users to assess, compare, and rank the risks posed by multiple food-hazard pairs at all stages of the food supply system, from primary production, through manufacturing and processing, to retail distribution and, ultimately, to the consumer. Using standard data entry templates, built-in mathematical functions, and Monte Carlo simulation techniques, iRISK integrates data and assumptions from seven components: the food, the hazard, the population of consumers, process models describing the introduction and fate of the hazard up to the point of consumption, consumption patterns, dose-response curves, and health effects. Beyond risk ranking, iRISK enables users to estimate and compare the impact of interventions and control measures on public health risk. iRISK provides estimates of the impact of proposed interventions in various ways, including changes in the mean risk of illness and burden of disease metrics, such as losses in disability-adjusted life years. Case studies for Listeria monocytogenes and Salmonella were developed to demonstrate the application of iRISK for the estimation of risks and the impact of interventions for microbial hazards. iRISK was made available to the public at http://irisk.foodrisk.org in October 2012.


Author(s):  
Robert F. Mills ◽  
Gilbert L. Peterson ◽  
Michael R. Grimaila

The purpose of this chapter is to introduce the insider threat and discuss methods for preventing, detecting, and responding to the threat. Trusted insiders present one of the most significant risks to an organization. They possess elevated privileges when compared to external users, have knowledge about technical and non-technical control measures, and potentially can bypass security measures designed to prevent, detect, or react to unauthorized access. In this chapter, we define the insider threat and summarize various case studies of insider attacks in order to highlight the severity of the problem. We then discuss best practices for preventing, detecting, and mitigating insider attacks, to include application of risk management principles specific to the insider threat. Finally, we provide a survey of ongoing research into detecting irregular activities that are potentially harmful to an organization.


2020 ◽  
pp. 35-67
Author(s):  
Kristin Weber ◽  
Christiana Klingenberg

Author(s):  
Mohamad J. Cheaitani

The use of an engineering critical assessment (ECA) approach to derive flaw acceptance criteria for pipe girth welds has become common practice. It allows the maximum tolerable size of weld flaws to be determined on a fitness-for-purpose basis, offering substantial advantages over the conventional workmanship approach. BS 7910:2005 is widely used to derive ECA-based flaw acceptance criteria for pipe girth welds. It offers a flexible assessment framework within the context of the well-established failure assessment diagram (FAD) approach. However, it can be relatively complex to apply and it may lead to assessments that are more conservative than codified pipeline-specific procedures. This paper illustrates, through practical case studies on assessing the significance of circumferential girth weld flaws, some of the options available to the user of BS 7910. The case studies cover the selection of the FAD (generalised or material-specific, with and without yield discontinuity), tensile properties (specified minimum or actual values); fracture toughness properties (single point CTOD values including δ0.2BL and δm, or full CTOD resistance R-curve), and welding residual stress (assumed to be uniform through the pipe wall with a yield strength magnitude, or considered to have a through-wall distribution associated with a specific level of welding heat input).


2011 ◽  
Vol 51 (4) ◽  
pp. 384 ◽  
Author(s):  
G. Nugent ◽  
W. J. McShea ◽  
J. Parkes ◽  
S. Woodley ◽  
J. Waithaka ◽  
...  

A workshop was convened in Chile in August 2010 as part of the 7th International Deer Biology Congress (IDBC). Its aim was to explore global differences in the policies and management of overabundant deer in protected areas. The main goal of the workshop was to provide South American researchers and managers with a snapshot of some of the approaches to management of deer overabundance used in a diverse array of case studies from North America, Europe, Australia and New Zealand. Various case studies were presented to illustrate the different methodological approaches in implementing deer control measures. Some general recommendations were formulated.


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