Tangible and intangible costs of "protecting human subjects": The impact of the National Research Act of 1974 onuniversity research activities

This article (1) examines the overall structure of regulatory research oversight in the United States; (2) details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3) describes the expansion of oversight regulation from biomedical and behavioral treatment areas to the social sciences. In addition, the paper describes three areas identified by compliance administrators as susceptible to abuse: (1) informed consent, (2) assessment of risks and benefits, and (3) equitable selection of human subjects. There is a discussion of existing tensions in the implementation of oversight policies and procedures. Finally, the paper identifies four issues for future consideration: (1) scope of the mandate regarding protection of human subjects, (2) impact on the nature of research being undertaken, (3) financial burden of compliance and oversight activities, and (4) ethical standards, constraints, and potential

Evaluating the economic impact of smart care platforms : qualitative and quantitative results of a case study

Background: In response to the increasing pressure of the societal challenge because of a graying society, a gulf of new Information and Communication Technology (ICT) supported care services (eCare) can now be noticed. Their common goal is to increase the quality of care while decreasing its costs. Smart Care Platforms (SCPs), installed in the homes of care-dependent people, foster the interoperability of these services and offer a set of eCare services that are complementary on one platform. These eCare services could not only result in more quality care for care receivers, but they also offer opportunities to care providers to optimize their processes. Objective: The objective of the study was to identify and describe the expected added values and impacts of integrating SCPs in current home care delivery processes for all actors. In addition, the potential economic impact of SCP deployment is quantified from the perspective of home care organizations. Methods: Semistructured and informal interviews and focus groups and cocreation workshops with service providers, managers of home care organizations, and formal and informal care providers led to the identification of added values of SCP integration. In a second step, process breakdown analyses of home care provisioning allowed defining the operational impact for home care organization. Impacts on 2 different process steps of providing home care were quantified. After modeling the investment, an economic evaluation compared the business as usual (BAU) scenario versus the integrated SCP scenario. Results: The added value of SCP integration for all actors involved in home care was identified. Most impacts were qualitative such as increase in peace of mind, better quality of care, strengthened involvement in care provisioning, and more transparent care communication. For home care organizations, integrating SCPs could lead to a decrease of 38% of the current annual expenses for two administrative process steps namely, care rescheduling and the billing for care provisioning. Conclusions: Although integrating SCP in home care processes could affect both the quality of life of the care receiver and informal care giver, only scarce and weak evidence was found that supports this assumption. In contrast, there exists evidence that indicates the lack of the impact on quality of life of the care receiver while it increases the cost of care provisioning. However, our cost-benefit quantification model shows that integrating SCPs in home care provisioning could lead to a considerable decrease of costs for care administrative tasks. Because of this cost decreasing impact, we believe that the integration of SCPs will be driven by home care organizations instead of the care receivers themselves

Smart home care platforms: where is the added value?

Due to changes in the demographic situation of most Western European countries, interest in ICT supported care services grows fast. eCare services that foster a better care information exchange, social involvement, lifestyle monitoring services, etc., offered via smart care platforms integrated in the homes of the elderly are believed to be cost-effective and could lead to an increased quality of life of both care receiver and (in)formal care giver. Currently adoption and integration of these smart care platforms is slowed down by several barriers such as an unclear added value, a lack of regulations or a sustainable financial model. In this work the added value of smart home care platforms is identified for the several involved key-actors such as the care receiver, the (in)formal care providers and the care organizations. In a second step several go to market strategies are formulated and are supported by the quantification of the potential impact on current care processes in terms of time and financial resources. Because the gap between the current way of providing home care and providing home care supported by a fully integrated smart care platform seems too big to bridge in one effort, a migration path is provided for stepwise adoption and integration of smart care platforms in the current way of home care provisioning

Quantitative, Spectrally-Resolved Intraoperative Fluorescence Imaging

Intraoperative visual fluorescence imaging (vFI) has emerged as a promising aid to surgical guidance, but does not fully exploit the potential of the fluorescent agents that are currently available. Here, we introduce a quantitative fluorescence imaging (qFI) approach that converts spectrally-resolved data into images of absolute fluorophore concentration pixel-by-pixel across the surgical field of view (FOV). The resulting estimates are linear, accurate, and precise relative to true values, and spectral decomposition of multiple fluorophores is also achieved. Experiments with protoporphyrin IX in a glioma rodent model demonstrate in vivo quantitative and spectrally-resolved fluorescence imaging of infiltrating tumor margins for the first time. Moreover, we present images from human surgery which detect residual tumor not evident with state-of-the-art vFI. The wide-field qFI technique has broad implications for intraoperative surgical guidance because it provides near real-time quantitative assessment of multiple fluorescent biomarkers across the operative field

A systematic review on diagnostic test accuracy of magnetic resonance neurography versus clinical neurosensory assessment for post-traumatic trigeminal neuropathy in patients reporting neurosensory disturbance

Objectives: To perform a systematic review of published studies on diagnostic accuracy of magnetic resonance neurography (MRN) vs clinical neurosensory testing (NST) for post-traumatic trigeminal neuropathy (PTTN) in patients reporting neurosensory disturbances (NSD). Methods: Human studies except case reports, reviews, systematic reviews and meta-analyses were included. PubMed, Embase, Web of Science and Cochrane Library were consulted. Risk of bias assessment was conducted using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Predetermined data extraction parameters were noted and summarized. Results: 8 studies met eligibility criteria of which 7 were retrospective, representing 444 subjects. Most studies were at high risk of bias with low applicability concerns. Populations and objectives were divergent with a large variation in timing (3 days-17 years post injury) and parameters (multiple coil designs, fat suppression techniques, additional contrast agent) of MRI acquisition. T-2 weighted 3 T imaging with short echo times (2.2-100 ms) and fat suppression was applied in seven studies, techniques varied. Determination of sensitivity and specificity could not be performed due to the methodological variation between studies and lacking comparative data between index and reference tests. Based on limited data, PTTN correlated reasonably well between clinical assessment, intraoperative findings and MRN abnormalities (k = 0.57). Increased signal intensity correlated with persistency of neurosensory disturbances in one study. Intra- (ICC 0.914-0.927) and interobserver (k = 0.70-0.891) MRN variability was considered good to excellent. One retrospective study showed substantial impact of MRN on clinical decision making in one-third of patients. Conclusion: Currently, there is insufficient scientific knowledge to support or refute the use of MRN. Based on limited data, MRN seems promising and reliable in detection and grading of PTTN. Methodological issues underline the importance for prospective blinded studies with standardization of signal intensity calculation and rigorous reporting of MRI acquisition parameters

The OCareCloudS project: toward organizing care through trusted cloud services

The increasing elderly population and the shift from acute to chronic illness makes it difficult to care for people in hospitals and rest homes. Moreover, elderly people, if given a choice, want to stay at home as long as possible. In this article, the methodologies to develop a cloud-based semantic system, offering valuable information and knowledge-based services, are presented. The information and services are related to the different personal living hemispheres of the patient, namely the daily care-related needs, the social needs and the daily life assistance. Ontologies are used to facilitate the integration, analysis, aggregation and efficient use of all the available data in the cloud. By using an interdisciplinary research approach, where user researchers, (ontology) engineers, researchers and domain stakeholders are at the forefront, a platform can be developed of great added value for the patients that want to grow old in their own home and for their caregivers

t4 Workshop Report: Integrated Testing Strategies (ITS) for Safety Assessment

Integrated testing strategies (ITS), as opposed to single definitive tests or fixed batteries of tests, are expected to efficiently combine different information sources in a quantifiable fashion to satisfy an information need, in this case for regulatory safety assessments. With increasing awareness of the limitations of each individual tool and the development of highly targeted tests and predictions, the need for combining pieces of evidence increases. The discussions that took place during this workshop, which brought together a group of experts coming from different related areas, illustrate the current state of the art of ITS, as well as promising developments and identifiable challenges. The case of skin sensitization was taken as an example to understand how possible ITS can be constructed, optimized and validated. This will require embracing and developing new concepts such as adverse outcome pathways (AOP), advanced statistical learning algorithms and machine learning, mechanistic validation and “Good ITS Practices”.JRC.I.5-Systems Toxicolog