Legal and ethical framework for global health information and biospecimen exchange - an international perspective.

BACKGROUND: The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. MAIN TEXT: Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. CONCLUSION: With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.

Escherichia coli testing and enumeration in live bivalve shellfish - Present methods and future directions.

A wide variety of pathogenic agents such as bacteria, viruses and parasites can be greatly concentrated in filter feeding bivalve molluscan shellfish (BMS), that are grown in faecally contaminated waters. Human health risks associated with the consumption of BMS are also compounded by the traditional pattern of consuming them raw or lightly cooked. Because of these well-established food safety risks, food legislation such as that in Europe stipulates that BMS production areas are monitored for faecal contamination and classified accordingly. In this review we provide information regarding the background and use of methods for determining and quantifying Escherichia coli (E. coli) in shellfish matrices, focussing on the Most Probable Number (MPN) based approach. This review also discusses other techniques for determining E. coli in food matrices, as well as specific tests across a range of other food microbiology applications. This information draws on several sources: published peer-reviewed reports, data derived from proficiency testing/ring trials, depuration and challenge studies, as well as specific examples from BMS classification and long-term monitoring studies. We also provide a discussion on possible avenues for future direction regarding testing methods in this food microbiology sector.

Fate of Human Noroviruses in Shellfish and Water Impacted by Frequent Sewage Pollution Events.

Knowledge of the fate of human noroviruses (NoV) in the marine environment is key to better controlling shellfish-related NoV gastroenteritis. We quantified NoV and Escherichia coli in sewage from storm tank discharges and treated effluent processed by a UV-disinfection plant following activated sludge treatment and studied the fate of these microorganisms in an oyster harvesting area impacted by frequent stormwater discharges and infrequent freshwater discharges. Oyster monitoring sites were positioned at intervals downstream from the wastewater treatment works (WwTW) outfall impacting the harvesting area. The decay rates of NoV in oysters as a function of the distance from the outfall were less rapid than those for E. coli that had concentrations of NoV of the same order of magnitude and were over 7 km away from the outfall. Levels of E. coli in oysters from more tidally influenced areas of the estuary were higher around high water than around low water, whereas tidal flows had no influence on NoV contamination in the oysters. The study provides comparative data on the contamination profiles and loadings of NoV and E. coli in a commercial oyster fishery impacted by a WwTW.

How COVID-19 changed clinical research strategies: a global survey.

OBJECTIVE: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics. METHODS: We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies. RESULTS: All 19 participating academic research institutions developed and followed similar strategies, including preventive measures, manpower recruitment, and prioritisation of COVID-19 projects. In contrast, measures for centralised management or coordination of COVID-19 projects, project preselection, and funding were handled differently amongst institutions. Regulatory bodies responded similarly to the pandemic by implementing fast-track authorisation procedures for COVID-19 projects and developing guidance documents. Quality and consistency of the information and advice provided was rated differently amongst institutions. CONCLUSION: Both academic research institutions and regulatory bodies worldwide were able to cope with challenges during the COVID-19 pandemic by developing similar strategies. We identified some unique approaches to ensure fast and efficient responses to a pandemic. Ethical concerns should be addressed in any new decision-making process.

Environmental occurrence and clinical impact of Vibrio vulnificus and Vibrio parahaemolyticus: a European perspective.

Vibrio vulnificus and Vibrio parahaemolyticus are ubiquitous Gram-negative bacterial pathogens found naturally in marine and estuarine waters, and are a leading cause of seafood-associated bacterial illness. These pathogens are commonly reported in the USA and in many Asian countries, including China, Japan and Taiwan; however, there is growing concern that V. vulnificus and V. parahaemolyticus may represent an important and increasing clinical problem in Europe. Several factors underlie the need for a greater understanding of these non-cholera vibrios within a European context. First, there is a growing body of evidence to suggest that V. vulnificus and V. parahaemolyticus infections are increasing, and tend to follow regional climatic trends, with outbreaks typically following episodes of unusually warm weather. Such findings are especially alarming given current predictions regarding warming of marine waters as a result of global climatic change. Second, a myriad of epidemiological factors may greatly increase the incidence as well as clinical burden of these pathogens - including increasing global consumption and trade of seafood produce coupled to an increase in the number of susceptible individuals consuming seafood produce. Finally, there is currently a lack of detailed surveillance information regarding non-cholerae Vibrio infections in Europe, as these pathogens are not notifiable in many countries, which probably masks the true clinical burden of many human infections. This review will present a pertinent overview of both the environmental occurrence and clinical impact of V. vulnificus and V. parahaemolyticus in Europe.