Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT

Using renewable energy to meet the energy needs of smallholder farmers: Are there policies to promote adoption in Ghana?

Integrating renewable energy (RE) technologies into agriculture can contribute to attaining sustainable production. Farmers’ adoption of RE in agriculture can lead to substantial reductions in Greenhouse gases (GHG) emissions as well as providing alternative income sources for farmers, and reliable energy supplies for farms and households. Policies can facilitate, support, or encourage farmers’ adoption of RE. However, it is not clear what policies currently exist which facilitate or promote the adoption of RE technologies in Ghanaian agriculture. This paper aims to identify policies in Ghana that can facilitate the adoption of RE in agricultural production. A policy review was conducted to identify such policies, evaluate their potential impact on RE adoption, and suggest paths to enhance RE adoption by farmers. These policies are focused on two aspects: 1) promoting solar energy and 2) the conversion of agricultural waste to energy. Noting limitations including the underdevelopment of the RE sector and the lack of a central policy to promote RE utilization in Ghanaian agriculture, the review suggests that policymakers need to fully implement provisions of the Renewable Energy Act-(832) (2011) through the application of, for example, policy levers such as subsidies, tax exemptions, financing, and training potential end-users in the agricultural community

SYNTHETIC BIOLOGY APPLIED IN THE AGRIFOOD SECTOR: SOCIETAL PRIORITIES AND PITFALLS

Synthetic biology offers potential for innovation in the agrifood sector, although concerns have been raised consumer rejection of applications will occur similar to that associated with the introduction of genetically modified foods. Risk-benefit assessment should address socio-economic, as well as health and environmental impacts. Ethical issues may be of particular relevance to the application synthetic biology, and may also resonate with societal concerns. A case-by-case analysis of relevant issues may be needed, and innovation must be driven by societal and consumer preferences as well as technological possibilities. Research into consumer and societal priorities is required early in the innovation trajector

Percepção do consumidor frente aos riscos associados aos alimentos, sua segurança e rastreabilidade.

An increase in consumer interest in food safety has been observed in the last few decades. Governments have been pressed to adopt measures that assure the safety of foods and, as a consequence, legislation related to the contamination of food by physical, chemical and microbiological contaminants is being implemented. Within this context it is relevant to investigate the perception of Brazilian consumers on such issues. The present work evaluated the criteria used by consumers from Rio de Janeiro and Campinas to buy foods, and their vision of the risks of food contamination. The perception of consumers on traceability and its importance in contributing to the safety of foods was also evaluated using the Focus Group methodology. Three sessions were carried out (two in Campinas and the third in Rio de Janeiro). Differences were found between the consumers from the two cities. The Campinas consumers were more concerned and interested in the matter than those from Rio de Janeiro, since they reported looking for more information on the food labels. Mention was made of the risks of food poisoning, botulism, and pesticides by respondents in both cities. The main products considered as showing health risks were meats and seafood, the latter particularly in Rio. Products considered safe by consumers included fruits (without pesticides), vegetables and dried products. All the consumer groups were concerned about food contamination by pesticides and heavy metals. In relation to microbiological contamination, the three groups highlighted the risks of bacteria, especially Salmonella. Traceability was considered relevant by the three groups, since it should contribute to a more efficient product recall if necessary. However, from the consumer perspective, it will also lead to a price increase, although increasing consumer confidence in the safety of the foods. Many of the consumer concerns reflected information published in magazines and newspapers, such as the use of hormones in chicken. Industries and retailers should communicate scientific information about safety topics, thus contributing to consumer education.Nas últimas décadas, tem-se observado um crescente interesse dos consumidores pelas questões relacionadas à segurança dos alimentos. Os governos têm sido pressionados a adotar medidas que assegurem a inocuidade dos alimentos e, consequentemente, legislações rigorosas quanto à contaminação dos alimentos por agentes físicos, químicos e microbiológicos estão sendo implantadas. Dentro desse panorama, conhecer a percepção do consumidor brasileiro sobre o tema é extremamente relevante. No presente estudo, avaliaram-se, em duas grandes cidades brasileiras (Campinas-SP e Rio de Janeiro-RJ), os critérios utilizados por consumidores para a compra de produtos alimentícios e suas visões sobre os riscos potenciais de contaminação dos alimentos. Avaliou-se também a percepção dos consumidores sobre a rastreabilidade e seu papel na melhoria da segurança dos alimentos, utilizando-se a metodologia focus group. Três sessões de discussão foram conduzidas (duas em Campinas e uma no Rio de Janeiro), tendo sido observadas diferenças entre os consumidores das distintas praças. Os consumidores de Campinas mostraram-se mais preocupados e interessados no assunto do que os do Rio de Janeiro, pois relataram buscar mais informações nos rótulos de alimentos. Menções relacionadas a riscos, como intoxicação alimentar, botulismo e agrotóxicos foram comuns para os entrevistados das duas cidades e, entre os principais produtos considerados com risco à saúde, ficaram as carnes e os frutos do mar, sendo estes últimos com maior ênfase no Rio de Janeiro. Dentre os produtos reconhecidos como seguros, destacaram-se as frutas (produzidas sem agrotóxicos), os legumes e os produtos secos/desidratados. Em todos os grupos, observou-se grande preocupação com a contaminação por agrotóxicos e metais pesados. Em termos microbiológicos, ambas as praças destacaram os riscos com bactérias, especialmente a Salmonella. O tema rastreabilidade se mostrou relevante nos três grupos, pois esta deve contribuir para o recolhimento mais eficiente de produtos, caso seja necessário. No entanto, sob a ótica do consumidor, a rastreabilidade leva ao aumento dos preços, embora aumente a confiança em relação à segurança dos alimentos. Muitas das preocupações dos consumidores refletem as informações publicadas em revistas e jornais, como o caso da crença de que hormônios são utilizados na cadeia da carne de frango. Indústria e varejistas devem incrementar a comunicação de informações científicas sobre a segurança dos alimentos, contribuindo, assim, na educação do consumidor

Critical review of methods for risk ranking of food related hazards, based on risks for human health.

This study aimed to critically review methods for ranking risks related to food safety and dietary hazards on the basis of their anticipated human health impacts. A literature review was performed to identify and characterize methods for risk ranking from the fields of food, environmental science and socio-economic sciences. The review used a predefined search protocol, and covered the bibliographic databases Scopus, CAB Abstracts, Web of Sciences, and PubMed over the period 1993-2013. All references deemed relevant, on the basis of of predefined evaluation criteria, were included in the review, and the risk ranking method characterized. The methods were then clustered - based on their characteristics - into eleven method categories. These categories included: risk assessment, comparative risk assessment, risk ratio method, scoring method, cost of illness, health adjusted life years, multi-criteria decision analysis, risk matrix, flow charts/decision trees, stated preference techniques and expert synthesis. Method categories were described by their characteristics, weaknesses and strengths, data resources, and fields of applications. It was concluded there is no single best method for risk ranking. The method to be used should be selected on the basis of risk manager/assessor requirements, data availability, and the characteristics of the method. Recommendations for future use and application are provided

The views of key stakeholders on an evolving food risk governance framework: Results from a Delphi study

Evidence of a decline in public trust associated with food risk governance over recent years has called into question the appropriateness of the current dominant risk analysis framework. Within the EU-funded SAFE FOODS project a novel risk analysis framework has been developed that attempts to address potential shortcomings by increasing stakeholder (including consumer) input, improving transparency, and formally incorporating benefit and non-health aspects into the analysis. To assess the viability of this novel framework, the views of food risk experts from the EU and beyond were sought using a distributed online questionnaire process called Delphi. In this paper the main results of this survey are described, revealing varying levels of support for the key innovations of the novel framework. Implications of our results for the new and old frameworks, for the future of risk analysis, and for the policy community more widely, are discussed

Online training courses on Expert Knowledge Elicitation (EKE)

This report summarises the training courses delivered under the contract OC/EFSA/AMU/2021/02 EKE: “Develop and conduct online training courses on Expert Knowledge Elicitation (EKE)”. The objective of the courses was to develop and conduct online training courses on applying the methodology described in the EFSA Guidance on Expert Knowledge Elicitation in Food and Feed Safety Risk Assessment” for EFSA staff and experts, as well as corresponding experts from EU member states. In addition to the three standard EKE methods (Sheffield, Delphi and Cooke), the training included a semi-formal method of EKE. All these methods may be used when EKE is performed within an existing EFSA working group to support uncertainty analysis as outlined in “The principles and methods behind EFSA\u27s Guidance on Uncertainty Analysis in Scientific Assessment”. In total, 12 courses were organised: two on “Steering an Expert Knowledge Elicitation”, two on “Conduct of the Sheffield protocol for an EKE”, one on “Conduct of the Cooke protocol for an EKE”, one on “Conduct of the Delphi protocol for an EKE”, two on “Conduct of a Semi-formal EKE”, two on “Reporting an Expert Knowledge Elicitation” and two on “Writing an Evidence Dossier for an Expert Knowledge Elicitation”. The courses had in total 149 participants and received very good feedback from the participants with a mean value of 4.2 of 5 possible, considering all numerical questions in the feedback questionnaire. Recommendations for future activities on training EKE methodologies are provided

Capturing health and eating status through a nutritional perception screening questionnaire (NPSQ9) in a randomised internet-based personalised nutrition intervention : the Food4Me study

BACKGROUND: National guidelines emphasize healthy eating to promote wellbeing and prevention of non-communicable diseases. The perceived healthiness of food is determined by many factors affecting food intake. A positive perception of healthy eating has been shown to be associated with greater diet quality. Internet-based methodologies allow contact with large populations. Our present study aims to design and evaluate a short nutritional perception questionnaire, to be used as a screening tool for assessing nutritional status, and to predict an optimal level of personalisation in nutritional advice delivered via the Internet. METHODS: Data from all participants who were screened and then enrolled into the Food4Me proof-of-principle study (n = 2369) were used to determine the optimal items for inclusion in a novel screening tool, the Nutritional Perception Screening Questionnaire-9 (NPSQ9). Exploratory and confirmatory factor analyses were performed on anthropometric and biochemical data and on dietary indices acquired from participants who had completed the Food4Me dietary intervention (n = 1153). Baseline and intervention data were analysed using linear regression and linear mixed regression, respectively. RESULTS: A final model with 9 NPSQ items was validated against the dietary intervention data. NPSQ9 scores were inversely associated with BMI (β = -0.181, p < 0.001) and waist circumference (Β = -0.155, p < 0.001), and positively associated with total carotenoids (β = 0.198, p < 0.001), omega-3 fatty acid index (β = 0.155, p < 0.001), Healthy Eating Index (HEI) (β = 0.299, p < 0.001) and Mediterranean Diet Score (MDS) (β = 0. 279, p < 0.001). Findings from the longitudinal intervention study showed a greater reduction in BMI and improved dietary indices among participants with lower NPSQ9 scores. CONCLUSIONS: Healthy eating perceptions and dietary habits captured by the NPSQ9 score, based on nine questionnaire items, were associated with reduced body weight and improved diet quality. Likewise, participants with a lower score achieved greater health improvements than those with higher scores, in response to personalised advice, suggesting that NPSQ9 may be used for early evaluation of nutritional status and to tailor nutritional advice. TRIAL REGISTRATION: NCT01530139 .Peer reviewedFinal Published versio

Making personalised nutrition the easy choice: creating policies to break down the barriers and reap the benefits

Personalised diets based on people\u27s existing food choices,and/or phenotypic, and/or genetic information hold potential to improve public dietary-related health. The aim of this analysis, therefore, has been to examine the degree to which factors which determine uptake of personalised nutrition vary between EU countries to better target of policies to encourage uptake, and optimise the health benefits of personalised nutrition technology. A questionnaire developed from previous qualitative research was used to survey nationally representative samples from 9 EU countries (N=9381). Perceived barriersto the uptake of personalised nutrition comprised three factors (data protection; the eating context; and societal acceptance). Trust insources of information comprised 4 factors (commerce and media;practitioners; government; family and friends). Benefits comprised single factor. Analysis of Variance (ANOVA) was employed to comparedifferences in responses between the United Kingdom; Ireland; Portugal;Poland; Norway; the Netherlands; Germany; and Spain. The resultsindicated that those in Greece, Poland, Ireland, Portugal and Spain,rated the benefits of personalised nutrition highest, suggesting aparticular readiness in these countries to adopt personalised nutritioninterventions. Greek participants were more likely to perceive the socialcontext of eating as a barrier to adoption of personalised nutrition,implying a need for support in negotiating social situations whilst on aprescribed diet. Those in Spain, Germany, Portugal and Poland scoredhighest on perceived barriers related to data protection. Government wasmore trusted than commerce to deliver and provide information onpersonalised nutrition overall. This was particularly the case inIreland, Portugal and Greece, indicating an imperative to build trust,particularly in the ability of commercial service providers to deliverpersonalised dietary regimes effectively in these countries. These findings, obtained from a nationally representative sample of EU citizensimply that a parallel, integrated, public-private delivery system would capture the needs of most potential consumer