New genomic techniques, old divides: Stakeholder attitudes towards new biotechnology regulation in the EU and UK
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SUBMITTER: Menary J
PROVIDER: S-EPMC10917245 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches.MethodAn online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe.ResultsA total of 764 organisations were invited to the survey during the period March-June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments.ConclusionMental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored.FundingThe E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 603098.
| S-EPMC6096292 | biostudies-literature
Project description:ObjectivesTo analyse demographic, social and geographic predictors of incompliant attitudes towards prescription completion in the UK.MethodsTwo waves of the Eurobarometer survey (85.1 and 90.1) were analysed, with a final sample size of 2016. Using logistic regression, the best-fitting combination of a set of identified variables was specified. The regression output and the model-averaged importance of each variable were analysed.ResultsCompared with a median prevalence region, respondents in the Nomenclature of Territorial Units for Statistics (NUTS) 1 London (OR = 2.358, 95% CI = 1.100-5.398) and Scotland (OR = 2.418, 95% CI = 1.083-5.693) regions were most likely to report an incompliant attitude. Respondents who correctly answered questions about whether unnecessary use of antibiotics could make them ineffective in future (OR = 0.353, 95% CI = 0.230-0.544), whether antibiotics kill viruses (OR = 0.644, 95% CI = 0.450-0.919) and whether antibiotics treat colds (OR = 0.412, 95% CI = 0.287-0.591) were less likely to report incompliant attitudes. Conversely, respondents who correctly responded that antibiotics can cause side effects (OR = 1.419, 95% CI = 1.014-1.999) were more likely to report incompliant attitudes. There was some evidence of associations between political orientation and level of compliance. Uncooperative survey respondents (OR = 2.001, 95% CI = 1.108-3.526) were more likely to report incompliant attitudes.ConclusionsIncompliant attitudes towards antibiotic prescription compliance in the UK are associated with a variety of factors, including regional geographic variation in attitudes. Knowledge about antibiotics can relate to good stewardship attitudes, but concerns over side effects are associated with poor attitudes. Further research should examine the underlying attitudes and beliefs that political orientation may be a marker for in the context of antibiotic stewardship. Survey samples reliant on self-selection are likely to be biased towards good stewardship.
| S-EPMC7021095 | biostudies-literature
Project description:Recently, the European Commission (EC) published a regulatory proposal on plants generated with new genomic techniques (NGTs) (5 July 2023). According to this proposal, NGT plant applications are categorized into category 1 NGT (NGT1) and category 2 NGT (NGT2) based on their molecular characteristics, which diverges from the current legislation centered around Directive 2001/18/EC. To demonstrate where the path of the proposal leads to in practice, we applied the proposed criteria for categorization to a list of NGT plant applications currently in the commercialization pipeline. Combining literature research and a descriptive statistical approach, we can show that 94% of the plant applications affected by the EC proposal, would be classified as NGT1 and thus would receive market approval without risk assessment, monitoring, and sufficient labeling provisions. The remaining 6% of applications would be classified as NGT2 plants, for which, in deviation from the current regulation, an adapted risk assessment is proposed. Screening of the intended traits in the pipeline highlights that certain NGT1 plants can pose similar environmental risks (e.g., invasiveness) to other genetically modified organisms (GMOs), as defined in Directive 2001/18/EC. For example, NGT1 applications based on RNA interference technology can exhibit insecticidal effects with potential side effects on non-target organisms (i.e., other insects). Our quantitative and case-specific elaboration of how the current EC regulatory proposal would affect the environment, health, and consumer protection will be informative for decision-makers and politicians.
| S-EPMC10973156 | biostudies-literature
Project description:Small Wind Turbines (SWTs) are a growing micro-generation industry with over 870,000 installed units worldwide. No research has focussed on public attitudes towards SWTs, despite evidence the perception of such attitudes are key to planning outcomes and can be a barrier to installations. Here we present the results of a UK wide mail survey investigating public attitudes towards SWTs. Just over half of our respondents, who were predominantly older, white males, felt that SWTs were acceptable across a range of settings, with those on road signs being most accepted and least accepted in hedgerows and gardens. Concern about climate change positively influenced how respondents felt about SWTs. Respondent comments highlight visual impacts and perceptions of the efficiency of this technology are particularly important to this sector of the UK public. Taking this into careful consideration, alongside avoiding locating SWTs in contentious settings such as hedgerows and gardens where possible, may help to minimise public opposition to proposed installations.
| S-EPMC4806928 | biostudies-literature
Project description:This study aimed to describe the acceptability and perceived barriers and enablers to establish a national registry targeting carriers of pathogenic variants in cancer susceptibility genes from stakeholders' perspectives. Such a registry may effectively target carriers to translate existing research findings into optimised clinical care and provide a population-level resource for further clinical research and new gene and therapy discovery. In-depth interviews were conducted with individuals from four stakeholder groups: carriers of pathogenic variants, healthcare professionals, data custodians from the field of familial cancer, and heads of molecular pathology laboratories. Interview data were subjected to a qualitative analysis guided by a thematic analysis framework using NVivo software. A total of 28 individuals were interviewed: 11 carriers, 8 healthcare professionals, 5 laboratory heads, and 4 data custodians. All carriers and healthcare professionals were enthusiastic about the potential research applications of the registry. Carriers described that altruistic motivations provided the foundation of their support of the planned registry. Some carriers felt comfortable with a broad consent (consenting once, prospectively), while others preferred a narrow consent approach (consenting each time data is accessed). Some carriers and data custodians and registry developers also expressed a reluctance to link family member data without appropriate consent. Participants' enthusiasm and support for a national registry herald a productive and responsive research partnership once the registry has been established. Participants' views can be used to inform the approaches to be taken to develop and manage such a registry as an implicit codesign approach.
| S-EPMC8799807 | biostudies-literature
Project description:Surgical castration of piglets without pain relief is still common practice in many countries. Possible alternatives for surgical castration are application of pain relief or anaesthesia or production of boars (entire males) and immunocastrates. Each of these alternatives faces advantages and disadvantages which may result in different citizen attitudes and consumers acceptability. Understanding which practice is acceptable to whom and why may further stimulate implementation. Consumer (n = 3251) and stakeholder (n = 1027) attitudes towards surgical castration without pain relief, surgical castration with anaesthesia, immunocastration, and production of boars were surveyed from April to June 2020 via an online questionnaire in 16 countries (>175 respondents per country). Surgical castration without pain relief was separated from each of the alternatives due to animal welfare and showed the lowest acceptability (32%). Within the alternatives, a further partitioning between the alternatives was based on perceived quality and food safety, with an acceptance of 85% for applying anaesthesia, 71% for immunocastration, and 49% for boar production. Differences depending on professional involvement and familiarity with agriculture could be observed, mainly for the acceptance of surgical castration without anaesthesia, immunocastration, and boars. Castration with anaesthesia was highly accepted by all types of respondents.
| S-EPMC7600221 | biostudies-literature
Project description:The development of new genetic modification techniques (nGMs), also referred to as "new (breeding) techniques" in other sources, has raised worldwide discussions regarding their regulation. Different existing regulatory frameworks for genetically modified organisms (GMO) cover nGMs to varying degrees. Coverage of nGMs depends mostly on the regulatory trigger. In general two different trigger systems can be distinguished, taking into account either the process applied during development or the characteristics of the resulting product. A key question is whether regulatory frameworks either based on process- or product-oriented triggers are more advantageous for the regulation of nGM applications. We analyzed regulatory frameworks for GMO from different countries covering both trigger systems with a focus on their applicability to plants developed by various nGMs. The study is based on a literature analysis and qualitative interviews with regulatory experts and risk assessors of GMO in the respective countries. The applied principles of risk assessment are very similar in all investigated countries independent of the applied trigger for regulation. Even though the regulatory trigger is either process- or product-oriented, both triggers systems show features of the respective other in practice. In addition our analysis shows that both trigger systems have a number of generic advantages and disadvantages, but neither system can be regarded as superior at a general level. More decisive for the regulation of organisms or products, especially nGM applications, are the variable criteria and exceptions used to implement the triggers in the different regulatory frameworks. There are discussions and consultations in some countries about whether changes in legislation are necessary to establish a desired level of regulation of nGMs. We identified five strategies for countries that desire to regulate nGM applications for biosafety-ranging from applying existing biosafety frameworks without further amendments to establishing new stand-alone legislation. Due to varying degrees of nGM regulation, international harmonization will supposedly not be achieved in the near future. In the context of international trade, transparency of the regulatory status of individual nGM products is a crucial issue. We therefore propose to introduce an international public registry listing all biotechnology products commercially used in agriculture.
| S-EPMC6389621 | biostudies-literature
Project description:Objectives(1) To explore existing knowledge of, and attitudes, to group B meningococcal disease and serogroup B meningococcal (MenB) vaccine among parents of young children. (2) To seek views on their information needs.DesignCross-sectional qualitative study using individual and group interviews conducted in February and March 2015, prior to the introduction of MenB vaccine (Bexsero) into the UK childhood immunisation schedule.SettingCommunity centres, mother and toddler groups, parents' homes and workplaces in London and Yorkshire.Participants60 parents of children under 2 years of age recruited via mother and baby groups and via an advert posted to a midwife-led Facebook group.ResultsAlthough recognising the severity of meningitis and septicaemia, parents' knowledge of group B meningococcal disease and MenB vaccine was poor. While nervous about fever, most said they would take their child for MenB vaccination despite its link to fever. Most parents had liquid paracetamol at home. Many were willing to administer it after MenB vaccination as a preventive measure, although some had concerns. There were mixed views on the acceptability of four vaccinations at the 12-month booster visit; some preferred one visit, while others favoured spreading the vaccines over two visits. Parents were clear on the information they required before attending the immunisation appointment.ConclusionsThe successful implementation of the MenB vaccination programme depends on its acceptance by parents. In view of parents' recognition of the severity of meningitis and septicaemia, and successful introduction of other vaccines to prevent bacterial meningitis and septicaemia, the MenB vaccination programme is likely to be successful. However, the need for additional injections, the likelihood of post-immunisation fever and its management are issues about which parents will need information and reassurance from healthcare professionals. Public Health England has developed written information for parents, informed by these findings.
| S-EPMC5623433 | biostudies-literature
Project description:The adoption of genome editing depends among others, on a clear and navigable regulatory framework that renders consistent decisions. Some countries like the United States decided to deregulate specific transgene-free genome edited products that could be created through traditional breeding and are not considered to be plant pests, while others are still challenged to fit emerging technologies in their regulatory system. Here we poll international experts in plant biotechnology on what approach should nations agree upon to accommodate current and future new breeding technologies and derived products. A key finding is product-based models or dual-product/process systems are viewed as potential appropriate frameworks to regulate outcomes of genome editing. As regulation of novel products of biotechnology is expected to impact research and trade, we test the impact of experts' worldviews on these issues. Results show that region influences worldviews of trade but not of agricultural innovation. In contrast, there was no effect of experts' worldviews on how products of novel biotechnologies should be regulated.
| S-EPMC7322807 | biostudies-literature
Project description:IntroductionNewborn bloodspot screening (NBS) involves testing a small sample of blood taken from the heel of the newborn for a number of serious and life-limiting conditions. In Canada, newborn screening programmes fall under provincial and territorial jurisdiction with no federal coordination. To date, we know very little about the underlying beliefs around different consent practices or how terminology is interpreted by different individuals. Differences in attitudes may have important healthcare consequences. This study will provide empirical data comparing stakeholder opinions on their understanding of consent-related terminology, the perceived applicability of different consent approaches to newborn screening, and the requirements of these different approaches.Methods and analysisParents, healthcare professionals and policymakers will be recruited in the provinces of Ontario and Newfoundland and Labrador. Parents will be identified through records held by each provincial screening programme. Healthcare professionals will be purposively sampled on the basis of engagement with newborn screening. Within each province we will identify policymakers who have policy analysis or advisory responsibilities relating to NBS. Data collection will be by qualitative interviews. We will conduct 20 interviews with parents of young children, 10 interviews with key healthcare professionals across the range of appropriate specialties and 10 with policymakers at each site (40 per site, total, N=80). The examination of the transcripts will follow a thematic analysis approach. Recruitment started in June 2014 and is expected to be complete by June 2015.Ethics and disseminationThis study received ethics approval from the Ottawa Health Science Network Research Ethics Board, the Children's Hospital of Eastern Ontario Research Ethics Board (both Ontario), and the Health Research Ethics Authority (Newfoundland and Labrador).ResultsThese will be reported in peer-reviewed publications and conference presentations. The results will have specific application to the development of parent education materials for newborn screening.
| S-EPMC4244491 | biostudies-literature