Search

The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules and their interpretation are strongly influenced by the concept of precaution, which reflects the concern that there is not enough knowledge to assess the impact of genome editing technology on individuals, society and future populations. However, the argument of precaution loses its strength with every new scientific discovery. The expanding knowledge in the field creates the need to replace regulation, which is based on the lack of knowledge (such as precautionary moratoriums) by the regulation that is based on the actual knowledge. The article reaches a conclusion that the EU framework for advanced treatments and medicinal products is in a state where it can, in principle, address the questions associated with the safety and efficacy of germline editing technologies. The EU framework is, however, not suitable to assess the moral and societal impacts of new technology, which should be left for member states.

Nuclear anxiety, which refers to the fear of nuclear war and its consequences, is expected to increase amid the Russian–Ukrainian War of 2022 (RUW-22). This study aimed to evaluate the prevalence of nuclear anxiety and its associated variables among university students in the Czech Republic during the first weeks of RUW-22. A cross-sectional survey-based study was carried out from March–April 2022, utilizing a digital self-administered questionnaire (SAQ) to collect data from the target population. The SAQ consisted of multiple-choice items inquiring about demographic characteristics; generalized anxiety symptoms using generalized anxiety disorder-7 (GAD-7); depressive symptoms using patient health questionnaire-9 (PHQ-9); and attitudes towards civilian uses of nuclear power, and nuclear war-related anxiety. Of the 591 participating students, 67.7% were females, 68.2% were Czech nationals, and 61.8% followed the RUW-22 news at least once daily. The mean GAD-7 score of our participants was 7.86 ± 5.32 (0–21); and their mean PHQ-9 score was 8.66 ± 6.29 (0–27). Regarding the civilian uses of nuclear power, most participants agreed that nuclear power was safe (64.5%), denied being afraid that civilian use of nuclear power might deteriorate their health (79.7%), and thought that public acceptance was important for building new nuclear power plants (56.9%). About 42.1% and 45.5% of the participants reported feeling depressed at the possibility of nuclear war and agreed that the chances that there would be a nuclear war in their lifetime were very high, respectively. When asked about their preparedness measures during the previous four weeks, less than one quarter (23.9%) reported looking for recommendations for protection against nuclear accidents, and less than one-fifth (19.3%) were looking for the nearest bomb shelter. The depression about nuclear war possibility was positively and relatively strongly correlated with the level of “feeling concerned about the RUW-22” (rs = 0.401), and it was moderately correlated with GAD-7 (rs = 0.377) and PHQ-9 (rs = 0.274) scores and weakly correlated with RUW-2-related news-following frequency (rs = 0.196). Within the limitations of the present study, nuclear anxiety was common among Czech university students. Its associated factors may include but are not limited to the female gender; common psychological disorders such as generalized anxiety and depression; RUW-22-related news following-frequency; and the level of “feeling concerned”.

Armed conflicts are public health emergencies that affect human lives at multiple levels. The mental health of adolescents and young adults is at high risk during crisis settings; therefore, this cross-sectional survey-based study aimed to evaluate anxiety and depressive symptoms among university students in the Czech Republic following the Russian-Ukrainian war of 2022 (RUW-22). The study used standardized screening instruments; the Generalized Anxiety Disorder (GAD-7) for anxiety and the Patient Health Questionnaire (PHQ-9) for depression. Of 591 students who participated in this study, 67.7% were females, 68.2% held Czech citizenship, and 63.8% were enrolled in medical or healthcare programs. The participants were highly concerned about the RUW-22 news, with a mean score of 7.17 ± 2.50 (0–10). While 34% and 40.7% of the participants in this study manifested moderate to severe levels of anxiety and depression, respectively, the mental health burden of the RUW-22 was confirmed by the positive correlation between “feeling concerned”, GAD-7 (ρ = 0.454), and PHQ-9 (ρ = 0.326). Female gender, higher frequency of news following, and social media use were associated with higher levels of anxiety and depressive symptoms; thus, proposing them to be risk factors for psychological disorders following the RUW-22.

Young adults had been widely perceived as a low-risk group for COVID-19 severity, therefore, they were deprioritised within the mass vaccination strategies as their prognosis of COVID-19 infection is relatively more favourable than older age groups. On the other hand, vaccination of this demographic group is indispensable to achieve herd immunity. A cross-sectional survey-based study was used to evaluate the side effects of mRNA-based COVID-19 vaccines among university students in the Czech Republic. The validated questionnaire was delivered in a digital form, and it consisted of demographic data, COVID-19 vaccine-related anamnesis, and local, systemic, orofacial, and skin-related side effects’ prevalence, onset, and duration. Out of the 539 included participants, 70.1% were females and 45.8% were &lt, 23 years old. The vast majority (95.2%) reported at least one side effect. The most common side effect was injection site pain (91.8%), followed by fatigue (62.5%), headache (36.4%), and muscle pain (34.9%). The majority of local side effects occurred after both doses (74.4%), while most systemic side effects occurred after the second dose only (56.2%). Most local (94.2%) and systemic (93.3%) side effects resolved within three days after vaccination. Females participants’ adjusted odds ratio (AOR) showed they were 2.566 (CI 95%: 1.103–5.970) times more likely to experience post-vaccination side effects, and the participants who received two doses reported an increased AOR of 1.896 (0.708–5.077) for experiencing side effects. The results of this study imply that mRNA-based COVID-19 vaccines are highly probably safe for young adults, and further studies are required to investigate the role of medical anamnesis, prior COVID-19 infection, and gender in side effects incidence.

Background: young adults represent a critical target for mass-vaccination strategies of COVID-19 that aim to achieve herd immunity. Healthcare students, including dental students, are perceived as the upper echelon of health literacy, therefore, their health-related beliefs, attitudes and behaviors influence their peers and communities. The main aim of this study was to synthesize a data-driven model for the predictors of COVID-19 vaccine willingness among dental students. Methods: a secondary analysis of data extracted from a recently conducted multi-center and multi-national cross-sectional study of dental students’ attitudes towards COVID-19 vaccination in 22 countries was carried out utilizing decision tree and regression analyses. Based on previous literature, a proposed conceptual model was developed and tested through a machine learning approach to elicit factors related to dental students’ willingness to get the COVID-19 vaccine. Results: machine learning analysis suggested five important predictors of COVID-19 vaccination willingness among dental students globally, i.e., the economic level of the country where the student lives and studies, the individual’s trust of the pharmaceutical industry, the individual’s misconception of natural immunity, the individual’s belief of vaccines risk-benefit-ratio, and the individual’s attitudes toward novel vaccines. Conclusions: according to the socio-ecological theory, the country’s economic level was the only contextual predictor, while the rest were individual predictors. Future research is recommended to be designed in a longitudinal fashion to facilitate evaluating the proposed model. The interventions of controlling vaccine hesitancy among the youth population may benefit from improving their views of the risk-benefit ratio of COVID-19 vaccines. Moreover, healthcare students, including dental students, will likely benefit from increasing their awareness of immunization and infectious diseases through curricular amendments.

Background: university students are believed to retain the highest levels of health literacy. They are perceived as the opinion leaders within their communities, therefore, their health-related beliefs and attitudes are deemed important for public health campaigns. This study aimed to investigate the COVID-19 vaccine hesitancy drivers among university students in the Czech Republic. Methods: a cross-sectional study using a self-administered questionnaire was carried out in the weeks before the unrestricted vaccine deployment to Czech adults. The questionnaire had 21 multiple-choice items stratified in 4 categories, demographic characteristics, COVID-19-related anamnesis and influenza vaccine experience, attitudes towards COVID-19 vaccination, and the possible drivers of COVID-19 vaccine hesitancy suggested by the WHO-SAGE. Results: out of the 1351 included students, 66.8% were females, 84.5% were Czech nationals, and 40.6% enrolled in healthcare programs. The overall COVID-19 vaccine acceptance level was 73.3%, 19.3% of participants were vaccine-resistant, and only 7.4% were vaccine-hesitant. Trust in the pharmaceutical industry, trust in healthcare providers, and perceived knowledge sufficiency predicted higher odds of vaccine acceptance. In contrast, media and social media, personal beliefs, immunity misconception, previous COVID-19 infection, and suspicions about novel vaccines and the local availability predicted higher odds of vaccine hesitancy. Conclusions: The findings of this study predict a fair probability to achieve community immunity (herd immunity) among the target population group. The primary prevention strategies in the Czech Republic need to be culturally sensitive and inclusive for foreign nationals. As one-quarter of the participating students are dependent on vaccine safety data, this study findings support the call for independent studies evaluating the side effects of COVID-19 vaccines.

Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (&lt, 55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs’ prevalence and their potential risk factors, a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19–64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1–3 days, and the below 35 years-old group was the least affected age group. The SEs’ frequency was insignificantly higher in females and previously infected participants, the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.

Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines. This study protocol preparation was funded by Masaryk University, grant numbers MUNI/IGA/1543/2020 and MUNI/A/1608/2020. Sí

The article aims to describe the current status quo of codes of conduct applied by research institutions to manage data protection issues in light of the General Data Protection Regulation (GDPR). We assessed whether the current codes of conduct meet the criteria of codes of conduct as defined by Article 40 of the GDPR. We have found that there are very few ‘codes of conduct’ or good practices that would meet the definition set out in Article 40 of the GDPR. We have found that universities and research institutions had neither the incentives nor the resources to create internationally binding codes of conduct and settled for declarative documents or internal guidelines. A good level of compliance with the Data Protection Directive and national laws was adopted even without codes of conduct which would apply beyond a single institution or grant agency. We have identified that the demand and need for binding codes of conduct are increasing, albeit only in specific research fields. The main incentive is international cooperation, the need for the standardization of data protocols, and most likely fear of high sanctions introduced by GDPR.

The research objective of the article is to analyse the rules on authorship and joint authorship of databases, as well as the ownership and joint ownership of database makers’ sui generis rights as provided for in the Directive 96/9/EC on the legal protection of databases DD and its selected national implementations, and to identify the underlying problems and discuss solutions how to overcome them contractually. In order to achieve this objective, an analysis of the black-letter law and case law is provided in the second section of the paper. The DD, however, does not provide much guidance when it comes to defining the author or joint authors and owner or joint owners and leaves a lot of leeway to Member States, as is further analysed in the third section. In the fourth section of the paper, the focus turns to issues of applicable law that determine the authors and rights owners in cases where the protectable subject matter was created/produced jointly by multiple entities from various jurisdictions. In the final fifth section of the paper, the appropriate contractual arrangements of jointly owned rights are presented as a possible solution to the legal uncertainty raised by the current black-letter law.

Background: COVID-19 vaccine side effects have a fundamental role in public confidence in the vaccine and its uptake process. Thus far, the evidence on vaccine safety has exclusively been obtained from the manufacturer-sponsored studies, therefore, this study was designed to provide independent evidence on Pfizer–BioNTech COVID-19 vaccine side effects. Methods: A cross-sectional survey-based study was carried out between January and February 2021 to collect data on the side effects following the COVID-19 vaccine among healthcare workers in the Czech Republic. The study used a validated questionnaire with twenty-eight multiple-choice items covering the participants’ demographic data, medical anamneses, COVID-19-related anamneses, general, oral, and skin-related side effects. Results: Injection site pain (89.8%), fatigue (62.2%), headache (45.6%), muscle pain (37.1%), and chills (33.9%) were the most commonly reported side effects. All the general side effects were more prevalent among the ≤43-year-old group, and their duration was mainly one day (45.1%) or three days (35.8%) following the vaccine. Antihistamines were the most common drugs associated with side effects, thus requiring further investigation. The people with two doses were generally associated with a higher frequency of side effects. Conclusions: The distribution of side effects among Czech healthcare workers was highly consistent with the manufacturer’s data, especially in terms of their association with the younger age group and the second dose. The overall prevalence of some local and systemic side effects was higher than the manufacturer’s report. Further independent studies on vaccine safety are strongly required to strengthen public confidence in the vaccine.

Obecné nařízení o ochraně osobních údajů klade na vysoké školy a veřejné výzkumné instituce značné nároky po materiální i organizační stránce. Publikace je zaměřena na ochranu soukromí a osobních údajů v oblasti výzkumu. Hlavním účelem této publikace je poskytnout metodickou podporu pro výzkumné organizace, etické komise i jednotlivé výzkumníky. Publikace záměrně nepokrývá ochranu osobních údajů v oblastech vysokých škol, jakými jsou kupříkladu studijní či personální agenda, a to z důvodu snahy o co nejpřehledněji zpracovaný, úzce zaměřený text. Zpracování osobních dat pro vědecké účely je poměrně specifickou problematikou, které se i v rámci GDPR dostává zvláštního zřetele. Publikace identifikuje ustanovení obecného nařízení (GDPR), která jsou relevantní pro oblast výzkumu a podává jejich koncentrovaný výklad ve vztahu k výzkumným činnostem. Díky prvním dvěma kapitolám je publikace přístupná i pro osoby, které doposud nejsou obeznámeny s regulací v oblasti ochrany osobních údajů. Pro čtenáře s pokročilou znalostí je určen zejména výklad následujících kapitol. Snahou autorského je poskytnout metodickou podporu zejména vedoucím výzkumných týmů, při plánování a realizaci výzkumných projektů a navazujících procesech správy výzkumných dat. Tato příručka vznikla v rámci Centrální rozvojového projektu VŠ zaměřujícího se na podporu konzistentní implementace GDPR v prostředí českých veřejných vysokých škol a klade si za cíl poskytnout vodítka pro korektní implementaci GDPR s maximálním využitím výjimek a možností, které jsou pro vědecké účely a akademický projev k dispozici. Text odráží právní stav k 31.12.2018.