I. THE ROLE OF RESEARCH ETHICS COMMITTEES IN OBSERVATIONAL STUDIES: EPIDEMIOLOGICAL REGISTRIES, CASE REPORTS, INTERVIEWS, AND RETROSPECTIVE STUDIES.

It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

Problematic Ethics: Public Opinion Surveys in Medico-legal Disputes.

Public opinion surveys and polls have a long history as tools for the reportage of public sentiment. Born in the "straw polls" of nineteenth century politics, their use expanded in the last century to include a range of commercial and social subjects. In recent decades, these have included issues of medico-legal uncertainty including, in a partial list, abortion, fetal tissue research, and the propriety of medical termination. Because public opinion surveys are assumed to be "scientific," and thus unbiased, there has been little discussion of either their suitability in areas of complex, medico-legal uncertainty or the ethics of their use in these areas. This paper reviews their general history and then their use in the debate over medical termination, often called "medical aid in dying." In this review, two problems are highlighted. First, there is the ambiguous nature of polls and the manner of their construction. Second, there is the manner in which they are deployed as simple and definitive statements in areas of complex medico-legal debate. The result calls for caution in their use by ethicists and a clear duty by both academics and journalists to understand the limits of the medium in areas of medico-legal debate and discussion.

The 1964 Surgeon General's report and Americans' beliefs about smoking.

Half a century ago, on January 11, 1964, the U.S. Surgeon General's office released a landmark report on the health consequences of smoking. That report received massive media attention and triggered a steadily growing number of federal, state, and local restrictions on the advertising, sale, and use of cigarettes. Little is known about the report's impact on American public opinion because all the timely public opinion polls that measured the report's impact were privately commissioned by the tobacco industry and were not made publicly available. A review of these polls shows that the 1964 Surgeon General's report had a large and immediate effect on Americans' beliefs that cigarettes were a cause of lung cancer and of heart disease. However, the report had less impact on public preferences for government action or on smoking rates.

Hospital admissions for acute myocardial infarction before and after implementation of a comprehensive smoke-free policy in Uruguay.

BACKGROUND: Stimulated by the WHO Framework Convention on Tobacco Control, many countries in Latin America adopted comprehensive smoke-free policies. In March 2006, Uruguay became the first Latin American country to adopt 100% smoke-free national legislation, which ended smoking in all indoor public places and workplaces, including restaurants and bars. The objective of this study was to evaluate trends in hospital admissions for cardiovascular disease 2 years before and 2 years after the policy was implemented in Uruguay. METHODS: Reports of hospital admissions for acute myocardial infarction (AMI) (International Classification of Disease-10 I21) from 37 hospitals (79% of all hospital admissions in the country), representing the period 2 years before and 2 years after the adoption of a nationwide smoke-free policy in Uruguay (between 1 March 2004 and 29 February 2008), were reviewed. A time series analysis was undertaken to compare the average monthly number of events of hospital admission for AMI before and after the smoke-free law. RESULTS: A total of 7949 hospital admissions for AMI were identified during the 4-year study period. Two years after the smoke-free policy was enacted, hospital admissions for AMI fell by 22%. The same pattern and roughly the same magnitude of reduction in AMI admissions were observed for patients seen in public and private hospitals, men, women and people aged 40-65 years and older than 65 years. CONCLUSIONS: The national smoke-free policy implemented in Uruguay in 2006 was associated with a significant reduction in hospital admissions for AMI.

Linking mass media campaigns to pictorial warning labels on cigarette packages: a cross-sectional study to evaluate effects among Mexican smokers.

OBJECTIVE: This study assessed the effects of pictorial health warning labels (HWLs) and a linked media campaign in Mexico. METHODS: Cross-sectional data were collected from a population-based sample of 1756 adult smokers, aged 18-55 years, during the initial implementation of pictorial HWLs, which some smokers had seen on cigarette packages while others had seen only the text-based HWLs. Exposure to the campaign and pictorial HWLs was assessed with aided recall methods, and other questions addressed attention and cognitive impact of HWLs, knowledge related to HWL and campaign content, and quit-related thoughts and behaviours. Logistic and linear regression models were estimated to determine associations between key outcomes and intervention exposure. RESULTS: In bivariate and multivariate adjusted models, recall of pictorial HWLs and of the campaign were positively associated with greater attention to and cognitive impact of HWLs, whereas only pictorial HWL exposure was associated with having refrained from smoking due to HWLs. Both recall of pictorial HWLs and of the campaign were independently associated with greater knowledge of secondhand smoke harms and toxic tobacco constituents. Smokers who recalled only the pictorial HWLs were more likely to try to quit than smokers who recalled neither the pictorial HWLs nor the campaign (17% vs 6%, p<0.001). CONCLUSIONS: Consistent with other studies, adult smokers' exposure to new pictorial HWLs in Mexico was associated with psychosocial and behavioural responses related to quit behaviour. Exposure to the complementary media campaign was associated with independent additive effects on campaign-related knowledge, and it enhanced psychosocial responses to pictorial HWLs.

Cigarette packet warning labels can prevent relapse: findings from the International Tobacco Control 4-Country policy evaluation cohort study.

OBJECTIVES: To investigate the links between health warning labels (WLs) on cigarette packets and relapse among recently quit smokers. DESIGN: Prospective longitudinal cohort survey. SETTING: Australia, Canada, the UK and the USA. PARTICIPANTS: 1936 recent ex-smokers (44.4% male) from one of the first six waves (2002-2007) of the International Tobacco Control 4-Country policy evaluation survey, who were followed up in the next wave. MAIN OUTCOME MEASURES: Whether participants had relapsed at follow-up (approximately 1 year later). RESULTS: In multivariate analysis, very frequent noticing of WLs among ex-smokers was associated with greater relapse 1 year later (OR: 1.52, 95% CI 1.11 to 2.09, p<0.01), but this effect disappeared after controlling for urges to smoke and self-efficacy (OR: 1.29, 95% CI 0.92 to 1.80, p=0.135). In contrast, reporting that WLs make staying quit 'a lot' more likely (compared with 'not at all' likely) was associated with a lower likelihood of relapse 1 year later (OR: 0.65, 95% CI 0.49 to 0.86, p<0.01) and this effect remained robust across all models tested, increasing in some. CONCLUSIONS: This study provides the first longitudinal evidence that health warnings can help ex-smokers stay quit. Once the authors control for greater exposure to cigarettes, which is understandably predictive of relapse, WL effects are positive. However, it may be that ex-smokers need to actively use the health consequences that WLs highlight to remind them of their reasons for quitting, rather than it being something that happens automatically. Ex-smokers should be encouraged to use pack warnings to counter urges to resume smoking. Novel warnings may be more likely to facilitate this.

Cigarette prices, cigarette expenditure and smoking-induced deprivation: findings from the International Tobacco Control Mexico survey.

AIM: Mexico implemented annual tax increases between 2009 and 2011. We examined among current smokers the association of price paid per cigarette and daily cigarette expenditure with smoking-induced deprivation (SID) and whether the association of price or expenditure with SID varies by income. METHODS: We used data (n=2410) from three waves of the International Tobacco Control Mexico survey (ie, 2008, 2010, 2011) and employed logistic regression to estimate the association of price paid per cigarette and daily cigarette expenditure with the probability of SID ('In the last 6 months, have you spent money on cigarettes that you knew would be better spent on household essentials like food?'). RESULTS: Price paid per cigarette increased from Mex$1.24 in 2008, to Mex$1.36 in 2010, to Mex$1.64 in 2011. Daily cigarette expenditure increased from Mex$6.9, to Mex$7.6 and to Mex$8.4 in the 3 years. There was no evidence of an association between price and SID. However, higher expenditure was associated with a higher probability of SID. There was no evidence that the association of price or expenditure with SID varied by income. CONCLUSION: Tax increases in Mexico have resulted in smokers paying more and spending more for their cigarettes. Those with higher cigarette expenditure experience more SID, with no evidence that poorer smokers are more affected.

Data from the GIPEyOP online election poll for the 2015 Spanish General election.

The general elections of 2015 in Spain took place in the middle of the Great Recession after several years of austerity economic policies. This election caused a political earthquake that shook the Spanish party system. During the campaign of that election, GIPEyOP (Elections and Public Opinion Research Group from University of Valencia) conducted a survey to collect relevant data about the electorate beliefs, intentions and motivations. This article describes the data set attained, which comprises 71 variables after removing, to ensure full anonymity, those variables that would potentially allow respondents to be identified. Respondents answered a self-administered online questionnaire and were recruited using chain sampling. A total of 14,261 valid observations were collected between 27th November and 18th December 2015. GIPEyOP employed the data collected up to 14th December to deliver a prediction of the election outcomes during that election campaign. Among other issues, this data set may be reused to assess theories of expectations' formation, to spot how social networks spread geographically and to measure gender, age and education technological gap of the Spanish population.

What do we know about public attitudes towards experts? Reviewing survey data in the United Kingdom and European Union.

Recent developments in contemporary politics have cast doubt on the status of expertise and led to the oft-repeated claim that the public have had enough of experts. In response, we review existing survey measures on experts and expertise in the European Union and United Kingdom with three main findings. First, there is insufficient survey data available to strongly support any claims regarding public attitudes to experts. Second, the evidence that does exist suggests broadly positive public attitudes towards experts, rather than the somewhat bleak commentary associated with descriptions of a 'post-truth' era. Third, there is scope for survey questions to provide improved macro-level descriptions of some of the attributes and expectations associated with experts, and that concepts from the academic literature can provide structure for such questions. Survey data has the potential to complement more granular, qualitative approaches as part of an interpretive social science approach.

I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

The use and value of polling to determine public opinion on GMOs in Europe: limitations and ways forward.

In this article, we review and assess existing surveys that attempt to gauge public opinion about GM crops. This review shows that consumer surveys can be something of a blunt instrument. Questionnaires, however well-constructed and professionally delivered, are answered in a vacuum of knowledge and elicit misleading responses. People recurrently admit they lack information on the technology behind GM food. It is a part of the general unfamiliarity with the food production process with which people show equal, if not greater, concern. Lacking control over a process involving such an emotive subject like food makes people uneasy and reluctant to accept "unknowns". In addition, if people give answers to hypothetical questions, they do so as "cautious citizens" rather than consumers and this is not a good guide to actual behavior in real life. Qualitative studies using focus groups can be a much better guide to how people really feel about issues, but they also need expert facilitation and analysis to be of real value. An even better guide to acceptance and purchasing behavior (if that is the objective) is to put people in a situation where they are actually making a choice of whether or not to buy GM products.

Educators of Prospective Teachers Hesitate to Embrace Evolution Due to Deficient Understanding of Science/Evolution and High Religiosity.

Acceptance of evolution by educators of prospective teachers remains superficially studied despite their role in having mentored schoolteachers whose weak support of evolution is known. Here, we contrast the views of New England educators of prospective teachers (n=62; 87% Ph. D./doctorate holders in 32 specializations) with those of the general faculty (n=244; 93% Ph.D./doctorate holders in 40 disciplines), both members of 35 colleges and universities, and with college students (n=827; subsample of the 35 institutions) who were polled on: (1) the controversy evolution vs. creationism vs. intelligent design (ID), (2) their understanding of how science/evolution works, and (3) their religiosity. The educators held intermediate positions in respect to the general faculty and the students: 94% of the general faculty, 75% of the educators, and 63% of the students said they accepted evolution openly; and 82% of the general faculty, 71% of the educators, and 58% of the students thought that evolution is definitely true. Only 3% of the general faculty in comparison to 19% of the educators and 24% of the students thought that evolution and creationism are in harmony. Although 93% of the general faculty, educators, and students knew that evolution relies on common ancestry, 26% of the general faculty, 45% of the educators, and 35% of the students did not know that humans are apes. Remarkably, 15% of the general faculty, 32% of the educators, and 35% of the students believed, incorrectly, that the origin of the human mind cannot be explained by evolution; and 30% of the general faculty, 59% of the educators, and 75% of the students were Lamarckian (=believed in inheritance of acquired traits). For science education: 96% of the general faculty, 86% of the educators, and 71% of the students supported the exclusive teaching of evolution, while 4% of the general faculty, 14% of the educators, and 29% of the students favored equal time to evolution, creationism and ID; note that 92% of the general faculty, 82% of the educators, and 50% of the students perceived ID as either not scientific and proposed to counter evolution based on false claims or as religious doctrine consistent with creationism. The general faculty was the most knowledgeable about science/evolution and the least religious (science index, SI=2.49; evolution index, EI= 2.49; and religiosity index, RI=0.49); the educators reached lower science/evolution but higher religiosity indexes than the general faculty (SI=1.96, EI=1.96, and RI=0.83); and the students were the least knowledgeable about science/ evolution and the most religious (SI=1.80, EI=1.60, and RI=0.89). Understanding of science and evolution were inversely correlated with level of religiosity, and understanding of evolution increased with increasing science literacy. Interestingly, ≈36% of the general faculty, educators and students considered religion to be very important in their lives, and 17% of the general faculty, 34% of the educators, and 28% of the students said they prayed daily. Assessing the perception of evolution by educators of prospective teachers vs. the general faculty and the students of New England, one of the historically most progressive regions in the U.S., is crucial for determining the magnitude of the impact of creationism and ID on attitudes toward science, reason, and education in science.

Os três sujeitos do diálogo intradiscursivo nas pesquisas sociais de atribuição de sentido: consequências para a avaliação / The three subjects of intra-discourse dialogue in social studies on the attribution of meaning: consequences for evaluation

O presente texto discute a relação de comunicação básica presente nas pesquisas sociais empíricas em que há atribuição de sentido a eventos significativos por atores sociais envolvidos. Postula a existência de três sujeitos em ação nesta relação: o sujeito do pensamento coletivo, o sujeito pesquisador autor da pesquisa empírica e o sujeito leitor desta pesquisa. Os segundos e terceiros sujeitos são sujeitos clássicos da pesquisa e o primeiro sujeito é a novidade introduzida pelo método do Discurso do Sujeito Coletivo. De fato, o pensamento coletivo reconstituído pela pesquisa, que é geralmente visto como resultado da pesquisa e fruto do trabalho do pesquisador/autor, ficando a ele atrelado, ganha, nesta metodologia, o estatuto de sujeito da pesquisa. Parte-se da ideia de que estes três sujeitos e suas complexas relações devem estar perfeitamente claros nas pesquisas para que a crítica destas pesquisas e a avaliação da sua qualidade possa ser estabelecida de modo adequado.