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Biomedical subjects

Francesco Rosmini

Publications and source records attributed to Francesco Rosmini.

12 recordsLinked to original sources
PubMed2004

[Italian regulation on the protection of human subjects participating to clinical studies, from the Nineties to 2004].

In chronological order, and in the light of bioethics principles, the authors describe the Italian regulation which concerns the protection of human subjects participating in clinical trials from 1990 to July 2004, the related institution of Ethical Committees and the adoption of the tool of the informed consent. The publication includes the ties that have connected the Italian regulations to the European one since the beginning. During such period, the reception of the Good Clinical Practice guidelines - which occurred in 1992 first, and finally in 1997 - has led to the establishment and the fostering of such important institutions as well as to the shaping of a network of Ethical Committees working on clinical trials and coordinated at a central level. In this paper the authors examine in particular: clinical trials of medicinal products, of medical devices and of ionizing radiations. Some implications of ethics are also discussed.

Clinical Trials as Topic↗
PubMed2003

[The informed consent procedure in epidemiological research].

After a brief introduction on the beginning and subsequent developments of informed consent (IC), this paper analyses its ethical, legal, medical and scientific implications and its specific applications to epidemiological research. The aim is to highlight how IC principles should be fulfilled through different procedures responding to the ethical and scientific requirements of epidemiological research. At least two improper applications, in fact, can deprive IC of its meaning: referring to ethical principles without discernment, or following IC guidelines without critical evaluation. Attempts to improve IC procedures adapting them to specific needs and scientific developments should be evaluated carefully and without preconceptions.

Clinical Trials as Topic↗
PubMed2002

Baseline cataract type and 10-year mortality in the Italian-American Case-Control Study of age-related cataract.

Age-related cataract is reported to be associated with increased risk of death. The authors investigated the association of presence and type of cataract with mortality in the participants of the Italian-American Case-Control Cataract Study (Parma, Italy, 1987-1989), which included 1,008 persons aged 45-79 years who had age-related cataract and 469 who had clear lenses. Slit-lamp and retroillumination lens photographs were taken at baseline and graded with the Lens Opacities Classification System II. During 10 years of follow-up (range, 8.9-11.8 years; 11,318 person-years), the authors collected information on 1,429 participants and documented 339 deaths. After adjustment for age, sex, and other mortality risk factors, mixed cataracts with a nuclear/posterior subcapsular component were significantly associated with higher risk of death by Cox proportional hazards regression analyses. Hazard ratios were 2.26 (95% confidence interval (CI): 1.07, 4.76) for nuclear/posterior subcapsular and 1.62 (95% CI: 1.01, 2.61) for cortical/nuclear/posterior subcapsular opacities. In multivariate analysis, mixed types of opacity (any) were associated with increased mortality for malignancy (hazard ratio = 1.81, 95% CI: 1.04, 3.15) and "other" causes (hazard ratio = 2.29, 95% CI: 1.07, 4.92). These findings are compatible with the hypothesis that mixed types of cataract with a nuclear/posterior subcapsular component are indicators of accelerated aging.

Aged↗
PubMed2002

Hay fever and asthma in relation to markers of infection in the United States.

BACKGROUND: The hygiene hypothesis proposes that declining exposure to infections is implicated in the rising trend of allergy and asthma. OBJECTIVE: We sought to test this hypothesis by examining the relationship of hay fever, asthma, and atopic sensitization with markers of infection in a large general population sample of the United States. METHODS: We analyzed the data of 33,994 US residents recorded in a public database of a nationally representative cross-sectional survey (Third National Health and Nutrition Examination Survey, 1988-1994). The variables examined were sociodemographic information, lifetime diagnosis and age at first diagnosis of hay fever or asthma, current skin sensitization to 9 airborne allergens and peanut, and current serology for Toxoplasma gondii, herpes simplex viruses type 1 and 2, and hepatitis A, B, and C viruses. RESULTS: Hay fever (adjusted odds ratio, 0.27; 95% CI, 0.18-0.41; P <.001) and asthma (adjusted odds ratio, 0.45; 95% CI, 0.31-0.66; P <.001) were less frequent in subjects seropositive for hepatitis A virus (HAV), T gondii, and herpes simplex virus 1 versus seronegative subjects after adjusting for age, sex, race, urban residence, census region, family size, income, and education. Skin sensitization to peanut and to all the airborne allergens examined, except for cockroach, was less frequent among HAV-seropositive versus HAV-seronegative subjects younger than 40 years of age. The prevalence of hay fever and asthma diagnosed at or before 18 years of age in HAV-seronegative subjects increased progressively from 2.7% (95% CI, 0.7%-4.7%) and 0.4% (95% CI, 0.1%-1.6%), respectively, in cohorts born before 1920 to 8.5% (95% CI, 7.3%-9.7%) and 5.8% (95% CI, 4.8%-6.8%), respectively, in cohorts born in the 1960s, whereas they remained constant at around 2% in all cohorts of HAV-seropositive subjects. CONCLUSION: In the United States serologic evidence of acquisition of certain infections, mainly food-borne and orofecal infection, is associated with a lower probability of having hay fever and asthma. Third National Health and Nutrition Examination Survey data support the hypothesis that hygiene is a major factor contributing to the increase in hay fever, asthma, and atopic sensitization in westernized countries.

Adolescent↗
PubMed2002

[Disease prevention and health promotion. Distinct and complementary strategies].

Health maintenance entails interventions beyond the biomedical knowledge, regarding: economic matters, education levels, improvement of work conditions, nutrition, housing, and environment; that is to say, overall well-being. According to the World Health Organization, well-being is not a health determinant but is included in the health definition. This is good from a social point of view and consistent with some economic findings, but can be misleading. The two aspects identifiable in the definition are: disease prevention and health promotion, which operate at different levels. The first one is conditioned by the sciences' reductionistic methodology and its strategies can be economically appraised; the other one is holistic and the economic and scientific evaluation of its actions is difficult. Moreover, both offer solutions to different questions of public health ethic. Thus, both are necessary and synergetic.

Health Promotion↗
PubMed2002

[Points of view in comparison on the 5ht revision of the Declaration of Helsinki].

The horror for the scientific crimes of the nazi period led the World Medical Association (WMA), in 1964, to settle by the Helsinki declaration, an ethical code for the medical research on human beings. The code was successively modified in order to account for the developments of the medical science in the past decades. In October 2000, the last revision, the 5th one, has been approved in Edinburgh. Its preparation lasted three years and entailed a passionate, but also profitable dispute between who believes that ethical principles must be followed even though they can hamper the scientific progress, and who thinks that more articulate evaluations should prevail. The initial victory of the more intransigent party resulted in the maintenance of the norm which entails the greatest restriction in using placebo, but, after one year and half, it was partially reshaped by a more permissive interpretation of the same WMA, while waiting for a new revision that is scheduled for this year.

Clinical Trials as Topic↗
PubMedDate not supplied

[Obtaining informed consent and resorting to ethical committee in clinical and epidemiological research in Italy. A survey].

OBJECTIVES: To describe how informed consent (CIn) and ethical review (CEt) are obtained in the Italian clinical and health research. DESIGN: survey SETTING: 6 Italian and 7 foreigner journals in the years 2001 and 2002. SAMPLE: 157 original or short articles, letters and case reports for which a member of an Italian institution was the corresponding author. MAIN OUTCOME: Mention in the text of CIn and CEt procedures. RESULTS: In 42% of such studies (95% CI: 35-50%), informed consent was obtained; in 30% (95% CI: 23-37%), ethical committee approval was obtained, in 27% (95% CI: 21-35%) both had been obtained. The probability of informed consent and ethical review varied with type of data used (primary or secondary source). No significant differences, however, were noted based on the type of study population (vulnerable or non-vulnerable), the year, or the country in which the article was published (Italy or elsewhere). Keywords search in the articles text showed that ethical aspects of the study were not debated. Ethical procedures were synthetically reported as a rule, yet there were differences in their formulation. CONCLUSIONS: The limited resorting to CIn and CEt procedures and the concision and variability of their description might depend on the plethora of the ethical, legal, editorial guidelines available for Italian researchers that partially overlap and partially present specific aspects whose interpretation is not free of niceties.

Epidemiology↗
PubMedDate not supplied

[Consulting an ethics committee, when is it necessary? Two examples].

We described the indications of laws and the commitment of researchers on the decision to submit two projects regarding observational studies to the ethics committee. Out of the two studies, the first one shows problems on data confidentiality and privacy, while the other one entails a risk, even though minimum, of physical damage for the study subjects. In Italy, the laws foreseeing the submission of research projects to the ethical committee are the Code for Personal Data Protection (Dlgs 196/2003), and the Good Clinical Practice regulations for the protection of research subjects (DM 15 luglio 1997); other provisions tied to such basic laws are also mentioned in the article. The laws on the protection of personal data tend to simplify prescriptions when the research relates to public health issues; the laws on the protection of the research subject do not almost totally pertain observational studies. We concluded that the researchers are free to submit or not both projects to the ethics committee. We underlined that the sensitivity of researchers on the endorsement of the same ethical principles can be different. We would think convenient also for epidemiological research, as well for clinic research, to establish an uniform approach. The recent issuing of the Additional Protocol on biomedical research to the Oviedo Convention may provide an opportunity.

Confidentiality↗