[Codes, guidelines and guidance of ethics of research: the issue of quality].

After an overview of the evolution of ethics laws for medical activities, we suggest a possible classification of documents regarding the ethical conduct of scientific research with human beings. The authors outline the necessity to define formal criteria for the development and the implementation of ethics standards.

A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract.

Background: The Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract was designed to assess the impact of a multivitamin-mineral supplement on age-related cataract. Trial results showed evidence of a beneficial effect of the supplement on all types of cataract combined, opposite effects on two of the three types of cataract (beneficial for nuclear opacities and harmful for posterior sub-capsular opacities) and no statistically significant effect on cortical opacities. No treatment recommendations were made.

Body mass index, cardiovascular risk factors, and carotid intima-media thickness in a pediatric population in southern Italy.

Objectives: Obesity and exposure to cardiovascular risk factors during adolescence may be associated with the development of atherosclerosis and cardiovascular diseases later in life. The objective of the study was to investigate whether any excess body weight, including moderate overweight, is associated with a more severe cardiovascular risk profile and signs of early atherosclerosis in a pediatric population.

Patients And Methods: A cross-sectional study was conducted among 646 adolescents ages 11 to 13 years from several primary schools of Reggio Calabria, Italy.

Cardiovascular risk factors, nonalcoholic fatty liver disease, and carotid artery intima-media thickness in an adolescent population in southern Italy.

The objective of this study was to determine, in an adolescent population, the prevalence of nonalcoholic fatty liver disease (NAFLD) and the association of NAFLD and cardiovascular risk factors with carotid artery intima-media thickness (IMT), a marker of subclinical atherosclerosis. The authors conducted a population-based study among 642 randomly selected adolescents aged 11-13 years in Reggio Calabria, southern Italy, between November 2007 and October 2008. Prevalences of overweight and obesity were 30.

Effects of multivitamin/mineral supplementation on plasma levels of nutrients. Report No. 4 of the Italian-American clinical trial of nutritional supplements and age-related cataract.

The use of multivitamin-mineral supplements has become increasingly common, but whether the use of such supplements improves micronutrient status remains still unclear. The objective of this report is to investigate how a long-term vitamin-mineral supplementation following the US Recommended Daily Intake (RDI) affected the plasma levels of selected nutrients in a subset (No. = 407) of participants in the Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS).

A randomized, double-masked, placebo-controlled clinical trial of multivitamin supplementation for age-related lens opacities. Clinical trial of nutritional supplements and age-related cataract report no. 3.

Objective: To evaluate the effect of a multivitamin/mineral supplement on development or progression of age-related lens opacities.

Design: Randomized, double-masked, single center, placebo-controlled clinical trial.

Participants: One thousand twenty participants, 55 to 75 years old and with early or no cataract, were randomly assigned to a daily tablet of a multivitamin/mineral formulation or a placebo.

Scientific research on human subjects and ethics procedures at the Istituto Superiore di Sanità: a survey of the articles issued in 2001.

Principles promoting the protection of subjects involved in biomedical research are interpreted differently within the scientific community. The purpose of this paper is to describe the attitudes of researchers working at the Istituto Superiore di Sanità (ISS) regarding the ethical implications of studies involving human beings, with particular emphasis on aspects concerning informed consent (IC) and ethics committee (EC) review. In 2001, ISS researchers published a total of 733 articles, 93 (12.

[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.

[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.

[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.

[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.

[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.

[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.

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).

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.