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Animal experimentation in Italy. Legislation and the authorization of research protocols.

In Italy, the European Directive 86/609/EEC ("The Council Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes") has been given effect with Legislative Decree 116/92, whose main objective is to guarantee the welfare of animals used in research and to prevent unnecessary experiments on animals from being carried out. The regulatory authority for controlling the use of laboratory animals in Italy is the Ministry of Health, which requires that researchers requesting authorization to perform experiments on animals submit not only a copy of the experimental protocol but also a detailed application form that focuses on how the animals will be used. In the evaluation process, the Istituto Superiore di Sanità (Italy's National Institute of Health), in particular, the Service for Biotechnology and Animal Welfare, plays a key decision-making role. The evaluation is conducted by experts in the given area of research and by a veterinarian specifically trained in evaluating experimental protocols involving animal use. In the present work, the evaluation process is explained and a point-by-point description of the application form is provided.

Animal Experimentation↗

[Risk management in health care systems: the new legislative orientations in medical civil responsibility].

The recent radical change in the relationships between physicians and patients has increased the frequency of malpractice. Consequently, on one hand, many physicians got used to avoiding any possible risk of denunciation by applying the so called "defensive medicine", while on the other hand, the insurance companies raised the prices of their premiums for policies concerning civil responsibility of health operators. In order to avoid this "vicious circle", some health structures created Units for the Risk Management related to malpractice, while others took advantage of the collaboration of Associations for Patients' Rights to create database about the most frequent medical mistakes. The need for a legislative change has been accepted by the Parliament which expects with the proposal n.108 (approved in spring 2002 by the Commission for Hygiene and Health of the Senate) to attribute the civil responsibility of the physicians to the hospitals (both private and public) for which they work, to constitute a Register of experts and to accelerate the legal disputes. The problem is complex and still to be solved, but it seems that time for a strong intervention in order to improve the situation has to come.

Humans↗

Nova Scotia: "blood samples" legislation passed.

On 18 October 2004 the Nova Scotia legislature passed the Mandatory Testing and Disclosure Act, thus becoming the third Canadian province or territory to pass similar legislation.

AIDS Serodiagnosis↗

[New legislation on expert witnesses in the Slovak Republic].

Legal framework for expert witnesses in the continental legal system differs from that of common law in many aspects. The position of an expert witness in continental legal system is more formalized and the processual rights and duties of an expert witness differs from rights and duties of witness in general. As of 1st September 2004 the Act No. 417/2002 Coll. on Expert Witnesses, Translators and Interpreters became effective in the Slovak Republic. The Act repealed expert witnesses legislation that originated from 1967 which is still effective in the Czech Republic. The authors present a short overview of the Act.

Expert Testimony↗

[New German legislation on occupational dermatoses (author's transl)].

According to the new German legislation on occupational dermatoses of January 1, 1977, a person suffering from an occupational dermatosis can be idemnified only in case that occupational disease "has compelled him to abstain from all activities that have caused or might be responsible of, the appearance, the aggravation or the recurrence of that disease".

Dermatitis, Occupational↗

[Legislation on professional respiratory diseases].

The legally protected occupational pathology consists of work accidents and occupational diseases. Diseases are considered to be occupational when there is a relationship of demonstrable causality between exposure to a determinate occupational risk and a specific disease. To facilitate recognition, different organisations (International Labour Organisation, European Community) draw up, update and recommend the use of lists that are voluntarily adopted by member states. In the case of the Spanish state, the system of the closed list has been adopted. The current list was published in 1978 and the system of notification and registration currently in use is in need of urgent reform, which has been started. It is frequently difficult to identify the work-related origin of occupational diseases and they are often treated in the public health care system without their relation to work being recognised. Knowledge of some basic aspects of the labour legislation by the health workers and the inclusion of a few questions during the anamnesis of patients would make their identification and adequate treatment possible.

Humans↗

New French legislation governing organ removals for therapeutic and scientific purposes.

In France the general principles of organ donation are: consent, absence of financial gain, anonymity, advertising is prohibited, healthcare safety. As regards organ removals from living persons, a panel of experts is required to give approval. The recipient's spouse, brothers or sisters, sons or daughters, grandparents, uncles or aunts and first cousins may be authorised to donate organs, as well as the spouse of the recipient's father or mother. The donor may also be any person who provides proof of having lived with the recipient for at least two years. As regards organ removals from Deceased Persons for Therapeutic Purposes, removals may be practised if the deceased did not make known their refusal during their lifetime (this may be recorded in the national registry set up for this purpose). The doctor must not seek the family's opinion, but rather ensure that the deceased did not express opposition to organ donation during his lifetime. The rule of presumed consent should apply, unless there is any danger to the health of the general public. This paper describes and discusses in detail the new legislation and its relationship to existing French legal codes.

Autopsy↗

All-terrain vehicle injuries: are they dangerous? A 6-year experience at a level I trauma center after legislative regulations expired.

All-terrain vehicles (ATVs) have increased in popularity and sales since 1971. This rise in popularity led to an increase in injuries resulting in voluntary industry rider safety regulations in 1988, which expired without renewal in 1998. Our purpose was twofold, to determine the incidence and severity of ATV injuries in our patient population and what, if any impact the safety regulations had. To further characterize the risk of ATV use, we compared them to a vehicle generally recognized as dangerous, the motorcycle (MC). Our trauma registry was reviewed from January 1998 through August 2004 for ATV or MC injured. Data collected included age, gender, mortality, Injury Severity Score (ISS), helmet use, and injury distribution. These were compared to our data from the decade of regulation. There were 352 MC and 221 ATV patients. ATV injured demonstrated a higher proportion of pediatric and female patients (P < 0.001 and P < 0.01, respectively), a decrease in helmet use (8.6% vs 64.7%, P < 0.001), and increased closed head injuries (CHI) (54.2% vs 44.9%, P < 0.05) compared with MC injured. ISS and mortality were similar. The average number of patients from 1988 to 1998 was 6.9/yr compared to 31.6/yr (P < 0.001) during 1998-2004 with equal ISS. Our data show that there has been a dramatic and progressive increase in the number of ATV crashes since expiration of industry regulations. ATVs are as dangerous as MCs based on patient ISS and mortality. There are significantly more children and women injured on ATVs. The lower rate of helmet use in ATVs may account for the significantly greater incidence of CHI. These data mandate the need for injury prevention efforts for ATV riders, in particular children, through increased public awareness and new legislation.

Accidents, Traffic↗

Return to work still possible after several years as a disability pensioner due to musculoskeletal disorders: a population-based study after new legislation in Sweden permitting "resting disability pension".

Different strategies have been used to stimulate a return to work (RTW) among individuals suffering from long-term ailments. In Sweden a new law on "resting disability pension" permits disability pensioners to go back to work without jeopardising their benefits. In this study different variables related to RTW during 2000 by means of this legislation were identified among disability pensioners with musculoskeletal disorders. Individuals in the study group, when compared to a control group, had more often been disability pensioners for several years, had additional education, estimated their previous job to have been physically strenuous to a lesser degree, were more satisfied with the treatment at the social insurance office and had a more positive self-image. This study shows that it may be meaningful to continue/resume rehabilitation efforts and to try to motivate an individual suffering from musculoskeletal disorders to return to work even after several years as a disability pensioner.

Adult↗

The Americans With Disabilities Act: explaining legislative intent through experiential learning.

Imparting the requirements of healthcare workforce legislation to students is only one aspect of preparing undergraduate healthcare management students to be effective managers. On first review, the Americans with Disabilities Act (ADA) appears quite straightforward. The Act applies to any employer with 15 or more employees and covers a full range of employment practices. What the law does not address are the skills in empathy and decision-making that are needed for effective implementation of the law. In this article, the authors describe an experiential learning model that was designed to teach healthcare management majors, (soon-to-be healthcare managers), not only the provisions of the ADA law but also skills in empathy and critical decision-making. Reflections from student participants are included. These reflections are examples of changes in students' empathy occurring as a result of participation in the ADA Experience. The authors also present actual case requests for "reasonable accommodation" made by persons employed in a healthcare setting.

Architectural Accessibility↗

Introduction to the EU REACH legislation.

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.

Animal Testing Alternatives↗

[Application of the legislation on safety occupational hygiene in the Military Navy].

The paper analyses the consequences of the promulgation legislative decree 626/94 on the sanitary organization of the Armed Forces and, particularly, of the Italian Military Navy. In this context, the authors describe the current safety and occupational hygiene organization, the tasks of the vigilance organs, and the actuative modalities of preventive measures on the ships (during navigation and in shipyard).

Accidents, Occupational↗

[Use and abuse of illicit drugs, also in the light of the new Italian legislation].

After presenting the new Italian legislation on the subject, the author describes the operative procedures, employed by the "Centro Ricerche di Laboratorio e di Tossicologia Forense" of the Italian State Police, for detection of illicit drugs' use by personnel on duty. The results obtained from 1998 to 2003 (on over 15,000 subjects/year) are presented. On this sample, sporadic positive (for cannabinoids) cases were found. The number of positive individuals would probably be higher, whether randomised controls were made without notice, and whether non-conventional matrices (e.g. keratinised tissues) were utilized to identify previous abuse.

Cannabinoids↗

New developments in mandatory blood testing legislation.

In November 2005, the Liberal government in Ontario introduced a bill that would allow policy officers, other community safety workers and victims of crime to find out more quickly whether they have been exposed to infection from certain viruses. Meanwhile, the Saskatchewan Medical Association (SMA) is opposing similar legislation enacted in that province.

AIDS Serodiagnosis↗

The impact of human rights advocacy, mental health legislation and psychiatric reform on the epidemiology of involuntary psychiatric hospitalizations.

Several years ago, the Ministry of Health published a report on the epidemiology of involuntary psychiatric hospitalizations. Many developments (advances in human rights advocacy, mental health legislation and the nascent Psychiatric Reform) have occurred in the mental health field in Israel since 1990 when the earlier report was released. Those favorable developments in mental health care were thought to have the capacity to modify the admission rates. We explored several parameters to check the hospitalization patterns (eg, by demographic factors, diagnosis) and found no substantial modifications. The case for an analytic study was clearly established.

Adolescent↗

[Origins of French telemedicine legislation].

After the creation of the european institute of telemedicine on 10 July 1989 at Paul Sabatier university in Toulouse, it became clear that legislation was needed to provide a solid framework for this new medical practice. The French government's decision in 1993 to create an experimental telemedicine network in the Midi-Pyrenees region, bringing together all public and private healthcare establishments, led us to manage telemedicine in much the same way as a hospital department. This resulted in the creation of institutional systems suited to multicenter networking and requiring particular regulations to govern healthcare professionals' responsibilities, financing, data security, and the use of new communication and information technologies. Articles specific to telemedicine were integrated into the law of 13 August 2004 relating to the reorganisation of French healthcare insurance.

France↗

Protection of third parties in current legislation and preventive practice.

The problem of safety and the management of risks to third parties, which may be caused by a change in the mental or physical health of an employee, is one which affects a number of different areas (infectious diseases, psychiatric illnesses, conditions of drug and alcohol abuse, etc.). Italian legislation deals with the issue of fitness for work through a variety of laws, decrees and regulations which, because many of them were issued in different historical circumstances, are not always mutually harmonized. The growing complexity of the workplace makes the role of the Occupational Physician more complex, and to this person the law assigns the exclusive task of monitoring the health of employees in the cases covered by the current regulations. In our opinion, the Occupational Physician, to the best of his knowledge and conscience, having taken into consideration all the aforementioned factors, must take each case on its merits, in the most responsible manner possible, weighing up the complexity and delicacy of the aspects discussed earlier, and decide to deliver a verdict of fitness and/or to break or not to break the obligation of confidentiality, tending, in our view, to favour the need to safeguard collective health, or that of third parties, should there be a conflict of interest.

Humans↗