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Standards in clinical research are laid down in the Nuremberg Code, the Declaration of Helsinki and EC directives on good clinical practice. Clinical research may relate to the causes of disease, improvement in diagnosis, improvement in treatment, and mechanisms of human biology. The patient has the right to informed consent, to withdrawal without prejudice and to confidentiality.
Preserving the environment and human health is an irreversible part of the activity towards stable development. Acknowledging the necessity of such development, the European countries commence working out of plans that subordinate their policy to this object. Concerning the health policy the new strategy requires improving of the integrated system for environmental and health control-an administrative framework that reflects the partnership between health and environmental institutions and the other sectors at all levels of control. The main means and instruments for control of health and the environment are: 1) information system for health and environment; 2) identification and evaluation of the health and environmental risks; 3) a framework of the current legislation; 4) additional measures for control, including economical and fiscal instruments; 5) professional training and qualification; 6) public information and health education; 7) public participation; 8) researches and technological works. The correct functioning of the complex "taking decisions-control system" and the expected results depend on the adequate working out and application of the above mentioned means. The national action plan for environment and health is a fundamental project on a large scale for preserving the health and environmental interests of the country targeting at its stable progress.
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IRBs provide an important role in the protection of research subjects/patients. Research investigators have an inherent potential conflict of interest as health care professionals; as physicians, they are dedicated to promoting the welfare of individual patients, whereas as researchers, they seek knowledge that can be generalized and is applicable to persons other than the individual patient under study. The second goal may be in conflict with the first. IRBs have the paramount responsibility of protecting the rights and welfare of human research subjects. Although the IRB system is not perfect, conscientious IRBs reassure the public that the rights and welfare of human subjects are seriously considered by people who do not have a vested interest in the outcome of the research. By exercising their responsibilities, IRBs promote the protection of human subjects. IRB approval provides a significant affirmation of the scientific and ethical qualities of research, and therefore offers important validation to research and research investigators. IRBs, acting in accordance with the guiding principles of the Belmont Report and within the regulatory guidelines of 45.CFR.46, are intended to provide balance between society's interest in advancing scientific knowledge and the mandate to protect the rights and welfare of human subjects.
50 years ago, in Nuremberg, 23 German doctors were accused of crimes against humanity. The anniversary is a solemn reminder of the dark origins of medical research ethics. Many researchers today believe that the medical experiments carried out under Hitler "vaccinated" postwar researchers against abuse. A review of the practices of postwar research shows that the "vaccination" had limited effect and that there is no reason to believe that the events which took place under Hitler were unique and will never happen again. After the war various measures were introduced to protect research subjects: informed consent, self regulation and independent research ethics committees. The measures have undoubtedly limited the abuse of subjects substantially. Nevertheless, in the Armed Forces, where abuse has been most rampant after the war, informed consent is not always practised and independent review is seldom carried out. With the support of grant institutions, journals and industry the protection of research subjects can be improved. It is recommended that medical faculties arrange an annual commemoration of the victims of medical research in order to raise consciousness and awareness among teachers and students.
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BACKGROUND: The macrolides are among the most effective antibiotics against infections due to Chlamydia and Mycoplasma. The drug in such cases must have marked antibacterial activity, good oral bioavailability, and high intracellular diffusion--indispensable for instance with Chlamydia infection. Rokitamycin, a macrolide with a 16-atom lactone ring, has the features for use in the treatment of genital infections caused by Chlamydia or Mycoplasma, penetrating the cell and reaching considerably higher concentrations than other drugs of the same class. The aim of this trial was to gain further knowledge of rokitamycin in genital infections, including cases infected with Mycoplasma hominis, comparing the efficacy and safety of this drug with josamycin, another macrolide widely employed in clinical practice. METHODS: Patients of either sex, over the age of 18 years, with infections due to Chlamydia trachomatis and Mycoplasma hominis, were admitted. The trial was conducted in accordance with the Declaration of Helsinki and amendments. Fifteen patients were given rokitamycin, one 400 mg tablet every 12 h, and another fifteen received josamycin, one 500 mg tablet every 8 h, for 14 days. Before starting treatment, after the 14 days and after 42 days' follow-up the severity of the following symptoms was assessed: pruritus, burning, erythema, pollakiuria, dysuria, using a four-point rating scale (0 = absent, 1 = mild, 2 = moderate, 3 = strong). The presence or absence of leukorrhea was noted. Patients entered the severity of subjective symptoms daily in a diary. At the end of the trial overall assessments were made on the clinical response, microbiological outcome and efficacy. RESULTS: Thirty patients of both sexes were admitted, age 21-43 years, with genital infections due to Chlamydia trachomatis and/or Mycoplasma hominis. Fifteen were given rokitamycin, 800 mg/day, and 15 josamycin, 1500 mg/day, for 14 days. In 13 cases in each group an antibiotic was prescribed for the partner too. At the start of the trial microbiological samples were taken; in 13 cases a urethral swab was taken (six in the josamycin and seven in the rokitamycin group), and 17 cervical swabs were taken (respectively nine and eight). At the end of the trial 93% of patients gave a negative microbiological result. Mycoplasma hominis was isolated from one patient treated with rokitamycin, and Chlamydia trachomatis from one patient given josamycin. Symptoms improved at a similar rate in both groups, with no significant differences between the drugs. Safety was excellent in both groups, with no complaints of adverse reactions. CONCLUSIONS: This trial demonstrates the excellent activity of macrolide antibiotics against genital infections due to Mycoplasma hominis and Chlamydia trachomatis. Rokitamycin and josamycin both gave good or excellent clinical and microbiological outcomes in more than 90% of the cases. Both were extremely well tolerated. These findings confirm and extend the indications for rokitamycin, found in earlier trials to be extremely effective in the treatment of urethritis due to Chlamydia trachomatis and--as a whole--in infections caused by this microrganism.
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This paper presents the situation concerning research and hospital ethics committees (HEC) in Switzerland. In fact, HECs are almost nonexistent. All the so-called "Ethics Committees" deal with the review of research projects. As there is no legislation governing research on human subjects, the Swiss Academy of Medical Sciences (SAMS) has issued guidelines concerning research on human subjects and, more recently, guidelines concerning Research Ethics Committees (REC). There is a wide disparity in the composition and the functioning of these committees, however. Half of them belong to university hospitals. Six of them review two-thirds of all reviewed protocols. Many RECs function more as educational bodies to enhance the quality of submitted protocols than as committees having the task to control and prohibit particular research projects.
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The use of children in research raises the questions about proper justification, assessment of benefit in relation to risk, ability to consent, compensation, and the just selection of subjects. Although substantive and procedural standards have evolved, subpopulations of vulnerable children created new challenges and concerns.
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