Construction of ethics in clinical research - Clinical trials registration

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Ethical Care of the Self and the Teacher in the Pedagogical Relationship: Reflections Based on the Latest Foucault

Our conception of education is that it is the responsible action whereby man becomes human, trains and faces the challenges that life and the world present, as man enters a larger, shared cultural tradition and thus joins the world. However such sharing implies that we must not just rely on tradition, but remain open to new ideas. It is essential for schooling to preserve a field where the art of living intersects with the world for which future generations are being prepared. It is in this field of intersection that this essay seeks to discuss Michel Foucault's thought, care of the self and the role played by others in the acquisition of ethical attitudes pertaining to one's conduct in life. Through reconstructing Foucault's ideas, we elaborate on the hypothesis that, before morally shaping students, teaching them values, or aiding in their skill acquisition in the sense prevailing in schooling today, it is important to understand the notion of care of the self (and how the notion implies interaction with others for effective care of the self). Care of the self is vital for thoroughly understanding the relationships between ethics and education in school. We particularly examine how Foucault's ideas and his analysis of the teacher's role in shaping the student's life conduct can help educators rethink pedagogical action in an ethical sense and find within it a certain openness to the formation of attitudes in educators and students

Hydroxyurea in the sickle cell anemia: toxicity and effectiveness

Objective: to evaluate the use of hydroxyurea with regard to effectiveness and toxicity in people with sickle cell anemia. Method: this is a retrospective descriptive study, developed with 57 medical records of patients with sickle cell anemia, treated at the University Hospital Center of Campo Grande (Mato Grosso do Sul, Brazil), from 1993 to 2005. Inclusion criteria: electrophoresis of hemoglobin in medical record; regular use of drugs, for an average of 196 weeks; dosage; and hematological analyses before starting treatment. Exclusion criteria: living with other hemoglobinopathies. The variables evaluated were: neutrophils count; platelets; leukocytes; hemoglobin; time using hydroxyurea; drug response to the optimal dosage; and number and type of episodes of hospitalization. The research protocol was approved by the Ethics Committee of Universidade Federal de Mato Grosso do Sul, under the Protocol 645. Results: of the 57 medical records, 3 cases were evaluated. Comparing the hematological values, according to Portaria 872, enacted on 11/12/2002, it was found that: cases A, B, and C present an use of hydroxyurea (500 mg/day) for four years, with an average of 196 weeks. Case A, female, decreased painful episodes and frequency of hospitalization, keeping hematological values with no toxicity. In Case B, female, there was one hospitalization due to pain crises and important hemolysis. It stood out, in case C, male, neutropenia with hematological values < 2,000/mm3 . Conclusion: in the cases analyzed, we observed a drop in the number of hospitalizations with the decrease in painful crises from three to one a year, and there was no toxicity with regard to the dosage and time using hydroxyurea, in all three cases. For more comprehensive results, one suggests further study on this therapy with significant samples of this clientele.

Evaluation of clinical, ultrasonographic and hysteroscopic parameters in the differentiation of endometrial polyps and cancer of endometrium

Study Objective: To evaluate the diagnostic accuracy of transvaginal ultrasound and office hysteroscopy in the differentiation between endometrial polyps and endometrial adenocarcinoma. Design: This is a prospective 100 women longitudinal study, 24 to 80 years, submitted to hysteroscopic polypectomy (n = 80) or surgery due to endometrial adenocarcinoma (n = 20), from january 2010 to December 2011. Clinical, ultrasonographic and hysteroscopic parameters were analyzed and compared with histopathologic find. Statistical analysis were performed utilizing the Tukey, Kruskal-Wallis, Dunn and Mann-Whitney test, with a confidence interval of 95% and p\0, 05 statiscally significant. Setting: Botucatu Medical School. Intervention: Prospective analysis of clinical, ultrasonographic and hysteroscopic parameters in patients with diagnosis suspected of endometrial polyps and adenocarcinoma of endometrium were performed. According to the diagnosis, hysteroscopic polypectomy or pan hysterectomy with lymph node sampling was realized. After the surgery and histopathological study, statistical analysis of parameters was performed and the results were compared between groups. It was Research Ethics Committee approved. Measurements and Main Results: There were no differences between age, BMI, menopause, TH use and associated diseases among groups. The main symptom of endometrial cancer was the postmenopausal bleeding, affecting 84,2% of women against 34,8% of polypectomy group. The majority of women with endometrial polyps were asymptomatic. Transvaginal ultrasonography showed no ability to differentiate cases of endometrial cancer compared with the cases of endometrial polyps, considering the presence of endometrial thickness and blood flow on color Doppler. Office hysteroscopy showed significant changes in 75% of the adenocarcinoma cases, especially the presence of diffuse hypervascularity with atypical vessels. Conclusion: Still remains an inability to establish clinical parameters and reliable ultrasound imaging to differentiate endometrial polyps and cancer of endometrium. Attention should be given to hysteroscopic exams presenting diffuse endometrial hypervascularization with architectural distortion of the vessels. The recommendation of our service remains the systematic removal of all endometrial polyps.