Ética e pesquisa médica: princípios, diretrizes e regulamentações

Castilho, Euclides Ayres de; Kalil, Jorge

doi:10.1590/s0037-86822005000400013

Cited by 35 publications

(31 citation statements)

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“…That includes guarantees of equal rights, equity in the distribution of assets, risks and benefits, respect for individual differences and the search for alternatives to meet them, freedom of expression and fair consideration of the interests involved 13,18 . According to this principle, a study must have social relevance, with significant advantages for participants and minimized burden on the most vulnerable, ensuring equitable consideration of the interests involved and their socio-humanitarian purpose 31 . Thus, for the intrinsic vulnerability to the disease as well as the understanding ability of the adolescent not become obstacles to the research, the ethical aspects must be respected 7 .…”

Section: Resultsmentioning

confidence: 99%

Ética na pesquisa com adolescentes que vivem com HIV/Aids

et al. 2015

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The article have sought to portray the experience of ensuring observance of the ethical aspects involved in data gathering with adolescents living with HIV/Aids. Data gathering in two studies is reported: one , using a quantitative approach with a cross-sectional design, with 23 adolescents, and another with a qualitative focus, with 8 adolescents. For both, the criteria for participation included current use of anti-retroviral therapy, awareness of their diagnosis, and being subject to outpatient monitoring at a specialized care service. Guaranteeing the ethical principles -autonomy, doing no harm, beneficence and justice involved: how to approach the adolescents to invite them to participate in the survey, the adolescents' fears regarding the research, the protection of family members and caregivers, the revelation of the diagnosis to the adolescent and to third parts, and confidentiality. The report of our experience aims to contribute to the discussion of issues involving the guarantee of ethical aspects in research. Keywords: Acquired Immunodeficiency Syndrome. HIV. Adolescent health. Research ethics. Nursing. Resumo Ética na pesquisa com adolescentes que vivem com HIV/AidsCom o presente trabalho, objetivou-se relatar a experiência de garantir os aspectos éticos envolvidos na etapa de coleta de dados com adolescentes que vivem com HIV/aids. Trata-se de relato de coleta de dados de duas pesquisas: uma, de abordagem quantitativa e delineamento transversal, com 23 adolescentes, e outra, de enfoque qualitativo, com 8 adolescentes. Para ambas, os critérios de participação dos adolescentes incluíram: estar em uso de terapia antirretroviral, ter conhecimento de seu diagnóstico e manter seguimento ambulatorial em serviço especializado. A garantia dos principios éticos -autonomia, não maleficência, beneficência e justiça -envolveram: a forma de abordagem para participar da pesquisa, os receios dos adolescentes quanto à pesquisa, a proteção dos familiares/cuidadores, a revelação do diagnóstico ao adolescente e a terceiros e o sigilo. O relato da experiência pretende contribuir para a discussão acerca das questões que envolvem a garantia dos aspectos éticos nas pesquisas. Palavras-chave: Síndrome da imunodeficiência adquirida. HIV. Saúde do adolescente. Ética em pesquisa. Enfermagem. ResumenÉtica en la investigación con adolescentes que viven con el VIH/SIDA El presente trabajo tiene como objetivo informar la experiencia de garantizar los aspectos éticos involucrados en la etapa de recolección de datos de los adolescentes que viven con el VIH/SIDA. Esto es un relato de la recolección de datos de dos investigaciones; una de un enfoque cuantitativo y diseño cruzado con 23 adolescentes y otra de enfoque cualitativo con 8 adolescentes. Para ambas, los criterios de participación de los adolescentes incluyen: estar en uso de la terapia anti-retroviral, saber sobre su diagnóstico y estar bajo tratamiento de servicio especializado. La garantía de principios éticos -autonomía, no maleficencia, beneficencia y justicia i...

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Section: Resultsmentioning

confidence: 99%

Ética na pesquisa com adolescentes que vivem com HIV/Aids

et al. 2015

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“…Three were principle investigators from the study centers, two were clinical study center coordinators, one was a representative of the Brazilian Society of Clinical Study Professionals (Sociedade Brasileira de Profissionais de Pesquisa Clinica-SBPPC), one was a representative of the Brazilian Association of Clinical Study Representative Organizations (Associação Brasileira de Organizações Representativas de Pesquisa Clínica-CRO), one was a regional director of clinical operations of the pharmaceutical industry and two were doctors responsible for conducting the studies in public and private reference hospitals. The interviews with the KIs were unstructured, conversational interviews [20,21]. They were recorded, transcribed, analyzed and provided information that could be used to develop interview questions for the clinical study subjects and to aid in understanding the discussions of the interviewed individuals [19].…”

Section: Methodsmentioning

confidence: 99%

Motives for participating in a clinical research trial: a pilot study in Brazil

2013

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BackgroundIn the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil.MethodsMixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing.ResultsThe motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study.ConclusionsThe present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

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“…However, it has undoubtedly become part of the new policies and financing procedures and in the approval of research projects, particularly those involving risk to human research subjects, in the majority of countries. 10,15,50 …”

Section: Basic and Applied Research Development And Innovation In Hementioning

confidence: 99%

Da produção à avaliação de tecnologias dos sistemas de saúde: desafios do século XXI

Novaes

2006

Rev. Saúde Pública

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The study analyzes factors and processes identified in the literature that determine the patterns of production, use and assessment of the health care technologies, which are part of the "medicalization" of contemporary societies. We also evaluate the scientific and technological public and health care policies proposed during the 1990s in developed and developing countries to enhance the impact of scientific and technological development on population health. Problems facing these policies were identified, as were the challenges to be overcome in the twenty-first century.

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Ética e pesquisa médica: princípios, diretrizes e regulamentações

Cited by 35 publications

References 1 publication

Ética na pesquisa com adolescentes que vivem com HIV/Aids

Ética na pesquisa com adolescentes que vivem com HIV/Aids

Motives for participating in a clinical research trial: a pilot study in Brazil

Da produção à avaliação de tecnologias dos sistemas de saúde: desafios do século XXI

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