Perfil de sujeitos de pesquisa clínica em um centro ambulatorial independente

Lacativa, Paulo Gustavo Sampaio; Szrajbman, Miriam; Silva, Daniele Argentina Santos Morais da; Melazzi, Ana Cláudia Caucegli; Gregório, Luiz Henrique de; Russo, Luís Augusto Tavares

doi:10.1590/s1413-81232008000300025

Cited by 12 publications

(11 citation statements)

References 11 publications

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“…The questionnaires were developed after a literature search and customisation to the current study objectives 20 25 26. The literature on survey methodology was also reviewed with a focus on the guidelines for web-based surveys (Checklist for Reporting Results of Internet e-Surveys, CHERRIES) as well as for observational studies (Strengthening the Reporting of Observational Studies in Epidemiology, STROBE) 27 28.…”

Section: Methodsmentioning

confidence: 99%

Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Dainesi

Goldbaum

2012

J Med Ethics

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Section: Methodsmentioning

confidence: 99%

Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Dainesi

Goldbaum

2012

J Med Ethics

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“…In Brazil, the general perception is that the risks to study subjects are greater than the benefits, and the term “human guinea pig” is commonly used to describe clinical study participants [9]. …”

Section: Introductionmentioning

confidence: 99%

“…Despite the rigor of these interventions, the idea persists that study subjects in Brazil participate in clinical studies for the wrong reasons [9]. …”

Section: Introductionmentioning

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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“…The Census of Instituto Brasileiro de Geografia e Estatística (Brazilian Institute of Geography and Statistics -IBGE) 39 in the municipality of Niterói showed that 24% of the population have not completed elementary education, 12.7% of them have completed elementary education, 28.8% are high school graduates and 23.9% have a college degree. The population distribution is not the same found in this study, which reinforces the idea that the scenario under study does not reflect society as a whole, only the portion that seeks public health care.…”

Section: Comprehension Of Informed Consent In Clinical Researchmentioning

confidence: 99%

“…In a study conducted in a private research clinic in Rio de Janeiro, Lacativa 39 cites that 59% of respondents reported participating in a study to better understand their health problems and other diseases that they could develop and that only 21% of them participated because they either did not access to medical care or such access was difficult in their city.…”

Section: Comprehension Of Informed Consent In Clinical Researchmentioning

confidence: 99%

Compreensão do termo de consentimento em pesquisa clínica

Assumpção¹,

Pinto²,

Velarde³

et al. 2016

Rev. Bioét.

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The informed consent form (ICF) is a document which explicitly confirms the consent of a participant in a research project, and should contain all necessary information clarifying the study in which the subject intends to participate. This study evaluates the level of comprehension of an ICF signed by 146 volunteers using a self-administered instrument. The average age of the sample was 47.29 years, and there was a prevalence of women (67.2%), incomplete primary education (53.4%) and no private health care (93.2%). The mean score of correct answers of 146 respondents was 53.1%. There was no association between the percentage of correct answers and the variables of gender, age, education and time of response. There was a significant association between taking the ICF home and the percentage of correct answers. The average value of correct answers found was not acceptable and educational measures must be implemented, seeking an increase in comprehension and the safety of participants. Keywords: Informed consent. Comprehension. Human experimentation. ResumoCompreensão do termo de consentimento em pesquisa clínica O termo de consentimento livre e esclarecido (TCLE) é documento onde se explicita o consentimento do participante, contendo todas as informações necessárias para que seja elucidada a pesquisa da qual se propõe participar. O objetivo deste trabalho foi avaliar o nível de compreensão do TCLE assinado por 146 voluntários, utilizando instrumento de coleta de dados autoaplicável. A média de idade foi 47,3 anos, com prevalência de participantes do gênero feminino (67,2%), ensino fundamental incompleto (53,4%) e sem assistência privada de saúde (93,2%). A média de acertos foi 53,1%. Não houve associação entre o percentual de acerto e as variáveis gênero, idade, escolaridade e tempo de resposta. Houve associação significativa entre levar a via do TCLE para casa e o percentual de acerto. O valor médio de acertos evidenciou a necessidade de novas medidas educativas, buscando aumentar a compreensão e a segurança dos participantes. Palavras-chave: Consentimento livre e esclarecido. Compreensão. Experimentação humana. Resumen Comprensión del consentimiento informado en la investigación clínicaEl consentimiento libre, previo e informado (CLPI) es un documento en el cual se explicita el consentimiento del participante, conteniendo toda la información necesaria para la elucidación sobre la investigación en la cual se propone participar. El objetivo de esta investigación fue evaluar el nivel de comprensión del consentimiento informado firmado por 146 voluntarios utilizando un instrumento auto-aplicable para la recolección de datos. La edad promedio fue de 47,3 años, con prevalencia de participantes de género femenino (67,2%); educación primaria incompleta (53,4%) y sin cobertura privada de salud (93,2%). El promedio de aciertos de los 146 entrevistados fue de 53,1%. No hubo asociación entre el porcentaje de respuestas correctas y las variables de género, edad, educación y tiempo de respuesta. Hubo una asociación si...

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Perfil de sujeitos de pesquisa clínica em um centro ambulatorial independente

Abstract: This paper assesses the quality of assistance in a clinical trial outpatient center as well as the patients´understanding of the informed consent (IC);

Cited by 12 publications

References 11 publications

Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

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

Compreensão do termo de consentimento em pesquisa clínica

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