Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Lobato, Lucas; Gazzinelli, Maria Flávia; Gazzinelli, Andréa; Soares, Amanda Nathale

doi:10.1590/0102-311x00127813

Cited by 6 publications

(7 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The limited understanding of information contained in the informed consent form may influence the voluntariness of an individual’s decision to participate [ 8 ]. In this sense, the results of the questionnaire related to knowledge about the clinical trial discussed above suggest that the informed consent obtained in Americaninhas may have been relatively compromised in relation to the voluntary decision to participate, in comparison to other places.…”

Section: Discussionmentioning

confidence: 99%

“…Regarding the desire to enroll in the clinical trial, we found that most participants actively wished to participate; however, paradoxically, in Americaninhas, half merely “tolerated” participation. This contradiction might be attributed to two factors: a difficulty in understanding the question, despite the care taken during questionnaire preparation and implementation; or, a limited voluntariness in the decision-making process, resulting from a lack of understanding of the information about the trial, third-party influences, or the level of trust in the researchers [ 8 ]. Another aspect that may be associated with limited voluntariness and that may help to explain this contradiction is the notion that participation in the clinical trial might improve one’s health.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries

et al. 2017

Self Cite

View full text Add to dashboard Cite

Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants’ understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively), which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001). Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, res...

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries

et al. 2017

Self Cite

View full text Add to dashboard Cite

show abstract

“…The difficulty of obtaining an ethically valid FPIC can also be a problem in pediatric research in Brazil, because of the country's low socioeconomic levels [21][22][23][24][25] . In Brazil, where the research participant's rights are explicitly protected by national resolution 6 , it is essential to evaluate the ethical quality of the FPIC for participants in biomedical pediatric research.…”

Section: Children's Knowledge Of the Terms Of Informed Assentmentioning

confidence: 99%

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Lobato

Gazzinelli²,

Pedroso³

et al. 2016

Rev. Bioét.

Self Cite

View full text Add to dashboard Cite

The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants. Keywords: Informed consent. Research, ethics. Child-Adolescent-Comprehension. Bioethics. Resumo Conhecimento de crianças sobre o termo de assentimento livre e esclarecidoEste estudo tem como objetivo descrever o conhecimento de crianças e adolescentes sobre as informações divulgadas pelo termo de assentimento em pesquisa clínica pediátrica, além de relatar as atitudes dos participantes. Trata-se de estudo experimental com abordagem quantitativa, realizado em municípios do Nordeste de Minas Gerais com 142 participantes de 7 a 15 anos, escolhidos para estudo clínico sobre esquistossomose. Essas crianças e adolescentes participaram do processo de assentimento, com a utilização do termo correspondente. Avaliaram-se os participantes com questionário semiestruturado. O conhecimento médio dos participantes sobre as informações da pesquisa foi 41,22%, com apenas 1,4% apresentando alto grau de conhecimento. Concluiu-se que a maioria das crianças desconhece as informações sobre a investigação e seus direitos enquanto participantes de pesquisa. Palavras-chave: Consentimento livre e esclarecido. Ética em pesquisa. Criança-Adolescente-Compreensão. Bioética. Resumen Conocimientos de los niños sobre el documento de consentimiento libre e informadoEste estudio tiene como objetivo describir los conocimientos de los niños y adolescentes sobre la información divulgada por el documento de consentimiento en la investigación clínica pediátrica, además de describir las actitudes de los participantes. Se trata de un estudio experimental con un enfoque cuantitativo, llevado a cabo en ciudades del noreste de Minas Gerais, Brasil, con 142 participantes, de 7 a 15 años de edad, seleccionados para un estudio clínico sobre esquistosomiasis. Estos niños y adolescentes participaron en el proceso de consentimiento mediante el documento de consentimiento correspondiente. Se evaluó a los participantes con un cuestionario semiestructurado. El conocimiento promedio de los participantes sobre la información de la encuesta fue del 41,22%, siendo que solo un 1,4% presentó un alto grado de conocimiento. Se concluye que la mayoría de los niños desconoce las informacione...

show abstract

“…(4) This question had a significant association when related to the professional who informed the patient (p=0.009), and in relation to the patient's sex (p=0.046). Another study (15) that aimed to evaluate patients' understanding of the information in the FICF by 143 patients showed that there was no correlation between sex and level of knowledge of the information in the document; however, the language used was directly correlated to their understanding. The text should conform to the intellectual level of the population served; in the case of Brazil, it must not exceed the level of primary education.…”

Section: Discussionmentioning

confidence: 99%

“…Data from one study show that the majority of participants in a clinical trial signed the FICF without sufficient knowledge of the study information, and were influenced in their decision to participate in the study. (15) Most of the patients surveyed denied feeling ashamed of asking questions about the FICF and the proposed surgical procedure, and claimed that they were not afraid of the professional who presented the FICF, with a significant relationship with the professional who informed the patient being observed (<0.001). In another study (18) carried out with adolescents, none of the patients interviewed said that they were afraid of the professional, or even the proposed procedure, but only the possible damages inherent to the treatment, such as pain.…”

Section: Discussionmentioning

confidence: 99%

Termo de consentimento informado: entendimento do paciente cirúrgico

et al. 2016

View full text Add to dashboard Cite

Objective: To know surgical patients' understanding of the free and informed consent form (FICF). Methods: Cross-sectional study conducted with patients in the immediate postoperative period of different surgical procedures. Intentional sample. Data were collected by means of a questionnaire with Likert type responses, and analyzed through descriptive and analytical statistics. Results: Of the 374 patients evaluated, 36.4% underwent surgical procedures on the musculoskeletal system, and 35.3% received the FICF from a non-medical professional (secretary). The patients agreed that they understood the information written on the FICF (44.7%), that the information was clear (59.6%), that doubts were clarified (57%), and that they knew the function of the FICF (59.6%). Only 28.6% of patients confirmed that they had obtained a signed copy of the FICF. Conclusion: Most participants understood the written information on the FICF, but it is necessary to expand this understanding to all patients, as well as provide a copy of the signed document. ResumoObjetivo: Verificar o entendimento dos pacientes cirúrgicos em relação ao Termo de Consentimento Informado (TCI). Métodos: Estudo transversal, realizado com pacientes em pós-operatório mediato de diferentes procedimentos cirúrgicos. Amostra intencional. Dados coletados por meio de questionário com respostas do tipo Likert, e analisados através de estatística descritiva e analítica. Resultados: Dos 374 pacientes avaliados, 36,4% foram submetidos a procedimentos do sistema musculoesquelético e 35,3% recebeu o TCI de profissional não médico (secretária). Os pacientes concordam que compreenderam as informações escritas do TCI (44,7%), que as informações foram claras (59,6%), que houve esclarecimento de dúvidas (57%) e que sabia qual era a função do TCI (59,6%). Somente 28,6% dos pacientes concordaram que obtiveram uma cópia do TCI. Conclusão: A maioria dos participantes compreendeu as informações escritas no TCI, mas é preciso ampliar esse entendimento para todos os pacientes, bem como disponibilizar a cópia do TCI para todos.

show abstract

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Cited by 6 publications

References 43 publications

A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries

A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Termo de consentimento informado: entendimento do paciente cirúrgico

Contact Info

Product

Resources

About