ABSTRACT
Objective. To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Methodology. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Results. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term ''placebo'' was mentioned by some participants. The motivation to participate was the personal benefit. Conclusion. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.
Objetivo. Comprender la percepción que tienen los participantes de los ensayos clínicos controlados (ECC) sobre el consentimiento informado y describir el significado de su participación en la investigación. Metodología. Estudio cualitativo que utilizó la técnica de grupo focal. La muestra estuvo constituida por 19 pacientes, quienes participaron en ensayos clínicos sobre hipertensión y enfermedad coronaria en un hospital especializado en cardiología en la ciudad de São Paulo. El referencial metodológico utilizado fue el análisis de contenido. Resultados. Algunos participantes tenían consciencia de la real naturaleza de estas investigaciones mientras otros tenían impresiones equivocadas. La lectura del consentimiento informado no siempre es realizada y cuando esta se hace el paciente no entiende su contenido. La falta de comprensión de lo que era el ''placebo'' fue mencionada por algunos participantes. La motivación en participar se centró en el beneficio personal. Conclusión. Este estudio muestra que la obtención del consentimiento informado en ECC es complejo y que hay necesidad de realizar adecuaciones en la estructura y aplicación del documento, con el fin de proteger a los participantes y mejorar la calidad de las investigaciones clínicas realizadas en el país.
Objetivo. Compreender a percepção que têm os participantes dos ensaios clínicos controlados (ECC) sobre o consentimento informado e descrever o significado de sua participação na investigação. Metodologia. Estudo qualitativo que utilizou a técnica de grupo focal. A mostra esteve constituída por 19 pacientes que participaram em ensaios clínicos sobre hipertensão e doença coronária num hospital especializado em cardiologia na cidade de São Paulo. O referencial metodológico utilizado foi a análise de conteúdo. Resultados. Alguns participantes tinham consciência da real natureza destas investigações enquanto outros tinham impressões equivocadas. A leitura do consentimento informado não é sempre realizada e quando esta se faz o paciente não entende. A falta de entendimento do que era o ''placebo'' foi mencionada por alguns participantes. A motivação em participar se centrou no benefício pessoal. Conclusão. Este estudo mostra que a obtenção do consentimento informado em ECC é complexo e que há necessidade de realizar adequações na estrutura e aplicação do documento, com o fim de proteger aos participantes e melhorar a qualidade das investigações clínicas realizadas no país.
Subject(s)
Female , Humans , Male , Middle Aged , Clinical Trials as Topic/psychology , Consent Forms , Informed Consent/psychology , Brazil , Clinical Trials as Topic/methods , Comprehension , Focus Groups , Motivation , PerceptionABSTRACT
BACKGROUND & OBJECTIVES: In India, phase-I human clinical trials for a preventive HIV vaccine are being conducted at Pune and Chennai Centres. In order to find out the willingness of populations at risk to participate in future preventive HIV vaccine trials (HIVVTs) and to assess the factors that enhance or deter them from participation, a study was conducted at Chennai and Madurai in Tamil Nadu. METHODS: This cross-sectional study was conducted among transport workers, people attending sexually transmitted infection clinics, injection drug users, men having sex with men, women in sex industry and a representative sample of monogamous married women, by employing measurement scales. A structured questionnaire on knowledge and attitudes about the HIV vaccine was used to measure the participants' knowledge and attitudes about HIV vaccine and HIVVTs. RESULTS: Of the 112 participants, 67 (60%) were men. Mean age of the respondents was 32 yr; 68 per cent were high school educated. Majority of respondents were willing to participate in a future HIVVT and the reasons were altruism, protection from HIV, and support for the researchers. Major concerns were vaccine efficacy, side effects of the vaccine and the impact of a HIV vaccine on the participants' lives. Majority (85%) agreed that sex without condom would not be safe despite the availability of an HIV vaccine. INTERPRETATION & CONCLUSION: It is likely that high-risk volunteers will be willing to enroll in HIVVTs. Barriers and concerns should be dealt with carefully by providing correct information. Also there is a need for more education to ensure participants' understanding of key concepts of HIV vaccine trial.
Subject(s)
AIDS Vaccines/immunology , Acquired Immunodeficiency Syndrome/prevention & control , Adult , Attitude , Clinical Trials as Topic/psychology , Cross-Sectional Studies , Female , Humans , Knowledge , Male , Pilot Projects , Sex Characteristics , Sexual BehaviorABSTRACT
The informed consent process has become a universal requirement for research involving human subjects. Its goal is to inform volunteers regarding research in order to make decision to participate or not. This study aimed to measure volunteers' comprehension levels concerning the clinical trial and to find out factors associated with that comprehension levels. Eighty-one volunteers who enrolled in a malaria clinical trial were recruited into the study. A semi-structured questionnaire was used to collect the information. Non-participant observation was used to observe the process of informed consent. Volunteers were interviewed three days after being recruited into the trial. The results show the volunteers' comprehension was low. Only 44% of volunteers had an acceptable level of comprehension. It also revealed that 20 volunteers were not aware of being volunteers. Most volunteers knew about the benefits of participating in the trial and realized that they had the right to withdraw from the study, but not many knew about the risks of the trial. The results indicated the method of informing about the trial affected the volunteers' comprehension level. No relationship was found between comprehension level and volunteers' socio-demographic characteristics and their attitude toward the consent process. The findings from this study demonstrate volunteers who participated in the clinical trial were not truly informed. Further studies regarding enhancing volunteers' understanding of the trial are needed.