Divulgação na mídia e recrutamento dos participantes de pesquisa
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Data
2019-07-29
Autores
Aragão, Silvana Francisco Noé
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
Os patrocinadores de pesquisas clínicas necessitam de um grande cuidado no recrutamento de participantes da pesquisa, em razão de seu estado de vulnerabilidade neste cenário. Neste sentido, os pesquisadores devem seguir aspectos fundamentais na condução dos protocolos de pesquisa como seguimento dos padrões nacionais e internacionais de boas práticas clínicas em pesquisa (BPCs). A comunicação de novas pesquisas utiliza de grandes veículos bem como propaganda direcionada para o recrutamento de voluntários ou sujeitos de pesquisa. O conhecimento e desenvolvimento de estratégias adequadas de recrutamento promovem melhor desempenho nas inclusões dos estudos clínicos, possibilitando ganho de tempo e dinheiro pelos patrocinadores do estudo, bem como, maior probabilidade de participação destes pacientes. Apesar disto, questões éticas e que protejam os pacientes são de extrema importância para se evitar a exploração destas pessoas que muitas vezes são humildes e de baixa renda. No Brasil, a resolução nº 251 de 1997 do Conselho Nacional de Saúde – Ministério da Saúde destaca a necessidade de descrever claramente as formas de recrutamento. A Comissão Nacional de Ética em Pesquisa (Conep), em seu Manual Operacional para Comitês de Ética em Pesquisa (CEP), apresenta entre vários pontos, a avaliação da vulnerabilidade dos participantes de pesquisa, a garantia de liberdade de decisão à participação, a necessidade do desenho científico claro apresentando susceptibilidade aos riscos e possibilidade de benefícios e praticabilidade da execução do protocolo. O presente estudo teve por objetivo realizar a elaboração, diagramação e publicação de um guideline de divulgação na mídia e recrutamento dos participantes de pesquisa clínica. Guideline – guia, é um conjunto de declarações , direções ou princípios, apresentando regras. Assim, foi realizada ampla consulta nos guidelines da ANVISA, FDA e EMA, bem como, a busca por artigos no PUBMED, SCIELO, LILACS e Google Schoolar relacionados ao recrutamento de participantes de pesquisa e a divulgação midiática dos estudos clínicos com chamamento. Foi elaborado um guideline para facilitar, o processo dos pesquisadores envolvidos na pesquisa clínica, diante das situações referentes à pesquisa com seres humanos, durante uma entrevista com a imprensa, divulgação na mídia e recrutamento. Espera-se que este trabalho ajude a novos pesquisadores e centros e pesquisa clínica a realizar o recrutamento de participantes da pesquisa de maneira clara, rápida, direta, ética e dentro da legislação vigente
Clinical research sponsors need great care in recruiting research participants because of their vulnerability in this scenario. Researchers should follow key aspects for the smooth conduct of research protocols as a follow-up of national and international standards of good clinical practice in research (GCPR). The communication of new researches uses large vehicles as well as targeted advertising for the recruitment of volunteers or research subjects. The knowledge and development of adequate strategies promote better performance in the inclusion of clinical studies, improvement save time and money on the sponsors of study, as well as a higher probability of participation in these patients. Despite this, ethical issues and patient protection are of the utmost importance to avoid the exploitation of these people who are often humble and low-income. In Brazil, Resolution No. 251 of 1997 of the Health National Council - Ministry of Health highlights the need to describe clearly the forms of recruitment. The National Commission for Research Ethics (Conep), in its Operational Manual for Research Ethics Committees (CEP), presents, among several points, the evaluation of the vulnerability of research subjects, the guarantee of freedom of decision to participation, the need of the clear scientific design presenting susceptibility to the risks and possibility of benefits and feasibility of the execution of the protocol. Guideline - guide, is a set of statements, directions or principles, presenting rules.The purpose of this study is to prepare a diagramation and publication of a guideline for dissemination in the media and recruitment of clinical research subjects. Will be generated a clinical research guideline and your preferences to better communicate with human search situations during a interview with press, media outreach, and recruitment. For this purpose, ANVISA, FDA and EMA guidelines will be consulted, as well as the search for articles in PUBMED, SCIELO, LILAC and Google Schoolar. It is hoped that this work will help new researchers and clinical research centers to recruit research participants in a clear, fast, direct and ethical way.
Clinical research sponsors need great care in recruiting research participants because of their vulnerability in this scenario. Researchers should follow key aspects for the smooth conduct of research protocols as a follow-up of national and international standards of good clinical practice in research (GCPR). The communication of new researches uses large vehicles as well as targeted advertising for the recruitment of volunteers or research subjects. The knowledge and development of adequate strategies promote better performance in the inclusion of clinical studies, improvement save time and money on the sponsors of study, as well as a higher probability of participation in these patients. Despite this, ethical issues and patient protection are of the utmost importance to avoid the exploitation of these people who are often humble and low-income. In Brazil, Resolution No. 251 of 1997 of the Health National Council - Ministry of Health highlights the need to describe clearly the forms of recruitment. The National Commission for Research Ethics (Conep), in its Operational Manual for Research Ethics Committees (CEP), presents, among several points, the evaluation of the vulnerability of research subjects, the guarantee of freedom of decision to participation, the need of the clear scientific design presenting susceptibility to the risks and possibility of benefits and feasibility of the execution of the protocol. Guideline - guide, is a set of statements, directions or principles, presenting rules.The purpose of this study is to prepare a diagramation and publication of a guideline for dissemination in the media and recruitment of clinical research subjects. Will be generated a clinical research guideline and your preferences to better communicate with human search situations during a interview with press, media outreach, and recruitment. For this purpose, ANVISA, FDA and EMA guidelines will be consulted, as well as the search for articles in PUBMED, SCIELO, LILAC and Google Schoolar. It is hoped that this work will help new researchers and clinical research centers to recruit research participants in a clear, fast, direct and ethical way.
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Palavras-chave
divulgação, mídia, pesquisa clínica, recrutamento, participantes da pesquisa, dissemination, media, clinical researc, recruitment, research participants