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OBJECTIVE: To study the content and mechanism of the US Food and Drug Administration (FDA)in balancing information disclosure and confidentiality, and make recommendations for China. METHODS: The design and mechanism of information disclosure and confidentiality balance system has been explored from the development of FDA information disclosure and confidentiality. RESULTS: The United States has a strict legal and regulatory system. New drug application has series measures to ensure FDA balance information between disclosure and confidentiality, such as active disclosure, request for information and non-public information, FDA IT system security plan, CDER expert network information disclosure, review and confirming of confidentiality provisions in FDA published articles or public speeches. CONCLUSION: It is suggested that China introduce the information disclosure and confidentiality clause in upper law, establish information disclosure procedure, and adopt internal information security measures.
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China's pre - hospital emergency resources are shortage, city traffic is congestion, and the arrival of ambulance takes some time. For this reason, the emergency center designed and manufactured a pre - hospital e-mergency volunteer mobile application software. This paper analyzed some ethical problems encountering in the practical application of the software in the 120 emergency alarm of Hangzhou area, such as volunteer identification, patient information confidentiality, volunteer rescue whether to cause a dispute and other issues, and gave the rele-vant solution countermeasures, including setting access threshold for the emergency volunteer, adopting various technical measures to protect the information of patient and formulating and perfecting the relevant legal regulations.
RESUMEN
O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira
Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual's willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn't know the type of study they participated in, 38,6% didn't know about the research they participated, 64,7% didn't receive information regarding other types of treatment, 62,7% didn't have information about compensation, 66,2% didn't read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population