4 Diseno de Estudios - Material y Metodo
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Transcript of 4 Diseno de Estudios - Material y Metodo
Materiales y Métodos
Describir, en secuencia lógica, el diseño y ejecución del estudio y análisis de los datos
Permite reproducir el estudio
Validez interna
Tipos de estudios
Observacionales
Describen
Comparan
Asocian
Experimentales
Miden propiedades
Miden eficacia / efectividad
Diseño de estudios
Es el procedimiento mediante el cual
• se mide un evento o • verifica una hipótesis
Tipos de estudios
Observacionales
Describen > Descriptivos
Comparan
Asocian > Analíticos
Experimentales
Miden propiedades > In vitro
Miden eficacia / efectividad > Clínicos
Partes de la sección MM
1. Sujetos
2. Diseño
3. Materiales, aparatos y procedimientos
4. Análisis estadístico
5. Validez y fiabilidad del método
Partes de la sección MM
• Población objetivo
• Población fuente
• Población elegible
• Muestra
• Criterios de I/E
• Reclutamiento
Sujetos
Diseño
Materiales, aparatos y procedimientos
Análisis estadístico
Validez y fiabilidad del método
Partes de la sección MM
• Tipo de estudio– Estudio observacional
• Descriptivo• Analítico
– Estudio experimental• In vitro• Animal• Clínico
– No aleatorio– Aleatorio
» Ciego» Doble ciego
Sujetos
Diseño
Materiales, aparatos y procedimientos
Análisis estadístico
Validez y fiabilidad del método
Partes de la sección MM
• Marca, Fabricante, Ciudad, País
• Posologias
Sujetos
Diseño
Materiales, aparatos y procedimientos
Análisis estadístico
Validez y fiabilidad del método
Uso de seres vivos
Estudios clínicos > Comité de ética (WMA)
Estudios animales
Uso de tejidos
¿Cuándo NO se necesita?
• Undergraduate projects with an education, training, or a practical experience focus do not normally require approval. Student coursework, assignments and essays are also exempt.
• Use of information freely available in the public domain.
• Research about a living individual involved in the public arena (including artists) based exclusively on publicly available information, documents, records, works, performances, public archives or third-party interviews.
• Studies of public behaviour that are purely observational (non-invasive and non-interactive), such as standing in a public place and noting the actions of passers-by. Ethics review is required if the disclosure of recorded observations identifies individuals (names, photographs) and places them at risk of harm, stigma or prosecution.
• Purely observational studies (with no element of intervention) in established educational settings, involving normal educational practices, researching current instructional strategies; or research on the effectiveness of instructional techniques, curricula, or classroom management.
• Testing within normal educational requirements and in accordance with a host institution’s normal practices and approvals.
• Quality assurance/audit projects that do not involve access to or collection of private, sensitive or health data.
• Education, training and practical classes among students, which do not involve students learning through testing procedures on each other.
• Evaluation Cycle Surveys of University staff and students, including student evaluation of teaching.
• Taste and food quality evaluation and consumer acceptance studies, if the food consumed is (i) wholesome without additives or (ii) contains a food ingredient, agricultural chemical or environmental contaminant, for a purpose and at a level declared safe by the relevant national food safety agency.
Fuente: http://www.research.unimelb.edu.au/humanethics/aboutapproval/whenapproval
Formato Comité de ética
1. Who are the participants or informants?
2. Vulnerable Groups
3. Participant recruitment details:
4. In EVERY-DAY or LAY LANGUAGE please provide a summary of the project – including aims and benefit: This section MUST be completed in LAY LANGUAGE.
5. Give details of the research plan
6. Give details of the ethical considerations
7. How will informed consent be obtained from participants or informants?
8. Provide details of procedures for establishing confidentiality and protecting privacy of participants or informants
9. Provide details of data security and storage
10. In what form will the data be collected
11.Give details of how feedback will be available to participants or informants
12.….
Partes de la sección MM
Sujetos
Diseño
Materiales, aparatos y procedimientos
Análisis estadístico
Validez y fiabilidad del método
