Reasons for resubmission of research projects to the research ethics committee of a University Hospital in São Paulo, Brazil
Clinics
;
64(9): 831-836, 2009. tab
Artículo
en Inglés
| LILACS
| ID: lil-526321
ABSTRACT
INTRODUCTION:
It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation.OBJECTIVES:
To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee.METHOD:
This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo.RESULTS:
One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5 percent concerned research with new drugs, vaccines and diagnostic tests, 48.5 percent consisted of undergraduate students' research projects, 68.9 percent of the research had no sponsorship, and 97.5 percent were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2 percent), lack of information about the protocol at the informed consent form (25.8 percent), as well as doubts regarding methodological and statistical issues of the protocol (77.1 percent). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support.CONCLUSION:
Among the ...
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Proyectos de Investigación
/
Comités de Ética en Investigación
/
Investigación Biomédica
/
Formularios de Consentimiento
Tipo de estudio:
Guía de Práctica Clínica
/
Estudio observacional
/
Estudio de prevalencia
/
Estudio pronóstico
/
Factores de riesgo
Límite:
Animales
/
Humanos
País/Región como asunto:
America del Sur
/
Brasil
Idioma:
Inglés
Revista:
Clinics
Asunto de la revista:
Medicina
Año:
2009
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade São Paulo/BR
Similares
MEDLINE
...
LILACS
LIS