[Factors related to the approval, development and publication of research protocols in a paediatric hospital]

Abstract

Background: Unpublished research is a frequent and reported problem. Objective. To analyze factors associated to approval, development and publication of research protocols submitted to Hospital Garrahan Institutional Review Board.

Method: Descriptive and observational study. The characteristics from every protocol submitted to the IRB (January/2001 to June/2006) were collected and a questionnaire was administered in order to explore the accomplishment of the study, meeting presentations, publications or mainspring for not-publication. We calculated OR and 95% CI to estimate what factors were related to the approval and the publication of the studies.

Results: 190 research protocols were evaluated; 125 (66%) were approved; 84 protocols were carried out (44%) and 40 (21%) were published. The approval was related to basic research (OR 8,6 95%CI 2.3-29) and fellowship participation (OR 9.4 95%CI 4-21.7); although, experimental design (OR 0.76 95%CI 0.61-0.96) and financial support by pharmaceutical industry (OR 0.19 95%CI 0.06-0.60) decreased approval odds. The main cause for not publication was the lack of time for the writing of the article. We have not found factors related to the publication.

Conclusion: From the presentation of a protocol up to its approval and publication there exists barriers that decrease progressively the possibility of completing the research.