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

Unpublished research is a frequent and reported problem.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.

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.

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.

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