[Adequacy of informed consent in clinical research: A descriptive cross-sectional study].

Abstract

Introduction and objectives: The principle of patient autonomy in the participation and incorporation of their health data in research projects is a legal and deontological obligation that must be fulfilled. The aim of this study was to know the degree of compliance and adequacy of informed consent in clinical research projects in a university hospital.

Material and methods: Through this cross-sectional study, the adequacy of the way patient data are obtained in the research projects presented to the Research Committee of a university hospital was analyzed. The adequacy of the way patient data were obtained in the research projects, dealing with informed consent and causes of exemption, was described with their frequencies distributions. It was assessed by means of the adjusted odds ratio through a backstep logistic regression model, including the predictable significant variables previously analyzed in the univariant analysis.

Results: A total of 565 protocols were included. The most frequent type of studies assessed were observational retrospectives (49.6%) and end-of-year projects (28.1%). The most frequent way of obtaining the patient data were by means of soliciting exemption of informed consent (48.3%). Obtaining the patient data process was considered appropriated in 51.1% of the projects. Projects with higher adequacy were those solicited by students (OR=4.2; CI_95%=2.0-8.8) and residents OR=3.0; CI_95%=1.2-2.4).

Conclusions: The majority of the projects assessed was retrospective observational studies in which exemption of informed consent was solicited. Projects with higher adequacy were solicited by students and residents.