Bridging the gap between researchers and patients: The role of the Institutional Review Boards in the informed consent process

Abstract

Background: The Institutional-Review-Boards (IRB) frequently give unfavorable opinions to evaluated studies due to deficiencies in informed consent forms (ICFs), which delays the ethical approval of the study and increases waste in research. Objective: To analyze the extent to which IRB in our center gives unfavorable opinions due to documents deficiencies and to evaluate types of objection. Material and methods: Retrospective observational study of decisions during the first review by the IRB in our center (2012-2015). We carried out a systematic review of minutes when decisions on approval of studies are collected. If not approval, we analyzed appealed objections. Results: 1858 clinical studies were evaluated by the IRB. 1558 required informed consent for participating (83.9%, CI95%:82.1-85.5), 987 were not approved during the first review due to deficiencies in ICFs (63.3%, CI95%:60.9-65.7). The main causes of objections for non-approval were unreadability (11.7%, CI95%:10.6-12.9), inadequate information given about access to personal data rights (9.2%, CI95%:8.1-10.2), biological samples management (7.8%, IC95%:6.9-8.8), and expected benefits (7.6%, IC95%:6.7-8.6). Conclusions: Deficiencies in ICFs are an important reason for non-approval of protocols evaluated by an IRB. There are three fundamental weaknesses on which the IRB plays a key role: 1) improving readability; 2) adapting them to regulations concerning data protection and biological materials management; 3) avoiding misleading information towards enrollment.