Characterization of Factors Predicting a Favorable Opinion of Research Applications Submitted for an Ethical Review Process
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Show full item recordEditorial
Frontiers
Materia
Research Ethics Committee (REC) Research applications Predictors Informed consent Leadership and mentoring Research methodology and ethics COVID-19 Spain
Date
2022-06-16Referencia bibliográfica
Mirpuri E... [et al.] (2022) Characterization of Factors Predicting a Favorable Opinion of Research Applications Submitted for an Ethical Review Process. Front. Med. 9:878786. doi: [10.3389/fmed.2022.878786]
Sponsorship
Call for Aids - Autonomous Government of La Rioja, Spain COV21-DONAC1/id.proy.1110; Rioja Health Foundation FRS-CEIMLAR-2022Abstract
Introduction: In Spain, biomedical research applications must receive a positive ethical
opinion from Research Ethics Committees (RECs) before being executed. There is limited
information on how to optimize the ethical review process to reduce delays. This study
was performed to characterize variables predicting favorable opinions at the first ethical
review performed by a REC.
Material and Methods: The study assessed all research applications revised by
a REC in 2019–2020. Data was extracted from REC’s database of La Rioja, Spain.
Variables collected covered three areas: (i) principal investigator’s profile; (ii) study design;
and (iii) ethical review process. A model based on multiple logistic regression analysis
was created to identify variables explaining favorable opinions in first rounds of ethical
review processes.
Results: The sample included 125 applications (41 submitted in 2019, and 84 in 2020).
At the first review, nine (7%) applications were rejected, 56 (45%) were approved, and
the remaining 60 (48%) required at least two reviews prior to approval. When comparing
both years, a 2-fold increase in the number of applications submitted, and a difference
in the ratio of applications with a favorable vs. non-favorable opinion were observed.
Furthermore, a model predicted 71% of probability of obtaining a favorable opinion in
the first ethical review. Three variables appeared as being explanatory: if the principal
investigator is either the group leader or the department’s head (OR = 17.39; p < 0.001),
and if the informed consent (OR = 11.79; p = 0.01), and methods and procedures (OR
= 34.15; p < 0.001) are well done.
Conclusions: These findings confirm an increase in the number of submissions and
a difference in the ratio of applications approved by year. Findings observed also
confirm deficiencies in “informed consent” and in “methods and procedures” are the two main causes of delay for favorable ethical opinions. Additionally, findings highlight
the need that group leaders and heads of departments should be more involved in
guiding and supervising their research teams, especially when research applications
are led by less experienced researchers. Based on these findings, it is suggested that
an adequate mentoring and targeted training in research could derive in more robust
research applications and in smoother ethical review processes.