Characterizing Ethical Compliance in Clinical Trial Proposals Based on Content Analysis of Research Ethics Committee Reviewers’ Comments on Proposals Submitted to the Research Ethics Committee of Iran University of Medical Sciences

Abstract

This study was conducted to assess the extent to which ethical considerations are addressed by researchers when developing clinical trial proposals, based on a content analysis of the comments made by reviewers of the Research Ethics Committee of Iran University of Medical Sciences. This qualitative, retrospective study was conducted using content analysis. First, approval was obtained from the Research Ethics Committee. Subsequently, proposals registered by investigators as clinical trials in Pajoheshyar (The comprehensive research management system of universities and research centers of Iran) during the two-year period from 2021 to 2022 were identified. The reviewers’ comments pertaining to each of the codes of interest were collected anonymously. Data were coded independently by two researchers. Data analysis was performed using MAXQDA 2020 software. A total of 401 proposals had been registered as clinical trials in Pajoheshyar at Iran University of Medical Sciences and had undergone ethical review. Of these, 273 required revision. The mean duration of the ethical review process, from submission of the proposal to receipt of the ethics approval code, was 53 days. The qualitative analysis yielded 15 main codes and 66 subcodes. The highest proportions of the ethical reviewers’ comments concerned informed consent (26.58%), study design and methodology (20.95%), and participant selection (9.19%), respectively. The findings of this study can help identify recurring ethical deficiencies in the design of clinical trials by researchers. The study highlighted the need for greater attention to certain ethical aspects of clinical trial design, particularly informed consent