Analysis of problems with application for ethical approval of research projects to Institutional Review Board, Institute for Population and Social Research Mahidol University

Abstract

This study aimed to analyze characteristics of the research projects that applied for
ethical approval from the Institutional Review Board at the Institute for Population and Social
Research (IPSR-IRB) and to identify problems during application process. The study conducted
secondary analyses of data on ethical evaluation results of 891 research projects that were
submitted between 2019 and 2020. The data were analyzed using descriptive statistics
(frequencies and percentage) and then were presented in tables and charts.
The results showed that 59.5% and 45.5% of the research projects led by university’s
faculties and graduate students, respectively, failed at their first attempt to obtain the IPSR-IRB
approval. Two major problems underlying the failure were: 1) unclear research methodology,
particularly with regard to sampling design, sample selection and data collection methods, and
2) poor management to address ethical issues such as lack of or incomplete information in the
participant information sheet. In addition, some applicants lacked knowledge over preparation
of required documents before submitting to the IPSR-IRB and research experience. Therefore,
the findings of this study suggest institutional support for appropriate IRB training workshop for
researchers with varied knowledge and experience levels of research practice, through hand-on
learning. An IRB support team should use the ethical evaluation results to improve their work.