QUALITY IMPROVEMENT OF POSTGRADUATE MEDICAL PROTOCOL (PMP) SUBMITTED TO NATIONAL MEDICAL RESEARCH REGISTRY (NMRR), MALAYSIA

Abstract

Postgraduate medical protocols (PMPs) collectively represent approximately 20% of the total number of medical research protocols approved by Medical Research & Ethics Committee (MREC) in 2012. Previous studies found most of these PMPs required further amendment upon an initial MREC review, which led to a delay in obtaining ethical approval. Therefore, this cross-sectional study aimed to identify the weaknesses of PMPs submitted for ethical approval. Present findings demonstrated the three main weaknesses identified in research protocols are the lack of description for (i) study design, (ii) total number of subjects planned to be enrolled and (iii) subject’s exclusion criteria; each with error rates of 21%, 20% and 13%, respectively. In addition, the two main weaknesses found in patient information sheets/ informed consent forms (PIS/ICFs) are the lack of description for (i) compensation in the event of trial related injury and (ii) anticipated trial expenses; each with error rates of 16% and 15%, respectively. Hence, this paper provides an in-depth discussion of how to improve the development of both research protocols and PIS/ICFs based on the five common weaknesses identified in this study. It also aims to serve as a useful guide for medical students to develop quality PMPs which are both ethical and scientifically-sound by adhering to all the applicable regulatory requirements.