Executive National Healthcare Group NHG, Singapore
Background: The Principal Investigator Self-Assessment (PISA) Programme, designed to enhance regulatory compliance and research conduct quality, faced operational challenges due to manual administration. PISA aims to familiarise PIs with IRB and regulatory requirements (e.g. Human Biomedical Research Act (HBRA) 2015) of proper research conduct. This impacted response rates from investigators, limiting the programme's effectiveness as a quality assurance tool.
Program
Description: The PISA programme encompasses self-assessment across key research domains: study team training, informed consent processes, participant recruitment, database management, investigational product handling, biological specimen management, and essential documentation compliance. To address challenges with PI response rates, the programme underwent a digital transformation by integrating with a new ethics review system online platform. This system allows seamless corporate login authentication, eliminating issues with regards to standalone credentials as in the old system. Additionally, this system features automated email notifications and reminders to selected PIs, utilising a common database with the Institutional Review Board (IRB) module on the same system to enhance programme efficiency. The digital platform also streamlines the self-assessment process, allowing for a comprehensive review of PI submissions. It facilitates efficient query management and response tracking within a unified interface.
Program
Assessment: Implementation of the programme on the new digital ethics review system platform yielded substantial improvements in response rates from new PIs, demonstrating enhanced programme outreach. The average response rate increased significantly from 51% to 79% within six months of digital implementation. Notably, while only one open-ended feedback was received in the year before implementation, there was an increase with 3 qualitative responses received in the subsequent 8 months. This overall increase in engagement suggests greater user participation and provides richer insights for continuous improvement. Furthermore, based on the responses received, PIs indicated having greater awareness of IRB and other regulatory requirements and reported improved ability to identify areas for research conduct enhancement. This validates the tool's effectiveness in promoting self-monitoring practices and strengthens our confidence that the PISA programme is serving its intended purpose. The centralised platform significantly reduced administrative burden, enabling efficient review processes and eliminating the need for email correspondence. The streamlined documentation system provides better visibility of historical interactions and responses, enhancing overall programme management.
Limitations: Limited understanding of programme objectives remains a fundamental barrier to participation, independent of the system platform used. While the new digital interface has reduced technical barriers and improved accessibility, there are still misconceptions about the programme’s purpose, with PIs confusing it with overlapping with existing audit processes or questioning the programme timeline. The length and readability of the assessment form were also identified as potential barriers to completion, indicating the need for refinement.
Discussion: The PISA programme's success demonstrates the value of user-centered design in quality assurance initiatives. By integrating self-assessment into investigators' existing workflow through a unified platform, we reduced resistance to participation due to technical barriers and provided easy reference to all existing research ethics activities. This approach aligns with broader QA strategies that embed compliance activities seamlessly into routine research operations. As a cornerstone of our risk-based Human Biomedical Research (HBR) Monitoring Programme, PISA exemplifies how digital transformation enhances regulatory oversight while reducing administrative friction. Other institutions can adopt this model by consolidating research ethics activities into unified platforms and ensuring seamless system integration. This model will be suitable for adoption by other organisations looking to enhance their quality management programmes while minimising administrative burden and increasing user engagement through streamlined, centralised access. Future enhancements will continue this user-centered approach, refining form design based on investigator feedback. This positions quality assurance as an enabler rather than impediment to research excellence.
