Office of Human Research Protection Programme National Healthcare Group, Singapore
Background: : In Singapore, public healthcare human subject research is reviewed by the NHG DSRB (Domain Specific Review Board) and the SingHealth CIRB (Centralized Institutional Review Board). When COVID hit in 2020, there was demand for pre-existing systems to facilitate cooperative reviews. This catalyzed the agreement to codevelop a new IRB IT platform -ECOS (Ethics & Compliance Online System) that enables research ethics review from cradle to grave. Today, ECOS services all 3 local public healthcare clusters with 10,000 local studies and 30,000 users on board.
Program
Description: : To co-create a new IRB review system between two different healthcare clusters, Multiple endorsements and approvals were Essential. Although necessary to ensure that the security of the infrastructure, user relatedness, data management, financial viability and sustainability are proper and appropriate, it added Time pressure on the project team. Detailed Coordination between the clusters, committee secretariat, the local healthcare IT project manager (Synapse) was necessary to ensure each committee approvals completed Timely without impeding on project delivery.
Program
Assessment: : Whilst the original plan was to procure an off-the-shelf product, this was shelved as no vendor could deliver that. A bespoke system had to be created, requiring much more resource and commitment from both clusters. The Existing IRB team had to carry on BAU ethics review work and design the requirements of the new system concurrently. Also, the current review forms used by SingHealth and NHG are different. Massive effort went into streamlining requirements and concurrence on workflows.
The project was awarded to a well-established vendor which had developed extensive products for the China market. Although the primary project business language is English, the application was usually written first in Chinese and then translated into English. This necessitated validation of translated documents before it can be used by business users for review, straining the delivery timeline. Mitigation measures include pre-planning for multiple iterations of reviews, ensuring adequate time by each stakeholder to review, and involving vendor management in weekly project meetings.
Limitations:: An extensive data Migration effort proceeded to relocate thousands of studies into the new system. Challenges include differences between old and new system forms, Multiple form versions, changing study status and limited staff to check on Migration scripts. As the Migration can only proceed after new system forms were available, this also constrained the data Migration period, adding further stress on the project.
Discussion: : With reference to the ECOS development journey, future IRB system developers should plan for adequate time to obtain funding and management approvals, buffer for specification requirement clarifications and potential communication challenges that come when working with cross border vendors. In addition, we recommend that thought goes into bringing in contract staff to support the study migration work and change management and to augment the IRB staff strength to avoid build-up of reviews and avoid staff burnout.
