Navigating Pandemic-Induced Delays in Exempted and Expedited Approvals by the Institutional Research Ethics Committee: An Insight From the Emerging Research Committee

Abstract

The pandemic that was followed by a lockdown situation afterward was something that had never happened suddenly in the past few years. Neither individuals nor institutions are ready to handle situations like this and must make some adjustments. The Institutional Research Ethics Committee (IREC) has also been affected and is still adjusting and dealing with challenges that arose during the pandemic (1,2). The IREC itself is a committee that reviews the methods and ethics of research projects involving human participants. They are also known as institutional review boards (IRBs) or research ethics boards (REBs). They aim to protect the safety and welfare of the research participants and ensure that the research meets the standards and regulations (3,4). Of course, this condition brings up a challenge for IREC to make a decision to approve a health research protocol (2,5-8).Bavdekar et al. previously recorded the challenges faced by IREC, which were divided into two troupes. They relate to the working area and the Standard Operating Procedures (SOP) (1). These two things are closely related. The challenges faced by IREC during the pandemic resulted in lag time approval for submitting a research protocol (1,9,10). The challenges related to the working area including circumstances of permission and scheduling the virtual meeting. While the use of instruments and technology could affect the SOP, including WiFi or ethernet connection (1,10,11). Lag time is the delay between submitting a research proposal and its approval by the ethical review boardIt can affect the quality and timeliness of the research outcomes. There are different types of review processes, such as exempted, expedited, or full review board, depending on the level of risk and complexity of the research (12). Exempted and expedited reviews are faster than full reviews, but they still require careful evaluation of the ethical aspects of the research (13).As an illustration, currently, there are more than ten ethics commissions in West Sumatra province registered with the central Health Research Ethics Committee. These ethics committees are based at the hospital as well as in academia. The Institutional Research Ethics Committee of the Faculty of Pharmacy, Universitas Andalas, is one of them. This ethics committee was established and has been officially operating since August 2022. Even though it has just been established, this ethics committee has qualified reviewers and experts in various research fields, especially those related to humans and other living individuals. Regulations regarding ethics commissions in Indonesia are contained in PMK No.7 year of 2016 (14,15) All ethical review activities are guided by the research ethics guidelines issued by the Council for International