Research protocol amendments at Makerere University College of Health Sciences Research Ethics Committees during the COVID-19 pandemic : a retrospective documentary analysis

Abstract

Background: It is an ethical and regulatory requirement globally, that protocol amendments are approved by the Research Ethics Committee before they are implemented to eliminate an apparent risk to the participants and to ensure smooth implementation of research. The COVID-19 pandemic led to disruption of several activities including research processes. However, it is not known to what extent the pandemic prompted protocol amendments. Objective: The study aimed to understand the reasons, frequency, nature, and responses of the Research Ethics Committees to applications for protocol amendments at Makerere University College of Health Sciences one year before and a year after Uganda introduced COVID-19, prevention and management restrictions. Methods: A desk review was used to retrospectively abstract data from protocol amendment requests submitted to Research Ethics Committees one year before and one year after COVID-19 restrictions were put in place by the Government of Uganda. A data abstraction template was used to code data for analysis using STATA version 15. Results: There were 259 protocol reviews and 345 amendments in the 2-year study period. During the one-year prior to COVID-19 pandemic, there were 140/259 (54%) reviews for a two-year total and contributed 201/345 (58%) amendments registered in the study period. One year after the introduction of COVID-19 prevention and management restrictions there were 46% reviews (119/259) and contributed 42% (144/345) amendments. During the two-year study period, there was a steady increase in uncommon reasons for which researchers sought amendments. The most prevalent reasons included informed consent (24%), the need to modify study tools at (11%), change of study sites at (10%), and the need to revise compensation at post the implementation of the COVID-19 mitigation measures. Other reasons included the need to collect more data/information, change of guidelines/regulations/laws and organizations, the need to adjust study budgets, sample storage plans of specimen, data safety and protection plans. When Uganda introduced the countrywide COVID-19, prevention and management restrictions, the RECs implemented new mandatory prevention requirements for conducting research during the pandemic. This was accompanied by a remarkable shift from regular Research Ethics Committee review meetings to expeditious individual member assigned amendment reviews as an approval mechanism. Conclusion: During the COVID-19 pandemic, there was a drop in the number of protocol reviews but researchers had a great need to implement project amendments. During this challenging context, the Research Ethics Committees’ attempt to cope with the heightened burden, may have led to the observed increase in irregular ethical research practices.