Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic

Abstract

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Recruiting underrepresented individuals in a double pandemic: Lessons learned in a randomized control trial

“…Other delays may be explained by changes to IRB policies as the research landscape shifted during the COVID-19 pandemic. Consistent with our experiences, research has shown that IRB offices were prioritizing reviews of COVID-related research and changes in protocols for research that was shifting from in-person to online [26]. However, it should be noted that not all delays were caused by the COVID-19 pandemic as 9 of the 21 (43%) institutions that began the sIRB process prior to the onset of the COVID-19 pandemic in the USA were onboarded to the sIRB before March 2020.…”

“…Consistent with our experiences, research has shown that IRB offices were prioritizing reviews of COVID-related research and changes in protocols for research that was shifting from in-person to online. 26 However, it should be noted that not all delays were caused by the COVID-19 pandemic as 9 of the 21 (43%) institutions that began the sIRB process prior to the onset of the COVID-19 pandemic in the United States were onboarded to the sIRB before March 2020. We were also surprised that some institution IRBs administered detailed reviews rather than abbreviated reviews prior to or even after ceding to a single IRB.…”

Managing the risks and benefits of clinical research in response to a pandemic

“…centers (AMCs). For example, electronic case report forms and consents are now standard operating procedures while regulatory processes have been streamlined and harmonized to maximize productivity and improve safety [12,13].…”

Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya

“…Some of the ethics issues identified in this study align with COVID-19 literature around virtual informed consent and the need to stay up to date with published data during an evolving pandemic to inform study designs 32,39 . During the Ebola outbreak, different ethics issues were raised in review of protocols such as on storage of blood samples for future use and the exclusion of pregnant women in clinical trials 30 .…”

“…Joint review is described as a way of streamlining different review processes into a single comprehensive review with multiple bodies to expedite time to study implementation 30,31 . A process similar to joint review described for ethics review committees in the United States of America during COVID-19 was perceived to improve overall review efficiency 32 . Other than the reported successes of the WHO's Africa Vaccine Regulatory Forum 33 , there is little evidence of joint review in previous health emergencies in low resource settings.…”