ABSTRACT
Covid-19 continues to teach the global community important lessons about preparedness for research and effective action to respond to emerging health threats. We share the COVID-19 experiences of a pre-existing cross-site ethics network-the Global Health Bioethics Network-which brings together researchers and practitioners from Africa, Europe, and Southeast Asia. We describe the network and its members and activities, and the work-related opportunities and challenges we faced over a one-year period during the pandemic. We highlight the value of having strong and long-term empirical ethics networks embedded across diverse research institutions to be able to: 1) identify and share relevant ethics challenges and research questions and ways of 'doing research';2) work with key stakeholders to identify appropriate ways to contribute to the emerging health issue response – e.g., through ethics oversight, community engagement, and advisory roles at different levels;and 3) learn from each other and from diverse contexts to advocate for positive change at multiple levels. It is our view that being embedded and long term offers opportunities in terms of deep institutional and contextual knowledge, existing relationships and access to a wide range of stakeholders. Being networked offers opportunities to draw upon a wide range of expertise and perspectives, and to bring together internal and external insights (i.e.drawing on different positionalities). Long term funding means that the people and resources are in place and ready to respond in a timely way. However, many tensions and challenges remain, including difficulties in negotiating power and politics in the roles that researchers and research institutions can and should play in an emergency, and the position of empirical ethics within research programmes. We discuss some of these tensions and challenges and consider the implications for our own and similar networks in future.
ABSTRACT
Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. Methods: A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. Results: Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process where one protocol was submitted to multiple review committees simultaneously . The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee's target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening and testing procedures; and the challenges of study design and community engagement during the pandemic. Conclusions: The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.
ABSTRACT
Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. Methods: A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. Results: Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process where one protocol was submitted to multiple review committees simultaneously . The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee’s target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection;COVID-19 prevention, screening and testing procedures;and the challenges of study design and community engagement during the pandemic. Conclusions: The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.