The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey [version 1; peer review: 2 approved]
Department of Pharmacology & Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, 400012, India
Lisa Amir
Forum of Indonesian Recognized Ethics Committees (FIRREC), Jakarta, 10430, Indonesia
Yashashri Shetty
Department of Pharmacology & Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, 400012, India
Sudha Ramalingam
Department of Community Medicine, PSG Institute of Medical Sciences and Reseach, Coimbatore, 641004, India
Phanthipha Wongwai
Clinical Coordination and Training Center, Forum for Ethical Review Committees in Asia and the Pacific (FERCAP), Thammasat University, Pathum Thani, 12120, Thailand
Edlyn B. Jimenez
National Institutes of Health, University of the Philippines Manila, Manila, Metro Manila, 1000, Philippines
Cristina E. Torres
National Institutes of Health, University of the Philippines Manila, Manila, Metro Manila, 1000, Philippines
Arthur M. Navarro
Clinical Coordination and Training Center, Forum for Ethical Review Committees in Asia and the Pacific (FERCAP), Thammasat University, Pathum Thani, 12120, Thailand
Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.
