Current COVID-19 outbreak has shaken almost all aspects of health. Pakistan is lower middle income country where health system is fragmented due to chronic state of underinvestment in health. Provision of basic health care during the current COVID-19 outbreak remains daunting task. Ethics and regulatory systems are not fully mature [1] to keep pace with the challenges associated with the surge in research related to this novel disease. Local Research Ethics Committees or Institutional Review Boards (collectively referred to as IRB in the remainder of this communication) work in somewhat decentralized way. National Bioethics Committee (NBC) Pakistan is the major, official body to uphold the bioethical principles in all sectors of health-care in the country [2]. It provides guidance for ethical review and provides periodic trainings for IRBs via national level research ethics committee (REC) however national level guidelines and regulations are silent on few of the key aspects which are related to research in both pandemic and non-pandemic situations. Although several international guidelines and regulations exist to guide the operations of IRB in line with ethical principles, the functioning of IRBs are subject to national guidelines, legislation and regulation which refine their structure and function to better serve local needs [3, 4]. During current COVID-19 outbreak, NBC developed guidance primarily describing on how it reviews COVID-19 research however local IRBs were not synchronized in any way [5]. As a result, local IRBs in Pakistan continue to work at their own adapting varying processes and timelines. Review of multicenter research by local IRBs and NBC continued in an uncoordinated fashion. Ethics preparedness emerged as a priority area for debate during ongoing pandemic covering a broad spectrum of challenges including ethics review of studies during pandemics promoting coordinated, efficient and comprehensive review. It has been reported to improve quality and efficiency of healthcare research by decreasing costs and time, and inefficiencies and uniform implementation of safety regulations for proposed intervention [6]. Work done in response to previous emergencies has clearly established the need to develop national standard operating procedure to guide ethics review process during global health emergencies and prepare in between the global health emergencies to deal with any future happening [7]. Unfortunately we were not prepared till the current pandemic hit the world. Building capacity for efficient and coordinated ethics review process is urgently needed especially in countries like Pakistan where ethics review works in decentralized manner and the time is now.
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2. http://nbcpakistan.org.pk/
3. Ekmekci PE, Guner MD. Inconsistencies in institutional review board decisions: A proposal to regulate the decision-making process.. Bratisl Lek Listy 2019; 120: 95–101.
4. Stepke FL. WORLD HEALTH ORGANIZATION Standards and operational guidance for ethics review of health-related research with human participants. Acta bioethica 2012; 18: 129–32.
5. http://nbcpakistan.org.pk/assets/rec-1.2-tors.pdf
6. Timmers M, van DJTJM, van WRPJ, et al.. How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.. BMC Med Ethics 2020; 21: 36.
7. Saxena A, Peter Horby and, Amuasi J, et al.. Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel. BMC Medical Ethics 2019; 20
Farah Asif. Ethics Review Preparedness During COVID-19 Outbreak and Local IRBs in Pakistan, The Forgotten Part . Annals of Clinical and Medical Case Reports 2020