Adapting the ethical review process for COVID-19 research: reviewers’ perspectives from Pakistan

Abstract

Background: Research ethics committees (RECs) globally have adapted their responses to provide timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National Bioethics Committee (NBC) of Pakistan has followed suit. Aims: To explore perceptions of NBC-REC reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR) system. Methods: This cross-sectional study used 3 methods of data collection: a demographic questionnaire filled in by permanent members and co-opted reviewers; qualitative in-depth interviews conducted with both groups; and document review related to COVID-19 research proposals. Results: Eight permanent members and 3 co-opted members participated. Under the RTR system, the time for review was established as 72 hours after receipt of the proposal. The Committee reviewed 55 projects over 10 months. Participants described numerous strengths of the new system, including introduction of online discussions via Zoom as well as presence of co-opted members leading to learning opportunities, particularly for junior members. The RTR system also allowed NBC-REC to gain recognition it had not enjoyed previously. Challenges identified by respondents included initial difficulty in initiating the system and tighter deadlines that may have compromised review quality. Poor scientific quality of proposals, compounded by external pressures to provide rapid approval, added to reviewers’ frustrations. While fruitful, the RTR system was considered unsustainable beyond a public health emergency. Conclusion: Adaptation of ethical review processes is essential in emergencies, however, existing guidelines have to be modified to suit contextual needs.

Challenges faced by ethics committee members in India during COVID-19 pandemic: A mixed-methods exploration

“…However, a study among EC members in China 13 recorded that although the risks were perceived to be potentially more to the individual participants, the long-term benefits to the society at large were considered greater. Although the pressure for issuance of quick approvals was felt and expressed as a need of the pandemic time, it was not perceived as political pressure as reported in the investigations conducted in other countries 14 15 .…”

Research ethics review during the COVID-19 pandemic: An international study

“…Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [17], China [18], Ecuador [19], Egypt [20], Germany [21], India [22–24], Iran [10], Ireland [25], Kenya [26], Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34–36]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs.…”

“…Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34][35][36] Conversely, several ERCs availed themselves of international guidelines (Box 2), in particular those prepared by WHO [37][38][39][40] and PAHO [41][42][43][44].…”

WHO’s support for COVID-19 research and knowledge management in the Eastern Mediterranean Region

“…20 Four regional webinars on ethics in research in the context of COVID-19 were conducted during 2020, in collaboration with bioethics, WHO collaborating centres and representatives of national ethics/bioethics committees in EMR countries. 21 Moreover, the work plans of these WHO collaborating centres were amended to fit COVID-19 response, particularly in the fields of bioethics, infection prevention and control, non-communicable diseases and mental health. 22 Excess mortality and health information system support All-cause mortality registration systems are key to determining the actual impact of the COVID-19 pandemic on human life.…”

“…In spite of the dire need for local evidence to be generated on the EMR’s response to the COVID-19 pandemic, all proposals recommended for WHO funding (eg, RPPH, migration health and IHR proposals referred to earlier) passed through two tiers of ethical review, that is, national/institutional ethical review and WHO’s regional ethical clearance, using expedited review processes for research during emergencies 20. Four regional webinars on ethics in research in the context of COVID-19 were conducted during 2020, in collaboration with bioethics, WHO collaborating centres and representatives of national ethics/bioethics committees in EMR countries 21. Moreover, the work plans of these WHO collaborating centres were amended to fit COVID-19 response, particularly in the fields of bioethics, infection prevention and control, non-communicable diseases and mental health 22…”