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Table 1 Examples of how responsive and effective ethical review was achieved for COVID-19 studies, shared by attendees at the Lisbon meeting

From: Preparing ethical review systems for emergencies: next steps

At the national level, the rapid development of national strategies played a key role in facilitating effective ethical review, including through setting out the respective roles of different levels of committee, and providing procedural and substantive guidance for individual ethics committees. Brazil and Panama, for example, rapidly implemented national strategies for allocating review requests, and then adjusted these in the light of experience. Brazil retained all clinical trials for review at national level without prior local review; Panama initially reviewed all COVID-19 studies centrally but then shifted to a system of delegation for studies considered less high risk. New Zealand had systems up and running within two weeks, based on existing WHO/ALERRT guidance and recommendations, while within one week Portugal had adopted new strategies to facilitate expedited assessment of COVID-19 research. India produced detailed national guidelines for its ethics committees by April 2020, and these were subsequently downloaded in over 45 countries

At the operational level, some committees succeeded in achieving very rapid turn-around times for the review of COVID-related studies. Examples shared included: 2–3 days in Brazil; 2–5 days in Portugal; 3 days in Barbados; 5 days in Egypt, 7 days in South Africa, and 7 days in Iran. Approaches used either at strategic or operational level included:

• Adopting more flexible systems, including making effective use of email and online meetings, and supporting more ad hoc communication with Principal Investigators (PIs) to minimise time-wasting ‘back and forth’ between applicant and committee (many countries). Building on this, New Zealand is exploring pre-review of applications, sharing summarised initial comments from either the secretariat or the committee members with the PI in advance of meetings, with the aim of facilitating a more constructive dialogue in the meeting itself

Simplifying procedures and documentation for multinational COVID-19 clinical trials with permission for incomplete submissions (for example lacking national documentation) to be updated at a later stage (Portugal)

• Bringing different forms of expertise into committees, ensuring that members had the necessary technological confidence to operate online, and allowing for alternate members in order to share the time commitment and enable rapid response (India)

Compensating committee members to ensure availability of reviewers (Singapore)

• Improving communication with regulatory bodies: for example members of the Iranian National Research Ethics Committee participated in scientific review meetings, thus ensuring they had better understanding of the protocols before they came to the NREC, while for some studies a member of the national regulatory authority sat as an observer in NREC meetings

The opportunities offered by the Lisbon summit in supporting regional as well as global cooperation were also emphasised. Fifteen participants from the African Region, comprising representatives of the WHO regional office and members of some national ethics committees held a regional side-event to deliberate on support for the establishment of national ethics committees in all the countries in the region and the contributions African countries could give to support bioethics globally. It was resolved that a regional summit of national ethics committees should be held in the African Region for the first time, focusing on the theme: “Preparing African Research and Ethics for the next pandemic”