Preparing ethical review systems for emergencies: next steps | BMC Medical Ethics

Nevertheless, significant challenges remain: some arising directly out of the emergency context, and others illustrating how unresolved issues within ethical review (in particular how best to review multi-site and multi-country studies) arise in particularly acute form in emergencies. Common experiences from research ethics committees around the globe, shared at the Lisbon meeting, included:

Extraordinary pressure on both national and local-level research ethics committees, with very high numbers of applications to review, coupled with similarly high numbers of amendments to existing studies in order to comply with COVID-related public health restrictions. The intense nature of the working environment was compounded by competing professional commitments for those involved, social and researcher pressure to ‘do something’, and in some cases strong political pressures to approve studies regardless of ethical or scientific concerns. Such pressures lead to burn-out, particularly when sustained over an extended period.

Inadequate resourcing, over and above existing well-recognised limitations in many countries. The large increases in funding made available for research as part of the emergency response to COVID-19 did not trickle through to review processes, despite the enormous increase in the number of applications, and the expectations of rapid response.

Capacity challenges, particularly for committees with less experience of reviewing complex trial designs, innovative methodologies, and multi-country studies. Inevitably these challenges were particularly acute for committees that were already inadequately resourced and supported.

Difficulties in negotiating the opportunity costs inherent in prioritising COVID-19 related studies. While establishing a separate ad hoc committee for fast-track reviews could be helpful, identifying which studies should be expedited for review was not straightforward, especially given concerns as to how many registered clinical trials for COVID-19 interventions were inadequately powered to produce reliable results [13, 14]. The scope for potential research waste raises difficult questions for research ethics committees, and highlights the responsibilities of other stakeholders to act earlier in the research process to prioritise and co-ordinate research proposals from a public health perspective.

The variable quality of studies, including data and tissue management plans that lacked clarity or detail because of pressure of time. It was reported that at times inadequate expert scientific scrutiny before studies were submitted for ethical review increased the burden of scrutiny on research ethics committees.

Co-ordinated review of multi-site studies in-country: while some countries reported how such studies were referred directly to a designated committee (including, for example, in Brazil, Panama, Barbados, Egypt, New Zealand), national strategies of this kind were far from universally in place and implemented. As already recommended by PAHO and widely implemented in Latin America [15], there is an urgent need for all countries to devise and implement a national (or subregional, or provincial, as relevant) strategy to organize ethics review in emergencies, and allocate responsibilities, in ways that minimise duplication and delay, particularly for multi-site studies. Such strategies also need to be able to account for how ethical issues specific to particular sites will be appropriately handled.

Co-ordinated review of multi-country studies: where multi-site studies also involve multiple countries, ensuring effective and timely review remains even more challenging, including also scope for tension between national and WHO-level review. The African Vaccine Regulatory Forum (AVAREF) has developed a model, whereby delegates from a number of participating countries come together in a joint meeting to discuss a protocol, with decisions then being delivered by the relevant committee in each country within an agreed timescale, informed by a shared understanding of the proposal [16]. Alternative possible models include exploration of circumstances in which mutual recognition by ethics committees of each other’s judgments could be acceptable. More ambitiously still, future consideration could be given to the creation of regional committees (or even a global committee) with a specific mandate to review protocols for research in emergencies on behalf of participating countries, coupled with the option of local review with respect to site-specific factors. In order to be successful, such an initiative would, however, require willingness to achieve any necessary legislative change at the level of national jurisdictions. Research on different models of research ethics cooperation is urgently needed in order to foster innovation and evaluate different models. Such approaches also need to be sensitive to the heterogeneity and diverse contexts of different ethics committees.