Table 1 Recommendations and suggested actions from the Workshop

• Recommendation 1 - A national standard operating procedure (SOP)for emergency response ethical review should be developed by and adopted by (N)RECs and/or in-country competent authority.

Suggested action - Regional workshops should be held with the aim of drafting a “model SOP” for emergency response ethical review for adaptation and adoption at country level and/or through sub-regional mechanisms.

• Recommendation 2 - The group recommended clarifying the terminology and expectations of pre-review, pre-approval, generic protocols etc., and proposing specific terminology that could be agreed upon (in multiple languages when appropriate, and at a minimum in English, French and Spanish).

Suggested action - A paper should be drafted that explores and clarifies the terminology and expectations of pre-approval, and which proposes specific terminology.

• Recommendation (3a) - Mechanisms should be explored for (regional) multi-country emergency ethical consultation to support rapid review at country level.

Suggested action - WHO should lead a process for a consultation on “multi-country rapid ethics review” in competent and legitimate fora, involving sub-regional mechanisms as appropriate.

• Recommendation (3b) - The role of WHO in multi-country ethical review in Public Health Emergencies of International Concern (PHEICs) and “other similar emergencies” (as for wording used during the workshop) should be clarified

Suggested action - WHO should define the scope of “other similar emergencies” and carry out regional consultations on the proposal for WHO supported review of multi-country research during PHEIC and “other similar emergencies”.

• Recommendation 4 - Emergency SOPs should include procedures for communications between (N)RECs and other key national stakeholders e.g. National Regulatory Authorities, Public health authorities, and between (N)RECs and relevant research stakeholders.

Suggested action - Procedures for communications between (N)RECs and other key stakeholders should be specified in the “model SOP” (see Action 1).

• Recommendation 5a - (N)RECs should request at a minimum, as part of a broader benefit sharing plan, a preliminary data sharing and sample sharing plan that outlines plans for how the results of the research and the samples will be made available for public health and other purposes, and first and foremost for the benefit of the population (countries) from which they were drawn. It is acceptable for the preliminary data and sample sharing plan to contain uncertainties when the health emergency is rapidly evolving and the need for research is urgent.

Suggested action - The requirement for submission of preliminary and full data and sample sharing plans should be specified in the “model SOP” (see Action 1).

• Recommendation 5b - (N)RECs should require applicants to submit a full data sharing and sample sharing plan within a defined period that lays out in detail how the results of the research and the samples will be made available for public health and other purposes, and first and foremost for the benefit of the population (countries) from which they were drawn.

Suggested action - The requirement for submission of preliminary and full data and sample sharing plans should be specified in the “model SOP” (see Action 1).

• Recommendation 6 - (N)RECs should engage with relevant national authorities (MoH, environment e.g. Nagoya protocol, Legal experts etc.) to ensure that MTAs are ethically sound.

Suggested action - An inventory should be conducted of resources used by (N)RECs related to MTAs.