Mobilisation of research funds in case of Public Health Emergencies
The EDCTP “Emergency Funding Mechanism” allows rapid mobilisation of research funding without a call for proposals in exceptional and duly substantiated emergencies. EDCTP considers a situation as an emergency if it is unforeseen and presents a serious and immediate risk to human health. The “Emergency” status will be adopted only after an official declaration of a situation as 1) a Public Health Emergency of International Concern (PHEIC) according to the World Health Organization, or 2) a public health emergency under Decision 1082/2013/EU or 3) an emergency under applicable national frameworks and regulations.
Following the Ebola Virus Disease (EVD) outbreak in the Democratic Republic of Congo (DRC) which was reported by the Ministry of Health to WHO on 1 August 2018, WHO has been monitoring the outbreak and producing External Situation Reports. As of 29 August 2018, WHO assessment considers the public health risk to be high at the national and regional levels and low globally. In the light of rising numbers of cases being reported in the DRC and the high public health risk, the EDCTP Association has agreed to activate the emergency funding mechanism to support Research and Innovation Actions as part of the European response to the emergency.
EDCTP invites proposals for Research & Innovation Actions to support research activities in DRC and neighbouring countries to manage and/or prevent the spread of the current EVD outbreak in DRC. Proposals must demonstrate the following:
- Addressing urgent research questions in the context of the current EVD outbreak
- Alignment with the national priorities of the DRC and neighbouring countries
- Partnership with researchers and institutions in DRC and neighbouring countries
- Strengthening of national and local research capacity
- Coordination and collaboration with other research and/or humanitarian activities operational in the countries affected
- Alignment with the WHO R&D Blueprint for rapid activation of R&D activities during epidemics
- Compliance with International Council on Harmonisation – Good Clinical Practice (ICH-GCP), regulatory and ethical standards
- Commitment to open access and data sharing principles.
Proposals should provide novel, critical and timely insights into the EVD outbreak and/or potential avenues for its management or prevention. Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established and/or to access time-dependent resources.
The following priorities have been identified:
- Clinical trials for therapeutics
Proposals should include products from the Monitored Emergency Use of Unregistered Interventions (MEURI) list. Evidence of regulatory and ethics approvals for all investigational products included in the study(ies) must be presented.
- Diagnostics for screening and identification of affected individuals
Proposals should enhance the availability and rapid deployment of diagnostic tools in order to ensure improved surveillance, including active case finding, case investigation, contact tracing and surveillance at Points of Entry (PoE).
- Clinical and epidemiological studies
Proposals should provide data on epidemiological characteristics such as geographical spread, viral genotype, and pathogenicity; clinical information on host susceptibility and host immune responses.
EDCTP considers that proposals for activities of between 6 and 24 months duration would allow this specific challenge to be addressed appropriately.
Proposals funded under this mechanism should answer the most pressing questions raised by responders to Public Health Emergency, as part of the efforts to manage and prevent the spread of the current EVD epidemic. Proposals should result in new knowledge to manage and prevent future outbreaks and should strengthen the capacities of at-risk countries to respond to epidemics.
Proposals funded under this mechanism must share the generated data within 30 days after generation, with all parties that need and can use the findings to address the declared Public Health Emergency.
A proposal/application will only be considered eligible if:
- its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
- it complies with the eligibility conditions set out below, depending on the type of action:
- Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities shall be established in two different Participating States (European Partner States)(1) and one of the legal entities must be established in a sub-Saharan African country(2). All three legal entities shall be independent of each other.
- ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.
(1) The following European countries are EDCTP Participating States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom.
(2) The following African countries are eligible: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe.
Procedure and application process
Single-stage application procedure with expedited review. Proposals must be submitted by 10 September 2018.
Evaluation, scoring and thresholds
Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.
The following aspects are considered under the evaluation criteria:
The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the work plan:
- Fit with the scope and objectives of the call topic description, the EDCTP2 Programme, and the EDCTP strategic research agenda
- Importance, relevance/pertinence and clarity of the objectives
- Soundness of the concept and credibility of the proposed approach/methodology
- Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) or research study now
- Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial
- Extent that the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally
- Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge.
The following aspects will be taken into account:
- The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to the expected impacts listed in the call and the EDCTP2 workplan under the relevant topic
- Likelihood to result in major advances in the field
- Advancing the clinical development of new and improved products.
- Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results
- Contribution to improved disease management and prevention through changes in policy, with the ultimate goal of improving public health
- Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials
- Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data.
- Quality and efficiency of the implementation
The following aspects will be taken into account:
- Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables
- Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met
- Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise
- Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role
- Feasibility and appropriateness of the methods and project management to achieve the objectives within the time frame of the grant
- Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues
- Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s)
- Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP)
- Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial
- Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).
Proposals will be subject to an expedited review procedure by an expert panel convened by EDCTP within 10 days of the deadline for proposal. There is no right to reply to the expert assessments (rebuttal procedure) and applicants will receive only the summary scores from the proposal evaluation.
The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 multi-beneficiary grant agreement) within three months of receipt of the evaluation outcome letter. All participants in the action must sign a consortium agreement prior to signature of the grant agreement. Project activities may commence immediately and prior to signature of the EDCTP2 grant agreement(1).
- The application form must be submitted online via EDCTPgrants (uploaded as a pdf)
- Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible.
(1)The starting date for successful projects may be fixed as a date before the entry into force of the grant agreement (GA), i.e. before the GA is signed by both parties. The earliest possible starting date for the action (project) is the date of submission of the proposal. If the consortium (via the coordinator) requests a fixed starting date before the entry into force of the GA, it (the consortium) assumes the risks implied by starting the action before the GA is signed, in particular not being reimbursed for the costs incurred (e.g. in case that the proposal is not successful or that the GA is not signed).
Documents and other information
- Application form (PDF)
- Template for essential information to be provided for proposals including clinical studies (Word)
- For questions related to this call for proposals, please contact: Jean Marie Vianney Habarugira firstname.lastname@example.org
- For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via email@example.com
- For guidance on online application procedure, please refer to the Guidance for applicants
- For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual and EDCTP2 FAQs
- EDCTP2 policy on clinical trials registration, publication and data sharing (PDF)
- Global Code of Conduct for Research in Resource-Poor Settings (PDF)