Deadline: 21 November 2019
The European and Developing Countries Clinical Trials Partnership (EDCTP) is currently accepting proposals for its 2019 Ethics and Regulatory Capacities Programme to support sub-Saharan African countries to establish and/or develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies in humans, as well as national and international collaboration in compliance with established, internationally acceptable good practices.
This scheme targets projects with the active involvement of NECs and/or NRAs from countries with both weak and strong ethics and regulatory capacities in sub-Saharan Africa.
The objectives of this call are to:
- Improve the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
- Promote quality control systems and process for NECs and NRAs, certification and accreditation of the various bodies, as well as adherence to international standards;
- Promote international cooperation in ethics and regulatory activities through the transfer of promising and successful innovative systems and/or technologies from other regions outside Africa and within Africa, fostering national and regional collaboration among these bodies;
- Strengthen linkages between ethics and regulatory functions with other important structures, such as clinical trial registries and systematic reviewers whilst simultaneously enforcing the sharing of data in compliance with global requirements;
- Promote the adoption and update of AVAREF, WHO, and other international standards and best practices by countries, groups of countries, or regional harmonisation initiatives;
- Support already established training centers to provide both innovative training and mentorship to NECs and NRAs.
This call will support proposed actions that address one or preferably more of the objectives outlined above. Proposals should include support for development or scale-up of innovative systems and technologies that support ethics and regulatory functions, training, networking and promotion of good practices and evidence-based adoption of accreditation models from relevant internationally endorsed/peer-reviewed documented sources.
- The call budget is 3 million EUR.
- The requested EDCTP contribution per project should not exceed 500,000 EUR. The funding level is 100% of eligible costs.
Projects funded under this call for proposals should:
- Contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’;
- Strengthen the functionality, recognition, and performance of NECs and NRAs in sub-Saharan African countries to ensure that the clinical trials meet the appropriate standards and generate principles that will contribute towards harmonised oversight for certification of ethics and regulatory bodies from both weak and strong countries.
- Contribute towards the development of sustainable strategies for both NECs and NRAs, strengthen linkages between these bodies and other important structures, such as clinical trial registries and systematic reviewers, and sharing of data in compliance with global requirements.
- Provide lessons that will inform continental or regional certifiers of ethics committees and regulatory agencies on how to formalise their function in sub-Saharan Africa.
- Involve NECs and/or NRAs from sub-Saharan African countries not previously funded under the EDCTP2 programme.
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 for participation set out below, depending on the type of action:
- At least one legal entity established in a Participating State or a sub-Saharan African country;
- Applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries;
- ‘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.
- The requested funder contribution per action shall not exceed EUR 500,000.
- The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
- The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Equatorial Guinea, 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, and Zimbabwe.
How to Apply
Interested applicants should submit their proposals online through the EDCTPgrants via given website.
For more information, please visit http://www.edctp.org/call/ethics-and-regulatory-capacities-2019/