EDCTP announces CFPs for Ethics and Regulatory Capacities

Deadline: 16 July 2020

The European & Developing Countries Clinical Trials Partnership (EDCTP) is seeking proposals for the Ethics and Regulatory Capacities.

The purpose of this Call for Proposals is to fund projects that are designed to support SSA 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 active involvement of NECs and/or NRAs from countries with both weak and strong ethics and regulatory capacities in SSA.

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;
To promote quality control systems and process for NECs and NRAs, as well certification and accreditation of the various bodies, as well as adherence to international standards;
To promote international cooperation in ethics and regulatory activities through 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 centres 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.

Countries should clearly indicate their mismatch between disease burden, research activity and level of regulation that justify the need for support in the areas of ethical and regulatory oversight.

Each project should have at least two new technical staff members recruited to the NEC/NRA team and trained in the new functions proposed in the actions. The proposal should clearly describe the new functions for which the new staff members are to be trained and the expected outputs and outcomes for the individuals recruited.

Due to the extraordinary global crisis of COVID-19 that is also affecting African countries, this topic should also be considered by applicants.

Funding Information

The call budget is EUR 2.5 million.
The requested EDCTP contribution per action should not exceed 500,000 EUR.
The funding level is 100% of eligible costs.

Duration

The maximum duration of the project is 24 months with a foreseen start date of 1 October 2021 or earlier.

Expected Impact

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 SSA 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 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 SSA.

Eligibility Criteria

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.
- ‘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.
- Applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries.
- The requested EDCTP contribution per action shall not exceed EUR 500,000.
- The maximum duration of the project shall be 24 months.

Evaluation Criteria

The following aspects are considered under the evaluation criteria:

Excellence
- Fit with the scope and objectives of the EDCTP programme, the EDCTP Association strategic research agenda and the call topic description.
- Importance, relevance/pertinence, and clarity of the objectives.
- Soundness of the concept and credibility of the proposed approach/methodology.
- Clarity, pertinence and importance of the strategic vision
- Soundness of the concept.
- Quality of the proposed coordination and/or support measures.
Impact
- Call-specific aspects as listed under ‘expected impact’ in each individual call.
- The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic.
- Likelihood to result in major advances in the field with potential benefit of the research to the affected populations.
- Effectiveness 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, where relevant.
- Sustainability of capacity beyond the end of the grant, where relevant.
- Contribution to networking, where relevant, including alignment with national, regional and/or pan-African development plans, and with other actors intervening in the same field.
- Communicate the project activities to different target audiences.
Quality and efficiency of the implementation
- 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).
- Quality of the leadership and a clear and effective governance structure.