Calls for proposals: Ethics and regulatory capacities

Background
Many partners contribute towards the establishment and capacity strengthening of ethical review frameworks and medicines regulatory bodies, as well as mapping, coordination, and where appropriate, practical, harmonisation of their processes in sub-Saharan Africa. Ensuring sustainable development, country ownership and collaboration among external partners are some of the key elements required to support ethics and regulatory functions in SSA.

The EDCTP Association has dedicated its efforts to ensure that all sub-Saharan African countries hosting clinical trials have functional and effective ethics and regulatory review structures at institutional, national and regional levels. The current strategy promotes strengthening and collaboration of national ethics committees (NECs) and National Regulatory Authorities (NRAs) to allow for long-term development plans towards strong regional collaboration and harmonisation goals.

Despite ongoing efforts by different partners and agencies, ethics and regulatory oversight in sub-Saharan African countries requires targeted attention to address the following gaps:

1. Growing amount and complexity of research activities in the African region requiring better systems and technologies (including digitisation) to improve harnessing of external expertise, processing of review of research applications, handling of documentation, as well as data handling and its analysis;
2. A better understanding of the needs and challenges facing countries with varying levels of clinical trial activity, and tailoring interventions;
3. A growing need for quality control, certification and accreditation of ethics and regulatory bodies, and adherence to common international standards; and
4. A growing need for efforts towards open data access and the need to promote linkages between ethics and regulatory functions with clinical trial registration and systematic research reviews.

Open date10 April 2020, 00:00

Close date16 July 2020, 17:00

Budget€2.5 million

Funding level100% of eligible costs

Scope
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 accepted 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:

1. 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;
2. To promote quality control systems and process for NECs and NRAs, as well as certification and accreditation of the various bodies, as well as adherence to international standards;
3. To 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;
4. 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;
5. Promote the adoption and update of AVAREF, WHO, and other international standards and best practices by countries, groups of countries, or regional harmonisation initiatives;
6. 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.

Linkage of the project to other on-going initiatives, such as the Regional Centres of Regulatory Excellence in Africa (1), WHO-TDR-SIDCER (Strategic Initiative for Developing Capacity in Ethical Review), Africa Vaccines Regulators Forum (AVAREF), Pan African Clinical Trials Registry (PACTR); African Medicines Regulatory Harmonisation (AMRH) and regional bodies, such as Africa Centre for Disease Control and Prevention (CDC), and WHO-AFRO is encouraged and should be demonstrated in the application. Plans to foster bi-lateral links between the European Medicines Agency (EMA) and the national regulatory authorities in SSA are also encouraged.   

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

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

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
A proposal/application will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. 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(2) or a sub-Saharan African country(3). 
   • ‘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 (4).
   • The requested EDCTP contribution per action shall not exceed EUR 500,000.
   • The maximum duration of the project shall be 24 months.

Apply here https://www.edctpgrants.org/
http://www.edctp.org/call/ethics-and-regulatory-capacities-2/