Ethics and regulatory capacities – 2020

Description

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.

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.

Notes
(1) African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 11 RCOREs throughout Africa: https://www.nepad.org/publication/regional-centres-regulatory-excellence-rcores

(2) 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.

(3) 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, Eswatini, 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, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

(4) This additional condition for participation according to RfP Art. 9.5 is required due to the objective of this Coordination & Support Action. It aims to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research on and use of medical interventions in humans. It is in line with the activities called for by the EU legislator (EDCTP2 Basic Act, Annex II, objective 1c) and contributes to the specific objectives of the EDCTP2 programme which calls, e.g., for cooperation with sub-Saharan Africa on building their capacity for conducting clinical trials in compliance with fundamental ethical principles, relevant legislation and international standards (EDCTP2 Basic Act, Annex I, objective 2b).

Procedure and application process

Submission and evaluation procedure
Single-stage application procedure. Proposals must be submitted by 16 July 2020, 17:00 CEST via EDCTPgrants. Evaluation results are expected to be made available by 15 December 2020.

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation (see Article 15 of the Horizon 2020 Rules for Participation Regulation No 1290/2013). Each criterion will be scored out of 5. The threshold for individual criteria will be 3. The overall threshold, applying to the sum of the three individual scores, will be 10.

For all proposals involving human participants, and/or human tissues, cells or personal data, the evaluation process will include an assessment of ethical issues.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 programme, the EDCTP Association strategic research agenda and the call topic description.
• Importance, relevance/pertinence, and clarity of the objectives.
• The soundness of the concept and credibility of the proposed approach/methodology.
• Clarity, pertinence and importance of the strategic vision
• The soundness of the concept.
• Quality of the proposed coordination and/or support measures.

 2. 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 a 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.

 3. Quality and efficiency of the implementation

• Quality and effectiveness of the work plan, including the 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 timeframe 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.

 Financial provisions

• 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.

Grant agreement
Participants in the projects (‘actions’) resulting from this call for proposals will be required to sign a General EDCTP2 grant agreement multi-beneficiary or mono-beneficiary, and to conclude a consortium agreement prior to the conclusion of the EDCTP2 grant agreement (where applicable).

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible

More information

• EDCTP2 Frequently Asked Questions about calls for proposals
• For specific questions related to this call for proposals, please contact Michelle Singh at singh@edctp.org.
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org.
• For guidance on applying to EDCTP, please refer to the Templates, guides and policies section of the EDCTP website.
• The EDCTP2 programme runs until the end of December 2024. Applicants should take into consideration the programme end date when planning their proposals.

Projects awarded under this call

AMÉLIORER
Enhancing Research Ethics and Regulatory Capacities in Benin

Ministry of Health, Benin
Project coordinator: Professor Flore Gangbo
Starting date: 1 July 2021
Duration: 24 months
Grant amount: EUR 500,000
Grant agreement: CSA2020ERC-3086

BCA-WA-ETHICS II
Building the capacities of West Africa in research ethics

Universidad de Zaragoza (UNIZAR), Zaragoza, Spain, with partners from Benin, Mali, and Senegal
Project coordinator: Ass. Prof. Guillermo Martínez Pérez
Starting date: 01 April 2021
Duration: 24 months
Grant amount: EUR 432,869
Grant agreement: CSA2020ERC-3079
Project website

BoCTRe
Botswana clinical trials regulation

Botswana Medicines Regulatory Authority, Gaborone, Botswana, with a partner from Botswana
Project coordinator: Dr Parthasarathy Gurumurthy
Starting date: 01 May 2021
Duration: 24 months
Grant amount: EUR 281,250
Grant agreement: CSA2020ERC-3078
Project website

CECaBI
Côte d’Ivoire Ethics Capacity Building Initiative

Ministère de la Santé, de l’Hygiène Publique et de la Couverture Maladie Universelle, Cote d’Ivoire
Project coordinator: Dr Louis Penali
Starting date: 1 July 2021
Duration: 24 months
Grant amount: EUR 500,000
Grant agreement: CSA2020ERC-3081

S-ROC/Cameroun
Strengthening the regulatory oversight of clinical trials in Cameroon

Ministére de la Santé Publique, Cameroon
Project coordinator: Dr Deli Vandi
Starting date: 1 June 2021
Duration: 24 months
Grant amount: EUR 265,315
Grant agreement: CSA2020ERC-3096

The Gambia ERC project
Building a Robust Ethics and Regulatory Capacity in The Gambia

Medical Research Council (MRC) Unit – The Gambia at the London School of Hygiene and Tropical Medicine (LSHTM), The Gambia
Project coordinator: Ms Elizabeth Stanley-Batchilly
Starting date: 1 July 2021
Duration: 24 months
Grant amount: EUR 500,000
Grant agreement: CSA2020ERC-3080