Ethics and regulatory capacities – 2019

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 sub-Saharan Africa.

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 fortification and collaboration of national ethics committees (NECs) and National Regulatory Authorities (NRAs) to allow for long-term development plans building towards strong regional collaboration and harmonisation goals.

Despite ongoing efforts by different partners and agencies, ethics and regulatory oversight in sub-Saharan African countries require 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. Growing need for quality control, certification and accreditation of ethics and regulatory bodies, and adherence to common international standards; and
4. 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 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:

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. Promote quality control systems and process for NECs and NRAs, certification and accreditation of the various bodies, as well as adherence to international standards;
3. 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 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.

Sub-Saharan African countries fit within three categories:

1. Countries with intense clinical trial activity;
2. Emergency-prone countries (e.g. countries where epidemics are likely to emerge or have emerged in the recent past) with fragile health systems; and
3. Countries with low clinical trial activity and with low risk of emergency/epidemics.

Proposals should clearly indicate the category(ies) of countries involved and how the proposed project will address the objectives of the call in the selected countries.

Each project should have at least two new staff members added to the team and trained in the new functions proposed in the actions.

Linkage of the project to other on-going initiatives, such as the Regional Centres of Regulatory Excellence in Africa*, 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 sub-Saharan Africa are also encouraged.

The EDCTP Association considers that proposals for actions of between 24- and 36-months duration would allow these specific challenges to be addressed appropriately. Nonetheless, this does not preclude submissions and selection of proposals for actions of a different duration.

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 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.^**

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*** 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.

Notes

*African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 10 RCOREs throughout Africa.

**For an up-to-date list of the sub-Saharan African countries that have already been funded under the EDCTP2 Ethics & regulatory capacities call, please see the EDCTP website.

***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.

*****This additional condition for participation according to the Rules for Participation (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
This is a single-stage application procedure. Proposals must be submitted by 21 November 2019, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 16 April 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;
• 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.

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 the 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), 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.

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 3 million EUR.
• The requested EDCTP contribution per project should not exceed 500,000 EUR.
• The funding level is 100% of eligible costs.

Grant agreement
Participants in 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 Nuraan Fakier at fakier@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

AccessAfrica
Improving post-trial access arrangements in clinical trials in sub-Saharan Africa

University of Oslo (UiO), Oslo, Norway, with partners from Ethiopia and Uganda
Project coordinator: Dr Rosemarie de la Cruz Bernabe
Starting date: 01 December 2020
Duration: 40 months
Grant amount: EUR 500,000
Grant agreement: CSA2019ERC-2680
Project website

AfriEthique
A European-African network for strengthening the ethics capacity for clinical research review in the Democratic Republic of Congo, the Republic of Central Africa, Chad, and the Republic of Congo

Fondation Congolaise pour la Recherche Médicale (FCRM), Brazzaville, Republic of the Congo, with partners from the Central African Republic, Chad, the Democratic Republic of the Congo, and the United Kingdom

Project coordinator: Professor Francine Ntoumi
Starting date: 01 October 2020
Duration: 30 months
Grant amount: EUR 493,750
Grant agreement: CSA2019ERC-2675
Project website

ASCEND
Moving Tanzania’s clinical research medicines regulatory capacity to the next level: Fostering medicine quality, safety and GCP clinical trials

Tanzania Medicines and Medical Devices Authority (TMDA), Dodoma, Tanzania, with partners from Tanzania, and the United Kingdom
Project coordinator: Mr Adam Mitangu Fimbo
Starting date: 01 November 2020
Duration: 30 months
Grant amount: EUR 498,750
Grant agreement: CSA2019ERC-2683

BERC-Africa
Building and enhancing regulatory capacity in Africa

Food and Drugs Authority (FDA) Ghana, Accra, Ghana, with partners from Germany, Ghana, and Norway
Project coordinator: Mrs Delese Darko (FDA)
Starting date: 01 October 2020
Duration: 36 months
Grant amount: EUR 281,039
Grant agreement: CSA2019ERC-2671
Project website

CCRREEA
Consortium for clinical research regulation and ethics capacity in the Eastern African Region

Uganda National Council for Science and Technology, Kampala, Uganda, with partners from Kenya, Malawi, Rwanda, Tanzania, and Uganda
Project coordinator: Ms Winfred Badanga Nazziwa
Starting date: 01 January 2021
Duration: 36 months
Grant amount: EUR 499,501
Grant agreement: CSA2019ERC-2684
Project website

SEA-RAFES
Strengthening and enhancing the “Réseau Africain Francophone d’Ethique en Santé”

Institut Pasteur de Dakar, Dakar, Senegal, with partners from the Central African Republic, Côte d’Ivoire, Democratic Republic of the Congo, France, Guinea, and Senegal
Project coordinator:  Dr Fabien Taieb
Starting date: 01 November 2020
Duration: 24 months
Grant amount: EUR 499,982
Grant agreement: CSA2019ERC-2690

SEARCH
Increasing the regulatory capacities for review of clinical trials in southern Africa by establishing European-African collaborations that facilitate implementation of efficient processes, harmonised procedures, standardised guidelines, and effective training programmes

Fundação Manhiça, Maputo, Mozambique, with partners from Botswana, eSwatini, Lesotho, and the United Kingdom
Project coordinator:  Dr Eusebio Victor Macete
Starting date: 01 January 2021
Duration: 36 months
Grant amount: EUR 500,000
Grant agreement: CSA2019ERC-2688
Project website

SNECFA
Strengthening National Ethics Committees in West and Central Francophone Africa

Cameroon Bioethics Initiative (CAMBIN), Yaoundé, Cameroon, with partners from Cameroon, Chad, Mali, Niger, and Switzerland
Project coordinator:  Dr Mbih Jerome Tosam
Starting date: 01 February 2021
Duration: 36 months
Grant amount: EUR 500,000
Grant agreement: CSA2019ERC-2676

ZAHRSSP
The Zambia Health Research Systems strengthening project: working towards a harmonised regulatory framework

National Health Research Authority (NHRA), Lusaka, Zambia
Project coordinator: Professor Victor Chalwe
Starting date: 01 September 2020
Duration: 36 months
Grant amount: EUR 467,119
Grant agreement: CSA2019ERC-2691
Project website