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Ethics and regulatory capacities

Status: Active
Type of action: Coordination & Support Actions (CSAs)
Call budget: €4.5 million
Funding level: 100% of eligible costs
Open date: 2 August 2018, 17:00
Close date: 22 November 2018, 17:00
Go to EDCTPgrants

Call identifier: CSA2018ERC

Description

Background
Whereas strides have been made towards establishment and strengthening of ethical review frameworks and medicines regulatory bodies in sub-Saharan Africa, targeted support is paramount to ensuring their continued development and consolidation within the ever-expanding R&D landscape in the region. Dedicated efforts are particularly required in countries where there are no or limited capacity for ethics review and national medicines regulatory bodies. The fortification of National Ethics Committees (NECs) and National Regulatory Authorities (NRAs) will allow for long-term development plans for regional regulatory harmonisation goals.

Scope
The purpose of this Call for Proposals is to support sub-Saharan African countries to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans, as well as national and international collaboration. This scheme targets both NECs and NRAs.

The objectives of this call are:

  1. To support NECs’ development of institutional and personnel capacities to enable them to perform their national ethical oversight function over the institutional review boards; efficiently review clinical trial applications; and to provide ethical oversight for clinical trials and health research in general.
  2. To support NRAs’ development of institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products. This may also include strengthening pharmacovigilance systems.

 

Proposals may include support for training, networking and promotion of good practices through improved recognition and accreditation of the relevant bodies. This may include relevant long-term training of regulatory staff, in particular through regulatory curricula provided by Regional Centres of Regulatory Excellence in Africa*.

EU countries or countries associated with Horizon 2020 are encouraged to participate. Proposals involving regulatory agencies should clearly indicate how they align their functions and activities with the African Vaccine Regulators Forum (AVAREF) guidelines and standards. Joint NEC and NRA applications are also encouraged.

Undergraduate training and Masters and PhD studies that are not directly relevant and applicable to the daily activities of NRAs and NECs will not be supported under this scheme.

EDCTP considers that proposals for actions of between 24 and 36 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission 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
  • contribute towards development of sustainable strategies for both NECs and NRAs.

 

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 set out below, depending on the type of action:
    • At least one legal entity established in a European Participating State** or a sub-Saharan African country ***.
    • In addition, 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 300,000 EUR.

 

Notes

* African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative (NEPAD). There are currently 10 RCOREs throughout Africa: http://www.nepad.org

** Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

*** Legal entities in the following sub-Saharan African countries are eligible to apply: 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, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & 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 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 its 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 22 November 2018 via EDCTPgrants. Evaluation results are expected to be made available by 16 April 2019.

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, grant proposals will be evaluated by experts, on the basis of the award criteria ‘excellence’, ‘impact’ and ‘quality and efficiency of the implementation’ (see Article 15 of the Horizon 2020 Rules for Participation Regulation No 1290/2013). Each criterion is scored between 0 and 5.

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 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

  • 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
  • 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.

 

3. 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 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.

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions
The call budget is €4.5 million.

The requested EDCTP contribution per project should not exceed 300,000 EUR. The funding level is 100% of eligible costs.

Grant agreement
The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 mono-beneficiary grant agreement or multi-beneficiary grant agreement) within three months of receipt of the evaluation outcome letter. Where applicable, all participants in the action must sign a consortium agreement prior to grant agreement signature.

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.

Documents and more information

Documents

 

More information