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Ethics and regulatory capacities

Status: Closed
Type of action: Coordination & Support Actions (CSAs)
Call budget: € 2M
Maximum funding: € 300,000
Funding level: 100% of eligible costs
Open date: 4 August 2016, 17:00
Close date: 22 November 2016, 17:00
Go to EDCTPgrants

The purpose of this call for proposals is to provide funding to actions that aim 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. This scheme targets both National Ethics Committees (NECs) and National Regulatory Authorities (NRAs).

Description

Backgrounds

Many African countries lack sound ethical review mechanisms and some even lack medicines regulatory bodies. There is a pressing need to develop and strengthen the national ethics and medicines regulatory frameworks in sub-Saharan Africa in order to strike a balance between the public health interest, the interests of the pharmaceutical industry, and ethical values.

Scope

The purpose of this Call for Proposals is to provide funding to actions that aim 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. This scheme targets both National Ethics Committees (NECs) and National Regulatory Authorities (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. National collaborative activities involving NECs and Institutional Review Boards, and/or transnational collaborations involving regional networking activities between NECs or NRAs and other partners from any EU country or country associated with Horizon 2020 are encouraged. 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 NECs and IRBs 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

Actions funded under this Call for Proposals should strengthen the functionality, recognition and performance of NECs and NRAs in sub-Saharan African countries. They will also contribute towards development of sustainable strategies for both NECs and NRAs.

Eligibility

At least one legal entity established in a European Participating State(1) or a sub-Saharan African country(2). In addition, applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries (3). The requested EDCTP contribution per action shall not exceed €300,000.

Notes:

  1. 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.
  2. 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, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.
  3. 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 legislations 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 2016 via EDCTPgrants. Applicants will be notified of the outcome by 21 April 2017.

Evaluation criteria, scoring and thresholds

This call follows a single-stage application procedure. 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. Each criterion is scored between 0 and 5. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10. Applicants have the opportunity to submit a written response to the expert reviewers’ comments prior to an expert review committee meeting convened by EDCTP to finalise the funding recommendations.

The following aspects are considered under the evaluation criteria:

1. Excellence

  • Fit with the scope and objectives of the EDCTP2 programme 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 for 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.

 

Financial provisions

The call budget is 2 million EUR.

The total requested EDCTP contribution shall not exceed 300,000 EUR. EDCTP may fund 100% of eligible project 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 conditional award letter. Where applicable, all participants in the action must sign a consortium agreement.

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
  • Please read carefully the guidance in the online application form before submitting your proposal.

Documents and more information

Documents 

 

More information