EDCTP - Ethics and Regulatory capacities, 2019

Application closing date: 21 Nov 2019

Expected number of grants: 5-7

Call budget: €3 million

Maximum funding: €500,000

 

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.

 

For the full call text, or to apply, visit the call webpage.

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