The mission of EDCTP is to accelerate research and development of drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria by supporting conducting of clinical trials using best practice. This includes adherence to ethics, good clinical practice, regulatory and other applicable guidelines. Paramount to this is the protection of safety, confidentiality and integrity of the research participants and their communities in accordance to international standards.
EDCTP requires that all clinical trials and research on human subjects or material must have ethical and applicable regulatory clearances before taking place. Normally release of EDCTP funds are tied to provision of evidence of signed and dated all necessary ethics and regulatory approvals. This includes clearances from all participating countries in the north and south.
Recognisant of the fact that ethics and regulatory oversight may not be optimal globally, EDCTP has made it a priority to strengthen ethics and regulatory framework in developing countries, especially in sub-Saharan Africa. This is taking place through ethics capacity development support grants, ethics training grants, support of national regulatory authorities and Pan-African Clinical Trials Registry (PACTR). All EDCTP clinical trials must be registered by the PACTR.
EDCTP also encourages and supports the harmonisation of ethics and regulatory framework in sub-Saharan Africa. It supports the African Vaccines Regulators’ Forum (AVAREF) that offers a common platform for joint review and inspection of clinical trials in Africa. Similarly EDCTP supports the European Commission Directive that promotes coordination of European Commission Directive 2001/83/EC, amended by Directive 2003/63/EC for regulating marketing authorisation of medicinal products for the European market which calls for coordination of the ethics and regulatory framework in Europe.
Compliance of EDCTP-funded projects with international ethical and scientific quality standards
Ethical considerations
All EDCTP funded projects must comply with internationally acceptable standards. All EDCTP supported clinical trials and studies involving human materials must be conducted in accordance with the ethical principles expressed in the World Medical Association Declaration of Helsinki, be consistent with Good Clinical Practices (GCP) and in compliance with fundamental rights in the Charter of Fundamental Rights of the European Union. Additionally, they should be in compliance with the local ethics requirements as well as the applicable regulatory requirement(s) in the countries involved. This includes compliance to country specific and regional material transfer agreements. All clinical studies have to be submitted to and approved by independent Ethics Committees that are ICH GCP compliant. It is mandatory that all studies and any amendments are conducted in compliance with the protocols that have received prior Institutional Review Board (IRB)/National Ethics Committee (NEC) approval/favourable opinion.
EDCTP will not support any studies that have not obtained duly signed and dated approval from the local Ethics Committee(s) from all countries involved in the actual conduct of these studies.
Applicants to EDCTP for funding are therefore encouraged to pay due attention to the various ethical aspects in the planning of studies including the process of obtaining informed consent, the obligations of investigators and sponsors, benefits and risks of study participation, recruitment, cultural values, and confidentiality measures in accordance to the Declaration of Helsinki ethical principles for medical research involving human subjects.
In addition, most applicable international and local laws, regulations and guidelines for human research protections are included in the International Compilation of Human Research Protections, 2010 Edition.
Regulatory requirements for conducting clinical trials
Regulatory requirements are part of the process of drug discovery and development and describe what is necessary for a new medicinal product to be approved for marketing in any country. Prior to testing on humans in clinical trials, medicinal products must be subjected to rigorous testing in the laboratory (preclinical trials) for which animals are used and must be approved by a competent authority for use in humans.
Although EDCTP’s mandate focuses on phase II and III clinical trials, all investigational products used in EDCTP supported trials must have sufficient efficacy and safety data available from preclinical and phase I evaluation studies and must have been approved by a competent regulatory body. This is in order to ensure safety and enable future registration of these products in compliance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
It is important that the rights, safety and well-being of volunteers participating in clinical trials of new medicines are observed in sub-Saharan Africa. Although regulatory capacities in different countries may differ, all EDCTP supported studies must comply with regulatory requirement(s) and legal rules in the countries involved. EDCTP is also committed to strengthening regulatory capacity in Africa through collaborative work with the World Health Organisation.
In countries where approval of clinical trials from the National Regulatory Authorities (NRAs) is a prerequisite, EDCTP requires this clearance before funding these studies.
Clinical trial sponsorship
It should be noted that EDCTP funds clinical trials but does not undertake clinical trials sponsor responsibility. The clinical trial sponsors for EDCTP funded studies must be identified legal entities with documented experience to act as clinical trials sponsors.
Further information is available from the following references:
Ethical Codes
Additional resources
Ethics, regulatory and clinical trials registrations activities supported by EDCTP
EDCTP supports various projects in order to strengthen ethics, regulatory and clinical trials registration in sub-Saharan Africa. Links to the project profiles and additional information about these projects are provided below:
Subscribe |Site map | Search: