Ethics and Regulatory

EDCTP Policy on Health Research Ethics Review

EDCTP Policy on Health Research Ethics Review
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 have ethical and applicable regulatory clearances before taking place. Normally release of EDCTP funds is tied to provision of evidence of 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 standards

Ethical considerations
All EDCTP funded projects must comply with internationally accepted 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 Practice (GCP) and in compliance with fundamental rights in the Charter of Fundamental Rights of the European Union. Additionally, they must comply with the requirements of the national ethics and regulatory authorities of the countries where the trial will be conducted. This includes compliance with 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.

EDCTP will not support any study that has not obtained signed and dated approval from the local Ethics Committee(s) from all countries involved in the actual conduct of the studies.

Applicants are required 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 with the Declaration of Helsinki ethical principles for medical research involving human subjects.

Additional information about international and local laws, regulations and guidelines concerning human research protections are included in the International Compilation of Human Research Protections.

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 requirement ensures safety and enables 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 committed to strengthening regulatory capacity in Africa through its grant schemes, as well as through its collaborative work with organisations such as 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 a grant can start. 

Clinical trial sponsorship
It should be noted that EDCTP provides financial support for clinical trials but it does not act as the sponsor of clinical trials. All proposed trials must be sponsored by an appropriate legal entity with documented experience of acting as the sponsor of clinical trials.

More information is available from the following references:

1. Ethical Codes

2. 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: