/Ethics & Regulatory Affairs

Ethics & Regulatory Affairs

Mission

The mission of EDCTP is to accelerate the clinical development of effective, safe, accessible, suitable and affordable medical interventions for poverty-related diseases, in partnership with sub-Saharan Africa.

To achieve this overall objective EDCTP funds clinical research, promotes networking and strengthens the capacity in sub-Saharan Africa to conduct clinical trials in compliance with fundamental ethical principles and relevant national, union and international legislation.

Of paramount concern is the protection of the rights of research participants and their communities in accordance with international standards.

 

Ethical considerations for EDCTP funded projects

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 the Charter of Fundamental Rights of the European Union.

Additionally, projects 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 agreements on transfer of human materials.

All clinical studies have to be submitted to and approved by independent Ethics Committees that are in compliance with the national law and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)/GCP.

It is mandatory that all studies and any amendments are conducted in compliance with the protocols that have received prior approval by the Institutional Review Board (IRB)/National Ethics Committee (NEC).

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

 

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

 

Ethics in planning and conducting clinical studies

Applicants for EDCTP grants are required to pay due attention to the various ethical aspects in the planning of studies, including:

  • Process of obtaining informed consent
  • Obligations of investigators and sponsors
  • Benefits and risks of study participation
  • Recruitment
  • Cultural values
  • Confidentiality measures in accordance with the Declaration of Helsinki ethical principles for medical research involving human subjects.

 

As part of its grant awarding process, EDCTP commissions an independent ethical review of shortlisted proposals.

EDCTP further requires that all of its supported clinical trials and research on human subjects or material have ethical and applicable regulatory clearances before actually taking place.

The approval of study reports submitted to EDCTP is tied to the provision of evidence of all necessary ethics and regulatory approvals.

All EDCTP-funded clinical trials must be registered in the Pan-African Clinical Trials Registry or any other World Health Organisation (WHO) accredited registry.

 

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 local manufacturing, importation, and 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.

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 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 among 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 like-minded organisations such as the World Health Organisation and others.

In countries where approval of clinical trials from the National Regulatory Authorities (NRAs) is a prerequisite, EDCTP requires this clearance before the actual start of the study.

 

Clinical trial sponsorship

EDCTP does not act as a 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.

 

Capacity development

In recognition of the fact that ethics and regulatory oversight may not be optimal in all countries, institutions, or research sites, EDCTP has made it a priority to strengthen institutional and personal capacities in ethics and regulatory framework in sub-Saharan Africa.

EDCTP work plans provide for ethics capacity development through:

  • Ethics capacity development support grants
  • Ethics training grants
  • Support of national regulatory authorities
  • Support for the Pan-African Clinical Trials Registry (PACTR).

EDCTP also encourages and supports the harmonisation of ethics and regulatory framework in sub-Saharan Africa. It supports initiatives like the African Vaccines Regulators’ Forum (AVAREF) that offer a common platform for joint review and inspection of clinical trials in Africa.

Similarly, EDCTP supports the European Commission Directive 2001/83/EC, for regulating marketing authorisation of medicinal products for the European market, which calls for coordination of the ethics and regulatory framework in Europe.

 

Resources

More information is available through the following references:

  1. Ethical Codes

 

  1. Additional sources