According to the G-EthicalEval, any research proposal in the Democratic Republic of the Congo (DRC) involving human participants must be submitted for evaluation of its scientific validity and ethical acceptability to an ethics committee (EC). An EC may be established under the auspices of national or local health authorities, national (or centralized) medical research councils, or other national representative bodies.

The G-EthicalEval further states that the EC must be independent of the research team and approved by the Ministry of Health (Ministère de la Santé). The investigator must obtain EC approval before undertaking the research.

Order1250-ZKM043 indicates that the purpose of the DRC’s national EC, the National Committee of Health Ethics (Comité National d’Éthique de la Santé (CNES)), is to review proposals for research on human beings based on the ethical principles of respect for the individual, beneficence, and justice. The CNES is also responsible for promoting the creation of and accrediting institutional ECs across the country, among other duties.

Ethics Committee Composition

Institutional Ethics Committee

The G-EthicalEval indicates that an EC should be made up of physicians, scientists, and representatives of other groups, such as nurses, lawyers, ethicists, and non-professionals, who are able to represent the cultural and moral values of the community and uphold the rights of the research participants. An EC must include both men and women.

According to the G-EthicalEval, to ensure the EC is composed of members that have experience as well as new members with a fresh perspective, a certain number of EC members may be renewed periodically. In addition, to ensure the independence of ECs and to avoid any conflict of interest, any member of the committee having special interests, direct or indirect, in a research proposal must exclude him/herself from the evaluation of the proposal.

National Committee of Health Ethics

As per Order1250-ZKM043, the CNES has 40 members, including:

  • One (1) delegate per province from institutional ECs
  • Scientific individuals (at most 10)
  • Religious individuals (at most five (5))
  • A delegate from the Order of Physicians
  • A delegate of the Order of the Pharmacists
  • A delegate from other health professional associations
  • A delegate from the Health Administration

Order1250-ZKM043 further indicates that CNES’ mandate is five (5) years, which is renewable once. The CNES is governed by an office composed of a president, a vice-president, a secretary-rapporteur, a deputy secretary-general, and a treasurer, all elected by and from among the members. The government’s Public Health authority appoints members of the office.

Terms of Reference, Review Procedures, and Meeting Schedule

The G-EthicalEval states that the EC’s written procedures must define all EC operating standards.

According to the G-EthicalEval, an EC must clearly define the roles necessary for smooth ethical evaluation. The different roles within the EC (such as president and secretary), the requirements of each role, the terms and conditions of attaining a role, and the duties and responsibilities associated with the roles must be detailed in writing.

As per the G-EthicalEval, EC members should receive basic training and access to continuing education on the ethical and scientific aspects of biomedical research. The conditions of appointment should detail the arrangements for providing EC members with initial training on the EC’s work, as well as opportunities to strengthen their expertise in conducting an ethics review. These provisions should also include the requirements or expectations for basic and continuing education of EC members. This training can be carried out in the context of cooperation with other ECs in the country or region, and also on other occasions favorable to the basic training and the continuous training of the EC’s members.

The G-EthicalEval indicates that the EC is responsible for establishing well-defined procedures for submitting an application for review. These procedures, as well as any standard forms, must be public and available to applicants. In order to aid researchers, it is desirable that these procedures and forms be harmonized among all the active ECs in the country.

The G-EthicalEval requires that ECs establish specific quorum requirements to review a proposal and make a decision. These requirements must include or specify at least the following:

  • The minimum number of members required to reach a quorum
  • The professional qualifications required and distribution of these requirements within the quorum
  • No quorum shall be composed exclusively of members of the same profession or the same sex
  • The quorum must include at least one (1) member whose primary area of expertise is not scientific and at least one (1) independent member of the institution or research site

The G-EthicalEval further requires that an EC meet regularly, on scheduled dates announced in advance in a publicly available calendar. The meeting requirements must include or specify at least the following:

  • Meetings should be scheduled according to a pre-established schedule, which can be modified according to the workload
  • EC members should have sufficient time, defined before the meeting, to review submitted documents
  • Meetings must be documented in minutes, and there must be a procedure for approval of the minutes
  • The applicant, the sponsor, and/or the investigator may be invited to present their proposal or to elaborate on certain specific points
  • Independent consultants may be invited to the meeting or provide written comments, subject to the confidentiality agreements in force
  • The EC must send its opinion within 15 days of the meeting