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Mali Adopts Stringent Guidelines for Clinical Trials

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In a bid to ensure the highest standards of ethics and safety in clinical trials, Mali has put in place a robust framework governing research protocols. This framework aims to safeguard the rights and well-being of research participants, ensure the integrity of clinical trials, and promote public trust in the research process.

Establishment of Ethics Committee (EC)

As per Order No.2019-011, the National Institute of Public Health (INSP) has established an Ethics Committee (EC) as one of its administrative bodies. The EC is responsible for reviewing and approving clinical research protocols, ensuring that they comply with good clinical practice (GCP) guidelines prepared by the Collaborative Institutional Training Initiative (CITI) Program.

Responsibilities of the EC

  • Reviews and approves clinical research protocols
  • Ensures compliance with GCP guidelines
  • Assesses the ethical validity of research projects
  • Provides opinions on response measures to health threats and crises
  • Notifies investigators of its decision in writing
  • Reviews and approves protocol amendments prior to their implementation

Guidelines for Investigators

  • Obligated to comply with all decisions and recommendations from the EC
  • Must inform the EC of any problems encountered during the study, including deviations from the protocol and complaints from participants

Role of the CNESS/INSP EC

The CNESS/INSP EC only participates in the EC review process when the research pertains to an emerging infectious disease, such as the Ebola virus disease outbreak.

Importance of Good Clinical and Laboratory Practices

MLI-17 emphasizes the importance of following good clinical and laboratory practices, mandating that clinical research must adhere to these standards. There is no stated expiration date for an EC approval in Law No.09-059, Decree No.2017-0245, or the FMPOS-USTTB-ECProcs.

Ethics Committee Fees

Mali has also established a system of ethics committee fees. However, information on these fees and payment instructions is not publicly available for the National Ethics Committee for Health and Life Sciences (CNESS).

Conclusion

The implementation of these guidelines aims to ensure that clinical trials in Mali are conducted with the highest ethical standards, protecting the rights and well-being of research participants while promoting public trust in the research process.