Keywords
Clinical Trials
Comparative Study
DOI:
https://doi.org/10.17566/ciads.v14i4.1398How to Cite
Abstract
Objective: to conduct a survey and comparative analysis of current and/or pending legislation in the field of biomedical research, particularly clinical trials, in the five Portuguese-speaking african countries, within the framework of the CT-Luso project. Methodology: documentary analysis based on the systematic survey and examination of 52 legislative instruments, complemented by a technical comparison with international requirements applicable to clinical research, namely Regulation (European Union) No. 536/2014 and the Declaration of Helsinki. Results: significant heterogeneity was found in the legal frameworks for biomedical research in the Portuguese-speaking african countries. Only some of the countries have specific legislation for clinical trials; the rest are governed by general health or research standards. Weaknesses were identified in regulatory authorities and ethics committees with uneven powers, affecting ethical evaluation and participant protection. A lack of alignment with international standards was observed, especially regarding informed consent, data sharing and transparency. However, there was political will for regulatory convergence, expressed in ongoing legislative initiatives and the strengthening of inter-institutional cooperation. Conclusion: the approach adopted by CT-Luso confirms that international legal cooperation is an effective tool for diagnosing vulnerabilities and guiding legislative reforms in clinical research. However, challenges remain in terms of ethical and regulatory harmonisation, which must be overcome in order to consolidate robust legal frameworks, ensure the protection of participants and strengthen the integration of portuguese-speaking african countries into international good scientific practice. The creation of regional coordination mechanisms and the progressive adoption of common ethical and legal benchmarks are decisive steps towards strengthening research governance and its sustainable integration into the global scientific arena.
Submitted: 09/28/25| Revision: 11/03/25| Approved: 11/03/25
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Copyright (c) 2025 Carla Barbosa, Daniela Marques Dias, André Gonçalo Dias Pereira, Walter Van-Trier, João Semedo, Miguel Pereira, Virgílio Uamba, Neidyne Afonso, Maria do Céu Patrão Neves (Autor)