The Experience of Ethics Committees in Portuguese Speaking Countries

Abstract

In recent decades we have seen an increase in scientific research, including in Portuguese Speaking Countries (PALOP). This growth highlighted the concern for compliance with the principles of bioethics in research involving human beings. Lack of resources, scarce legislation, poor training of members of bioethics committees, limited knowledge of the main international guidelines, limited training on ethics and bioethics in research, are some of the characteristics common to the PALOPs. On the other hand, language constitutes a barrier considering that most of the literature is available in English. As an example, between 2005-2016 the EDCTP partnership funded 74 ethics projects in Africa with only two for the PALOP. The creation of bioethics committees in these countries dates back to the year 2000 in Angola, Cape Verde and Mozambique and from 2010 in Guinea-Bissau and São Tomé and Príncipe, all with Portuguese and Brazilian influence. In 2011, the National Committee on Bioethics in Health in Mozambique registered an increase in research, triggering the creation process of Institutional Bioethics Committees, with regulations and norms for the creation, functioning and hierarchy. In 2016, during the International Conference on “Ethics in Scientific Research: the first step towards south-south cooperation”, Angola, Mozambique, Brazil and Cuba signed the Malange Declaration. It expresses the commitment of the health ethics committees to work as a network in south-south collaboration, recognizing the need to boost training in bioethics. Mozambique's declaration reinforces this commitment. However, only in Mozambique is there a boost in the formation and regulation of bioethics committees. Currently, it is the PALOP country with the highest number of research projects evaluated. Between 2017-2021, two projects financed by EDCTP were implemented, in the perspective of North-South collaboration between Portugal and the PALOP. LusoAfro-BioEthics, aimed at Strengthening Bioethics Committees in Mozambique, Angola and Cape Verde. Highlights include online courses in Portuguese, the availability of a website in Portuguese and the implementation of the online research protocol submission process for Mozambique. BERC-luso, an Ethical and Regulatory Capacity Building project in the five PALOP countries, with the aim of developing and strengthening national drug regulation systems and capacities for the ethical review of clinical research. In September 2022, representatives of the Ethics Councils, Bioethics Associations and Clinical Research Committees of Portugal and the PALOP, gathered at the Lusophone Bioethics Meeting, signed the Lisbon Declaration with the commitment to Bioethical Cooperation and One Health in Lusophone countries between 2022-2026. The challenges for the PALOP continue to be training in ethics and bioethics in undergraduate and postgraduate courses as well as in intensive courses for the preparation and evaluation of research projects and the legislation for the creation, organization and hierarchy of Bioethics Committees and define norms and procedures in research using living beings, including clinical trials.