Assisting countries in establishing national bioethics committees: UNESCO's Assisting Bioethics Committees project.

The Universal Declaration on Bioethics and Human Rights adopted by UNESCO in 2005 advocates for the establishment of independent, multidisciplinary, and pluralist ethics committees at national, regional, local, or institutional levels. The purpose of these committees is (a) to evaluate the relevant ethical, legal, scientific, and social issues related to research involving human beings; (b) to provide advice on ethical problems in clinical settings; (c) to assess scientific and technological development, formulate recommendations, and contribute to the preparation of guidelines; and (d) to foster debate, education, and public awareness of and engagement in bioethics (Article 19). Already in the very first draft of the Declaration the need to promote and establish national bioethics committees was mentioned. Although the text was gradually elaborated, the same basic idea has been preserved throughout the process of drafting, negotiating, and adopting the text.

A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects.

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.

Women in developing countries and benefit sharing.

The aim of this paper is to show that any process of benefit sharing that does not guarantee the representation and participation of women in the decision-making process, as well as in the distribution of benefits, contravenes a central demand of social justice. It is argued that women, particularly in developing countries, can be excluded from benefits derived from genetic research because of existing social structures that promote and maintain discrimination. The paper describes how the structural problem of gender-based inequity can impact on benefit sharing processes. At the same time, examples are given of poor women's ability to organise themselves and to achieve social benefits for entire communities. Relevant international guidelines (e.g. the Convention on Biodiversity) recognise the importance of women's contributions to the protection of biodiversity and thereby, implicitly, their right to a share of the benefits, but no mechanism is outlined on how to bring this about. The authors make a clear recommendation to ensure women's participation in benefit sharing negotiations by demanding seats at the negotiation table.