Social value, clinical equipoise, and research in a public health emergency.

The 2016 CIOMS International ethical guidelines for health-related research involving humans states that 'health-related research should form an integral part of disaster response' and that, 'widespread emergency use [of unproven interventions] with inadequate data collection about patient outcomes must therefore be avoided' (Guideline 20). This position is defended against two lines of criticism that emerged during the 2014 Ebola outbreak. One holds that desperately ill patients have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context. The second holds that clinical trials in contexts of high-mortality diseases are morally suspect because equipoise does not exist between a standard of care that offers little prospect of clinical benefit and a UMI that might offer some clinical advantage.

Social responsibility and global health: lessons from the Rio Olympics Zika controversy.

The outbreak of Zika virus infection in the Americas and its possible association with microcephaly raised several concerns among global health authorities regarding the organisation of the Olympic and Paralympic Games scheduled for August and September 2016, in the city of Rio de Janeiro, Brazil. It generated an international controversy over the continuation of the Games with debates on the ethical principle of social responsibility. Based on the principles of social responsibility and health in the Universal Declaration of Bioethics and Human Rights, the present comment ponders on the application of such principles in the context of mega-events and global health.

Ethical challenges for international collaborative research partnerships in the context of the Zika outbreak in the Dominican Republic: a qualitative case study.

BACKGROUND: The establishment of international collaborative research partnerships in times of infectious disease outbreaks of international importance has been considered an ethical imperative. Frail health research systems in low- and middle-income countries can be an obstacle to achieve the goal of knowledge generation and the search for health equity before, during and after infectious disease outbreaks. METHODS: A qualitative case study was conducted to identify the challenges and opportunities facing the Dominican Republic with regards to developing international collaborative research partnerships in the context of the Zika outbreak and its ethical implications. Researchers conducted 34 interviews (n = 30 individual; n = 4 group) with 39 participants (n = 23 males; n = 16 females) representing the government, universities, international donor agencies, non-governmental organisations, community-based organisations and medical societies, in two metropolitan cities. RESULTS: Five international collaborative research projects related to the Zika virus were identified. Major ethical challenges were linked to the governance of health research, training of human resources, the institutionalisation of scientific activity, access to research funds and cultural aspects. Capacity-building was not necessarily a component of some partnership agreements. With few exceptions, local researchers were merely participating in data collection and less on defining the problem. Opportunities for collaborative work included the possibility of participation in international research consortiums through calls for proposals. CONCLUSIONS: The Dominican government and research stakeholders can contribute to the international response to the Zika virus through active participation in international collaborative research partnerships; however, public recognition of the need to embrace health research as part of public policy efforts is warranted. A working group led by the government and formed by national and international research stakeholders will be key to identify ways in which the country could respond to the ethical demand of generating new knowledge in times of outbreaks.

Pursuing Justice in Haiti's Cholera Epidemic.

In 2010, the nation of Haiti was leveled by a shattering earthquake that killed thousands and devastated its already fragile infrastructure. During relief efforts to aid Haiti's suffering population, the United Nations sent troops to Haiti to assist the rebuilding of country's most basic services. But those troops unknowingly carried with them the bacteria that cause cholera, and through the UN's negligent actions, it triggered a horrifying cholera epidemic that continues to harm the Haitian people. Those injured by the cholera epidemic have sought relief in the US federal court system to obtain justice for those killed or sickened by the cholera outbreak. The UN has declared legal immunity for causing the epidemic, yet the litigation on this matter is ongoing.

A pandemia de Influenza no Rio Grande do Sul: estamos preparados para enfrentar uma segunda onda? / Pandemic Influenza in Rio Grande do Sul: we are prepared to face a second wave?

Devido à relevância do tópico na atualidade, dois artigos nesse número da Revista abordam a epidemia de influenza - “Bioética e Pandemia de Influenza” (3) e “Pandemia de Influenza A (H1N1): o que aprender com ela?” (4). Goldim, revisando aspectos bioéticos, afirma que em uma situação de pandemia, todos são co-responsáveis, não havendo possibilidade de se manter neutro. Dentro desse espírito, este editorial foi delegado a um cardiologista e a um geriatra que procuraram se “engajar no mesmo esforço solidário”, sem representar qualquer entidade, mas como cidadãos brasileiros